• Study will evaluate preliminary safety and effectiveness in a cohort of up to 24 patients
• Innovative regenerative technology will use patients’ own skin cells to try to close chronic Diabetic Foot Ulcer (DFUs)
• DFUs represent a significant new potential patient population for Avita Medical

Northridge, CA, USA, Perth, Australia and Cambridge, United Kingdom, May 31, 2016 / B3C newswire / -- The first patient suffering from a Diabetic Foot Ulcer (DFU) has been enrolled in a clinical trial in the UK aimed at evaluating the feasibility of the medical device ReGenerCell™ in the safe and effective treatment of this widespread complication of diabetes, Avita Medical said today.

Avita Medical Ltd. (ASX: AVH), (OTCQX: AVMXY), a regenerative medicine company specializing in the treatment of wounds and skin defects, said the new research takes Avita into a significant new indication area, after the recent release of positive study outcomes for ReGenerCell™ in the treatment Venous Leg Ulcers (VLUs). The DFU clinical study has now started at Manchester Royal Infirmary, with London’s King’s College and Northwick Park hospitals to join shortly. DFUs are a common and growing complication of diabetes, and can often lead to amputation amongst the UK’s 4 million diabetics, whose condition costs the NHS £10bn a year to treat.(1)

The Company said the first patient had been treated at the Manchester Royal Infirmary and that the study aimed to enroll up to 24 patients with DFUs, who will each be followed over a 26-week evaluation period. The ReGenerCell™ device enables medical professionals to create an autologous suspension of skin cells, which is then applied to the patient’s wound to trigger healing. The treatment will be evaluated as an adjunct to standard care treatments, such as debridement, cleansing, dressings, and offloading. As well as the key outcome measures of incidence of healing and rate of wound closure, the study will also explore patient and physician satisfaction, the Company said.

“We are keen to evaluate any treatment that has the potential to improve patient care and at the same time reduce cost,” said Mr Tawqeer Rashid, Chief Investigator and Consultant Vascular Surgeon at Manchester Royal Infirmary. “With this study we will be evaluating the clinical benefits of the ReGenerCell™ treatment for patients whose quality of life is often severely reduced.”

The Company said it had embarked on the study following many successful patient outcomes, indicating that the regenerative approach could be a very effective means of treating DFUs, which are typically long-term open wounds resistant to most standard treatments. Pioneering work at a wound clinic in Italy achieved complete wound closure for three DFUs of four within 50 days of treatment (2), and similarly successful outcomes have been shown in DFU patients treated in the UK, notably those treated by Dr Harvey Chant at the Royal Cornwall Hospital, the Company said.  

“Clinicians from different parts of the world have found ReGenerCell™ to be an effective treatment of diabetic foot ulcers in their practices. A clinical study will allow us to formalize our understanding of the treatment effect and will serve in the development of the clinical guidance and evidence needed for commercialization,” said Andrew Quick, Avita’s Senior Vice President of Clinical Development.

The Company said that diabetes was a growing and significant healthcare problem in many of the markets in which it has approval, including Australia (1.7million) (3) and China, which has 114 million diabetics: 1 in 3 in the world. (4)

“Most healthcare authorities around the world are facing an epidemic of diabetes and one of their most expensive challenges is how to treat foot ulcers which, sadly, once started, typically lead to a slow and lingering decline,” said Avita CEO Adam Kelliher. “If our approach can get these ulcers to heal, then it could offer hope to many diabetics around the world.”

Using a small sample of skin, the ReGenerCell™ device enables the production of a Regenerative Epithelial Suspension (RES™). The autologous suspension contains the multi-phenotype cells and wound-healing factors essential for natural healthy skin regeneration and healing. The procedure performed at the patient’s bedside takes about 30 minutes from collecting the skin sample to treatment of the affected area. In cases of chronic wounds, including DFUs and VLUs, the suspension is sprayed or dripped onto the skin.  It has been shown to significantly reduce the healing time of wounds and leaves the patient with skin with similar elasticity, texture and pigmentation to surrounding skin, with limited scarring.

About Avita Medical Ltd
Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient’s own skin. The company’s lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use.

Contacts

Avita Medical Ltd
Adam Kelliher
Chief Executive Officer
+44 (0) 1763 269 772
akelliher@avitamedical.com

Tim Rooney
Chief Financial Officer
+ 1 (818) 356-9400
trooney@avitamedical.com
   
Gabriel Chiappini
Company Secretary
+61 (0) 8 9474 7738
gabriel@laurus.net.au

Media Contacts

UK/EU
Instinctif Partners
Gemma Howe/Sue Charles
Phone: +44 (0)20 7866 7860
avitamedical@instinctif.com
    
USA
The Ruth Group
David Burke, Investor Relations
Kirsten Thomas, Public Relations
+1 (646) 536-7009 / +1 (508) 280-6592
dburke@theruthgroup.com / kthomas@theruthgroup.com
    
Australia
Monsoon Communications
Dean Felton
Investor Relations / PR
+61 (0) 3 9620 3333
deanf@monsoon.com.au

(1) https://www.diabetes.org.uk/About_us/News/Number-of-people-with-diabetes-reaches-over-4-million/
(2) DeAngelis B, Migner A, Lucarini L, Agovino A, Cervelli V. The use of a non-cultured autologous cell suspension to repair chronic ulcers. International Wound Journal 2013; doi: 10.1111./iwj. 12047 (Epub)
(3) https://www.diabetesaustralia.com.au/diabetes-in-australia
(4) Yu Xu, Limin Wang, Jiang He, et al. Prevalence and Control of Diabetes in Chinese Adults. JAMA 2013; 310(9): 948-59

Oss and Maastricht, The Netherlands,  June 1, 2016 / B3C newswire / -- ChemConnection, a privately-held company manufacturing nanomedicines, bioconjugates, peptides, and small molecules, announces the successful GMP production of CriPec® docetaxel for its customer Cristal Therapeutics, a privately-held life sciences company developing nanomedicines against cancer and other diseases.

“ChemConnection has made a tremendous leap forward in becoming the global lead center for nanomedicines manufacturing” said Gerjan Kemperman, CEO of ChemConnection. “Recent investments in our manufacturing and analytical capabilities have boosted the advancement of nanomedicines. The successful completion of the process and analytical development, and GMP production of CriPec® docetaxel shows our expertise in sophisticated nanomedicine development and manufacturing. The continued partnership with Cristal Therapeutics will further strengthen our position in the nanomedicines manufacturing field.”

“We are very pleased with the partnership with ChemConnection on the scale up and GMP production of CriPec® docetaxel as being the lead product, based on our proprietary CriPec platform” said Joost Holthuis, CEO of Cristal Therapeutics. "The manufacturing of CriPec® docetaxel has resulted in a technical package that adds significant value to our portfolio and enabled the start of the clinical evaluation in patients with solid tumors.”

About ChemConnection
ChemConnection BV is a contract manufacturing organization offering enabling technologies for the development and GMP manufacture of nanomedicines including drug loaded nanoparticles, liposomes, iron oxide nanoparticles, and theranostics. The offered technologies include continuous manufacturing technologies, purification technologies and analytical development and characterization technologies. The most advanced products currently in development are CriPec® docetaxel, a targeted drug loaded liposome, and an iron oxide nanoparticle for MRI diagnostics.

Contact

ChemConnection
Gerjan Kemperman, CEO
Pivot Park, Alfred Nobel Building
Kloosterstraat 9, 5349 AB Oss
The Netherlands
info@chemconnection.eu
+31 412 84 60 24

Bispecific Cancer Antibody Pipeline Optimized by GlymaxX® Manufacturing Technology

Berlin, Germany and Utrecht, The Netherlands, June 1, 2016 / B3C newswire / -- ProBioGen AG and Merus N.V. today jointly announced that Merus has signed a commercial multi-product license agreement for ProBioGen’s GlymaxX® ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) enhancement technology. Under the terms of the agreement, Merus has obtained non-exclusive use of GlymaxX® technology for Merus’ Biclonics® pipeline of bispecific cancer antibodies to enhance their ADCC activity. Financial details of the license agreement were not disclosed.

MCLA-158 is the first GlymaxX®-modified ADCC-enhanced bispecific antibody being developed under this commercial license. MCLA-158 is being developed as a potential treatment for colorectal cancer and other types of solid tumors. The compound is designed to bind to cancer stem cells that express EGFRs (epidermal growth factor receptors) and Lgr5 (leucine-rich repeat-containing G protein-coupled receptor 5).

Merus had previously utilized the GlymaxX® Technology for its lead candidate, MCLA-128, which is designed to bind to HER2 and HER3-expressing solid tumors. Merus reported interim clinical data from an ongoing phase 1/2 clinical trial for MCLA-128 in April 2016. These data included a favorable safety profile and early signs of anti-tumor activity in patients with advanced solid tumors.

“We are pleased that Merus is again collaborating with ProBioGen for development of their promising antibody cancer therapy, MCLA-158,” said Dr. Wieland Wolf, CEO of ProBioGen. “Merus’ Biclonics® platform represents an encouraging approach to the killing of cancer cells, and we believe that Biclonics® utilizing our enhanced ADCC technology hold great promise in potentially transforming the cancer treatment paradigm.”  

“ProBioGen’s GlymaxX® technology is proven to increase an antibody’s ability to bind to cellular targets, resulting in greater cell-killing proficiency,” said Ton Logtenberg, PhD, Chief Executive Officer of Merus. “We are eager to advance development of MCLA-158 utilizing this exciting technology, and we plan to file an IND with the FDA by the end of next year. At the same time, we are continuing to advance our other GlymaxX®-enabled candidate, MCLA-128 for HER-expressing solid tumors, and we expect to report topline results from our ongoing Phase 1/2 trial in the second half of 2017.”   

ProBioGen’s GlymaxX® technology is based on the heterologous, cytosolic expression of a bacterial enzyme that redirects the de-novo fucose synthesis pathway towards a sugar-nucleotide that cannot be metabolized by the cell. The enzyme mediates the secretion of antibodies with minimized fucose content. The resulting modification of the glycostructure of IgG1 antibodies enhances their binding to natural killer, or NK, cells and thus the ADCC response in potency assays. Consequently, the potency of the modified antibodies, directed against tumor or infected cells, is substantially increased.

 
About ADCC
ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity is an important antibody function, leading to the selective killing of target cells, i.e. cancerous cells or pathogen-infected cells. Several therapeutic antibody drugs on the market rely on ADCC as a mechanism of action. ADCC enhancement has the potential to increase the therapeutic effect and/or to greatly reduce antibody dosage requirements, resulting in fewer side-effects and treatment costs.

About GlymaxX®
The GlymaxX® technology, developed by ProBioGen, prevents the synthesis of the sugar “fucose” and hence, in antibody-producing cells, its addition to the N-linked carbohydrate part of the antibody. The absence of fucose is known to greatly enhance ADCC. The GlymaxX® technology is based on the stable introduction of a gene for an enzyme which literally eliminates the producer cells’ fucose biosynthesis pathway. As a unique feature, differentiating it from other approaches, GlymaxX® can be applied to both novel and already existing antibody producer cell lines and entire antibody expression and discovery platforms, without negatively affecting their productivity or product characteristics. Moreover, it is simple, rapid, potent, and universally applicable to different Chinese hamster ovary, or CHO, hosts and all other eukaryotic cell species. GlymaxX® can be rapidly applied in a few weeks to any existing antibody producer cell line, can be used in the context of ProBioGen’s pre-engineered GlymaxX® host cells, or can be introduced into entire animal cell expression platforms by modifying the host cell line. ProBioGen offers its GlymaxX® technology royalty-free as a service or as an individual license.

About ProBioGen AG
ProBioGen is a specialist for the development and manufacturing of complex therapeutic glyco-proteins. Combining both state-of-the-art development platforms together with intelligent product-specific technologies yields biologics with optimized properties.

Rapid and integrated cell line and process development, comprehensive analytical development and following 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 is operational since more than 20 years and is located in Berlin, Germany.

About Merus N.V.
Merus is a fully-integrated biotechnology company developing cancer therapeutics that combine the benefits of monoclonal antibodies with the ability to simultaneously bind to multiple targets. Merus has two lead programs in development: MCLA-128 for the treatment of solid tumors and MCLA-117 for the treatment of acute myeloid leukemia. Merus is also developing a broad pipeline of preclinical programs. Merus’ technologies encompass the proprietary MeMo® transgenic mouse for the production of common light-chain human antibodies and the CH3 heterodimerization technology for the production of full-length IgG Biclonics®. These Biclonics® are robustly produced from a single clonal manufacturing cell line, using industry-standard systems. Merus’ Biclonics® are designed to bind to multiple disease-associated targets, thereby eliminating tumor cells more efficiently and preventing tumor cells from escaping treatment. In Merus’ Biclonics®-ENGAGE approach used in the MCLA-117 program, bispecific antibodies are used to induce the cytotoxic activity of T-cells to kill cancer cells.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the impact our Biclonics® platform can have on cancer, MCLA-158’s potential to treat colorectal cancer and other types of solid tumors, the potential benefits ProBioGen’s GlymaxX® technology may have on our Biclonics® pipeline, the timing of FDA filings and the timing and anticipated results from our clinical trials.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding, which may not be available and which may require us to restrict out operations or require us to relinquish rights to our technologies or bispecific antibody candidates; potential delays in regulatory approval, which would impact the ability to commercialize our product candidates and affect our ability to generate revenue; the unproven approach to therapeutic intervention of our Biclonics® technology; potential difficulties in validating and developing companion diagnostics, which could harm our development strategy; our limited operating history; economic, political, regulatory and other risks involved with international operations; exchange rate fluctuations or abandonment of the euro currency; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential adverse public reaction to the use of cancer immunotherapies; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our potential exposure to costly and damaging liability claims; post-marketing restrictions or withdrawal from the market; failure to obtain marketing approval internationally; compliance with environmental, health, and safety laws and regulations; anti-kickback, fraud, abuse, and other healthcare laws and regulations exposing us to potential criminal sanctions; recently enacted or future legislation; failure to compete successfully against other drug companies; potential competition from other drug companies if we fail to obtain orphan drug designation or maintain orphan drug exclusivity for our products; the possibility that governmental authorities and health insurers may not establish adequate reimbursement levels and pricing policies to support our products; the potential failure of our product candidates to be accepted on the market by the medical community; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; potential competition from biosimilars; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents being found invalid or unenforceable; potential lawsuits for infringement of third-party intellectual property; adequate protection of our trademarks; our potential failure to obtain extensions of the terms of patents covering our products; potential difficulties protecting our intellectual property rights in certain jurisdictions; changes in United States patent law; protection of the confidentiality of our trade secrets; claims asserting that we or our employees misappropriated a third-party’s intellectual property or otherwise claiming ownership of what we regard as our intellectual property; compliance with patent regulations; potential system failures; our ability to attract and retain key personnel; managing our growth could result in difficulties; the price of our common stock may fluctuate substantially; certain of our shareholders and members of our management board own a majority of our outstanding shares and exercise significant control over us; a significant portion of our total outstanding shares are eligible to be sold into the market; provisions of our Articles of Association or Dutch corporate law might deter favorable acquisition bids for us or prevent a beneficial change of control; we may lose our foreign private issuer status and incur significant expenses as a result; and unfavorable or lacking analyst research or reports might cause the price of our common shares to decline.

These and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission, or SEC, on May 20, 2016 relating to our Registration Statement on Form F-1, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

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

Merus B.V.
S. Margetson
s.margetson@merus.nl
Padualaan 8
3584CH Utrecht, The Netherlands

Media Inquiries for Merus
akampion
Dr. Ludger Wess or Ines-Regina Buth
Phone: +49 40 88 16 59 64 / +49 30 2363 2768
info@akampion.com

Company also announces new ASCO data presentation from the prospective PROMIS study assessing the clinical impact of the definitive MammaPrint 70-gene assay results for patients previously classified as indeterminate by the 21-gene assay (OncotypeDx)

Irvine, CA, USA and Amsterdam, The Netherlands, June 1, 2016 / B3C newswire / --  Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces the appointment of Gabriel N. Hortobagyi, MD, FACP, FASCO, as Chair of its Medical Advisory Board. Dr. Gabriel Hortobagyi is an internationally recognized expert in clinical and translational research of breast cancer and brings more than 35 years of experience as a Breast Medical Oncologist. He is Professor and Chair Emeritus of the Department of Breast Medical Oncology at the MD Anderson Cancer Center (MDACC) and is also the past President of the American Society of Clinical Oncology (ASCO). He is currently the Chair of the Southwest Oncology Group Breast Committee and a member of the Scientific Advisory Board of The Breast Cancer Research Foundation.

“I am thrilled for the opportunity to advise one of the leading molecular diagnostic companies in the industry,” said Dr. Hortobagyi. “Their cancer diagnostic tests, including MammaPrint and BluePrint are some of the most advanced in genomic testing field. In fact, with the recent MINDACT trial results, MammaPrint now has the highest level of evidence a breast cancer diagnostic test can achieve. The additional clinical and genomic data from that trial has the potential to significantly advance the field of breast cancer oncology even further.”

The company also announced that it will be presenting new prospective data for the MammaPrint 70-gene assay at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, which takes place on June 3-7 in Chicago. The recently completed PROMIS study (PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score) evaluates the clinical impact of the definitive MammaPrint result in 831 ER+, LN- (lymph node negative) breast cancer patients, who were previously given an indeterminate/intermediate result with the 21-gene assay OncotypeDx (RS 18-30 clinical range, 11-25 trial range for 39-67% of tested patients).  

The PROMIS poster will be presented on Sunday, June 5 from 8 a.m. to 11:30 a.m. CT. Michaela Tsai, MD, one of the four principal investigators of PROMIS, will present the study. Agendiawill also be exhibiting at ASCO in Exhibit Booth #22109, from June 4-6 during Exhibit Hall hours (9 a.m. – 5 p.m.). 

Session: Breast Cancer – HER2/ER
Session Title: The 70-gene signature to provide risk stratification and treatment guidance for patients classified as intermediate by the 21-gene assay
Location: Hall A, McCormick Place
Poster Session: Board #59 / Abstract #571

Agendia, Inc., together with the European Organisation for Research and Treatment of Cancer (EORTC) and Breast International Group (BIG), presented results from the initial analysis of the primary objective of the Microarray In Node-negative (and 1 to 3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) study at the American Association for Cancer Research Annual Meeting 2016 in New Orleans in April 2016. As a follow-up to the primary analysis, scientific data reviews will be available at the Agendia Exhibit Booth (#22109) at ASCO as well.

The MINDACT trial is the first prospective randomized controlled clinical trial of a breast cancer recurrence genomic assay with level 1A clinical evidence and the first prospective translational research study of this magnitude in breast cancer to report the results of its primary objective.  

“The positive results of the MINDACT trial along with the new PROMIS results, add further proof that the data evaluating the clinical value of MammaPrint are the most robust in the industry,” said Mark Straley, Chief Executive Officer at Agendia. “With our strong clinical trial results, our robust pipeline of products, and the recent appointments of Dr. Hortobagyi to our advisory board and Dr. Audeh as our new Chief Medical Officer, we’re making exciting advances in our continued pursuit to bring more effective, individualized treatments within reach of cancer patients.”

MINDACT included 6,693 patients and is a phase III, prospective, randomized controlled, clinical trial comparing the use of MammaPrint 70-gene assay with clinical-pathological criteria (current standard of care) for selecting early breast cancer patients who should be treated with adjuvant chemotherapy.

For more information on Dr. Hortobagyi, PROMIS or MINDACT, please visit the Agendia newsroom: http://www.agendia.com/agendia-news-and-press-releases/.

 
About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer and colorectal cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint® FFPE 70-gene assay as well as the BluePrint® 80-gene molecular subtyping assay that provides deeper insight, leading to more clinically actionable biology.  These tests can help physicians assess a breast cancer patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.

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. It is also a critical partner in the ISPY-2, NBRST and the MINDACT trials.

Contacts

Scott Speer (US media)
FleishmanHillard
+1 (310) 482-4283
scott.speer@fleishman.com

Léon Melens / Lynne Trowbridge / Jen Lewis (EU media)
Instinctif Partners
+31 (0)6 538 16 427 / +44 (0)20 7457 2020
agendia@instinctif.com

Potsdam, Germany, June 3, 2016 / B3C newswire / -- The medical technology company Emperra was selected to participate in the German Accelerator Life Sciences (GALS) program. The initiative of the Federal Ministry for Economic Affairs and Energy supports young German medical and healthcare companies in expanding into the lucrative US market.

Christoph Lengauer, the CEO of GALS, stated "We are excited to work with Emperra. Integrated solutions such as ESYSTA have the potential to change the way we provide diabetes care. Emperra's approach can improve the lives of millions of patients." GALS and Emperra will prepare in the next months the market entry in the US.  Together with GALS, Emperra has set ambitious goals for the future. The CEO of Emperra, Dr. Christian Krey, emphasized that “for Emperra, a successful launch of the ESYSTA system in the U.S. is an important milestone on the way to become a globally successful company with an unique Diabetes Management Program. We are really looking forward to the opportunity to take this important step with the support of GALS.”

It is of particular advantage that the GALS has recently opened an office in Berlin. The Program Director for Germany, Jared Sebhatu, and his team will be located at Mindspace, a co-working hub in Berlin’s Friedrichstrasse. GALS covers the costs for the mentor program and infrastructure for office space in Boston, MA. Moreover, the initiative grants the German young entrepreneurs access to an extensive network of experts.

Emperras ESYSTA® digital health solution provides self-empowerment and decision support for patients with insulin dependent Diabetes mellitus and connects them remotely with physicians, relatives and caregivers. For the first time, diabetes data management, analytics and connected devices - like the smart Emperra insulin pen and blood glucose meter - have been combined to improve the management of diabetes with real time analytics. With the ubiquity of cloud based electronic e-health management among all stakeholders via computers, tablets and smartphones the ESYSTA system enables improved treatment and patient guidance. Medical and economic benefits were proven in a study in cooperation with a health-insurer as significant reduction of HbA1c over 12 months as well as a reduction in insulin consumption without a higher rate of hypoglycemic events were shown. The system meets all requirements pertaining to medical products as defined by CE (DIN EN ISO 13485) and to reliable data management. The data is stored in encrypted form on highly secure servers which satisfy the strictest IT security standard in accordance with ISO / IEC 27001:2013.

“The unique environment with MIT, Harvard and the well-known Joslin Diabetes Center will help us to perform clinical studies in Boston”, says Krey, “and also to accelerate our US launch.”

The fact that Emperra was selected to GALS fits very well into the increasing international visibility and reputation of Emperra. Last year the International Journal of mHealth awarded the 2015 Global Digital Health Award and Emperra was elected into the top 100 of the world's eHealth drivers.

About Emperra GmbH E-Health Technologies
Emperra GmbH E-Health Technologies is a research and development-focused medical technology start-up company from Potsdam that offers innovative concepts and solutions in the fields of e-health technology and tele-diabetology. Emperra combines innovative software with ground-breaking hardware and integrates these into a medical and scientific concept aimed at providing doctors, patients, caregivers and relatives with telemedicine-based product systems.

About the German Accelerator Life Sciences
The German Accelerator Life Sciences (GALS) is an initiative of the German Federal Ministry for Economic Affairs and Energy, with the goal of helping German startups and young companies to be successful in the global marketplace. GALS offers support in multiple areas, from free office space in the world’s leading life science innovation hub Boston, to mentoring and advising from industry experts and experienced leaders in the space. GALS opened its doors in October 2015 and has its headquarters in Cambridge, Massachusetts.

Contacts

Emperra
Dr. Christian Krey
CEO
EMPERRA GmbH E-Health Technologies
Friedrich-Ebert-Straße 33
14469 Potsdam
Germany
+49 331 - 979 34 80 0
c.krey@emperra.com
https://www.emperra.com

GALS
Jared Sebhatu
Program Director, Germany
German Accelerator Life Sciences
c/o Mindspace
Friedrichstrasse 68
10117 Berlin
Germany
(+49) 175 413 0094
jared.sebhatu@germanaccelerator.com
http://www.germanaccelerator.com/life-sciences

Berlin, Germany, June 3, 2016 / B3C newswire / -- BioGenes GmbH, a global leader in host cell protein (HCP) assay development, has entered into a collaboration with Eurofins BioPharma Product Testing Munich (Eurofins Munich), an internationally renowned  Contract Research Organization for (bio)pharmaceutical product-testing and Centre of Excellence for Bioassays, to serve as its preferred partner for HCP related impurity testing.

BioGenes will provide generic 360-HCP kits and specific HCP assay development services as well as related 2D electrophoresis (2D-DIGE) and concomitant antibody preparation. Eurofins Munich will provide complementary analytical services to BioGenes spanning the complete product development cycle from lead discovery to late stage clinical development.

Eurofins BioPharma Product Testing Munich GmbH, in cooperation with BSL Bioservice Scientific Laboratories Munich GmbH, supports its clients especially in the fields of bioassays, microbiology, in vitro toxicology, pharmacology, and biocompatibility. Immunoanalytical and bioanalytical studies are offered as support of non-clinical and clinical programs. Eurofins BioPharma Product Testing covers the whole range from standardized tests to special requirements and tailor-made studies.

With a strong dedication to quality and customer service since its foundation in 1992, BioGenes is the trusted and experienced immunoassay expert and a well-respected partner for leading pharmaceutical and biotech companies worldwide.

About BioGenes
BioGenes GmbH specializes in highly sophisticated and customized antibody and immunoassay development and is an experienced and reliable partner for process development improvements in all areas of quality control, diagnostics and drug discovery. BioGenes is certified to meet the international requirements and regularities of quality assurance and animal welfare. The Company maintains long-term relationships with research institutes, universities and biotech and pharmaceutical companies, including eight of the ten largest pharmaceutical companies in the world. The company has been evaluated by a leading global accounting and auditing firm to be one of the leading companies in HCP assay development.

Contact

Dagmar Schwertner-Knoll
Marketing/Sales Director
BioGenes GmbH
+49-30-65762380
dagmar.schwertner@biogenes.de

IMAB362 nearly doubles survival in patients with the highest levels of Claudin18.2 target

Mainz, Germany, June 5, 2016 / B3C newswire / -- Ganymed Pharmaceuticals AG, a biopharmaceutical company developing highly targeted immunotherapies against cancer, announced outstanding data from its randomized Phase II clinical study of IMAB362 in first-line treatment of gastric cancer at the ASCO 2016 Annual Meeting.

IMAB362 is a first-in-class monoclonal antibody targeting the cell surface molecule Claudin18.2. The Phase II study in patients with advanced biomarker-positive gastric cancer reached all its endpoints. As a key finding, IMAB362 significantly extended median overall survival when added to standard chemotherapy (13.2 months vs. 8.4 months, HR 0.51, p=0.0001). Patients with the highest levels of Claudin18.2 had an even longer median overall survival (16.7 months vs 9.0 months, HR 0.45, p<0.0005). IMAB362 was well tolerated during the study; most frequent adverse effects were vomiting, nausea and neutropenia.

“Patients diagnosed with advanced gastric cancer currently have a poor prognosis and few available therapeutic options. Results of our study clearly show clinically meaningful efficacy for patients and a favorable risk/benefit profile in this indication of high medical need,” said Dr. Salah-Eddin Al-Batran, a medical oncologist and Director at the Institute of Clinical Cancer Research, Nordwest Hospital in Frankfurt, who presented the data at the ASCO.

“This antibody combines high precision targeting of Claudin18.2 positive tumors with strong immuno-oncological modes of action,” said Dr. Özlem Türeci, Co-Founder and CEO of Ganymed. “We are very excited to see that patients in our study benefited very significantly from being treated with IMAB362 with more than twice the number of patients still living at the end of the study after receiving IMAB362 plus chemotherapy compared to chemotherapy alone.”

About the Study
The study included 161 patients with advanced or recurrent gastric or gastroesophageal junction cancer with a specific minimal level of Claudin18.2 in the tumor. Claudin18.2 levels were assessed from tumor biopsy specimen using the validated CE-marked diagnostic assay CLAUDETECT®18.2. Patients were then randomly assigned to receive standard chemotherapy (epirubicin, oxaliplatin and capecitabine) with IMAB362 (800/600 mg/m2) or chemotherapy alone. Moreover, an additional 85 patients were treated in an added exploratory arm with a higher IMAB362 dose.

Key Findings
Compared to chemotherapy alone, IMAB362 extended the median time to disease progression from 4.8 to 7.9 months (HR 0.47, p=0.0001) and the median overall survival from 8.4 to 13.2 months (HR 0.51, p=0.0001). Among the patients with the highest levels of Claudin18.2, the median overall survival was 16.7 months with IMAB362 and 9 months with chemotherapy alone (HR 0.45, p<0.0005).

Treatment with IMAB362 was well tolerated during the study. Vomiting (34.5% of patients with grade 1/2 and 3.6% with grade 3/4 in the control arm versus 55.8% of patients with grade 1/2 and in 10.4% with grade 3/4 in the IMAB362 arm) and low blood counts (neutropenia; 21.4% of patients with grade 1/2 and 21.4 % with grade 3/4  in the control arm versus 23.4% of patients with grade 1/2 and in 32.5% with grade 3/4 in the IMAB362 arm) were slightly more common in the IMAB362 group. The rates of severe adverse effects were not increased with IMAB362 compared to chemotherapy alone.


About IMAB362
IMAB362 is a first-in-class immunotherapeutic investigational drug that is selective and specific for the tight junction protein Claudin18.2. This unique target is restricted to differentiated stomach cells only and is absent from all other healthy tissues. Claudin18.2 is upregulated in various cancers including in about 80% of gastrointestinal adenocarcinomas, 60% pancreatic tumors as well as in biliary, ovarian and lung cancers. Hence, IMAB362 is of interest for various high medical need cancers, in which this unique target is expressed.

IMAB362 has received orphan drug designation in the US and Europe for gastric and pancreatic cancer. Its mechanism of action includes activation of antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and – in combination with chemotherapy – T-cell infiltration and modulation of the tumor microenvironment. IMAB362 showed single agent anticancer activity in previous clinical studies in heavily pretreated patients with Claudin18.2-positive gastroesophageal cancer.

About Ganymed Pharmaceuticals AG
Ganymed Pharmaceuticals AG is a biopharmaceutical company developing a new class of immunotherapeutic cancer drugs called Ideal Monoclonal Antibodies (IMABs). IMABs are unique in that they are highly selective for proteins which are present on tumor cells, but do not bind to healthy cells. This unmatched tumor cell specificity makes IMABs cancer cell selective allowing them to efficiently kill tumor cells without harming normal healthy tissues. They can thus be administered at optimal dose and have a broad therapeutic window with reduced risks of side effects.

Ganymed is also developing IMAB027, a monoclonal antibody targeting Claudin6 which is absent in healthy adult organs, but is expressed in a wide range of solid cancers, including testicular, ovarian, uterine, and lung cancers. Ganymed recently completed a Phase I clinical trial (OVAR) to assess the efficacy and safety of IMAB027 as single agent in patients with advanced ovarian cancer and foresees initiating Phase II studies by end of 2016.

Ganymed is a private company that was founded in 2001 as a spin-off from the Universities of Mainz and Zurich. Its majority shareholder is ATS Beteiligungsverwaltung GmbH. Other investors include Future Capital AG, MIG Fonds, FCPB Gany GmbH, and private individuals.


Contacts

Ganymed Pharmaceuticals AG
Dr. Luc St-Onge
Business Development
An der Goldgrube 12
55131 Mainz
Germany
+49 (0)6131 1440 109
bd@ganymed.ag

Media Contact
Frank Butschbacher, CIR
Investor Relations & Communications
Mobile: +43-650-78 44 940
Office: +43-2236-892036
office@butschbacher.net

Billingham, U.K.,  June 6, 2016 / B3C newswire / -- FUJIFILM Diosynth Biotechnologies, a leading global biologics Contract Development and Manufacturing Organization (CDMO), has announced that it is in the process of establishing a long-term collaboration with MSD, a global biopharmaceutical company known as Merck in the U.S. and Canada, to invest in and operate a large-scale microbial-biologics facility for supply of active pharmaceutical ingredient (API) to its customers.

This collaboration involves a $60-million USD investment by MSD at its Brinny manufacturing plant in Innishannon, County Cork, Ireland. MSD in Brinny has been in operation for more than 30 years and is an integrated site for the development, testing and manufacturing of biologics.

It is intended that the large-scale biologics operations at MSD in Brinny will be operational in early 2018 for biotech and pharma customers of Fujifilm Diosynth.

The collaboration:

• Addresses a market need for large-scale microbial biologics manufacturing;
• Complements Fujifilm Diosynth’s existing microbial capacity that ranges from 100L up to 5000L both in the USA and UK; and
• Enables Fujifilm Diosynth’s customers to benefit from MSD’s strong track record with large-scale microbial operations.

Fujifilm Diosynth will lead customer interactions, program management and process and analytical development, and the MSD facility in Brinny will operate as cGMP manufacturing support for Fujifilm Diosynth’s CDMO business, enabling seamless technology transfer and technical support.

Microbial fermentation remains vital technology for the process of manufacturing biologics, and this investment, drawing on the latest production advances, will enable Fujifilm Diosynth’s existing and future customers to have a clear and secure line-of-sight to higher product volumes along with lower cost-of-goods. The latter is particularly important as products enter late clinical phase and commercialization.

Steve Bagshaw, CEO of Fujifilm Diosynth, said “We are delighted to progress this collaboration which illustrates how innovative approaches bridging pharma and CDMO can build value for suppliers and ultimately patients.”

Sanat Chattopadhyay, president of the MSD Manufacturing Division, said: “MSD is excited to collaborate with Fujifilm Diosynth through expanded capabilities in bulk microbial fermentation and downstream support services. This will allow MSD to use and further develop the skills and competencies of the people at the MSD site in Brinny and build on the site’s long tradition of manufacturing excellence.”

About Fujifilm
FUJIFILM Diosynth Biotechnologies an industry-leading Biologics Contract Development and Manufacturing Organization with locations in Billingham, UK, RTP, North Carolina and College Station, Texas.  FUJIFILM Diosynth has over thirty  years of combined experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect cell line systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™ cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation.  For more information, go to: www.fujifilmdiosynth.com

FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies.  In the year ended March 31, 2016, the company had global revenues of $19.0 billion, at an exchange rate of 113 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com

Contact

Liza M. Rivera
Fujifilm Diosynth Biotechnologies
+1 919-325-6972
Liza.rivera@fujifilm.com

Uppsala, Sweden, June 7, 2016 / 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 a new range of On-line SPE Cartridges, an alternative SPE format, designed for use primarily in integrated SPE-HPLC-(MS/MS) systems. Containing EVOLUTE® EXPRESS ABN or ISOLUTE® ENV+ sorbents, On-Line SPE cartridges consist of a stainless steel cartridge with standard HPLC compatible end fittings.

Biotage On-line SPE cartridges allow sample preparation to be fully integrated into an automated analytical workflow. The on-line approach can reduce sample size, handling and preparation, and increases throughput while minimizing waste and solvent consumption. The columns come with standard stainless steel HPLC fittings, and are compatible with most systems.

Biotage On-line SPE cartridges are primarily aimed at the environmental market for extraction of trace organic analytes from water samples. Trace analysis of organics in water traditionally involves large sample volumes, labor intensive procedures and relatively high use of solvents. The on-line SPE approach uses a well-established hardware setup, and fully integrates sample preparation into the analytical workflow. Typical sample volumes of 1-10mL, and lower solvent usage mean sample collection, transport and handling, along with solvent disposal costs, are much reduced.

“The availability of the most popular Biotage SPE sorbents such as ISOLUTE® ENV+ in the On-line SPE format allows our customers to fully automate extraction of a wide range of trace organics from water, including very polar analytes such as acid herbicides” said Dr. Claire Desbrow, Product Manager Analytical Chemistry (Application Development), 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 China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 293 employees with sales of 610 MSEK in 2015. 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

• The PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) included 840 women at 58 US institutions.
• 45% of patients with an intermediate/indeterminate Recurrence Score from a 21-gene assay OncotypeDx (commercial assay RS 18-31) were reclassified as Low Risk by Agendia’s FDA-cleared 70-gene assay MammaPrint.  90% of physicians adhered to the treatment decisions based on the definitive MammaPrint results.
• 76% of patients were spared from overtreatment with chemotherapy among the MammaPrint Low Risk patients who were previously indicated to receive chemotherapy based on the indeterminate 21-gene assay results.
• Based on the recent outcomes from the phase III, prospective, randomized MINDACT trial, it is safe to withhold chemotherapy in MammaPrint Low Risk patients, even in the presence of high risk clinical factors.

Irvine, CA, USA and Amsterdam, the Netherlands, June 7 2016 / B3C newswire / -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, has presented new prospective data for its MammaPrint® 70-gene breast cancer recurrence assay at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Results from the Prospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score (PROMIS) show that MammaPrint can provide clear guidance on whether a patient should receive chemotherapy, compared to the indeterminate results from 21-gene assay (OncotypeDx). MammaPrint provides a definitive, binary High or Low Risk result for a patient’s cancer recurring and thus whether the patient needs more aggressive, or less aggressive therapy.

Between 38-67% of women tested in different studies using the 21-gene assay were classified as having an intermediate/indeterminate Recurrence Score (between 18 and 30).¹ PROMIS evaluated 840 estrogen receptor (ER)-positive, lymph node (LN) positive or LN negative women across 58 US institutions who had previously received an intermediate/indeterminate risk score from the 21-gene assay. Patient samples were re-tested using MammaPrint to refine the risk classification and provide additional treatment guidance.

Of the 840 intermediate risk patients, MammaPrint reclassified 55% (466) of these patients as High Risk and 45% (374) as Low Risk of the individual’s cancer recurring. No correlation between definitive MammaPrint results or the indeterminate 21-gene assay Recurrence Score could be identified, reinforcing the discordance between these assays and inability to use the results interchangeably. MammaPrint was shown to provide additional prognostic information independent from clinicopathological factors to support the treatment decision. 

Based on the outcome of the MammaPrint test, 34% (282/840) of physicians changed their treatment decisions, preventing both under and over treatment: 37% (171/466) of the high risk patients had chemotherapy added to their treatment recommendation and 29% (108/374) of the low risk patients had chemotherapy removed from their treatment recommendation. Of the MammaPrint Low Risk patients who were previously indicated to receive chemotherapy based on the 21-gene assay results, 76% of patients (108/142) decided to forego chemotherapy, preventing unnecessary overtreatment in this group.

Medical oncologist Dr. Michaela Tsai from the Virginia Piper Cancer Center, Minneapolis, MN and primary author of the PROMIS poster commented, “Of 466 intermediate patients reclassified as High Risk by MammaPrint, 342 have an Recurrence Score <= 25 and were not recommended for chemotherapy by St. Gallen Guidelines (Goldhirsch, Winer et al. 2013), risking up to a 73% chance of under-treatment.”  She also noted, “79% of physicians reported that they had greater confidence in their treatment recommendations with MammaPrint.”

Dr. William Audeh, Chief Medical Officer of Agendia said: “The clinical performance of MammaPrint and its ability to accurately inform and guide treatment decisions has been definitively proven by the recent presentation of the MINDACT trial at the 2016 AACR meeting. This unique phase III prospective, randomized, controlled study provides the highest level of clinical evidence to MammaPrint above any other genomic assay for making adjuvant therapy decisions in early-stage breast cancer.”  

MINDACT included 6,693 patients and is a phase III, prospective, randomized controlled, clinical trial comparing the use of MammaPrint 70-gene assay with clinicopathological criteria (current standard of care) for selecting early-stage breast cancer patients who should be treated with adjuvant chemotherapy.

“The PROMIS trial showed the positive impact a binary test could have in the clinical setting by providing a clear risk assessment of the patient to physicians” said Mark Straley, Chief Executive Officer at Agendia. “MammaPrint is the only FDA-cleared assay for early-stage breast cancer patients of all ages, further validating the quality and clinical utility of the test.”

About Agendia
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer and colorectal cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint® FFPE 70-gene assay as well as the BluePrint® 80-gene molecular subtyping assay that provides deeper insight, leading to more clinically actionable biology.  These tests can help physicians assess a breast cancer patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.

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. It is also a critical partner in the ISPY-2, NBRST and the MINDACT trials.

Media Contacts:

Scott Speer (US media)
FleishmanHillard
+1 (310) 482-4283
scott.speer@fleishman.com

Léon Melens / Lynne Trowbridge / Jen Lewis (EU media)
Instinctif Partners
+31 (0)6 538 16 427 / +44 (0) 20 7457 2020
agendia@instinctif.com

(1) Lo, Mumby et al. 2011, Sulayman, Spellman et al. 2012, Stemmer, Klang et al. 2013, Sparano, Grey et al. 2015

First risk-mitigating virus-retentive filter for cell culture media

Goettingen, Germany, Aubagne, France, June 13, 2016 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, has launched Virosart® Media for virus retention in cell culture media. With this new media filter, the company offers a fast and cost-effective solution for manufacturers to reduce the risk of virus contamination resulting from raw materials, such as chemically defined media, during fermentation.

Virosart® Media is a single-use filter that provides the highest level of safety for customers’ upstream processes as it is qualified for > 4 log¹⁰ reduction of small, non-enveloped viruses (e.g., MVM) and as a mycoplasma and leptospira retentive filter.

A major benefit of this new filter is that mid-scale and process filters of the Virosart® Media product family will also be qualified as a sterile filter based on the current ASTM guideline. The first product of the Virosart® Media family is a lab filter with a filtration area of 5.0 cm² for down-scale, flow and capacity studies. The mid-scale filter with 0.29 m² and the process filters with 1 m² and 3 m² will follow in the second half of 2016.

Providing superior filter capacity for cell culture media and high patient safety is one of the biggest challenges in today’s upstream processing. ”In the past, downstream virus filters have been used in upstream processing as there were no other adequate solutions available. Our new membrane filter Virosart® Media finally closes this gap in the market,” stated Birte Kleindienst, expert for viral clearance at Sartorius Stedim Biotech.

By launching Virosart® Media filter, SSB rounds out customers’ individual risk mitigation strategy in upstream processing with an additional option: With the filters Sartopore® 2 XLG (0.2 µm) for sterile filtration, Sartopore® 2 XLM (0.1 µm) for retention of mycoplasma and with its new Virosart® Media filter (20 nm) for virus retention, SSB enables customers to mitigate risk at three different levels.

More information
www.sartorius.com/virosart-media

Image File

Caption: Virosart® Media family: First risk-mitigating virus-retentive filters for cell culture media
For high resolution please click the image.

Links for downloading:

https://www.sartorius.com/fileadmin/media/global/company/virosart-product.jpg

https://www.sartorius.com/fileadmin/media/global/company/virosart-application.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 a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 million euros.

Contact

Dominic Grone
Group Corporate Communications
Sartorius Corporate Administration GmbH
Goettingen, Germany
Phone +49. (0)551-308.3324
Fax +49. (0)551-308.3410
dominic.grone@sartorius.com
www.sartorius-stedim.com

Cellca’s Cell Line and Upstream Process Development Services Now Integrated

Glasgow, UK, June 14, 2016 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry announced that its subsidiary BioOutsource launched an updated website to spotlight Sartorius Stedim Cellca’s cell line and upstream process development services for the biopharmaceutical industry. The new microsite features insights into the technology and development services of Cellca most recently acquired by SSB. The availability of both subsidiaries’ unique range of integrated services will support biopharma companies to rapidly and cost-effectively develop their biologics and biosimilars.

The new microsite divides into four easy-to-navigate sections that explain Cellca’s unique CHO Expression Platform which comprises of Expression Vector, Host Cell Line, CHO Media System and Upstream Process Design. This structure gives a simple overview of the technical details and time-saving benefits of this robust, scalable expression platform for individual applications.  

Cellca’s cell line and upstream process development services complement BioOutsource’s broad range of bioanalytical and biosafety testing, as well as pre-qualified biosimilar assays. As a result, scientists and potential customers can source all their needs for developing biologics and biosimilars from one trusted supplier. Additionally, as both Cellca and BioOutsource have been part of Sartorius Stedim Biotech since 2015, biopharma firms that need to commercialize their biologics will not only benefit from this niche expertise, but can also access Sartorius Stedim Biotech’s extensive global upstream process development capabilities to accelerate the development timeline of their biologics and biosimilars.   

Gerry MacKay, Managing Director of Sartorius Stedim BioOutsource, commented: “We’re pleased to be launching our new microsite because it signals the availability of our unique integrated services. Developers of biologics and biosimilars can now go to our site to find out how to access a fully integrated pathway from cell line development and data characterization through to upstream process development. They can also discover how these services will support them to comply with regulatory standards for timely, cost-effective development of their biosimilars.”

To find out about Cellca’s cell line and upstream process development services, scientists should click this link to the new microsite: www.biooutsource.com/cell-line-and-upstream-process-development/

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 a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 million euros.

Contacts

Gemma Fulton
Marketing Manager
Sartorius Stedim BioOutsource Ltd,
Glasgow, United Kingdom
Phone +44(0)141.946.4222
Fax +44(0)141.946.4552
gemma.fulton@sartorius-stedim.com
www.biooutsource.com

Uppsala, Sweden, June 14, 2016 / B3C newswire / -- Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, is pleased to announce that they have achieved ISO 14001:2004 certification. This certificate is an international standard for an environmental management system (EMS) that helps businesses such as Biotage control and improve practices that are potentially harmful to the environment. This comes after years of dedicated work and close collaboration between employees, consultants and managerial staff.

In addition to establishing a series of quality standards regarding business practices and the environment, ISO 14001:2004 certification also comes with various other benefits to the titleholder, including: reduction of costs through efficient use of materials and management of legal compliance by prioritizing environmental risks.

“We at Biotage are incredibly honored to receive ISO 14001 certification of our environmental management systems that have been developed over the years. This certification is much more than just legal compliance; for us, it is a driver by which Biotage can effectively manage responsible business practices that seek to limit negative environmental impact through control of emissions and other potentially harmful actions” said Chris Williams, UK Managing Director, Biotage.

ISO 14001:2004 helps businesses like Biotage manage challenges, systems and risks concerning environmental performance.  The certification serves as assurance to management, employees and external partners that the environmental impact of operations is being measured, monitored and continually improved.

Biotage’s official certification of its environmental management system was confirmed on 5th May 2016 by BSI, the reputable certification body that provides compliance, risk, and technical support.

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 China, Japan, the United Kingdom, the United States and a worldwide network of distributors. Biotage has 293 employees with sales of 610 MSEK in 2015. 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

New expandable benchtop workstation with unique single-use bioreactor design offers a simple approach to process development for fermentation and cell culture

Goettingen, Germany, Cambridge, UK June 15, 2016 / B3C newswire / -- Sartorius Stedim Biotech (SSB) today introduced the ambr® 250 modular, an innovative benchtop mini bioreactor system for parallel fermentation or cell culture. This system combines a unique single-use bioreactor vessel and expandable system design to offer bioprocess scientists access to advanced benchtop bioreactor technology for process development.

The new ambr® 250 modular system consists of a workstation with 2, 4, 6 or 8 single-use bioreactors, with a working volume range of 100 to 250 mL. These mini bioreactors, based on the same stirred tank bioreactors in the well-established ambr® 250 high throughput system, contain impellers suitable for fermentation or cell culture and show excellent scale up to larger bioreactors. They are also fully integrated with liquid reservoirs and syringe pumps, allowing rapid experimental set up and turn around, thus significantly increasing lab efficiency.

The system brings simplicity to the lab bench. By following three easy steps a bioreactor and all the required accessories can be connected in just a couple of minutes. Once installed, the bioreactor has all the required process services for parameter control, including pH, DO, temperature or agitation. Additionally, feeds can now be delivered with high accuracy from the reagent reservoirs via the syringe pumps into the bioreactor. One control unit is capable of controlling up to eight bioreactor stations independently via an easy to use touch screen user interface.

Mwai Ngibuini, Product Manager at SSB, states: “Our new ambr® 250 modular provides an excellent single-use platform, which enables rapid process development and optimization for scale-up to larger bioreactors such as BIOSTAT® pilot and manufacturing scale bioreactors. Utilizing this single-use workflow, will allow bioprocess scientists to improve productivity in their scalable bioprocess development and reduce development time lines, ensuring production of industrial enzymes, biologics and vaccines is more cost-efficient.”

There will be two live webinars on Tuesday July 19, to introduce this exciting new product, and present data on system performance and applications. Bioprocess scientists wishing to join the live webinar, or request a recording, are invited to register at:

http://view6.workcast.net/register?cpak=9191870715355221

Image File

Caption: New ambr® 250 modular bioreactor system for process development
For high resolution please click the image.

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 a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 million euros.

Dominic Grone
Senior Manager Corporate Communications, Sartorius Stedim Biotech
+49 (0)551.3083324
dominic.grone@sartorius.com

Michaela McAdam,
Marketing Communications Manager, Sartorius Stedim Biotech
+44 (0) 1763 227200
Michaela.McAdam@sartorius-stedim.com

Leuven, Belgium, June 16, 2016 / B3C newswire / -- TROD Medical NV, the medical device company developing tools for focal ablation announces completion of enrollment in its clinical study at two world-renown cancer research institutions, University College London (UCL) and New York University (NYU). 

The clinical teams at NYU and UCL presented last month at the 111th American Urological Association’s Annual Meeting (San Diego, CA), on patients treated with Encage. Together with a study running at the Moffitt Cancer Center (Tampa, Florida), over 40 patients have now been treated using Encage. Results not yet published show total tissue destruction in target ablation zones and very significant reduction of side effect (erectile dysfunction and urinary incontinence rates down to 0%).

Prof. Mark Emberton from UCL said: “The wonderful thing about Encage is its simplicity.  It uses an energy source that clinicians are familiar with and provides very controlled and predictable tissue destruction.  It is also extremely versatile in that it can be used to treat small prostate cancers with precision but can also be used to treat the prostate in a zonal manner.”

“Encage is a disruptive technology with the potential to maximize target ablation zones in the prostate while minimizing the all too common side effects associated with current treatments” said Andre Faure, CEO of TROD Medical. He continued, “This significant clinical work at prestigious US and UK institutions builds on the CE Mark Approval for Encage obtained in January 2016, and US FDA 510(k) clearance secured in 2008, and has led to significant attention from major strategic players in urology and surgical oncology.”

TROD Medical’s Encage is a bipolar, radio frequency-based, helical ablation probe enabling minimally invasive focused soft tissue ablation.

Trod Medical will be attending the NYU Symposium on Advances in Prostate Imaging, Detection and Ablative Treatment of Prostate Cancer on 17-18 June in New York City.

About TROD Medical NV
TROD Medical is a medical device company, focused on the development of tools for use in the focal ablation of soft tissues. The Company, founded in 2006 by Dr. Andre Faure, has developed significant expertise in developing innovative ablation technologies, particularly radio frequency (RF) ablation devices.

Trod Medical’s proprietary product, Encage, is a bipolar, radio frequency-based, helical ablation probe enabling minimally invasive focused soft tissue ablation. The device represents a major breakthrough in treatments where collateral tissue damage is a significant burden to patients, such as those with prostate cancer.

TROD Medical is a private venture-backed company with headquarters in Leuven (Belgium) and facilities in the Tampa Bay area (USA), and Paris (France).

Contacts

TROD Medical
Andre Faure, CEO
andre.faure@trodmedical.com

Instinctif Partners
Daniel Gooch / Christelle Kerouedan / Lynne Trowbridge
trod@instinctif.com
+44 (0)20 7457 2020

Vienna, Austria, June 16, 2016 / B3C newswire / -- Hookipa Biotech AG, a company pioneering a new class of immunotherapies and vaccines, today announces the appointment of Mr. Jörn Aldag as CEO.

Mr. Aldag brings significant leadership experience and sector knowledge to Hookipa from leading biotechnology companies including uniQure, Molecular Partners and Unum Therapeutics. In particular, he has an impressive track record of building companies based on unique technology platforms, and bringing them to public markets in order to access the depth of capital needed to develop clinical stage assets. Alongside his CEO role at Hookipa Mr. Aldag will remain Chairman of Molecular Partners and a Board member of Unum Therapeutics, both of which are developing next-gen immuno-oncology therapies.

Prior to his appointment as CEO of Hookipa, Mr. Aldag was CEO of Nasdaq-listed uniQure N.V, a company pioneering adeno-associated virus based gene therapy. Under his leadership uniQure received the first ever approval of a gene therapy product by the European Medicines Agency, built a broad pipeline of gene therapy products across several disease areas, obtained approximately $200 m through its NASDAQ-listing and follow-on, and closed a multi-billion $ collaboration in cardiovascular gene therapy. Previous experience includes President and CEO of Evotec AG (1997-2008). In his position at Evotec AG, he designed many alliances with leading pharma companies, listed the Company on the Frankfurt Stock Exchange and Nasdaq and managed the acquisition of LSE-listed Oxford Asymmetry and Nasdaq-listed Renovis Inc. Mr. Aldag holds business degrees from the European Business School and Harvard Business School (AMP).

Mr. Aldag replaces Dr. Katherine Cohen, who started the Company in 2011 and led its development from early science to clinical stage. As CEO, Dr. Cohen successfully raised €27 million in funding for the Company through Series A and Series B financing rounds, as well as raising an additional €11 million in non-dilutive funds.

Commenting on his new role, Mr. Aldag said, “Hookipa’s Vaxwave® technology platform has tremendous application in both infectious disease and in oncology, and I applaud what Katherine and the team have built to bring this vaccine technology to the next level. The Company is at a very exciting time of its development. Our lead program, HB-101 against Cytomegalovirus, having completed pre-clinical testing and GMP manufacturing, is poised to start a Phase 1 trial in Q3 2016 and our Human Papillomavirus immunotherapy candidate is entering pre-clinical testing.”

Dr. Cohen commented, “It has been a tremendous journey to lead Hookipa and bring the Company to what it is today. I look forward to seeing further success of the Company under Jörn’s leadership.“

“On behalf of the Board, the team and our highly supportive investors I would like to thank Katherine for her contribution to the Company. I am delighted to welcome Jörn Aldag as CEO, to lead the Company through the next stage of its development. Given his experience and track record, I am confident that he will enable Hookipa to realise the tremendous potential of its technology in both oncology and infectious disease”, Chairman John Lambert said.

About Hookipa Biotech
Hookipa Biotech is an immunotherapy company developing next-generation cancer immune-therapeutics and vaccines using novel, proprietary arenavirus vector platforms. Hookipa has raised €11 million in non-dilutive funds and €27 million equity investment from internationally renowned venture capital investors including Sofinnova Partners, Forbion Capital Partners, Boehringer Ingelheim Venture Fund, Takeda Ventures and BioMedPartners.

About Vaxwave®
Hookipa’s broadly enabling Vaxwave® technology platform is based on replication-defective lymphocytic choriomeningitis virus vectors that allow induction of strong humoral and cellular immune responses to viral, bacterial and tumor antigens. Strong therapeutic efficacy data have been generated in various pre-clinical models. One of the most distinguishing features of this vector platform is its homologous prime-boosting capacity, and Vaxwave® based immunotherapy can be applied repeatedly to boost the immune system and generate potent CD8+ T cell responses against targeted antigens. Vaxwave® is patent-protected by issued patents and patent applications worldwide.

Issued for and on behalf Hookipa Biotech AG by Instinctif Partners.

Contacts

At the Company
Jörn Aldag
Chief Executive Officer
Hookipa Biotech AG
Helmut-Qualtinger-Gasse 2
1030 Vienna
Austria
Office@Hookipabiotech.com

Media enquiries
Sue Charles/ Daniel Gooch/ Alex Bannister
Instinctif Partners
+44 (0)20 7866 7905
hookipa@instinctif.com  

Mainz, Germany, June 16, 2016 / B3C newswire / -- BioNTech Diagnostics GmbH, a subsidiary of BioNTech AG, announces the publication of new study data that prove the significant advantages of the in vitro diagnostic test kit MammaTyper® (CE / IVD marked) over the currently established methods of detection used in breast cancer subtyping [1]. In the prospective-retrospective study, MammaTyper® achieved ground-breaking results with precise quantitative detection of the biomarkers ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67). It must be emphasized particularly that MammaTyper® was superior to immunohistochemistry with regard to the prognosis when measuring MKI67 (Ki-67). Thus the study shows that MammaTyper® ensures patient stratification as recommended by the St Gallen criteria, including reliable measurement of proliferation by MKI67. "The positive study dataforMammaTyper® underline our commitment to making personalized medicine broadly available for treating cancer", added Dr Sierk Poetting, Managing Director at BioNTech Diagnostics.

Over the past few years, the IHC method has been discussed time and again by expert groups with regard to its reproducibility, objectivity and comparability. Differences do arise, particularly when measuring the proliferation marker Ki-67 which is used, for example, to differentiate between luminal A and luminal B tumours, among other things [2-5].

Previous studies have already shown that molecular detection of mRNA expression of the markers by RT-qPCR (reverse transcription quantitative real time polymerase chain reaction), on which the in vitro diagnostic test kit MammaTyper® is also based, have significant advantages over IHC [6-8].

The recently published prospective-retrospective randomized MammaTyper® clinical study [1] enrolled a total of 769 patients from the FinHer study [9]. It was the first to compare quantitative measurements of tumour ESR1-, PGR-, ERBB2- and MKI67-mRNA using MammaTyper® with the results of ER-, PR-, and Ki-67 protein expression by IHC or of HER2 by chromogenic in situ hybridization (CISH). The results were correlated with disease-free survival and the overall survival period. The data show that quantitative measurement of ESR1- and PGR- and ERBB2-mRNA by MammaTyper® correlates with the results from IHC and in situ hybridization in pathology laboratories [ER/ESR1: 92 %, p < 0.0001; PR/PGR: 83 %, p < 0.0001 and HER2/ERBB2: 92 %, p < 0.0001, OPA*].

Measurements of MKI67 mRNA expression with MammaTyper® showed that patients who express a low level of MKI67 have a significantly better prognosis with regard to disease-free survival and overall survival than patients with a high MKI67 expression. In contrast, measurement of Ki-67 protein expression by IHC showed no significant difference between these two groups for the prognosis of the two parameters.

The study also showed that the patients identified as luminal B by MammaTyper® who were treated with docetaxel FEC had a more favourable prognosis for disease-free survival and overall survival than those who were treated with vinorelbin FEC. The IHC results were not able to show this relation between subtype and response to the medication. This means that, compared to IHC, breast cancer subtyping by MammaTyper® opens up new opportunities of providing predictive information about the benefits of adjuvant taxane treatment.

In summary, the study clearly shows that, in comparison to established methods, MammaTyper® allows a precise biomarker measurement method that can be standardized and, due to the reliable detection of Ki-67, provides better indications of the need for and benefits of chemotherapy.

*OPA: Overall percent agreement

About MammaTyper®
MammaTyper® is a molecular in vitro diagnostic test for quantitative detection of the mRNA expression status of the genes ERBB2 (HER2), ESR1 (ER), PGR (PR) and of MKI67 (proliferation marker Ki-67) in the tumour tissue of female patients with newly diagnosed invasive breast cancer. The test has been validated for total RNA extracted from tissue specimens or biopsies.
MammaTyper® is used for molecular subtyping of breast cancer tissue according to the St. Gallen classification (2013) in luminal A-like, luminal B-like (HER2 negative), luminal B-like (HER2 positive), HER2 positive (non-luminal) and triple negative (ductal) tumours, and offers the possibility of significantly improving the diagnosis and, ultimately, the treatment of female patients with breast cancer. MammaTyper® is intended for use by a doctor together with further clinical pathological factors. The test is very simple, and can be carried out in any pathology laboratory. The test can be used on all female patients with newly diagnosed invasive breast cancer and provides the results on the same day. With MammaTyper®, BioNTech underlines its commitment to making personalized medicine generally available in the field of cancer treatment.

About BioNTech AG
BioNTech AG is an immunotherapy leader with bench-to-market capabilities, developing truly personalized, well-tolerated and potent treatments for cancer and other diseases. Established by clinicians and scientists the Group is pioneering disruptive technologies ranging from individualized mRNA based medicines through innovative Chimeric Antigen Receptors /T-cell Receptor-based products and novel antibody checkpoint immunomodulators. BioNTech’s clinical programs are supported by an in-house molecular diagnostics unit whose products include MammaTyper® a molecular in-vitro diagnostic kit, marketed under CE and IVD marking in Europe and certain other countries. Founded in 2008, BioNTech is privately held, with Strüngmann Family Office as a majority shareholder, having closed the largest initial financing in the European biopharma sector’s history.

About BioNTech Diagnostics GmbH
BioNTech Diagnostics is a fully-owned subsidiary company within the BioNTech AG Group. The ISO 9001/13485 certified company has extensive product and service offerings ranging from biomarker discovery and validation through molecular screening assays, patient stratification and companion diagnostics to clinical monitoring, all to international regulatory standards. Early detection of diseases that have a high mortality rate and the appropriate selection of therapies are crucial for a successful treatment of patients. BioNTech Diagnostics’ mission is to provide new and innovative diagnostic tests to extend lives of patients, improve their quality of life and support the use of appropriate therapy for each individual patient.


Contacts

BioNTech Diagnostics GmbH
Dr. Gerd Hempel
+49-6131-9084-0
media@biontech.de

COMMPartners GmbH Co. KG
Sonja Hinz
+49-8024-47013-10
info@commpartners.de

1 Wirtz Ralph M et al. (2016) Biological subtyping of early breast cancer: a study comparing RT-qPCR with immunohistochemistry. Breast Cancer Res Treat. DOI 10.007/s10549-016-3835-7 (Published online 24 May 2016)

2 Hammond MEH, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, et al., American Society of Clinical Oncology, College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010 Jul;134(7):e48–72.

3 Wolff AC, Hammond MEH, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, et al., American Society of Clinical Oncology, College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan 1;25(1):118–45.

4 De Dueñas EM, Hernández AL, Zotano AG, Carrión RMP, López-Muñiz JIC, Novoa SA, et al. Prospective evaluation of the conversion rate in the receptor status between primary breast cancer and metastasis: results from the GEICAM 2009-03 ConvertHER study. Breast Cancer Res Treat. 2014 Feb;143(3):507–15.

5 Orlando L, Viale G, Schiavone P, Fedele P, Nacci A, Rizzo P, et al. Discordance in pathology report after central pathology review in early breast cancer and its impact on treatment choice. ASCO Meeting Abstracts. 2011 May 20;29(15_suppl):585.

6  Lehmann-Che J, Amira-Bouhidel F, Turpin E, Antoine M, Soliman H, Legres L, et al. Immunohistochemical and molecular analyses of HER2 status in breast cancers are highly concordant and complementary approaches. Br J Cancer. 2011 May 24;104(11): 1739–46.

7  Susini T, Bussani C, Marini G, Nori J, Olivieri S, Molino C, et al. Preoperative assessment of HER-2/neu status in breast carcinoma: The role of quantitative real-time PCR on core-biopsy specimens. Gynecologic Oncology. 2010 Feb 1;116(2):234–9.

8 Wilson TR, Xiao Y, Spoerke JM, Fridlyand J, Koeppen H, Fuentes E, et al. Development of a robust RNA-based classifier to accurately determine ER, PR, and HER2 status in breast cancer clinical samples. Breast Cancer Res Treat. 2014 Nov;148(2):315–25.

9 FinHer-Studie, identifier ISRCTN76560285.

• The peer-reviewed article, authored by scientists from the University of Central Florida, concludes that the triple combination of the RHB-104 active components provides excellent synergistic activity in the inhibition of mycobacterial growth, potentially leading to a new and effective treatment for Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) infection
• RedHill is conducting a first Phase III clinical study with RHB-104 for Crohn’s disease (the MAP US study), with nearly 200 patients recruited out of a total of 270 planned, and interim data and safety monitoring board (DSMB) analysisexpected in the second half of 2016
• The development of RHB-104, a proprietary and potentially ground-breaking therapy with potent intracellular, anti-mycobacterial and anti-inflammatory properties, is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP infection in susceptible patients

Tel-Aviv, Israel, June 23, 2016 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced the publication of an article demonstrating the potential efficacy of RHB-104 for Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis (MAP) infection.

The article was published in the peer-reviewed journal Gut Pathogens and was authored by scientists from the University of Central Florida(1) (UCF) College of Medicine’s Burnett School of Biomedical Sciences(2).

RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy with potent intracellular, anti-mycobacterial and anti-inflammatory properties, currently undergoing a first Phase III study for Crohn’s disease and a Phase IIa study for multiple sclerosis. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by MAP infection in susceptible patients.

The article(3), entitled “RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis” describes a pre-clinical study intended to determine the efficacy of the RHB-104 active components (the antibiotics clarithromycin, clofazimine and rifabutin) against MAP strains isolated from the blood, tissue and milk of Crohn’s disease patients. The researchers determined the minimum inhibitory concentrations of the active components, separately and in dual and triple combinations, against 16 MAP clinical strains and 19 other mycobacteria.

The results of the study demonstrated that the RHB-104 active components, in their individual concentrations or in dual combinations, were not as effective against all microorganisms, compared to the triple combination at minimum inhibitory concentrations level. The authors concluded that lower concentrations of the triple combination of RHB-104 active components provided synergistic anti-MAP growth activity compared to individual or dual combinations of the drugs and, consequently, administration of RHB-104 is considered favorable and should lead to tolerable dosage that is desirable for long-term treatment of Crohn’s disease.

Dror Ben-Asher, RedHill’s CEO, said: “I would like to thank the scientists at the University of Central Florida in Orlando for this article which supports the continued development of RHB-104 for Crohn’s disease. RHB-104 is one of RedHill’s flagship gastrointestinal programs and is currently undergoing a Phase III study, named the MAP US study, in the U.S. and additional countries. With nearly 200 patients recruited out of a total of 270 planned, the MAP US Phase III study is advancing well and we expect interim data and safety monitoring board (DSMB) analysis during the second half of 2016. The final results from the Phase IIa proof-of-concept study with RHB-104 in multiple sclerosis are also expected in the second half of 2016, following our previous announcement of encouraging preliminary data in March 2016.”

Dr. Reza Fathi, Ph.D., RedHill’s Senior VP R&D, added: “We are pleased with the important findings described in this article which provide further validation of the synergistic activity and potential efficacy of RHB-104 in eradicating Mycobacterium avium subspecies paratuberculosis, or MAP, - a suspected etiological agent of Crohn’s disease and possibly additional autoimmune, inflammatory and mycobacterial diseases. The results from this study suggest that RHB-104, if approved, could become a new and effective therapy for the treatment of Crohn’s disease.” 

RHB-104 is currently undergoing a first Phase III study for Crohn’s disease in the U.S., Canada, Israel, Australia and additional countries (the MAP US study). Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.

RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The open label Phase IIa, proof-of-concept clinical study is evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). RedHill announced encouraging top-line interim results from this study in March 2016. Final results of the completed 48-week study are expected during the second half of 2016. 

The MAP US Phase III study and the CEASE-MS Phase IIa study 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) and a second Phase III study which is being prepared (the MAP EU study), RHB-104 is a proprietary and potentially groundbreaking oral antibiotic combination therapy, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. Clinical trials conducted with earlier formulations of RHB-104 include an Australian Phase III study conducted by 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. RHB-104 is covered by several issued and pending patents. RedHill is also conducting the CEASE-MS 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 (RRMS), with top-line interim results announced.

About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a 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 inflammatory and gastrointestinal diseases and cancer. RedHill’s current pipeline of proprietary products 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 and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA^™ (RHB-102)- a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. 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 uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumors; (vii) RP101- currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) 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 Germany in October 2015; and (ix) RHB-101- a once-daily oral pill formulation of the cardio drug carvedilol.

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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company's business. 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 25, 2016. 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) The University of Central Florida provides laboratory provides services as a sub-contractor as part of RedHill’s MAP US Phase III study with RHB-104.
(2) RedHill announced in September 2011 that it had acquired an exclusive license from the University of Central Florida to a patent-protected diagnostic test for the detection of MAP.
(3) Alcedo KP, Thanigachalam S, Naser SA. RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis, Gut Pathogens, 2016, 8:32.

• Additional non-dilutive funds to accelerate US market approval and product launch
• Support aims to increase familiarity/acceptance in US burn centers, demonstrate economic benefits and increase acceptance of ReCell® in US Burns Centers
• Funds will be deployed to support recruitment of additional US operational staff

Northridge, CA, USA, Perth, Australia and Cambridge, United Kingdom, June 27, 2016 / B3C newswire / -- A US Federal authority charged with supporting development of medical countermeasures for possible mass casualty events has agreed to fund Avita Medical a further $US7.96 million to support the regenerative medicine company in its plans for US market approval and product launch of ReCell®, the Company said today.

Avita Medical Limited, (ASX:AVH; OTCQX:AVMXY) which makes Autologous Cell Harvesting Devices for treatment of burns, chronic wounds and certain aesthetic conditions, said the award supplements the contract executed last September with the Biomedical Advanced Research and Development Authority (BARDA), worth up to $US53.9m. The initial contract with BARDA, an authority under the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, includes procurement and various elements of support for late-stage development of ReCell®. The new contract addendum, worth up to $US7.96 million (AUD $11m), commences immediately, giving further operational support to facilitate the overarching objective of BARDA for preparedness via securing effective treatment of burn injuries secondary to detonation of a nuclear device.

The additional funds will bolster ongoing work toward the Company’s filing of a PMA application, along with funding new initiatives toward gaining familiarity and acceptance of ReCell® within US Burn Centers, including health economic modelling of the benefits associated with ReCell® for burns treatment and continuing engagement with US Burn Centers for use of ReCell® under the Company’s open Investigational Device Exemptions (IDEs) for treatment of a range of burn injuries including the particularly extensive burns associated with Compassionate Use. Towards this, Avita will utilize these funds towards recruitment of new personnel at the Company’s office in Northridge, California. The new staff will be focused on such operational areas as regulatory, supply chain, quality systems, clinical support and reimbursement.

“This welcome infusion of significant non-dilutive capital to fund our activities in the US, which we would otherwise have had to fund ourselves, greatly supports Avita Medical on its commercial journey,” said Avita CEO Adam Kelliher.  “We are particularly excited about the health economics support, which we hope will enable us to show how innovative approaches such as ours can both help burn victims and save money as these are the key drivers to support our reimbursement efforts.”

BARDA’s initial contract funds the completion of Avita’s FDA approval trial, for which all treatments have now been completed, and the cohort is currently being observed over a 52-week safety period.  As well as an initial procurement of some 5,000 devices, the contract also funds an education programme, so that burns surgeons across the US will be trained as well as supplied with the medical devices, should there be a mass casualty event involving numerous burn injuries. The procurement order could be placed prior to FDA approval based on the possibility for deployment of ReCell® devices under an Emergency Use Authorisation. The Company said it is in close communication with BARDA on the progress of its FDA approval pathway, which is scheduled to complete in calendar Q3 2017.   

About ReCell® AND RES™
ReCell® is Avita Medical’s unique proprietary technology that enables a clinician to rapidly create, at point of care in approximately 30 minutes, Regenerative Epithelial Suspension (RES™) using a small sample of the patient’s skin. RES™ is an autologous suspension comprising the cells and wound healing factors necessary to regenerate natural, healthy skin. RES™ has a broad range of applications and can be used to restart healing in unresponsive wounds, to repair burns using less donor skin, yet with improved functional and aesthetic outcomes, and to restore pigmentation and improve cosmesis of damaged skin.

About Avita Medical Ltd
Avita Medical develops and distributes regenerative products for the treatment of a broad range of wounds, scars and skin defects. Avita’s patented and proprietary collection and application technology provides innovative treatment solutions derived from a patient’s own skin. The company’s lead product, ReCell®, is used in the treatment of a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell® is patented, CE-marked for Europe, TGA-registered in Australia, and CFDA-cleared in China. In the United States, ReCell® is an investigational device limited by federal law to investigational use.

 
Contacts

Avita Medical Ltd
Adam Kelliher
Chief Executive Officer
+44 (0) 1763 269 772
akelliher@avitamedical.com

Tim Rooney
Chief Financial Officer
+ 1 (818) 356-9400
trooney@avitamedical.com

Gabriel Chiappini
Company Secretary
+61 (0) 8 9474 7738
gabriel@laurus.net.au

UK/EU

Instinctif Partners
Gemma Howe/Sue Charles
+44 (0)20 7866 7860
avitamedical@instinctif.com

USA

The Ruth Group
David Burke, Investor Relations
Kirsten Thomas, Public Relations
+1 (646) 536-7009 / +1 (508) 280-6592
dburke@theruthgroup.com / kthomas@theruthgroup.com

Australia

Monsoon Communications
Dean Felton
Investor Relations / PR
+61 (0) 3 9620 3333
deanf@monsoon.com.au

Positive results in a double-blind controlled study in the knee

Krems an der Donau, Austria, June 29, 2016 / B3C newswire / --  OrthoSera GmbH, an orthobiologics company developing serum-based solutions for musculoskeletal indications announces that a double-blind, controlled study with BoneAlbumin™, the company's first marketed product has been accepted for publication in International Orthopedics. The technology is covered by a patent, which has recently been granted by the European Patent Office and is already issued in the US.

The technology is based on the proprietary serum albumin coating of bone allografts, a fully-human bone substitute that has shown strong stem cell induction capacity. This feature is unique among cell-free bone grafts as this is the only off-the-shelf tissue product that is capable of further enhancing the innate bone inducing ability of allografts. The current study has proven with high statistical significance that BoneAlbumin™ implantation not only results in better remodeling on CT images but significantly reduced pain at the implantation site even 6 months after surgery. In the sports medicine field anterior cruciate ligament (ACL) replacement with patellar bone-tendon-bone (BTB) autograft is the first choice of implant by many surgeons, especially for athletes with high demands on the knee joint. Donor-site pain is the major side-effect of BTB harvesting and the current study has shown that it can be avoided by a novel, off-the-shelf bone graft implantation. This is a significant step forward in bone tissue engineering as it achieves better implantation abilities without the cost or complexity of cell-based therapies.

BoneAlbumin™ is already in use in the European dental market with almost 1,000 successful implantations since its introduction in late 2015 and additional clinical indications being investigated by key opinion leaders in orthopedics.

About OrthoSera
With headquarters in Krems/Austria and subsidiaries in the US and Hungary, OrthoSera GmbH is a commercial-stage regenerative medicine company. The serum-based approach to address various degenerative diseases like osteoarthritis is expected to become a game changer in the orthobiologics market. OrthoSera puts special emphasis on designing simple and affordable protocols allowing a wider patient population to benefit from their solutions. The first commercial product BoneAlbumin™, an innovative albumin-coated bone allograft, is currently marketed in Europe with a special focus on dental and orthopedic indications.

Contact

OrthoSera GmbH
Dr. Marion Ettenauer
Dr.-Karl-Dorrek-Straße 23-29
A-3500 Krems an der Donau
+43 664 77 883 16206
marion.ettenauer@orthosera.com
www.orthosera.com