Biotech Newswire (full text)

RedHill has initiated commercial activities in the U.S. with its gastrointestinal-focused sales force, promoting two gastrointestinal specialty products, Donnatal® and EnteraGam®

Tel-Aviv, Israel, Raleigh, NC, USA, June 13, 2017 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the initiation of the promotion of two gastrointestinal specialty products, Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)(1) and EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI)(2) in the U.S.

RedHill’s U.S. commercial operations, headquartered in Raleigh, NC, include a gastrointestinal-focused sales force of more than 30 sales representatives promoting Donnatal® and EnteraGam® in select U.S. territories.

Guy Goldberg, RedHill’s Chief Business Officer, said: “We are excited to initiate promotion of Donnatal® and EnteraGam® in the U.S. This strategic step marks the transition of RedHill into a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company in the U.S. RedHill has assembled an experienced sales force and an accomplished commercial home office team with a proven track-record in the GI field. We are eager to serve the needs of patients and target the greater market potential of Donnatal® and EnteraGam®. Our U.S. commercial operations are an integral part of RedHill’s strategic plan to commercialize our proprietary late-stage GI products, BEKINDA® (RHB-102)(3) for gastroenteritis and IBS-D, RHB-105 for H. pylori infection and RHB-104 for Crohn’s disease in the U.S., if approved by the FDA.”

Donnatal® is a prescription oral drug used with other drugs for the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel). RedHill has an exclusive co-promotion agreement with Concordia Pharmaceuticals Inc., a subsidiary of Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) (“Concordia”), granting RedHill certain U.S. promotion rights for Donnatal®. Under the terms of the agreement, RedHill and Concordia will share the revenues generated from the promotion of Donnatal® by RedHill, based on an agreed upon split.

EnteraGam® is a medical food intended for the dietary management of chronic diarrhea and loose stools which must be administered under medical supervision. RedHill has a license agreement with Entera Health Inc. (“Entera Health”), granting RedHill the exclusive U.S. rights to EnteraGam®. Under the terms of the agreement, RedHill will pay Entera Health royalties based on net sales generated from the sale of EnteraGam® by RedHill.

About Donnatal®
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast-acting liquid.

Important Safety Information about Donnatal®
Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe.

Further information, including prescribing information, can be found on www.donnatal.com.

Please see the following website for complete important safety information about Donnatal®:
http://www.donnatal.com/professionals/important-safety-information/

To report suspected adverse reactions, contact Concordia Pharmaceuticals Inc. at
1-877-370-1142 or email: medicalinformation@concordiarx.com, or the FDA at
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

About EnteraGam®
EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision. EnteraGam® binds microbial components(4), such as toxic substances released by bacteria, that upset the intestinal environment. This helps prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea and loose stools in people who have specific intestinal disorders(5).

Safety Information about EnteraGam®
EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.

EnteraGam® does not contain any milk-derived ingredients such as lactose, casein or whey. EnteraGam® is gluten-free, dye-free and soy-free.

Please see full Product Information.

To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) RHB-105- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

Contacts

Company contact
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

(1) Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
(2) EnteraGam® (a serum-derived bovine immunoglobulin/protein isolate, SBI) is a commercially-available medical food, intended for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, which must be administered under medical supervision.
(3) BEKINDA® is an investigational new drug, not available for commercial distribution.
(4) Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine immunoglobulin/protein isolate binds to pathogen-associated molecular patterns. Poster presented at: Federation of American Societies for Experimental Biology; April 26-30, 2014; San Diego, CA.
(5) Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine immunoglobulin/protein isolate: postulated mechanism of action for management of enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights into the pathophysiology of IBS: intestinal microflora, gas production and gut motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.

The positive Phase III top-line results indicate that the study successfully met its primary endpoint and BEKINDA® 24 mg was shown to be effective, safe and well tolerated in patients with acute gastroenteritis and gastritis
RedHill will host a conference call and webcast to discuss the top-line results from the BEKINDA® Phase III study on Wednesday, June 21, 2017, at 8:00 am EDT; Please visit the Company’s website for dial-in information and webcast access: http://ir.redhillbio.com/events.cfm

Tel-Aviv, Israel, Raleigh, NC, USA, June 14, 2017 / B3C newswire / --RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced positive top-line results from the Phase III GUARD study with BEKINDA® (RHB-102)(1) 24 mg for acute gastroenteritis and gastritis. The study successfully met its primary endpoint of efficacy in treatment of acute gastroenteritis. BEKINDA® was found to be safe and well tolerated in this indication.

The randomized, double-blind, placebo-controlled Phase III GUARD study evaluated the efficacy and safety of BEKINDA® 24 mg in treating acute gastroenteritis and gastritis. 321 adults and children over the age of 12 were enrolled at 21 clinical sites in the U.S. and randomized in a 60:40 ratio to receive either BEKINDA® 24 mg or placebo, respectively. The primary endpoint of the study was the proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose of the study drug until 24 hours post dose, compared to placebo.

Top-line results indicated that the Phase III GUARD study successfully met its primary endpoint in the Intent to Treat (ITT) population (p = 0.04), despite high positive outcome rate in the placebo arm. BEKINDA® improved the efficacy outcome by 21%; 65.6% of BEKINDA® treated patients as compared to 54.3% of placebo patients (p = 0.04; n=192 in the BEKINDA® group and n=129 in the placebo group). Correcting for a randomization error, the difference in effect is greater with 65.8% vs. 53.9% favoring BEKINDA® vs. placebo in reaching the primary endpoint of the study (p = 0.03). In per-protocol (PP) analysis of patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed (n=177 in the BEKINDA® group and n=122 in the placebo group), BEKINDA® improved the efficacy outcome by 27%; 69.5% of patients in the BEKINDA® group vs. 54.9% in the placebo group (p = 0.01). BEKINDA® 24 mg was also shown to be safe and well-tolerated. Importantly, electrocardiogram results showed no adverse changes with treatment.

Robert A. Silverman, MD, MS, Emergency Medicine specialist at Northwell Health and Lead Investigator of the BEKINDA® Phase III GUARD study, said: "The positive results of the Phase III GUARD study demonstrate that BEKINDA® 24 mg is beneficial in the treatment of acute gastroenteritis and gastritis and can provide patients with 24 hours of relief. Gastroenteritis is a very common illness in the U.S., with approximately 179 million cases annually. If approved by FDA, BEKINDA® may become the new standard of care helping us treat patients quickly and effectively in both the emergency and outpatient settings.”

Terry F. Plasse, MD, RedHill’s Medical Director, added: “We are excited about the positive outcome of the Phase III GUARD study, which met its efficacy primary endpoint and demonstrated the safety and tolerability of BEKINDA® 24 mg. Notably, when looking at results by initial severity of nausea, we see a treatment effect even in patients with very severe nausea at baseline, suggesting that the drug works regardless of the initial severity of gastroenteritis. We continue to analyze the data, with the final clinical study report expected in the third quarter of 2017. We look forward to presenting the data to the FDA and discussing the potential path for marketing approval of BEKINDA® 24 mg in the U.S. and whether additional clinical studies are required prior to NDA filing. We are also expecting top-line Phase II results from the clinical study of BEKINDA® 12 mg in diarrhea-predominant irritable bowel syndrome (IBS-D) in September 2017. I would like to thank the patients, investigators, clinical staff and service providers who participated in the GUARD study and commend the RedHill team for achieving this important milestone.”

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. BEKINDA® 24 mg is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the FDA, BEKINDA® 24 mg could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis.

RedHill will continue to analyze the GUARD Phase III study top-line data, including secondary endpoints, and plans to meet with the FDA to present the data and discuss the clinical and regulatory path towards potential marketing approval of BEKINDA® 24 mg in the U.S. Additional clinical studies may be required prior to potential submission of a New Drug Application (NDA).

The top-line results from the GUARD Phase III study were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report (CSR), expected in the third quarter of 2017.

Acute gastroenteritis and gastritis are inflammations of the mucus membranes of the gastrointestinal tract leading to a combination of symptoms which include nausea, vomiting, diarrhea or abdominal pain. Acute gastroenteritis is a common infectious disease, with approximately 179 million cases annually in the U.S.(2) It is caused by many different infectious agents, most commonly by viral infections, accounting for up to 70% of cases(3). Noroviruses cause the most outbreaks of non-bacterial acute gastroenteritis in all age groups and often occur in epidemic outbreaks in schools, nursing homes and other group settings(3). Gastroenteritis and gastritis are major causes of emergency room visits, with up to 474,000 estimated hospitalizations annually in the U.S. alone(2). Oral rehydration is the preferred therapy in mild to moderate dehydration, whereas intravenous fluids are recommended in more severe cases(4). Adding ondansetron, the active ingredient in BEKINDA®, to the standard intravenous rehydration therapy has shown to significantly reduce the amount of vomiting in children with gastroenteritis(5); however, to the best of RedHill’s knowledge, its efficacy in adult gastroenteritis patients has not been shown beneficial in a randomized clinical trial in the U.S.

Ondansetron is approved as an antiemetic in patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting and from postoperative nausea and vomiting(6). BEKINDA® may decrease the frequency of vomiting, improve the success and compliance of oral rehydration therapy and decrease the rate of intravenous therapy in patients suffering from gastroenteritis. BEKINDA® is targeting a potential worldwide market estimated to exceed $650 million annually(3). For additional information on acute gastroenteritis and BEKINDA®, please see presentation and webcast from the R&D Day held by RedHill on April 27, 2017: http://ir.redhillbio.com/events.cfm.

RedHill will host a conference call and webcast call on Wednesday June 21, 2017 at 8:00 a.m. EDT, to review the Phase III GUARD study top-line results. Please visit the Company’s website for dial-in information and webcast access: http://ir.redhillbio.com/events.cfm

BEKINDA® is being studied for an additional indication. A randomized, double-blind, placebo-controlled Phase II study with BEKINDA® 12 mg is currently ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Enrollment of patients for the Phase II study has been completed, with top-line results expected in September 2017.

The Phase II study and the Phase III GUARD study with BEKINDA® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

The top-line results from the Company’s GUARD study are preliminary in nature, as they are based solely on top-line information provided to the Company by an independent third-party contractor. The Company intends to examine the data from this study in greater detail, along with all the information gathered during this study, including all safety and other secondary objectives. Such analysis may result in findings inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the top-line results reported in this release as the final definitive results of the GUARD study. Once the Company has fully analyzed the results of the GUARD study, including the CSR, it will announce the definitive findings.

About BEKINDA® (RHB-102)
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. Successful top-line results from a Phase III clinical study of BEKINDA® 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study) were announced in June 2017. A Phase II study with BEKINDA® 12 mg is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with patient enrollment completed and top-line results expected in the third quarter of 2017.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) RHB-105- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

Contacts

Company contact
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

(1) BEKINDA® is an investigational new drug, not available for commercial distribution.
(2) Scallan E, Griffin PM, Angulo FJ, Tauxe RV, Hoekstra RM, Foodborne Illness Acquired in the United States - Unspecified Agents, Emerg Infect Dis. 2011;17(1):16-22.
(3) Graves S. Nancy, Acute Gastroenteritis, Prim Care Clin Office Pract 40 (2013) 727–741.
(4) Reeves JJ, Shannon MW, Fleisher GR, Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial, Pediatrics. 2002;109(4):e62.
(5) Elliott, Elizabeth Jane, Acute Gastroenteritis in Children, BMJ, 334.7583 (2007): 35–40. PMC. Web. 8 Feb. 2017.
(6) Ondansetron prescribing information.

Berlin, Germany, June 15, 2017 / B3C newswire / -- ProBioGen AG and TissUse GmbH have signed a license and cooperation agreement to integrate ProBioGen’s Human Artificial Lymph Node Model into the Multi-Organ-Chip technology of TissUse. With the Lymph Node Model direct effects of substances on the human immune system can be monitored. The Multi-Organ-Chip technology emulates multiple interacting human organs on a device, not larger than a microscope slide, to imitate the complex processes in the human organism over periods of up to two months. This technology is envisioned to explore how the human organism reacts to new medicines, cosmetic substances or chemicals without expensive animal testing. TissUse now licenses the patented Lymph Node Technology Platform (HuALN) from ProBioGen and thereby expands the range of applications of Multi-Organ-Chip technology to predictions of immune reactivity in interaction with other organs.

“The combination of ProBioGen’s unique HuALN model and our human Multi-Organ-Chip technology will in future initially allow for the analysis of immunological reactions of human organs on active substances. Disease mechanisms in systemic autoimmunological diseases, allergies and anti-tumoral reactions will be elucidated with such Multi-Organ-Chip systems,” explains Dr Uwe Marx, CEO of TissUse.

“This partnership will bring together two highly motivated teams with a wide scope of experience and comprehensive know-how. We look forward to a fruitful collaboration increasing the scope of applications for our artificial lymph node system to allow its use for even broader pharmaceutical applications,” says Dr Wieland Wolf, chairman of ProBioGen.

About TissUse GmbH
TissUse is a vibrant Berlin, Germany-based, growth company which has developed a unique “Multi-Organ-Chip” platform that – for the first time ever – provides preclinical insight on a systemic level using human tissue. This enabling technology platform consists of a miniaturized construct that closely simulates the activity of multiple human organs in their true physiological context. TissUse’s Multi-Organ-Chips provide a completely new approach to predict, for example, toxicity, ADME profiles and efficacy in vitro, reducing and replacing laboratory animal testing and streamlining human clinical trials.
TissUse is additionally applying its platform and know-how to develop spin-off programmes in a variety of tissue and organ repair areas, starting with the cosmetic market of hair transplants.

About ProBioGen AG
ProBioGen is a specialist in the development and manufacturing of complex therapeutic glycoproteins. Combining state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimised properties.

Rapid and integrated cell line and process development, comprehensive analytical development and reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA).

ProBioGen has been operational for more than 20 years and is based in Berlin, Germany.

About the Human Artificial Lymph Node (HuALN) Model
The proprietary and unique Human Artificial Lymph Node Model (HuALN) was developed by ProBioGen as superior 3D micro-organoid model for analysing substance effects on the human immune system in vitro. It is based on a patented, miniaturised and perfused bioreactor for the long-term cultivation of immune cells. Human blood-derived dendritic cells, T and B lymphocytes and mesenchymal stem cell-derived stromal cells are inoculated into the bioreactor’s 3D hydrogel matrix, which is perfused with cell culture medium and aerated, just as in a real human lymph node. Upon antigen-stimulation, the cells self-organise into immune-competent micro-organoid structures within the 3D matrix. The perfused bioreactor is typically operated for four weeks and, thus, allows multiple and repeated exposure of the immune cells to the test compounds.

This innovative technology predicts drug-related effects – wanted or unwanted – on the human immune system. The HuALN Model allows the specific investigation of immunofunction, such as immunomodulation, immunogenicity and immunotoxicity, in vitro. A broad range of substance classes, from small molecules, proteins and peptides to nucleic acids, can be tested, covering biopharmaceuticals, vaccines and cosmetics.

The read-outs are on the T and B cell level, looking specifically at cytokine profiles, cell surface makers, cell proliferation, IgM and IgG secretion, anti-drug antibodies (ADA formation) and functional cell tests.

The HuALN technology is offered by ProBioGen as a service and can be licensed to third parties.

Contacts

TissUse GmbH
Dr Reyk Horland
Vice President Business Development
TissUse GmbH
Oudenarder Str. 16
13347 Berlin, Germany
+49 30 513 026 400
info@tissuse.com
www.tissuse.com

ProBioGen AG
Dr Gabriele Schneider
Vice President Business Development
Goethestr. 54
13086 Berlin, Germany
+49 30 924 006-0
cmo@probiogen.de
www.probiogen.de

Subject to a successful outcome and any additional regulatory feedback, the confirmatory Phase III study (ERADICATE Hp 2) is expected to complete the package required for a potential U.S. NDA for RHB-105, newly branded as TALICIA™
The two-arm, randomized, double-blind, active comparator, confirmatory Phase III study is planned to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection in up to 65 clinical sites in the U.S., with a primary endpoint of eradication of H. pylori infection at 42 through 70 days after initiation of treatment
The first Phase III study with TALICIA™ (RHB-105) (ERADICATE Hp) successfully demonstrated 89.4% efficacy in eradicating H. pylori infection (p<0.001), supporting the potential superior efficacy of TALICIA™ (RHB-105) over current standard-of-care (SoC) therapies
TALICIA™ (RHB-105) was granted QIDP designation by the FDA under the GAIN Act, including Fast-Track development, NDA Priority Review and extended U.S. market exclusivity, for a total of eight years
H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma and is estimated to affect over half of the adult population worldwide
The World Health Organization (WHO) recently published a global priority list of 12 life-threatening multidrug-resistant bacteria, in which H. pylori infection was classified in group 2 high-priority bacteria for which new treatments are urgently needed
The 2015 global and U.S. market potential for H. pylori eradication therapies at current branded prices, were estimated at approximately $4.83 billion and $1.45 billion, respectively

Tel-Aviv, Israel / Raleigh, NC, USA, June 15, 2017 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced the initiation of a confirmatory Phase III study with RHB-105, newly branded as TALICIA™(1), for the treatment of H. pylori infection (the ERADICATE Hp 2 study).

TALICIA™ (RHB-105) is a proprietary, fixed-dose, oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule for the eradication of H. pylori infection.

The two-arm, randomized, double-blind, active comparator confirmatory Phase III ERADICATE Hp 2 study will compare TALICIA™ (RHB-105) against a dual therapy amoxicillin and omeprazole regimen at equivalent doses. The study is planned to enroll 444 non-investigated dyspepsia patients with confirmed H. pylori infection in up to 65 clinical sites in the U.S. Subjects will be randomized in a 1:1 ratio to receive four capsules, three times daily, of either TALICIA™ (RHB-105) or the active comparator, for a period of 14 days. Subjects will be assessed for the study’s primary endpoint of eradication of H. pylori infection at 42 through 70 days after initiation of treatment.

Subject to its successful outcome and any additional regulatory feedback, the confirmatory Phase III study, along with the results from the successfully completed first Phase III study with TALICIA™ (RHB-105) (the ERADICATE Hp study) and data from the completed supportive PK program, are expected to support a potential U.S. New Drug Application (NDA) for TALICIA™ (RHB-105).

The first Phase III study with TALICIA™ (RHB-105) successfully met its protocol-defined mITT primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The study results demonstrated 89.4% efficacy in eradicating H. pylori infection with TALICIA™ (RHB-105). Notably, the 89.4% efficacy in eradicating H. pylori infection with TALICIA™ (RHB-105) was also superior to subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study, which demonstrated 63% eradication rate in the mITT population (p=0.006), further supporting the potential efficacy of TALICIA™ (RHB-105) as a treatment for H. pylori infection. Treatment with TALICIA™ (RHB-105) appeared to be safe and well tolerated.

TALICIA™ (RHB-105) was granted Qualifying Infectious Disease Product (QIDP) designation by the U.S. Food and Drug Administration (FDA), providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, TALICIA™ (RHB-105) is entitled to receive, thanks to its QIDP status, an additional five years of U.S. market exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.

RedHill is pursuing with TALICIA™ (RHB-105) an indication of first-line treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically indicated only for patients with active or recent history of duodenal ulcer disease. If approved, TALICIA™ (RHB-105) may be the first H. pylori eradication therapy in the U.S. to target this broader indication, which would significantly expand the potential patient population for this drug candidate.

H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide(2). The growing resistance of the H. pylori bacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current SoC for H. pylori eradication, reaching an estimated 30%(3). Despite the strong unmet medical need, no new drug has been approved by the FDA for this indication in over a decade. The World Health Organization (WHO) recently published a global priority list of 12 life-threatening multidrug-resistant bacteria, in which H. pylori infection was classified as a high-priority bacteria for which new treatments are urgently needed(4).

The 2015 global and U.S. market potential for H. pylori eradication therapies at branded prices, were estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication(5).

The confirmatory Phase III ERADICATE Hp 2 study with TALICIA™ (RHB-105) will be registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About TALICIA™ (RHB-105)
RHB-105, newly branded as TALICIA™, is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pylori infection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. A first Phase III study with TALICIA™ (RHB-105) (the ERADICATE Hp study) was completed in the U.S. with positive results. The study demonstrated an overall success rate of 89.4% in eradicating H. pylori, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard-of-care efficacy levels of 70%, with high statistical significance (p<0.001). A confirmatory Phase III study (ERADICATE Hp 2 study) has been initiated in the U.S. Additional studies may be required, subject to FDA review. TALICIA™ (RHB-105) has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, TALICIA™ (RHB-105) will also receive an additional five years of exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) TALICIA™ (RHB-105)- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

Contacts

Company contact
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

(1) TALICIA™ is an investigational new drug, not available for commercial distribution.
(2) Hunt, R. H., et al. "Helicobacter pylori in developing countries." World Gastroenterology Organisation Global Guidelines (2010): 1-15.
(3) Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664.
(4) WHO report - Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics: http://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en/
(5) Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. Pylori Eradication Market, May 18, 2015.

Warsaw, Poland, June 21, 2017 / B3C newswire / -- OncoArendi Therapeutics SA announced that it has selected OATD‑02 as its clinical development candidate for cancer immunotherapy. Submission of the Company's second Investigational New Drug ("IND") application is expected by the third quarter of 2018.

OATD-02 is a highly potent and selective small molecule inhibitor of two arginase isoforms (Arg-1 and Arg-2) in both biochemical and cell-based-assays. OATD-02 is the second arginase inhibitor to enter development.

OATD-02 has been shown to be effective in vivo in three different mouse models of cancer (colorectal, lung and melanoma) and demonstrated superior antitumor efficacy in combinations with the PD-L1 checkpoint inhibitor and with gemcitabine; resulting in a controlled tumor growth, and, in some cases in a full regression.

Pilot studies also suggested a therapeutic potential of OATD-02 in glioblastoma multiforme (GBM), the most malignant brain tumor with no effective treatment.

“We believe that small molecule drugs preventing cancer cells from escaping from the immune surveillance have great potential in combination therapies and to be transformational medicines in the treatment of many types of cancer. The increasing number of clinical trials with multiple IDO inhibitors and various check-point inhibitor combinations additionally validate this approach. At OncoArendi, we are dedicated to research and development of the first-in-class or best-in-class small molecule-based therapies that in combination with other modalities, could significantly improve the treatment of unmet medical needs in many solid and hematopoietic cancers " said Marcin Szumowski, PhD, CEO of OncoArendi Therapeutics. "We are particularly excited about the potential of arginase as an additional new target in cancer immunotherapy and the potential of OATD-02 to become the best-in-class arginase inhibitor on the market. This compound demonstrated a potent extracellular and cellular activity while its pharmacological profile makes it suitable for oral dosing.”

Formal pre-clinical development of OATD-02 will be initiated next month with GLP toxicology studies expected in Q4 of this year and first in human studies anticipated in the third quarter of 2018. OncoArendi Therapeutics’ arginase inhibitors, including OATD-02, are protected by two pending patents covering two structurally different groups of compounds.

About Arginase Science
Arginase has been recently validated as a promising target in immuno-oncology. Arginase is an enzyme that catalyzes the final step in the urea cycle, during which the body disposes of harmful ammonia. However, in cancer, arginase through its capacity to decrease arginine levels, blocks the natural antitumor immunity by suppressing activation and proliferation of T cells. Even a moderate decrease of arginine levels is immunosuppressive. T-cells deprived of arginine do not die – they retain the ability to expand when arginine is replenished. Since the majority of human cancers exhibit a highly increased arginase activity and decreased plasma arginine levels, arginase inhibitors are expected to exhibit a wide clinical utility, in particular in combinations with other therapeutic modalities, such as checkpoints inhibitors and immunogenic therapies.
With a decade-long expertise in the type of chemistry required to synthesize and optimize arginase inhibitors, promising initial data and a strong development team, OncoArendi has laid out a clear strategy to bring to the clinic the best in class arginase inhibitor.

About OncoArendi Therapeutics
OncoArendi Therapeutics SA is an innovative biopharmaceutical company based in Poland, focused exclusively on discovery and development of small molecules to treat patients with unmet medical needs in cancer and respiratory diseases. It currently employs 70 people, the majority of whom hold PhD degrees in biology and chemistry and has raised over 35 million USD to support the progression of four distinct new chemical entities at various stages of development to Phase II clinical trials.

OncoArendi has been developing arginase inhibitors for the past three years and has selected OATD-02 out of the in-house library of over 200 compounds obtained through rational drug design. OncoArendi continues to develop inhibitors against other undisclosed targets in cancer metabolism.

OncoArendi also has broad interest and commitment to chitinase science with three distinct small molecule drug discovery programs directed against different chitinase family targets. Its first clinical candidate OATD-01 is positioned to enter first-in-human Phase I clinical trial this fall. Potential therapeutic applications for compounds resulting from this R&D Chitinase Platform include treatment of numerous diseases such as asthma, idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) and sarcoidosis, as well as fibrotic diseases of other organs and some types of cancer.

Contacts

Nicolas Beuzen
Business Development Director
n.beuzen@oncoarendi.com

Marcin Szumowski
President & CEO
m.szumowski@oncoarendi.com

OncoArendi Therapeutics S.A.
Zwirki i Wigury 101
02-089 Warsaw
Poland

New modular membrane chromatography solution for large-scale applications

Goettingen, Germany and Aubagne, France, June 23, 2017 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has expanded its range of single-use membrane chromatography solutions with Sartobind® Cassettes. This convenient, pod-like modular system has been developed for commercial applications in both capture and polishing.

New Sartobind® cassettes offer the same flow path, bed heights (4 and 8 mm) and void volume ratios as Sartobind® capsules, and are compatible with Q, S, STIC PA and phenyl ligands. The new design goes beyond the previous 5 L size limitation for capsule formats, expanding the boundaries of membrane chromatography. Multiple cassettes, each with 0.8 L or 1.6 L membrane volume, can be set up in three different stainless steel holders resulting in maximum membrane volumes of 20, 50 or 100 L, respectively. Data demonstrates direct scalability from the 3 mL Sartobind® nano capsule to 20.8 L (13 cassettes) in the Pilot Filter Holder. Pressure-flow performance and the shape of breakthrough curves are identical to the smaller capsule sizes, independent of the number of cassettes used. Set up can be accomplished within minutes, even at manufacturing scale, whether for capture applications or for flow-through removal of process contaminants.

The capture of large proteins such as viruses and virus-like particles (VLPs), protein conjugates and blood factors plays a key role in modern bioprocessing. The unique Sartobind® cassette system now enables large-scale bind-and-elute membrane chromatography for such targets.

“For the first time, the high binding capacity of membrane adsorbers can be used at almost any scale in commercial vaccine manufacture. Now, a 200 L Q anion exchange column for adenovirus capture can be easily replaced by a 20 L Q adsorber cassette system”, says Dr. Stefan Fischer-Frühholz, membrane chromatography expert at Sartorius Stedim Biotech.

For more information about Sartobind® membrane adsorbers click here: www.sartorius.com/sartorius/en/EUR/filtration-and-purification/membrane-chromatography

Image Files

Caption: New Sartobind® cassettes go beyond the previous size limits of membrane adsorbers and can be directly scaled from a 3 mL capsule (Nano) up to 20.8 L.
For high resolution please click the image.

Caption: The newly developed Sartobind® cassette system is a unique single-use solution enabling large-scale bind and elute membrane chromatography.
For high resolution please click the image.

Links for downloading
Sartobind® Cassette membrane adsorbers:
https://www.sartorius.com/mediafile/global/company/sartobind_cassettes_1.jpg
https://www.sartorius.com/mediafile/global/company/sartobind_cassettes_2.jpg

A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. In 2016, the company employed approx. 4,700 people, and earned sales revenue of 1.051,6 million euros.

Contact

Dominic Grone
Senior Manager Corporate Communications
Sartorius Corporate Administration GmbH
+49.(0)551.308.3324
dominic.grone@sartorius.com
www.sartorius-stedim.com

Advanced software solution ensures superior manufacturing quality and enables effective decision-making

Goettingen, Germany, Malmö, Sweden, June 26, 2017 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier to the biopharmaceutical industry, has launched the Active Dashboard 2, an advanced software solution. Offered by its subsidiary, Sartorius Stedim Data Analytics, formerly known as Umetrics, the release features significant improvements for applications in biopharmaceutical, pharmaceutical, and other manufacturing industries. Delivering in-depth insights into process performance across the manufacturing network, managerial staff can take evidence-based proactive actions that will help to achieve better timely decisions, ensuring superior manufacturing success.

Active Dashboard 2 provides real-time process information from multivariate SIMCA®-online data analysis systems — part of the Umetrics™ Suite of Data Analytics Solutions. The Active Dashboard 2 software now offers innovative data visualization options, such as easy self-service visual analytics with cross-filtering to reduce the involvement of data analysis experts; role-based display of relevant information; and the ability to connect to other data sources.
In addition, management and other authorized employees can now visualize process information on any laptop, tablet or smartphone with a web browser.

“The improvements in Active Dashboard 2 will help our customers to enhance their competitive advantage — both globally and locally. With in-depth insights into data of their manufacturing processes, they can significantly improve the decision-making process,” stated Jonas Elfving, Product Manager at Sartorius Stedim Data Analytics.

Sartorius Stedim Data Analytics is a leading provider of data analytics with multiple applications in high-tech industries worldwide. Its product and service portfolio enables customers to maximize the value of their data during the entire product lifecycle, facilitating better decision-making and process excellence. To learn how Sartorius Stedim Data Analytics can help you grow your business, please visit http://umetrics.com and follow its LinkedIn page.

Image Files

Caption: Active Dashboard 2 provides real-time process information from multivariate SIMCA®-online data analysis systems
For high resolution please click the image.

Caption: Active Dashboard 2 enables innovative data visualization for applications in biopharmaceutical, pharmaceutical and other manufacturing industries
For high resolution please click the image.

Download-Links
www.sartorius.com/mediafile/global/company/active_dashboard_1.png
www.sartorius.com/mediafile/global/company/active_dashboard_2.jpg

Contacts

Dominic Grone
Senior Manager Corporate Communications
Sartorius Corporate Administration GmbH
+49.(0)551.308.3324
dominic.grone@sartorius.com

Marie Wensley
Marketing Manager
Sartorius Stedim Data Analytics
Phone: +46 40 664 25 94
marie.wensley@sartorius-stedim.com

Attracted by the strong performance of BioGeneration Ventures (BGV), new investors joined BGV III including the European Investment Fund, whose contribution comes from InnovFin Equity Facility and the Dutch Venture Initiative II
BioGeneration Ventures focuses on entrepreneurship and innovation in therapeutics, medical devices and diagnostics in Europe
BGV III already made 4 investments and expects to make 15 investments in total

Naarden, The Netherlands, June 27, 2017 / B3C newswire / -- BioGeneration Ventures (BGV), the early stage life sciences venture capital firm with funds focussed on European biotechnology companies, announces today an investment by the European Investment Fund (EIF) and other new investors in BGV III, taking the total capital commitments to EUR 66m, out of a maximum EUR 75m. The Fund is supported by the “InnovFin – EU Finance for Innovators” initiative under Horizon 2020 and the European Fund for Strategic Investments.

The new fund will build on the track record of the first two BGV funds which yielded major successes including Dezima Pharma and Acerta Pharma. BGV was founding investor in both companies which were sold within three years at multi-billion dollar valuations. At USD 7 billion Acerta was the largest private exit in Europe in the biotech sector to date. These companies are typical examples of the biotech sector’s ability to generate so-called “unicorns” delivering outsized returns for investors.

The firm’s third fund will focus on therapeutics, medical devices and diagnostics, within Europe, in particular in Benelux and Germany. Four investments have already been made from the fund into German immuno-oncology company Catalym, and Dutch companies Escalier Biosciences, Scenic Biotech and Varmx, working on autoimmune diseases, target discovery, and haematology respectively.

Edward van Wezel, Managing Partner said: “Our third fund makes BGV amongst the largest life sciences funds dedicated to seed investments in Europe. Over the last decade we have made over twenty investments in the European life sciences ecosystem. We’ve observed an ever-increasing interest from pharma in acquiring innovations earlier. With this third closing we are significantly exceeding our target fund size and are delighted with the commitment of EIF and other new and existing investors in BGV III. We expect to reach the maximum fund size of EUR 75m before the end of 2017.”

Pier Luigi Gilibert, Chief Executive of the European Investment Fund, said: “The EIF enhances SMEs access to finance. By investing in BGV’s new fund, the EIF is continuing its long-standing support for entrepreneurship and innovation in early stages of company development.”

BGV operates as a joint venture with Forbion Capital Partners, providing access to the later stage perspective on early innovation and a global network of experts and pharma companies. The BGV team has broad experience in investment, life sciences, business development, and commercial operations. The team includes experienced biotech entrepreneurs as venture partners and advisors.

About BioGeneration Ventures (BGV)
BioGeneration Ventures (BGV) is a specialist life sciences venture capital firm, with a focus on early stage European biotech, medtech, and diagnostics companies. BGV has a strong track record of significant financial returns through investing in innovations in healthcare and providing the expertise to build world-class teams. BGV manages funds investing in areas where the science, the unmet medical need, and the potential to promptly demonstrate a significant proof of concept all come together.

Successful investments include divestment of Dezima Pharma to Amgen for up to USD 1.55 billion in total deal value and in Acerta Pharma for up to USD 7 billion with a guaranteed payment of USD 4 billion. In both companies BGV was founding investor. The Acerta Pharma sale was the largest exit ever of a privately held European biotech company. Over the last decade BGV has made over 20 investments.

About EIF
The European Investment Fund (EIF) is part of the European Investment Bank Group. Its central mission is to support Europe's micro, small and medium-sized businesses (SMEs) by helping them to access finance. EIF designs and develops venture and growth capital, guarantees and microfinance instruments which specifically target this market segment. In this role, EIF fosters EU objectives in support of innovation, research and development, entrepreneurship, growth, and employment.

About the Investment Plan for Europe
The Investment Plan focuses on strengthening European investments to create jobs and growth. It does so by making smarter use of new and existing financial resources, removing obstacles to investment, providing visibility and technical assistance to investment projects. The Investment Plan is already showing results. The projects and agreements approved for financing under the European Fund for Strategic Investments – the financing arm of the plan – so far are expected to mobilise over EUR 168 billion in total investments across 28 Member States and to support more than 387 000 SMEs.

On 14 September 2016, the European Commission proposed extending EFSI by increasing its firepower and duration as well as reinforcing its strengths. Find the latest EFSI figures by sector and by country here.

About InnovFin Equity
InnovFin Equity is part of InnovFin – EU Finance for Innovators, the new generation of EU financial instruments and advisory services developed under Horizon 2020, the EU's research and innovation programme, to help innovative firms access finance more easily.

InnovFin Equity consists of several predominantly early stage equity products. The products aim at improving access to risk finance by early-stage RDI-driven SMEs and small midcaps through supporting mainly early-stage risk capital funds that invest, on a predominantly cross-border basis, in individual enterprises. SMEs (and small midcaps) located in Member States or in Horizon 2020 Associated Countries are eligible as final beneficiaries. The aggregate investments to venture capital funds made out of InnovFin SME Venture Capital are expected to support between EUR 1.6 to EUR 2 billion of equity financing to final beneficiaries.

About DVI II
Publicly launched in March 2016, DVI-II is a EUR 200m Venture and Growth Capital Fund-of-funds initiative of the EIF and PPM Oost, supported by the Dutch Ministry of Economic Affairs.

DVI-II intends to build a balanced portfolio of 15 to 20 venture and growth capital funds that are able to demonstrate a strong investment focus on the Netherlands. DVI-II supported Fund Managers need to focus on companies in their early or development stages. Eligible funds should also have a strong innovative angle, by focusing on companies operating in different technology areas, such as ICT, Life Sciences, Cleantech or Energy.

As an advisor to DVI-II, the EIF can rely on over 20 years of experience in the European Venture Capital market and successful implementation of similar initiatives in close collaboration with national and regional partners across Europe.

Contacts

BioGeneration Ventures
Edward van Wezel
info@biogeneration.vc
+31 35 69 930 00

LifeSpring Life Sciences Communication (for Dutch media)
Leon Melens
lmelens@lifespring.nl
+31 6 538 16 427

Instinctif Partners (For other European media)
Dr Christelle Kerouedan / Daniel Gooch
BGV@instinctif.com
+44 20 7457 2020

Award entails publication in Science magazine and prize money of U.S. $25,000
Exceptional scientists are invited to apply

Goettingen, Germany, June 27, 2017 / B3C newswire / -- Sartorius, a leading international pharmaceutical and laboratory equipment provider, together with the renowned Science magazine will award a Sartorius & Science Prize for Regenerative Medicine & Cell Therapy. This prestigious annual award is geared towards exceptional scientists who focus on achieving advancements in basic or translational research in these areas. All scientists who have earned a Ph.D. or an M.D. within the past ten years may submit an essay on regenerative medicine, cell therapy, gene therapy or immunotherapy, as well as on materials or tissue engineering.

The winner of the Sartorius & Science Prize for Regenerative Medicine & Cell Therapy will be awarded U.S. $25,000 and have his or her essay printed in Science magazine. In addition, the winner will receive an attractive Sartorius product package gratis. Moreover, the grand prize essay and those of up to three runners-up will be published in Science Online. Runners-up will receive prize money of U.S. $5,000.

Regenerative medicine and cell therapy address stimulation of the body’s repair mechanisms. Furthermore, these therapeutic approaches can lead to technologies allowing tissue and transplantable organs to be grown in the lab. “This area will play a major role in the future. Sartorius’ innovative bioanalytical tools help scientists answer fundamental and complex biological questions. We are excited to enable medical progress in these fields, both with our technologies and this award. The prize will be conferred as a token of appreciation to scientists,” said Gerry MacKay, member of the Sartorius Group Executive Committee and Executive Vice President of Marketing, Sales and Services for Sartorius’ Lab Products & Services Division.

Founded by Thomas Edison, Science is published by the American Association for the Advancement of Science (AAAS), the world's largest general scientific society. “Science is delighted to join Sartorius in awarding a prize in the exciting area of regenerative medicine and cell therapy. We look forward to promoting basic or translational research in fields ranging from gene therapy to materials engineering, which has the potential to improve human health,” said Valda J. Vinson, Deputy Editor Research of Science.

Applicants need to submit a 1,000-word essay describing their research and implications for regenerative medicine and cell immunotherapy, as well as supporting documents. The application deadline is October 1, 2017. The awards ceremony will be held in 2018 in Goettingen, Germany.

For more information about the Sartorius & Science Prize for Regenerative Medicine & Cell Therapy, visit https://www.passionforscience.com/win-it

Image files

Caption: Logo of the Sartorius & Science Prize for Regenerative Medicine & Cell
For high resolution please click the image.

A Profile of Sartorius
The Sartorius Group is a leading international pharmaceutical and laboratory equipment provider with two divisions: Bioprocess Solutions and Lab Products & Services. Bioprocess Solutions with its broad product portfolio focusing on single-use solutions helps customers produce biotech medications and vaccines safely and efficiently. Lab Products & Services, with its premium laboratory instruments, consumables and services, concentrates on serving the needs of laboratories performing research and quality assurance at pharma and biopharma companies and on those of academic research institutes. Founded in 1870, the company earned sales revenue of more than 1.3 billion euros in 2016. Over 6,900 people work at the Group's 50 manufacturing and sales sites, serving customers around the globe.

Contact

Timo Lindemann
Sartorius
Senior Manager Corporate Communications
+49 (0)551.308.4724
timo.lindemann@sartorius.com

Singapore, June 28, 2017 / B3C newswire / -- MerLion Pharmaceuticals (“MerLion”) today announced that a joint project with the Defence Science and Technology Laboratory, UK (Dstl) titled “‘Efficacy of Finafloxacin against Biological Threat Agents” has been awarded a grant from the United States’ Defense Threat Reduction Agency (DTRA) Chemical and Biological Defense Program.

The multi-year, multi-phase project will study the impact of MerLion’s novel fluoroquinolone finafloxacin for the treatment of infections caused by the biological threat agent Burkholderia pseudomallei (B. pseudomallei). In addition, the broad spectrum efficacy of finafloxacin against other intracellular bio-threat agents such as Francisella tularensis (F. tularensis) and Yersinia pestis (Y. pestis), and other multi-drug resistant (MDR) pathogens of clinical significance will be investigated in further detail.

During the initial period of the project MerLion and Dstl will work towards gaining U.S. Food and Drug Administration (FDA) agreement about the next steps for the development of finafloxacin as an approved antibiotic.

This project will build on data generated both in vitro and in vivo in an existing long-standing collaboration between Dstl and MerLion which has shown that, in addition to activity against MDR pathogens, finafloxacin has significant potential for the treatment of bio-threat agents. Finafloxacin has already demonstrated strong and rapid-onset activity against B. pseudomallei, F. tularensis and other intracellular bio-threat pathogens.

Finafloxacin acts powerfully against two bacterial molecular targets and its rapid bactericidal effect is further enhanced by its activity in the acidic environment found at most sites of bacterial infection.

In addition, finafloxacin has been shown to be a poor substrate of the major multidrug efflux transporters which affect other fluoroquinolones and is thus able to maintain its efficacy against fluoroquinolone-resistant B. pseudomallei where resistance caused by efflux pumps is predominant.

MerLion has previously reported positive results for finafloxacin from a Phase 2 study in patients hospitalized with complicated urinary tract infections (cUTI) and pyelonephritis which showed that a five day course, starting with IV and switching to oral dosing, was more effective that treatment with the current standard of care (ciprofloxacin).

“We already have compelling pre-clinical results generated in the collaboration with our partners from Dstl for finafloxacin’s activity against various bio-threat pathogens, as well as data from our positive clinical studies treating patients with cUTI infections”, said David Dally, CEO of MerLion.

He added that “The new project will enable us to investigate the activity of finafloxacin against a variety of very difficult-to-treat pathogens in more detail and will help to position finafloxacin as an effective therapy against multiple bioterrorism threats, as well as a treatment for other life-threatening infections.”

About MerLion Pharmaceuticals
MerLion Pharmaceuticals Pte Ltd is a biopharmaceutical company, headquartered in Singapore with R&D operations in Berlin, Germany which is focused on the advanced clinical development of its antibacterial lead program, finafloxacin. MerLion is a privately held company supported by a group of leading global investors including Aravis Venture Partners, Singapore based EDBI, Heidelberg Capital and Nomura Research & Advisory.

About Dstl
The Defence Science and Technology Laboratory (Dstl) is an executive agency of UK’s Ministry of Defence and is one of the principal government organisations dedicated to science and technology in the defence and security field. Dstl ensures that innovative science and technology contribute to the defence and security of the UK.

About DTRA
DTRA is the US Government Agency responsible for combating weapons of mass destruction. DTRA develops and delivers cutting-edge technologies to assist with these endeavours.

About Finafloxacin
Finafloxacin is a novel fluoroquinolone antibiotic with many “best in class” features. In clinical and pre-clinical settings the compound has shown a substantially improved therapeutic profile as compared to the existing gold standard and a broad utility in treating many severe infections, including those caused by resistant Gram-negative pathogens.

Finafloxacin’s superior profile arises from the compound’s unique mode of action, being equally active at physiological pH conditions and in the acidic environments which occur at the most sites of bacterial infections. Most other antibiotics, including other fluoroquinolones, show decreased activity under acidic tissue conditions, which result in significantly reducing their overall efficacy.

Results from a double-blind controlled clinical Phase 2 trial revealed a higher, more rapid and sustained level of microbiological eradication and improved clinical outcomes for patients treated with finafloxacin compared to those treated with ciprofloxacin. The trial’s primary and secondary endpointswere all successfully achieved. Finafloxacin was found to be both safe and well tolerated.

MerLion has developed IV and oral formulations of finafloxacin with equivalent bioavailability, offering physicians various options for in-hospital and out-patient treatment regimens.

MerLion has licensed Finafloxacin to a major pharmaceutical partner for use in North America for ear infections. In 2014 Xtoro™, an otic suspension of finafloxacin, was approved by the FDA for treatment of acute otitis externa, commonly known as “swimmer’s ear”, caused by Pseudomonas aeruginosa and Staphylococcus aureus.

About Burkholderia pseudomallei
Burkholderia pseudomallei is a Gram-negative, bipolar, aerobic, motile rod-shaped, soil-dwelling bacterium, endemic in tropical and subtropical regions worldwide. It infects humans and animals and causes the disease melioidosis.

Contacts

MerLion
David Dally, CEO
Tel: +65 6778 5700
enquiry@merlionpharma.com

Instinctif Partners (media relations)
Sue Charles / Gemma Harris
+44 20 7866 7860
merlion@instinctif.com

Uppsala, Sweden, June 29, 2017 / B3C newswire / -- Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce the launch of three new TurboVap® evaporation systems - second generation systems, which build upon the solid foundations of the historic TurboVap® product line.

The new TurboVap® LV, II and EH systems incorporate many new customer driven features and enable end users to switch quickly between the functionality they are presently accustomed to in the classic instruments. Each system has enhanced visibility, a compact design, removable/adjustable nozzles, exchangeable manifolds, evaporation flow gradients, and a touch screen interface.

The TurboVap® EH system is seamlessly integrated with the Biotage® Extrahera™ and is aesthetically very similar, with similar internal lighting, glass sides and a glass lid, greatly improving sample visibility. In parallel, Biotage are introducing a series of Multi-Racks that offer greater flexibility in the variety of different tube and vial sizes that can be processed. Each system of course still has the highly efficient patented gas vortex shearing technology, which is synonymous with the TurboVap® brand.

“Our new TurboVap® enhanced evaporation systems, are built on the reliability and performance associated with the TurboVap name. The new systems will increase laboratory efficiency, improve the cost of analysis and enable improved user control of the evaporation process” said Mr. Paul Roberts, Global Product Manager, Analytical Consumables and Systems, Biotage.

For further information visit www.biotage.com or call: in Europe +46 18 56 57 10, in North America toll free 1 800 446 4752, in Japan +81 3 5627 3123, other areas please call +46 18 56 57 10.

About Biotage
Biotage offers solutions, knowledge and experience in the areas of analytical and medicinal chemistry. Customers include the world’s top pharmaceutical and biotechnology companies, as well as leading academic institutes. The company is headquartered in Uppsala, Sweden, with offices in South Korea, China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage approximately 300 employees, with sales of 667 MSEK in 2016. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange.

Contact

James Churchill
Marketing Communications
Biotage GB Ltd.
Distribution Way
Dyffryn Business Park
Ystrad Mynach
Hengoed, Wales
CF82 7TS United Kingdom
Tel: +44 (0)1443 811 849
Mobile: +44(0)7875484778
james.churchill@biotage.com

Findings that midkine plays an essential role in the metastatic spread of malignant melanomas were published in the prestigious journal NATURE
Cellmid holds the most significant global IP portfolio around midkine globally
This high quality independent study provides strong validation of Cellmid’s cancer therapeutic and diagnostic programs targeting midkine

Sydney, Australia, July 05, 2017 / B3C newswire / --Cellmid Limited (ASX: CDY) is pleased to advise that the highest ranked paper Nature has published the results of a significant study showing for the first time that midkine, around which the Company holds extensive intellectual property rights, is a crucial agent in the promotion of melanoma metastasis.

The paper, entitled “Whole-body imaging of lymphovascular niches identifies pre-metastatic roles of midkine”, by Professor Marisol Soengas and her group based in CNIO in Madrid, describes how midkine drives the often-fatal metastatic spread of melanoma cells from the primary tumour in the skin to distant organs such as liver, lung, bone and brain. This independent study published in Nature is highly significant for Cellmid for four key reasons:

It provides strong validation for Cellmid’s cancer therapeutic and diagnostic programs, which use the Company’s proprietary midkine antibodies;
It adds to the considerable data on the prognostic value of detecting midkine in different cancer types, where elevated midkine levels in various tissues correspond with poor therapeutic outcomes;
It significantly increases visibility and credibility of Cellmid’s cancer therapeutic programs targeting midkine; and
As the holder of the most significant intellectual property and antibody assets around midkine globally the publication places the Company in a unique position for partnerships.

The Company’s antibodies against midkine have already shown considerable promise in reducing tumour growth and restricting new blood supply to different solid tumours (some of these results have been released in the ASX announcements on 3 October 2013 and 5 October 2016). Together with these new discoveries around metastasis, inhibiting midkine for better treatment of melanoma becomes a compelling drug development program for Cellmid.

While most conventional anti-cancer treatments aim to kill rapidly dividing tumour cells, the ability to stop the spread of metastatic tumour cells would be of immense benefit for many advanced cancer patients with diverse tumour types.

It is widely accepted that lymphatic vessels are often the escape route for cancer cells to spread initially to nearby lymph nodes, followed by metastasis to more distant vital organs. The sprouting of new lymphatic vessels from the tumour into surrounding lymph nodes was thought to facilitate this step-wise metastatic spread via a process called lymphangiogenesis.

However, the group at CNIO in Madrid used a sophisticated mouse model to demonstrate that the primary tumour induces aberrant lymphangiogenesis in lymph nodes and organs located at considerable distances from the tumour, creating a pre-metastatic niche for tumour cells to lodge in. Importantly, midkine release from the tumour was found to stimulate distant lymphangiogenesis, creating a route for cancer cells to colonize sites throughout the body independent of local spread into lymph nodes adjacent to the primary tumour.

Midkine also enhanced the ability of tumour cells to adhere to lymphatic vessels. Therefore, midkine not only promotes lymphangiogenesis, but also tumour cell colonization in newly formed lymphatic vessels. These actions of midkine extend Cellmid’s current knowledge about midkine’s role in tumours as well as in blood vessel formation and cellular interactions throughout the body. Together with previous studies, the current findings provide strong rationale for Cellmid’s oncology program targeting midkine with therapeutic antibodies.

In their Nature News and Views commentary on the study, Hoshino and Lyden from Weill Cornell Medicine in New York describe how “…MDK (midkine) downregulation in an aggressive melanoma led to drastic inhibition of lymphangiogenesis, and reduced number of metastases”, concluding that this work “…might open a door to diagnostic and therapeutic strategies that aim to deal with metastases before they arise”. David Olmeda, lead author on the Nature paper, lends further support for Cellmid’s midkine program in oncology “…we focussed on… MIDKINE, because it was new and could represent an alternative therapeutic target”.

About Cellmid Limited (ASX: CDY)
Cellmid is an Australian life sciences company with lead programs in multiple disease indications. The Company, through its wholly owned subsidiaries, Lyramid, Kinera and Advangen, develops and markets innovative novel therapies and diagnostic tests for fibrotic diseases, cancer, ischemic diseases of the heart and hair loss. Cellmid holds the largest and most comprehensive portfolio of intellectual property relating to the novel targets midkine (MK) and FGF5 globally. Intellectual property pertaining midkine is being exploited through wholly owned subsidiaries Lyramid and Kinera. Advangen, Cellmid’s consumer health business, sells its FGF5 inhibitor hair growth products in Australia, Japan and the USA and currently expanding distribution in other territories. For further information, please see www.cellmid.com.au and www.evolisproducts.com.au.

Contact

Maria Halasz, CEO
+612 9221 6830
Twitter: @mariahalasz

ASCO recommends MammaPrint® for clinical high risk, hormone receptor-positive, HER2-negative breast cancer, to inform decisions on withholding chemotherapy
ASCO recommends MammaPrint as currently the only genomic test to be used to guide treatment decisions for 1-3 lymph node positive early-stage breast cancer patients
Revised ASCO Guidelines mark the fourth positive international guideline update for MammaPrint in 2017, recognizing the highest level of clinical evidence provided by MINDACT

IRVINE, CA, USA and AMSTERDAM, the Netherlands, July 10 2017 / B3C newswire / -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the American Society of Clinical Oncology (ASCO®) has today published revised early-stage breast cancer guidelines in the Journal of Clinical Oncology, titled The Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early Stage Invasive Breast Cancer: American Society of Clinical Oncology Practice Guideline (1).

This focused update is dedicated exclusively to Agendia’s MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test and was triggered by the practice-changing data from the randomized, prospective, phase III MINDACT trial which was published in August 2016 (2).

In a significant update to the 2016 guidelines, the ASCO panel identified MammaPrint as currently the only genomic test to be considered to inform treatment decisions in women with estrogen receptor-positive or progesterone receptor-positive, HER2-negative breast cancer with lymph node negative, or one to three positive lymph nodes who are at a high clinical risk of recurrence. For these patients, MammaPrint is now recommended by the ASCO Guidelines to inform decisions on withholding adjuvant (post-surgery) systemic chemotherapy due to its ability to identify patients with a good prognosis with limited chemotherapy benefit.

This is the first time that ASCO has recommended a genomic test to inform treatment decisions in withholding chemotherapy for lymph node positive patients, for whom lymph node involvement often causes them to be classified at high clinical risk and requiring chemotherapy. It is noted that such patients “should be informed that a benefit of chemotherapy cannot be excluded, particularly in patients with greater than one involved lymph node.”

Dr William Audeh, Chief Medical Officer at Agendia said: “This is a significant update to the ASCO guideline and testament to the clinical utility of the MammaPrint test as demonstrated in the MINDACT trial. MammaPrint is the only breast cancer genomic test that has been validated in a truly clinically high risk (luminal B) cohort of patients, providing physicians and their patients with unique genomic information to help personalize how their treatment is managed. The ASCO panel stated that reduction of overtreatment is an important goal, and confirmed the utility of MammaPrint in achieving this.

“This is the second guideline update for MammaPrint in three weeks. Based on MINDACT, both ASCO and the St. Gallen panel have now endorsed this test for both lymph-node negative and lymph node positive patients. Indeed, each of the four guidelines which included a review of the published findings of this unique trial so far this year have added or expanded their recommendation of MammaPrint,” said Dr. Audeh.

Mark R. Straley, Chief Executive Officer at Agendia said: “I am very pleased to see MammaPrint recommended by the updated ASCO guidelines. This will enable a whole new group of lymph-node positive patients to benefit from genomic testing, and not have their complex treatment decisions based entirely on clinical factors alone. At Agendia we are dedicated to improving the quality of life for early-stage breast cancer patients. ASCO’s recommendation is a powerful force in helping to extend the benefits of MammaPrint to reach many more women.”

MammaPrint is currently the only genomic breast cancer risk-of-recurrence test backed by level 1A prospective, randomized evidence to support the de-escalation of chemotherapy in patients who are classified as clinically high risk. As stated in the ASCO guidelines, “the reduction of overtreatment in patients with early-stage breast cancer is an important goal […] such a reduction would likely have the greatest societal and individual impact in patients with ER/PgR–positive disease.”

The ASCO guidance on the use of biomarkers in early-stage breast cancer supports the position of the recently-published biennial 2017 St. Gallen International Breast Cancer Guidelines that there is “no role for gene testing in clinical pathological low risk cases” (3), which are mostly node-negative, lower grade and smaller tumors (high estrogen receptor-positive, grade 1-2 and less than or equal to 2 cm).

MammaPrint was recognized as being supported by the highest level of clinical evidence by both the German Gynecological Oncology Group (AGO) and the European Group on Tumor Markers (EGTM) in March 2017. The test is also recommended for use in other important oncology practice guidelines including those of the European Society for Medical Oncology (ESMO), and several national guidelines in Europe.

You can access The Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early Stage Invasive Breast Cancer: American Society of Clinical Oncology Practice Guideline from the Journal of Clinical Oncology here: http://ascopubs.org/doi/full/10.1200/JCO.2017.74.0472

About MINDACT
The Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial (EORTC 10041/BIG 3-04) is an independent, prospective, randomized, phase III, controlled clinical trial that investigated the clinical utility of MammaPrint, when used in conjunction with standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy.

From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer enrolled in the trial, across 112 centers in nine countries. The results were published in the prestigious New England Journal of Medicine in August 2016.

About MammaPrint
MammaPrint is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA and carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.

About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a Molecular Subtyping Assay that provides deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.

For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.

Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

Contacts:

Instinctif Partners
Daniel Gooch / Lynne Trowbridge
Tel: +44 (0) 20 7866 7905
agendia@instinctif.com

_________________________________________________________________

1 Krop I, Ismaila N, Andre F et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. DOI: 10.1200/JCO.2017.74.0472 Journal of Clinical Oncology - published online before print July 10, 2017

2 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.

3 Curigliano G, Burnstein H, Winer E et al. De-escalating and Escalating Treatments for Early Stage Breast Cancer: The St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol 2017 mdx308.

Tokyo, Japan, Basking Ridge, NJ, USA and Dortmund, Germany, July 11, 2017 / B3C newswire / -- Daiichi Sankyo Co., Limited (hereafter, Daiichi Sankyo), Max Planck Innovation GmbH and the Lead Discovery Center GmbH have signed an agreement providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center.

This new partnership builds on biology insights in the field of transcriptional regulation from the work of Prof. Matthias Geyer at the Max Planck Institute of Molecular Physiology in Dortmund and the Research Center caesar (Center of Advanced European Studies and Research) in Bonn, Germany. Combined with the Lead Discovery Center’s strong drug discovery expertise in the design of highly selective kinase inhibitors, Daiichi Sankyo, Max Planck researchers and the Lead Discovery Center will now closely cooperate to further optimize these novel compounds that target cancer cell transcription and proliferation.

Daiichi Sankyo together with the Max Planck Society, supported by Max Planck Foundation, will jointly fund the respective drug discovery efforts at the Lead Discovery Center. Once the project has achieved proof-of-concept in relevant in vivo models, Daiichi Sankyo has the exclusive rights to license the program at pre-defined terms for subsequent preclinical and clinical development. The agreement includes an upfront payment as well as development and sales milestones plus royalties. The licensing revenues will be shared between Max Planck Society, the Lead Discovery Center and all contributing researchers and institutions.

“The Lead Discovery Center is our prime partner for innovative drug discovery projects and developing novel compounds with a high therapeutic potential from the Max Planck Institutes. This agreement with Daiichi Sankyo, a recognized leader in the development and supply of innovative pharmaceutical products, again shows the high quality of research projects driven at the Max Planck laboratories. Moreover, the agreement is a great opportunity to advance the research findings into pharmaceutical development, providing potential new treatment options for patients with cancer,” according to Dr. Matthias Stein-Gerlach, patent and licensing manager at Max Planck Innovation, Max Planck Society´s technology transfer organization.

“This project collaboration and option agreement is building on the excellent experiences that Daiichi Sankyo and the Lead Discovery Center previously made from a discovery alliance that started in 2014, as well as close ties and many interactions between Daiichi Sankyo and the Max Planck Society, such as the collaboration with the Axel Ullrich lab. Max Planck Innovation has been instrumental to close this partnership,” adds Dr. Bert Klebl, Managing Director and CSO at the Lead Discovery Center.

“It is a great pleasure for us to start this research collaboration with Max Planck Innovation and the Lead Discovery Center to further generate innovation for our cancer drug discovery efforts,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head of Oncology Research and Development, Daiichi Sankyo. “We are excited about the integration of Max Planck Society’s high quality science and the Lead Discovery Center’s expertise in lead discovery into Daiichi Sankyo’s drug research and development platform.”

Daiichi Sankyo, the Lead Discovery Center and the Max Planck Society aim to further expand their collaboration into additional programs in the future.

About Max Planck Innovation
Max Planck Innovation is responsible for the technology transfer of the Max Planck Society and, as such, serves as a link between industry and basic research. With its interdisciplinary team it advises and supports scientists in evaluating their inventions, filing patents, and founding companies. Max Planck Innovation offers the industry unique access to the innovations of the Max Planck Institutes, and therefore performs an important task: the transfer of basic research results into products, which contributes to economic and social progress.

About the Lead Discovery Center
The Lead Discovery Center was established in 2008 by the technology transfer organization Max Planck Innovation, as a novel approach to capitalize on the potential of excellent basic research for the discovery of new therapies for diseases with high medical need. The Lead Discovery Center takes on promising early-stage projects from academia and transforms them into innovative pharmaceutical leads that reach initial proof-of-concept in animals. In close collaboration with high-profile partners from academia and industry, the Lead Discovery Center is building a strong and growing portfolio of small molecule leads with exceptional medical and commercial potential.

The Lead Discovery Center sustains a preferred partnership with the Max Planck Society and has formed alliances with AstraZeneca, Bayer, Boehringer Ingelheim, Merck KGaA, Daiichi Sankyo, Qurient, Johnson & Johnson Innovation, Roche and Sotio as well as leading translational drug discovery centers around the globe.

About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our Antibody Drug Conjugate (ADC) and Acute Myeloid Leukemia (AML) Franchises, our cancer pipeline includes more than 20 small molecules, monoclonal antibodies and ADCs stemming from our powerful research engines: our two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc. headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com

Contacts

Daiichi Sankyo, Inc.
Jennifer Brennan
jbrennan2@dsi.com
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)

Lead Discovery Center GmbH
Thomas Hegendoerfer
hegendoerfer@lead-discovery.de
+49 231 9742 7002

Max Planck Innovation GmbH
Markus Berninger
berninger@max-planck-innovation.de
+49 89 2909 1930

Oncotype DX® test endorsed for guiding treatment decisions on adjuvant chemotherapy both in node-negative and in node-positive disease
Gene expression signatures recommended for the first time as preferable to standard pathology, when adequate reproducibility is not granted

Geneva, Switzerland, July 12, 2017 / B3C newswire / -- Genomic Health today announced that the 15th St. Gallen International Breast Cancer Conference Expert Panel endorsed the use of genomic tests in early-stage breast cancer and recognised the Oncotype DX Breast Recurrence Score® test for its prognostic ability as well as its value in guiding treatment decisions on adjuvant chemotherapy for patients with early-stage, endocrine sensitive, invasive breast cancer.

In particular, Oncotype DX® was the only test supported by a majority of panelists (58.6 percent) for its value in providing information that can help physicians “decide to omit chemotherapy” in patients with node positive disease (up to three nodes). The guidelines, which are reviewed bi-annually, have been recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

“We are pleased that this expert panel once again recognized the value of the Oncotype DX test. An extensive body of clinical evidence highlights the unique ability of our test to identify both patients who can be spared chemotherapy and – importantly - those who will clearly benefit from it, while providing a positive impact on healthcare systems,” said Calvin Chao, Vice President of Global Medical Affairs at Genomic Health. “In addition to these updated guidelines, it is encouraging to see recently published data reinforcing that there is a spectrum of biology in breast cancer and growing evidence from all research groups on the importance of more precise estimates of risk and chemotherapy benefit as provided by the Oncotype DX individualized Recurrence Score result.”

The Oncotype DX Breast Recurrence Score test is incorporated in all major international guidelines, including NICE, St. Gallen International Breast Cancer Expert Panel, ESMO, ASCO and NCCN. The test was also included in the 8th edition of the American Joint Committee on Cancer (AJCC) criteria for breast cancer staging, which will be effective in January 2018. This is particularly significant since AJCC has, for the first time, added molecular markers to staging criteria and identified Oncotype DX as the only gene test that can be used to determine formal staging of breast cancer patients along with hormonal status (ER, PR), and HER2 status.

Breast cancer is the most common cancer in European women(1) and affects many of them during their years dedicated to working and raising a family. While chemotherapy is routinely offered, research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from it.(2)
The Oncotype DX test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems. This is supported by substantial real-world evidence showing that the test can reduce the number of women undergoing unnecessary chemotherapy by up to 60 percent.(3)

About Oncotype DX
Oncotype DX is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Healthcare systems across Europe are recognizing the value of the test, which is incorporated in all major international clinical guidelines. Following assessment and recommendation by NICE, the Oncotype DX test is widely available to patients across the UK. In France, Oncotype DX is available through a funding mechanism for genomic tests. Other European countries where the test is reimbursed include Switzerland, Ireland, Greece and Spain.

About Genomic Health
Genomic Health, Inc. is a world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 750,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™ test. The company is based in Redwood City, California with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements relating to the ability of any potential tests Genomic Health, Inc. may develop to optimize cancer treatment and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's yearly report on Form 10-K for the quarter ended March 31, 2017. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Oncotype IQ, Oncotype DX Breast Recurrence Score, Recurrence Score, and Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

Contact

Media:
Federico Maiardi
Genomic Health
+41 79 138 1326
fmaiardi@genomichealth.com

(1) http://eco.iarc.fr/EUCAN/Country.aspx?ISOCountryCd=968, last accessed on 21/06/17
(2) Paik et al., J Clin Oncol. 2006; Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) et al. Lancet. 2012
(3) Loncaster J et al., Eur J Surg Oncol. 2017

The second independent Data and Safety Monitoring Board (DSMB) meeting of the RHB-104 Phase III study for Crohn’s disease (MAP US study) is planned to be held in late July 2017 and will assess the safety and efficacy of RHB-104 in the first 222 subjects who have completed week 26 assessments
The DSMB meeting will include an interim efficacy analysis and an evaluation of an option for early stop for success for overwhelming efficacy; its recommendation is planned to be announced by early August 2017
To date, approximately 300 patients of the planned total of 410 patients have been enrolled in the ongoing Phase III MAP US study
The MAP US study is a randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s disease, with a primary endpoint of remission at week 26
An ongoing open-label extension Phase III study (MAP US2 study) is evaluating the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the Phase III MAP US study and remain with active Crohn’s disease; these patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the Phase III open-label extension study

Tel-Aviv, Israel / Raleigh, NC, USA, July 12, 2017 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the second independent Data and Safety Monitoring Board (DSMB) meeting of the RHB-104 Phase III study for Crohn’s disease (the MAP US study) is expected to convene in late July 2017 and will assess the safety and efficacy of RHB-104 in the first 222 subjects who have completed week 26 assessments. RedHill expects to announce the recommendation of the DSMB meeting by early August 2017.

The independent DSMB meeting will conduct safety and interim efficacy analyses and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold for overwhelming efficacy of RHB-104 versus placebo at the primary endpoint (two-sided p-value<0.003). The primary endpoint of the MAP US study is disease remission, defined as a reduction in Crohn’s Disease Activity Index (CDAI) to less than 150 at week 26. Assuming the study is not stopped for success or inefficacy following the DSMB meeting, completion of recruitment for the MAP US study is expected by the beginning of 2018.

Additionally, the Company updated that it has completed the enrollment of approximately 300 out of the 410 subjects planned to be enrolled in the RHB-104 Phase III study for Crohn’s Disease (the MAP US study).

RHB-104 is a proprietary, orally-administered, potentially groundbreaking, antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties, targeting a suspected underlying bacterial infectious cause of Crohn’s disease, Mycobacterium avium subspecies paratuberculosis (MAP).

The MAP US study is a randomized, double-blind, placebo-controlled first Phase III study evaluating the safety and efficacy of RHB-104 in patients with moderately to severely active Crohn’s disease (defined as CDAI between 220 and 450). The MAP US study is being conducted in up to 150 clinical sites in the U.S, Canada, Europe, Israel, Australia and New Zealand. Additional clinical data will need to be generated to support a U.S. New Drug Application (NDA) for RHB-104.

In December 2016, a first pre-planned independent DSMB meeting reviewed safety data from the ongoing MAP US study and provided a unanimous recommendation to continue the study as planned. Assuming the Phase III MAP US study is not stopped early, a third, safety-focused, independent DSMB meeting will be held once 75% of the 410 patients planned to be enrolled in the study will have completed 26 weeks of study participation.

RedHill recently initiated an open-label extension Phase III study (MAP US2 study) to the first Phase III MAP US study with RHB-104 for the treatment of Crohn’s Disease. The MAP US2 study is intended to assess the safety and efficacy of RHB-104 in patients who have completed 26 weeks of treatment in the MAP US Phase III study and remain with active Crohn’s disease (CDAI > 150) at week 26, the MAP US study’s primary endpoint. These patients have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label MAP US2 extension study. The data collected in the MAP US2 study will be supplemental to the MAP US study data. The MAP US2 study’s primary endpoint is disease remission at week 16, defined as CDAI of less than 150. The MAP US2 study is planned to enroll approximately 100 subjects in up to 150 clinical sites in the U.S., Canada, Europe, Israel, Australia and New Zealand. Additional open-label studies with RHB-104 for Crohn’s disease are planned to provide further supportive clinical data for potential future marketing applications.

The clinical studies with RHB-104 are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About RHB-104
Currently in a first Phase III study for the treatment of Crohn’s disease (the MAP US study), RHB-104 is a proprietary, orally-administered, potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, antimycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is related to Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by Pharmacia/Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (pop-PK) study is ongoing as part of the Phase III MAP US study. Additionally, an open-label extension Phase III study (the MAP US2 study) is ongoing to assess the safety and efficacy of RHB-104 in patients who have completed week 26 assessments in the ongoing Phase III MAP US study and remain with active Crohn’s disease (CDAI > 150) at week 26. RHB-104 is covered by several issued and pending patents. RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing-remitting multiple sclerosis (the CEASE MS study), with top-line final results suggesting meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development. RHB-104 was granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA for the treatment of nontuberculous mycobacteria (NTM) infections, providing a Fast-Track development pathway, as well as NDA Priority Review and an additional five years of U.S. market exclusivity, if approved. RedHill is in discussions with the FDA regarding the development of RHB-104 development program for NTM infections.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) TALICIA™ (RHB-105)- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

Contacts

Company contact
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

Widespread availability of self-administered eSAGE (BrainTest® https://braintest.com) expected to be a major factor in overcoming the many obstacles in identifying early cognitive impairment

London, UK, July 17, 2017 / B3C newswire / --BrainTest Inc., a medical software company that provides scientifically validated cognitive screening instruments on a wide range of tablets and mobile devices, today announced that the results of its Validity/Equivalency Study were presented at the Alzheimer’s Association International Conference 2017 (AAIC).

Data presented by Dr. Douglas W. Scharre, Professor of Clinical Neurology and Psychiatry at The Ohio State University Wexner Medical Center demonstrates eSAGE performs similarly with neuropsychological batteries, MoCA, and MMSE and shows no scale bias compared to the validated SAGE. Meaning eSAGE has a high sensitivity (71%) and specificity (90%) in detecting cognitive impairment from normal subjects, with the added advantage of private at-home self-administration. Dr. Scharre’s results and data presentation will be available for the remainder of the AAIC at Location S8, P1-304.

Results of eSAGE Validity/Equivalency Study
Of the 426 subjects screened, 66 completed the evaluation. eSAGE score correlation to a battery of neuropsychological tests was 0.73 (p < 0.0001) with no significant difference between the paper and digital format. Spearman correlation of SAGE versus eSAGE was 0.88 (p < 0.0001), and they are related by the formula: eSAGE score = –1.05 + 0.99 × SAGE score. Since the slope is very close to 1 (p = 0.86) there is strong evidence that the scaling is identical between eSAGE and SAGE, with no scale bias. Overall, eSAGE scores are lower by an average of 1.21 and the decrease is statistically significant (p < 0.0001). For those subjects familiar with smartphones or tablets (one measure of digital proficiency), eSAGE scores are lower by an average of 0.83 points (p = 0.029). With a score 16 and higher being classified as normal, eSAGE had 90% specificity and 71% sensitivity in detecting those with cognitive impairment from normal subjects.

Design of eSAGE Validity/Equivalency Study
Over an 18 month period subjects aged 50 and over who had taken SAGE were recruited from community and clinic settings. Subjects were randomly selected to participate in a clinical evaluation including neuropsychological evaluations. SAGE and eSAGE were administered using a crossover design. Subjects were identified as dementia, MCI, or normal based on standard clinical criteria. Associations were investigated using Spearman correlations, linear regression, and sensitivity and specificity measures. The results of the study were recently published in Alzheimer’s Research & Therapy. For more information visit: https://alzres.biomedcentral.com/articles/10.1186/s13195-017-0269-3

About SAGE Test
The Self-administered Gerocognitive Examination (SAGE) is a brief cognitive assessment for mild cognitive impairment (MCI) and early dementia, created by Dr. Douglas Scharre, Professor of Clinical Neurology and Psychiatry at The Ohio State Wexner Medical Center in Columbus, Ohio. It was validated in the setting of mild cognitive impairment, and has subsequently been adopted in numerous other settings clinically. SAGE has the advantage of self-administration, brevity, and 4 interchangeable forms to avoid retest and practice biases.

About BrainTest Inc.
BrainTest is a medical software company that provides scientifically validated cognitive screening instruments on a wide range of tablets and mobile devices. The company empowers patients to monitor their cognition and learn objective evidence-based recommendations about their brain health in the comfort and privacy of their own homes. Through its partnership with The Ohio State University, BrainTest holds the exclusive digital rights to the Self-Administered Gerocognitive Examination (SAGE Test).

Contact
Michael Kader
+1-614-388-9550
press@braintest.com
https://braintest.com

Top-line results are expected in September 2017
The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® (RHB-102) 12 mg in 127 U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D),with a primary endpoint of response in stool consistency as compared to baseline
IBS is one of the most common gastrointestinal disorders, with up to 30 million American sufferers, of which over 50% are cases of IBS-D; The U.S. market for IBS-D therapies grew by approximately 550% between 2013-2016, to an estimated $473 million in 2016, and is expected to continue to grow by approximately 14% annually (2016 – 2022)
If approved, BEKINDA® 12 mg has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D
Positive top-line results from the Phase III GUARD study with BEKINDA® 24 mg for acute gastroenteritis and gastritis indicated that the study successfully met its primary endpoint, and BEKINDA® 24 mg was shown to be effective, safe and well tolerated in patients with acute gastroenteritis and gastritis

Tel-Aviv, Israel / Raleigh, NC, USA July 17, 2017 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that the last patient enrolled in the Phase II study with BEKINDA® (RHB-102)(1) 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) has completed the treatment course and follow-up visit. Top-line results are expected in September 2017.

BEKINDA® is a proprietary, bimodal extended-release, once-daily, oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the efficacy and safety of BEKINDA® 12 mg in adults, 18 years and older, who suffer from IBS-D. The study enrolled 127 subjects at 16 clinical sites in the U.S.

Subjects enrolled in the study were randomized 60:40 to receive either BEKINDA® 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with stool consistency response as compared to baseline, per FDA guidance definition (a decrease of ≥50% in the number of days per week with at least one stool that has a consistency of 6 or 7 per the Bristol stool scale and no increase in abdominal pain over the week). Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.

IBS is one of the most common gastrointestinal disorders(2). It is estimated that up to 30 million Americans suffer from IBS(3), of which over 50% are cases of IBS-D(4). The U.S. market for IBS-D therapies grew by approximately 550% between 2013-2016, to an estimated $473 million in 2016, and is expected to continue to grow with a compound annual growth rate (CAGR) of 14% (2016 – 2022)(5).

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal transit time in humans(6). Alosetron (Lotronex®), a different 5-HT3 antagonist of the same class of drugs as ondansetron, has been approved by the FDA for the treatment of women with severe chronic IBS-D, but is under a restricted prescribing (REMS) program due to potential severe side effects(7). Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies(8) and, in light of its safety profile, RedHill believes that BEKINDA®, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.

In addition to the BEKINDA® 12 mg Phase II IBS-D program, RedHill recently announced positive top-line results from the Phase III GUARD study with BEKINDA® 24 mg, a different formulation of BEKINDA®. The Phase III GUARD study successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA® 24 mg was found to be safe and well tolerated in this indication.

About BEKINDA
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. Positive top-line results from a Phase III clinical study of BEKINDA® 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study) were announced in June 2017. A Phase II study with BEKINDA® 12 mg is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with patient treatment completed and top-line results expected in September 2017.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill promotes two gastrointestinal products in the U.S. - Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, and EnteraGam®, a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill’s clinical-stage pipeline includes: (i) TALICIA™ (RHB-105)- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study and an ongoing confirmatory Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with successful top-line results in a Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP).

Contacts

Company contact
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.)
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com

(1) BEKINDA® is an investigational new drug, not available for commercial distribution.
(2) GlobalData PharmaPoint: Irritable Bowel Syndrome – Global Drug Forecast and Market Analysis to 2023.
(3) Lovell RM, Ford AC, Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis, Clin Gastroenterol Hepatol (2012), 10(7)712-721; Saito YA et al, The epidemiology of irritable bowel syndrome in North America: a systemic review, Am J Gastroenterol (2002), 97(8): 1910-5.
(4) GlobalData PharmaPoint: Irritable Bowel Syndrome – Global Drug Forecast and Market Analysis to 2023.
(5) EvaluatePharma – USA sales by indication (IBS-D) (July 2017).
(6) Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.
(7) www.fda.gov, post market drug safety information for patients and providers.
(8) Steadman CJ et al, Selective 5-hydroxytryptamine type 3 receptor antagonism with ondansetron as treatment for diarrhea-predominant irritable bowel syndrome: a pilot study, Mayo Clin Proc (1992), 67(8):732-8; Clayton NM et al, The pharmacological properties of the novel selective 5-HT3 receptor antagonist, alosetron, and its effects on normal and perturbed small intestinal transit in the fasted rat, Neurogastroenterol (1999), 11: 207-217; Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.

London, UK, July 24, 2017 / B3C newswire / -- Orchard Therapeutics Limited (“Orchard”), a clinical-stage biotechnology company dedicated to bringing transformative autologous ex-vivo gene therapies to patients with rare diseases of high unmet medical need is delighted to announce today that the US Food and Drug Administration (FDA) granted a Rare Paediatric Disease Designation to OTL-101, its lead programme for the treatment of adenosine deaminase severe combined immunodeficiency, commonly known as ADA-SCID or “bubble baby” disease. OTL-101 is developed in collaboration with the University of California, Los Angeles (“UCLA”) and University College London / Great Ormond Street Hospital (“UCL” and “GOSH”).

ADA-SCID is a rare inherited disorder of the immune system. ADA-SCID is caused by mutations in the gene encoding for the enzyme adenosine deaminase, which result in a severe deficiency in white blood cells and life-threatening infections. In the absence of treatment, ADA-SCID is fatal within the first year of life.

To be granted Rare Paediatric Disease Designation, a drug must be designed for the treatment of a serious or life-threatening disease which affects less than 200,000 patients in the United States and which primarily includes patients aged between 0 and 18 years.

This designation acknowledges that the company may qualify for a paediatric priority review voucher at the time the drug gets approved for this indication. That voucher could then be redeemed to receive a priority review of a subsequent marketing application for a different product or be transferable to other company.

Dr. Donald Kohn, Professor in the Departments of Paediatrics; Microbiology, Immunology and Molecular Genetics (MIMG); and Molecular and Medical Pharmacology and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA commented: “We are very pleased that the FDA has granted Rare Paediatric Disease Designations to OTL-101. It validates that ADA-SCID is a very rare inherited disorder affecting mainly children and adolescents, who are at urgent need of efficacious innovative medical treatment.” Kohn is a paid consultant on the Orchard Therapeutics Limited Scientific Advisory Board, and The Regents of the University of California have licensed intellectual property to Orchard Therapeutics Limited.

Anne Dupraz, PhD, Orchard’s Chief Regulatory Officer added: “Together with Orphan Drug and Breakthrough Therapy Designations, this additional designation is another important development step for the OTL-101 clinical programme. It reflects the potential of this gene therapy treatment to address the significant unmet medical need of children with ADA-SCID and eligibility for a Paediatric Disease Priority Review voucher at time of approval.”

To date, over 40 ADA-SCID patients have been treated with OTL-101, autologous ex-vivo lentiviral gene therapy at UCLA, Los Angeles and at the Great Ormond Street Hospital (GOSH) in London, UK. All patients have survived (100% overall survival) with follow-up up to 5 years and the treatment has been shown to restore patients’ immune function, with a favourable safety profile.

Orchard’s development pipeline of autologous ex-vivo gene therapies includes novel treatments for primary immune deficiencies (such as ADA-SCID) and inherited metabolic disorders (such as Sanfilippo syndrome type A).

About ADA-SCID
ADA-SCID is a rare inherited disorder of the immune system. The incidence of ADA-SCID is currently estimated between 1 in every 200,000,000 to 1,000,000 live births according to literature sources. The actual incidence could be higher. ADA-SCID is caused by mutations in the gene encoding for the adenosine deaminase enzyme, which result in a severe deficiency in white blood cells and life-threatening infections.

About Orchard Therapeutics Ltd.
Orchard Therapeutics is a clinical-stage biotechnology company dedicated to bringing transformative ex-vivo gene therapies to patients with serious and life-threatening orphan diseases. The company was recently named a Fierce 15 Company for 2016 by Fierce Biotech.

Contact

Orchard Therapeutics Limited
Sylvie Blanchier-Franklin
sylvie.blanchier@orchard-tx.com
+44 (0) 20 3823 2149

Labège, France, July 25, 2017 / B3C newswire / -- Antabio SAS, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs, announced today that it has been awarded up to $8.9 million non-dilutive funding from CARB-X, the world's largest public-private partnership devoted to antibacterial R&D. Antabio was selected by CARB-X from a group of 368 applicants worldwide and is part of the first cohort that includes companies from Continental Europe. The award provides immediate funding of up to $2.8 million with options for up to $8.9 million upon achievement of milestones.

The funding will be used to accelerate the development, up to completion of Phase 1 clinical trials, of Antabio’s novel small molecule drug for the treatment of chronic Pseudomonas infections in Cystic Fibrosis patients. Cystic Fibrosis is a genetic condition leading to long-term infections and progressive lung damage. The most frequent infection in adult patients is caused by the bacterium Pseudomonas aeruginosa (PA), which grows as biofilm clusters that are resistant to immune clearance and conventional antibiotics. Antabio’s PEI program (Pseudomonas Elastase Inhibitors) powered by CARB-X seeks to develop inhibitors of the PA LasB elastase virulence factor thereby targeting the bacterium’s ability to evade the immune system and cause disease. The objective is to clear PA infections when Antabio’s PEIs are given alongside antibiotics.

“This award enables Antabio to develop a new paradigm in the treatment of infectious disease, i.e. that of targeting the bacterium’s ability to cause disease and evade attack by the immune system and antibiotics. Opening up alternative ways to fight disease is particularly important given the increases in multidrug resistant pathogens and the shortage of new antibiotics” said Martin Everett, CSO of Antabio.

“We are delighted to collaborate with CARB-X on developing our novel Pseudomonas virulence inhibitors that have a clear potential for enhancing eradication of chronic infections in CF sufferers” said Marc Lemonnier, CEO of Antabio. “As a company powered by CARB-X, Antabio will benefit from substantial non-dilutive funding, access to complementary world-class expertise including NIAID pre-clinical services and free technical consulting from RTI International. This new and exciting opportunity builds up on our longstanding strategy of collaborating with leading global players, such as the Wellcome Trust and CARB-X, to accelerate the development of life-saving treatments for drug-resistant infections”.

CARB-X, which stands for Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, is backed by the US Government – through the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) - and the UK charity Wellcome Trust. It was launched in July 2016 to address the gap in antibiotic research and development and innovations to improve diagnosis and treatment of drug-resistant infections.

Kevin Outterson, Executive Director of CARB-X and Professor of Law at Boston University said: “Drug-resistant infections are complex and developing new antibiotics challenging, timely and costly. But restoring the R&D pipeline is vital to address the seriously increasing threat of superbugs which have become resistant to existing drugs. This is a global problem and CARB-X is a critical part of the global solution. We are looking to support the best potential new treatments and diagnostics across the world. We are especially pleased that today’s awards mean we are now supporting scientists in 6 countries. The projects offer exciting potential. But we need greater global support from governments, industry and civil society to get the new treatments the world urgently needs.”

About ANTABIO
Antabio is a private biopharmaceutical company developing novel antibacterial resistance-breakers to treat drug-resistant infections in areas of highest unmet medical need. Two of Antabio’s programs have received Wellcome Trust Seeding Drug Discovery Awards to date: (i) a novel, safe and efficacious inhibitor of bacterial metallo ß-lactamases to be combined with a carbapenem for the treatment of drug-resistant nosocomial infections and (ii) a first-in-class inhibitor of Pseudomonas virulence to be co-administered with standard-of-care antibiotics for the long-term management of chronic respiratory infections. The company’s lead product is expected to enter the clinic in 2019 with a fast track to anticipated marketing approval by 2021. Antabio has built a best in class, international team of experts in the field and is currently seeking to raise additional funds to progress its pipeline up to the next value inflection point. The Company is also looking to in-license additional assets focused on Gram-negative antibiotic resistant therapies. Please visit www.antabio.com and follow us on Twitter @antabio

About CARB-X
CARB-X is the world's largest public-private partnership devoted to antibacterial R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, we will spend $450 million from 2017-2021 to support innovative products moving towards human clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is a charitable global public-private partnership led by Boston University School of Law. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit www.carb-x.org and follow us on Twitter @CARB_X.

Contact

Carine Bonnet-Danaire
press@antabio.com

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