(Prepublished online, Blood, Jan. 11, 2013)

Non-inferiority of anagrelide compared to hydroxyurea in WHO-essential ET.

Vienna, Austria, March 18, 2013 / B3C newswire / - Anagrelide a selective platelet lowering agent is not inferior compared to hydroxyurea in preventing disease related complications in patients with WHO-ET. ANAHYDRET study data now provide evidence that anagrelide can be considered as first line therapy for lowering of platelet count in WHO-ET.

High platelet counts in essential thrombocythemia (ET) can be effectively lowered by treatment with either anagrelide or hydroxyurea. However, previous data on this treatment stem from PVSG classified ET and until recently it was still unknown whether existing treatment recommendations could also be applied to ET patients diagnosed according to the contemporary World Health Organization (WHO) classification (WHO-ET). Now, data of the ANAYDRET study confirm anagrelide to be non-inferior to hydroxyurea in the treatment of WHO-ET.

“Our thanks go to the investigators and their staff who participated in this compelling study. I truly believe that these results with anagrelide will translate into clinical benefits for patients with ET”, Dr. Rudolf Widmann, CEO of the sponsor AOP Orphan Pharmaceuticlas AG, Vienna, Austria commented.

In 259 previously untreated, high-risk ET patients, diagnosed according to the WHO classification system, efficacy and tolerability of anagrelide compared to hydroxyurea was investigated in a prospective randomized non-inferiority phase III study in an a-priori ordered hypothesis. Confirmatory proof of non-inferiority of anagrelide was achieved after 6 months using the primary endpoint criteria and further confirmed after an observation time of 12 and 36 months for platelet counts, hemoglobin levels, leukocyte counts (significantly lower in hydroxyurea group due to its non-selective mode of action) (all p<0.001) and ET related events (Hazard Ratio [95%CI]=1.19[0.61-2.30], 1.03[0.57-1.81] and 0.92[0.57-1.46] respectively). During the total observation time of 730 patient-years, there was no significant difference between the anagrelide and hydroxyurea group regarding incidences of major arterial (7 vs. 8) and venous (2 vs.6) thrombosis, severe bleeding events (5 vs. 2), minor arterial (24 vs. 20) and venous (3 vs. 3) thrombosis and minor bleeding events (18 vs. 15), or discontinuation rates (adverse events 12 vs. 15 or lack of response (5 vs. 2). Disease transformation into myelofibrosis or secondary leukemia was not reported.

“I am extremely pleased with the ANAHYDRET study results. With this well designed study, we now have clear evidence for an equi-effective treatment option devoid of the leukemogenic properties of hydroxyurea”, declared Prof. Heinz Gisslinger, Medical University of Vienna, principal investigator on behalf of the ANAHYDRET Study Group.

About ET
Essential thrombocythemia (ET) is a disorder of the bone marrow characterized by a neoplastic overproduction of platelets (thrombocytes). This overproduction of platelets can lead to an increased risk of blood clots (thrombus) and bleeding (hemorrhage). However, with permanent control of platelet numbers, most patients with ET have a near normal life expectancy.

About Anagrelide
Anagrelide (Thromboreductin®) is an oral imidazoquinazoline agent which selectively slows the maturation of platelet precursor cells. Anagrelide is indicated for the reduction of elevated platelet counts in at risk patients with ET.

About Hydroxyurea
Hydroxyurea is a mild cytostatic agent working by antagonizing the production of deoxyribonucleotides (DNA components). Thereby hydroxyurea non selectively slows the proliferation of rapidly growing cells such as blood cells. Hydroxyurea is indicated for the treatment of several neoplastic blood diseases.

Contact

Daniela Gruber
AOP Orphan Pharmaceuticals AG
Wilhelminenstraße 91/IIf
1160 Vienna / Austria
T +43 1 503 72 44-42
F +43 1 503 72 44-61
daniela.gruber@aoporphan.com

Canterbury, UK, March 18, 2013 / B3C newswire / – Ziarco, a recently-launched biopharmaceutical company focusing on steroid-unresponsive inflammation and allergic diseases, has appointed pharma leader and former President of Pfizer Global R&D, Dr John L. LaMattina as Strategic Advisor. His role at Ziarco will be to provide input on the company's corporate, R&D strategy and growth plans.

Commenting on his appointment, Dr LaMattina said: "Ziarco has amassed an excellent portfolio of early drug candidates with great potential. I am very much looking forward to working with the Ziarco team to convert these assets into valued new medicines."

Ziarco’s CEO, Dr Mike Yeadon, commented: "We are delighted that John is joining the team as a Strategic Advisor. Under his inspirational leadership during his long career at Pfizer, not only were several excellent medicines discovered and developed, but many of what are now industry-recognised R&D best-practises were established, as were many future leaders also. His expertise will be invaluable to use as we drive our portfolio of preclinical and clinical programs forward."

John L. LaMattina, PhD
Dr. LaMattina is a Senior Partner at PureTech and was previously President, Pfizer Global Research and Development and Senior Vice President, Pfizer Inc.
During Dr. LaMattina’s leadership tenure Pfizer advanced a number of important new medicines including Chantix, Selzentry, Lyrica, Inlyta, Xalkori and Xaljenz. He is the author of numerous scientific publications and U.S. patents. In addition, Dr. LaMattina is the author of “Drug Truths: Dispelling the Myths About Pharma R&D” and “Devalued & Distrusted – Can the pharma industry restore its broken image.” Dr. LaMattina serves on the Board of Directors of Ligand Pharmaceuticals, Vedanta and Gelesis, and is a member of the Scientific Advisory Board of Trevena Pharmaceuticals.

About Ziarco
Ziarco is a clinical-stage biotechnology company developing innovative therapeutics targeting inflammatory and allergic diseases. The company’s product pipeline includes a histamine H4 receptor antagonist programme with potential in multiple therapeutic areas, including asthma, allergic rhinitis, pruritus, skin diseases and pain. A lead H4 antagonist has completed a Phase 1 multiple ascending dose study. A second clinical-stage programme targets inflammatory disorders by inhibiting cytosolic phospholipase A2 (cPLA2). The pipeline is completed by a histamine H3 receptor antagonist programme possessing CNS-sparing properties which is in advanced preclinical development and an early-stage spleen tyrosine kinase (SYK) inhibitor programme suitable for topical administration. Investors in Ziarco include Biotechnology Value Fund L.P. and other affiliates of BVF Partners L.P. and Pfizer Venture Investments.

Ziarco Contact:
Mike Yeadon
+44-1227-459119
mike.yeadon@ziarcopharma.com

New offering will expand access to powerful analytical platforms

Germantown, MD, USA, March 19, 2013 / B3C newswire / - Xceleron, a leader in the design and use of ultra-sensitive Accelerator Mass Spectrometry (AMS) in novel clinical investigations, has announced a partnership with JCL Bioassay, a leader in the use of highly sensitive LC-MS/MS and proprietary methodologies. The new partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and N. America.   

Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability and human metabolism. Investigations of this type conducted early in drug development allow confident critical decision-making that offers a very cost-effective alternative when compared to later stages of clinical development.

The partnership between Xceleron and JCL Bioassay will provide access to clinical design expertise and the most appropriate analytical platform for the purpose of early clinical investigation. Xceleron and JCL Bioassay have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations and both companies have recently built, equipped and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.

“This partnership emphasizes the critical role of contemporary analytical platforms in driving down the cost of drug development. Whether in Phase 0 or enriched Phase I, we can confidently provide critical PK and PD information before Phase II” said Dr Michael Butler, CEO of Xceleron.

“With 27 years’ experience in providing services for bioassay work coupled with-state-of-the-art analytical instruments, our researchers are well positioned to conduct ultrasensitive bioanalyses. This has led to the continuous growth of our company as a leader in the bioanalytical field and enables our customers to make rapid and precise decisions on their drug development programs. The partnership with Xceleron further expands the geographic and technological scope of the services we can provide to our customers and promotes the use of these cutting-edge analytical platforms to detect low level analytes in early drug development” said Jenny Lin, Vice President of Operations and CSO of JCL Bioassay USA, Inc.

 
About Xceleron
Xceleron provides bioanalytical AMS services for accelerated early drug development. The company pioneered human microdose and microtracer techniques using ultra-sensitive AMS to investigate the pharmacokinetics and metabolism of developmental drugs in Phase 0, Phase I and Phase II/III clinical trials. It has been providing drug development services for more than 10 years and has conducted more GLP and GCP studies than any other analytical service provider of its type.

About JCL Bioassay
JCL Bioassay USA, located in Hoffman Estates, IL, is a leading Japanese CRO and a global provider specialized in Bioassay services in support of TK/PK studies for pre-clinical and clinical developments. The company provides cutting-edge capabilities and sophisticated expertise in Bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. The company also pioneered microdosing analysis in Japan. As a strategic drug development partner, JCL Bioassay USA helps sponsors to overcome challenges in Bioanalysis with expertise, rapid turn-around-time and high quality services.

Company Contact:
Michael Butler
Xceleron
+1 240 361 1900 ext 2050
mike.butler@xceleron.com

Media Contacts:
Sylvie Berrebi
+44 (0)7795 197271
Sylvie@sciad.com

Richard Anderson
+44-(0)7973-950376
richard@smartpathdigital.com

London UK, March 25, 2013 / B3C newswire / - CoCo Therapeutics Ltd, a newly formed UK Biotechnology Company today announced the appointment to its Clinical and Scientific Advisory Group of Clive Ballard, Jonathan Corcoran, Roy Lobb, Andrew Wood and Steve Butcher.

• Clive Ballard is Professor of Age Related Diseases, Co-Director of the Biomedical Unit for Dementia at the Institute of Psychiatry, Co-Director of the Wolfson Centre for Age Related Diseases, Kings College London and Director of Research for the Alzheimer’s Society.
• Jonathan Corcoran is the founding Scientist of CoCo Therapeutics, Professor of Molecular Neurobiology and Director of the Neuroscience Drug Discovery Unit, Wolfson Centre for Age Related Diseases, Kings College London.
• Roy Lobb is a Consultant to the Biotech industry, specialising in early discovery research. Dr Lobb was a Co-Founder of Avila Therapeutics.
• Andrew Wood is a Venture Partner at Advent Venture Partners and formerly had responsibilities for European CNS R&D and business development at Eli Lilly & Co.
• Steve Butcher is Chief Operating Officer (COO) of CoCo Therapeutics and was formerly COO of TopoTarget A/S and CSO of BioImage A/S.

Commenting on these appointments, Steve Butcher said "We are very pleased to be supported by such an expert group of advisors as we progress our RAR-alpha agonist programme for Alzheimer’s disease".

Alzheimer’s disease (AD) is the most common cause of dementia, affecting around 5.3 million people in the US, 417,000 people in the UK and many millions of others worldwide. It is estimated that this incidence will more than double by 2050, should current trends continue.

About CoCo Therapeutics
CoCo Therapeutics is a UK biotechnology company focussed on the discovery of new drugs for the treatment of Alzheimer’s disease. The company’s programmes are based on the recent scientific discoveries from the laboratory of Professor Jonathan Corcoran at King’s College London, made during research funded by the Wellcome Trust. This research has implicated RAR-alpha, a novel target, in Alzheimer’s disease.

Contact
Steve Butcher
Chief Operating Officer, CoCo Therapeutics Ltd
T: +44 20 7932 2100
E: steve.butcher@cocotherapeutics.com
W: www.cocotherapeutics.com

Nijmegen/Utrecht, the Netherlands, March 26, 2013 / B3C newswire / – InteRNA Technologies B.V., a biopharma company engaged in the development of microRNA (miRNA)-based therapeutics for oncology, announces today the closing of an equity financing round. New investors participating in this round include the ‘Innovation & Investment Fund Gelderland’, managed by PPM Oost and several business angels.

The proceeds of this financing will be used to progress lead product candidate, miR-3157, for melanoma through preclinical studies towards clinical development. miR-3157 is a microRNA-based compound that has shown outstanding efficacy data in initial preclinical studies of human melanoma. These data were presented at the Society for Melanoma Research Congress in November 2012. Recently, the Company was granted US patent 8,362,230, conferring broad and strong IP protection for miRNA-3157 and related compounds.

InteRNA has developed a promising platform for discovery and validation of miRNA based drug candidates against previously undruggable targets in cancer and other major diseases. In addition to its own miR-3157 program, the Company intends to partner development of other compounds with selected pharmaceutical companies.

“Building on our leadership position in the field of miRNA-based drugs, and backed by a strong and broad intellectual property position on a large collection of potential miRNA drug candidates, InteRNA is building a competitive pipeline of breakthrough therapeutics, both through internal development and in collaboration with partners. The present funding provides us additional resources to progress development of our lead compound and further validate the power of our platform”, said Roel Schaapveld, CEO of InteRNA Technologies.

About InteRNA Technologies B.V.
InteRNA Technologies develops cancer therapeutics based on a broadly applicable proprietary technology platform for the rapid identification and validation of therapeutic miRNAs. The Company has exclusive access to one of the largest miRNA libraries in the world. At present, InteRNA has established in vivo proof of concept for multiple pipeline candidates. The Company is pursuing a proactive partnership strategy to acquire appropriate delivery technologies for its products and expects to engage in corporate partnerships to progress several of its products into clinical development.
InteRNA Technologies was incorporated in December 2006 by Aglaia Oncology Fund as a spin-off from the Hubrecht Institute, Utrecht, the Netherlands.

Contacts:

Roel Schaapveld, PhD, MBA
CEO
InteRNA Technologies B.V.

Corporate office
Nijmegen City Centre
Jonkerbosplein 52
6534 AB Nijmegen
The Netherlands

Phone: +31 (0)24 352 96 33 / +31 (0)30 2532386
E-mail: schaapveld@interna-technologies.com

Clipster® Aseptic Disconnector makes aseptic tubing disconnection easy

Goettingen, Germany / Aubagne, France , March 26, 2013 / B3C newswire / -Sartorius Stedim Biotech, a leading international supplier for the pharma and biotech industries, has launched new sizes XS and S of the Clipster® Aseptic Disconnector, in addition to the existing size L. This single-use device allows an aseptic disconnection of Silicone (Pt) as well as thermoplastic elastomer (TPE) tubes in biopharmaceutical manufacturing processes. It is safe, quick, easy to use and available as a stand-alone product or pre-mounted on single-use transfer lines and bag assemblies.

The Clipster® Aseptic Disconnector is used after a fluid transfer to disconnect transfer lines and bag assemblies. The disconnection of tubes can be performed in non-classified and classified environments while maintaining product sterility. It is performed with a hand-held tool which ensures easy execution in various space requirements. The Clipster® Aseptic Disconnector XS, S or L can be applied to multiple tubing material (silicone and TPE) and sizes from 1/8”x1/4” up to 1/2” x 3/4”.

The validation of this key single-use device has been carried out under the most stringent test regimes. Biological and physical tests have been combined to provide data representing a variety of process conditions including critical applications.

Caption: The Clipster® Aseptic Disconnector XS (yellow), S (red) and L (white) is used after a fluid transfer to disconnect single-use transfer lines and bag assemblies made of silicone or TPE tubes.
(For high resolution picture please right click the image and select "Save target as...")

A Profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge equipment and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions”. Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed 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 enjoys a worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs around 3,000 people and in 2012 earned sales revenue of 544 million euros.

Press contact
Dominic Grone
Sartorius Group Corporate Communications
Phone: +49.(0)551. 308.3324
Fax: +49.(0)551.308.3572
dominic.grone@sartorius.com

Renowned industry experts to advise Definiens on clinical digital pathology market

Munich, Germany, March 26, 2013 / B3C newswire / – Definiens, the global leader of image and data analysis solutions for quantitative digital pathology, today announced it has appointed an Advisory Board comprising renowned industry experts and visionaries in digital pathology. As part of its market expansion strategy, Definiens established the new Board to provide independent advice on trends and opportunities in tissue diagnostics and clinical digital pathology.

Members of the Advisory Board include:

• Ron A. Andrews, President, Medical Sciences, Life Technologies and former CEO of Clarient and CEO of GE Molecular Diagnostics
• Prof. Uwe Bicker, Dean of the Medical Faculty Mannheim, University of Heidelberg and a member of the board of directors of Sanofi SA
• Prof. Manfred Dietel, Director, Institute of Pathology, Charité Berlin and chairman of the German Society for Pathology
• Eric F. Glassy, M.D., Medical Director, Pathology, Inc.and chairman of the Digital Pathology Working Group of the College of American Pathologists
• Prof. Gerd Binnig, Founder and CTO, Definiens (Moderator)

“Definiens is working to advance personalized medicine by contributing to the development of next generation diagnostics, and bringing those novel diagnostics into clinical practice. Our innovations have the potential to transform daily clinical practice for the benefit of both patients and pathologists, particularly in oncology,” said Thomas Heydler, CEO of Definiens. “We will greatly benefit from the wealth of experience of the Advisory Board members while expanding our business into tissue diagnostics and clinical digital pathology.”

As part of its goal to guide Definiens during the company’s expansion, the Advisory Board will discuss trends in digital pathology and highlight opportunities for image and data analysis to revolutionize clinical practice in pathology. Specific topics of discussion will include pathology workflow, tissue diagnostic test development, personalized medicine and next-generation cancer treatment, as well as future technology and market requirements. Definiens founder and Nobel laureate, Professor Gerd Binnig, will catalyze the discussions.

“With the novel opportunities enabled by digital pathology, progress in diagnosing and treating cancer will be accelerated. The visionary power and expertise brought together in the Definiens Advisory Board will be invaluable on our path towards bringing advanced image analysis to clinical pathology,” said Prof. Gerd Binnig, Founder and CTO of Definiens.

 
About Definiens
Definiens is the leading provider of image analysis and data mining solutions for life sciences, tissue diagnostics and clinical digital pathology. Definiens software provides detailed cell-by-cell readouts from target structures on whole tissue slides, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy. Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives.
Definiens is headquartered in Munich, Germany and has offices throughout the United States.

Media Contact
Definiens AG
Dr Florian Leiss
Manager Marketing Communications
+49 (89) 2311-8024
fleiss@definiens.com

Heidelberg, Germany and Carlsbad, USA, March 27, 2013 / B3C newswire / – Medicyte has signed a licensing agreement for the rights to use Lentiviral vector technology from Life Technologies to develop and market next generation, cell-based upcyte® cell products to the biopharma and academic research markets.

Various data, already presented at academic meetings, indicates that Medicyte’s upcyte® hepatocytes combine the benefits of quantity (generation of up to 2000 vials per donor) with the quality of primary hepatocytes. The new generation of upcyte® hepatocytes show more comparable results to primary cells in in-vitro assays (such as CYP 3A4-Induction, genotoxicity or hepato- and cytotoxicity). ‘With the technology we have licensed from Life Technologies, we are capable to bring more predictive, reliable, and standardized cell strains on the market’ commented Dr. Joris Braspenning, CEO of Medicyte GmbH.

Financial terms of the agreement are not being disclosed.

 
About Medicyte
Medicyte is specialised in the controlled generation and standardisation of human primary cell products in virtually unlimited quantities and of highest quality for cell therapy and cell-based R&D. Medicytes proprietary technologies upcyte® and vericyte® enable to expand in a controlled way human hepatocytes from different donors and other cell types in a standardized procedure, thereby making these cells for the first time commercially available in high numbers and consistent quality. Increasingly pharmaceutical companies consider using upcyte® hepatocytes for in vitro ADMET testing.

About Upcyte® Technology
Currently, the primary cell types commercially available are restricted, and their poor proliferative capacity limits their use in cell-based assays. The use of immortalized cell lines in cell-based models, on the other hand, is compromised by their transformed and not healthy phenotype.
Using Medicyte´s innovative upcyte® technology, primary cells are driven into proliferation, thus allowing controlled induction of cell proliferation without immortalization, uncontrolled cell growth or changing typical characteristics.
Therefore, upcyte® cells and corresponding cell-based assays can become available in sufficient quantities with a consistent quality that can be used for research, screening and drug development. That allows true standardization of cell based assays.

 
For further information, please contact

Dr.Birgit Tramnitz
Business Development Manager
b.tramnitz@medicyte.com
Im Neuenheimer Feld 581
69120 Heidelberg / Germany
www.medicyte.com

Center for visual inspection and logistics sets high safety and control standards

Ravensburg, Germany, March 27, 2013 / B3C newswire /  – Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices. The facility was already granted manufacturing approval and cGMP certification for Europa from the RP Tuebingen, Germany in 2012.

The 18,000-square-meter facility, known as Ravensburg Vetter West (RVW), began operations in April 2012. The site provides high-bay warehousing for cold storage and room-temperature products, as well as visual inspection. Featuring state-of-the-art technology, which helps adapted to the needs of the separate supply and manufacturing processes, RVW also harnesses extensive use of renewable energy sources, including photovoltaic and geothermal.

“We’re pleased with the outcome of Ravensburg Vetter West’s first FDA GMP inspection,” said managing director Thomas Otto. “We at Vetter work diligently to meet regulatory requirements. Maintaining high quality standards is a job we take seriously to be a reliable and efficient partner for our customers.”

About Vetter
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.

Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com

Somatoprim reduces human growth hormone secretion safely and effectively in acromegaly patients

Tel Aviv, Israel, April 3, 2013 / B3C newswire / - Aspireo Pharmaceuticals Limited (“Aspireo”), an Israeli biopharmaceutical company, focused on the development of Somatoprim, a novel somatostatin analog (SSA), today announced results of a phase IIa study in acromegaly patients. The study was designed to investigate the safety, tolerability and efficacy of single ascending doses of Somatoprim (DG3173) in up to 20 treatment-naïve acromegaly patients.

Analysis of the results shows that Somatoprim demonstrated a dose-dependent effect on lowering excess growth hormone (hGH) on treatment-naïve patients suffering from acromegaly. No serious adverse events were reported and the reported adverse events were mild to moderate and of transient nature.

Carsten Dehning, CEO of Aspireo said: “The result of this clinical study provides proof-of-concept that Somatoprim has the potential to be a safe and effective treatment for acromegaly. An analysis of the pharmacodynamic and pharmacokinetic relationship gives us further valuable insight into the dose dependent effectiveness of Somatoprim in reducing growth hormone secretion.”

About Somatoprim
Somatoprim (DG3173) is a novel and proprietary somatostatin analog (SSA) that is based on a novel amino acid composition. Somatoprim has demonstrated a unique receptor binding and pharmacological profile which is significantly differentiated from SSAs that are currently marketed or in clinical development. In particular, Somatoprim has shown an improved side effect profile with reduced adverse effects on the gastrointestinal tract and glucose metabolism. Furthermore, assessment of growth hormone secretion in cultured human somatotroph adenoma tissue treated with Somatoprim indicates that it has the potential to increase the response rate of acromegalic patients to SSA therapy. Somatoprim is currently in phase I/II of clinical development. Somatostatin analogs have been approved for the treatment of acromegaly, carcinoid tumours, and Cushing’s disease but have also demonstrated significant potential in diabetic retinopathy. Somatostatin analogs are generating more than USD 1.5 billion in annual sales in a continually growing market.

About Aspireo
Aspireo Pharmaceuticals Ltd is a biopharmaceutical company focused on the development of a novel somatostatin analog (SSA) for the treatment of diseases resulting from hormone-active tumors, such as acromegaly, neuroendocrine and gastroenteropancreatic tumors, Cushing’s Disease and diabetic retinopathy. Aspireo’s sole development compound is Somatoprim (DG3173), a novel and proprietary somatostatin analog that is based on a novel amino acid composition and a unique backbone cyclization technology used for stabilization of the peptide. Aspireo is an Israeli company established in 2010 by TVM Capital as a Project Focused Company (PFC). For additional information please visit www.aspireopharma.com.

For further information please contact

Carsten Dehning
Chief Executive Officer
Aspireo Pharmaceuticals Limited
+49 (170) 6308687
dehning(at)aspireo.com

Uppsala, Sweden, April 3, 2013 / B3C newswire / – Biotage (STO: BIOT), a leading global supplier of solutions and technology for analytical, medicinal and peptide chemistry, has announced the launch of ISOLUTE® Myco SPE columns, a new product for the ‘catch and release’ clean up of mycotoxins from food matrices, prior to analysis by LC-MS/MS.

The ISOLUTE® Myco sorbent is a proprietary polymeric phase (patent pending) optimized for the extraction of a broad spectrum of mycotoxins from a wide range of foodstuffs; enabling chemists to utilize a single SPE product to extract all relevant mycotoxins from an individual foodstuff. Using a single, easy to use sample preparation product, along with optimized matrix specific application notes, scientists can prepare diverse samples for analysis by LC-MS/MS.

ISOLUTE® Myco SPE columns have been developed for use together with LC-MS/MS analysis, their selective clean up enables robust, reliable quantitation of mycotoxins without compromising analytical data quality. The coupling of a dedicated polymer based sorbent with LC-MS/MS analysis saves both time and money as more samples can be processed each day compared to IAC based clean up. The tabless 3 mL format of the ISOLUTE® Myco columns is suitable for a variety of processing equipment including vacuum manifolds, positive pressure manifolds and automated SPE workstations.

“ISOLUTE® Myco SPE columns are a real step forward in mycotoxin sample preparation, helping scientists to fully exploit the advantages of higher productivity and highly selective LC-MS/MS analysis through the use of a truly optimized sample preparation regime” says Dr. Claire Desbrow, Global Product Manager.

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 +81 422 28 1233, 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 272 employees with sales of 462.9 MSEK in 2012. Biotage is listed on the NASDAQ OMX Nordic Stock Exchange. 

For further press information from Biotage please 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
Email: james.churchill@biotage.com

Rutherford, NJ, USA, April 5, 2013 / B3C newswire / - Cancer Genetics, Inc., a diagnostics company focused on developing genomic-based, oncology tests and services, today announced the pricing of its initial public offering of 600,000 shares of its common stock at a price to the public of $10.00 per share. The gross proceeds to Cancer Genetics from the initial public offering are expected to be $6,000,000 (assuming no exercise of the over-allotment option), before underwriting discounts and commissions and other offering expenses payable by Cancer Genetics. Cancer Genetics has granted the representative of the underwriters a 45-day option to purchase up to 90,000 additional shares of common stock from Cancer Genetics to cover over-allotments, if any. Shares of Cancer Genetics’ common stock are expected to be quoted on the OTCQB Marketplace, operated by OTC Markets Group, under the symbol “CGIX” beginning on April 5, 2013. Investors will be able to find Real Time Level II quotes for “CGIX” on www.otcmarkets.com.

The offering is expected to close on April 10, 2013, subject to customary closing conditions.

Aegis Capital Corp. is acting as sole book-running manager for the offering.

Feltl and Company, Inc. is acting as co-manager for the offering.

This offering is being made only by means of a prospectus. Copies of the prospectus relating to this offering may be obtained by contacting Aegis Capital Corp., Prospectus Department, 810 Seventh Avenue, 18th Floor, New York, NY 10019, telephone: 212-813-1010, e-mail: prospectus@aegiscap.com.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on April 4, 2013. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cancer Genetics
Cancer Genetics, Inc. is an early-stage diagnostics company focused on developing and commercializing proprietary genomic tests and services to improve and personalize the diagnosis, prognosis and response to treatment (theranosis) of cancer. The proprietary tests being developed by Cancer Genetics target cancers that are difficult to prognose and predict treatment outcomes by using currently available mainstream techniques. These cancers include hematological, urogenital and HPV-associated cancers. Cancer Genetics recently has begun to provide its proprietary tests and services along with a comprehensive range of non-proprietary oncology-focused tests and laboratory services that it has provided historically to oncologists and pathologists at hospitals, cancer centers and physician offices. Cancer Genetics is currently offering its tests and laboratory services in its 17,936 square foot laboratory located in Rutherford, New Jersey, which has been accredited under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity testing.

Contact
Elizabeth Czerepak
Chief Financial Officer
(201) 528-9200
eczerepak@cancergenetics.com

London, UK, April 8, 2013 / B3C newswire / - Canbex Therapeutics Ltd announced today that it has completed a £2.1m ($3.2m) fundraising round that will enable the Company to complete the early development of its lead candidate for the treatment of spasticity in multiple sclerosis (MS). Merck Serono Ventures, the venture capital arm of Merck Serono, led the financing for this round.

“The goal of the Canbex programme is to set a new standard in the treatment of spasticity through improved tolerability,” said Jesse Schulman, CEO of Canbex. “Spasticity is among the most serious and debilitating symptoms of MS. VSN16R, our lead investigational candidate, has the potential to make a difference to people with MS.”

Nilesh Kumar, Director of Merck Serono Ventures, will join the Canbex Board of Directors. Kumar said: “We believe that an effective and well-tolerated treatment for spasticity would address an important medical need, and that VSN16R has the potential to make a major contribution in the area of symptomatic treatments of MS.”

Canbex is a spin-out of University College London (UCL) and was founded by a leading scientific team including Professor David Baker and Professor David Selwood, later joined by Professor Gavin Giovannoni, a practicing MS clinician who is a global leader in MS drug development and clinical research. The company received a Translation Award from the Wellcome Trust in 2011 to support development of VSN16R.

In addition to Merck Serono Ventures, other participants in the financing round included UCL Business PLC (UCLB), the technology transfer company of UCL, and the Wellcome Trust, through the release of the remaining tranches of funding from the 2011 Translation Award. 

UCLB Senior Business Manager Abigail Watts commented: “UCLB are delighted that with this latest investment Canbex will see its lead MS therapeutic move into human trials.”

Past investors in Canbex include Fast Forward, the commercial drug development arm of the US National Multiple Sclerosis Society, the Bloomsbury Bio-Seed Fund and the venture capital fund Esperante SA.

To contact Canbex, please email us at enquiries@canbex.co.uk.

About Canbex
Canbex is a single-asset company that was established for the purpose of developing the VSN compound series. In addition to its pioneering scientific founders, Canbex has assembled a skilled and focused management team. Development activities are carried out through outsourcing to well-established CROs and CMOs. The company’s capital efficiency and lean management strategy ensure that funds are deployed overwhelmingly to compound development and that the company is well structured for exit.

About Merck Serono Ventures
Merck Serono Ventures is the strategic, corporate venture capital fund of Merck Serono, the division for biopharmaceuticals of Merck KGaA of Darmstadt, Germany. The fund invests in emerging biotechnology companies with the potential to provide breakthrough medical solutions in Merck Serono’s focus therapeutic areas: neurodegenerative diseases, oncology, immuno-oncology and immunology. In addition, Merck Serono Ventures invests in companies developing innovative technologies that could enable the discovery and development of new products in its core therapeutic areas.

About UCL Business PLC
UCLB is a leading technology transfer company that supports and commercialises research and innovations arising from UCL, one of the UK’s top research-led universities. UCLB has a successful track record and a strong reputation for identifying and protecting promising new technologies and innovations from UCL academics. It invests directly in development projects to maximise the potential of the research and manages the commercialisation process of technologies from the laboratory to market. UCLB supports UCL’s Grand Challenges of increasing UCL’s positive impact on and contribution to Global Health, Sustainable Cities, Intercultural Interaction and Human Wellbeing.

About the Wellcome Trust
The Wellcome Trust is a global charitable foundation dedicated to achieving extraordinary improvements in human and animal health. It supports the brightest minds in biomedical research and the medical humanities. The Trust’s breadth of support includes public engagement, education and the application of research to improve health. It is independent of both political and commercial interests.

About “Fast Forward”
Fast Forward, LLC is a nonprofit organisation established by the National Multiple Sclerosis Society USA in order to accelerate the development of treatments for MS. Fast Forward accomplishes its mission by connecting university-based MS research with private-sector drug development and by funding small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. More information about Fast Forward and the National MS Society can be found at www.fastforward.org and www.nationalmssociety.org.

Novel, high-tech line fully validated; first customer project underway

Ravensburg, Germany, April 8, 2013 / B3C newswire / ­– Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new award-winning filling line at the company’s Ravensburg Vetter South facility is fully validated and ready for cGMP filling, after successful media-fill completion. One customer project is underway, with more in the wings. The line’s capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 pre-sterilized syringes per minute. The line currently fills 1ml standard-format syringes, with additional formats to be added in the near and long terms. Featuring novel technologies that enhance safety and maximize API yield, it was designed to exceed cGMP requirements.

Highlights of the new commercial line, which features both speed and flexibility, include:

• Minimal human contact to enhance safety:
  - Fully automated transfer of sterile packed tubs from preparation room to Class-A cleanroom and throughout the filling process. Includes a novel approach to zonal transition when moving tubs to higher cleanroom classes.
  - Use of Restricted Access Barrier Systems (RABS).

• Novel disinfection techniques
  - A special spray disinfection tunnel for bagged tubs, co-developed by Vetter and the equipment manufacturer.

• Optimized personnel and material flows
  - One-way design to minimize potential for product mix-up and contamination risk.

• Advanced track and trace
  - An end-to-end track-and-trace system with integrated scanners and printers, including automated disposal of rejects and sample removal following the filling process

• Techniques and technology to maximize API yield
  - Optimized routing that shortens the distances between the compounding area and filling station.
  - 100-percent, fully automated in-line control of syringe closures using a 3-D scanner prior to filling, to minimize API loss and reduce risk of contamination
  - In-line monitoring of filling quantities using an automatic weighing system

Peter Soelkner, Vetter Managing Director, noted, “With our launch of the new filling line, Vetter continues to expand its prefilled-syringe capabilities due to increased customer demand.” He added, “Whether our customers require small-batch clinical fills or high-volume commercial fills, we can accommodate their needs.”

Vetter webinar “Navigating the future of aseptic manufacturing”
Register today for the free, live webinar and find out how to meet challenges in aseptic manufacturing with your CDMO. This live event will take place Tuesday, April 16, 2013, at 10:00 AM EST.

 
About Vetter
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.

Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707
E-mail: PRnews@vetter-pharma.com
www.vetter-pharma.com

Vienna, Austria, April 8, 2013 / B3C newswire / – S-TARget therapeutics (“S-TARget”), a biotechnology company developing vaccines that address the cause of severe allergic diseases, announced today that it has achieved in vivo proof of concept for its drug candidate SG100. SG100 is being developed for the prevention and therapy of severe allergic asthma caused by house dust mite (HDM) allergens.

In a study of SG100 in naïve rhesus monkeys, S-TARget has demonstrated that repeated injections of the candidate vaccine induced a Th1 cell mediated memory immune response against natural HDM allergens. A Th1 immune response is considered a “healthy” immune response to allergens. By contrast, a Th2-mediated immune response can lead to allergic diseases—which in the case of exposure to HDM allergens include severe and persistent asthma. The study has also shown that SG100 can be safely applied in a relevant animal model.

“We are excited about the data from this study as it shows that S-TARget’s technology platform is safe and efficacious in a highly relevant animal model”, commented Geert Mudde, PhD, Chief Scientific Officer of S-TARget and Co-founder of the company.

Dr Mudde continued: “Based on this proof-of-concept study, we are currently initiating a follow-on study with SG100 in a clinically highly predictive non human primate animal model of house dust mite induced allergic asthma. The goal is to demonstrate the ability of SG100 to not only induce a Th1-mediated immune response, but to remodel existing ‘allergic’ Th2 cells into ‘healthy’ Th1 cells, thus triggering a normal immune response to future HDM exposure. SG100 is specifically designed for the human immune system (it will not work in rodents) to achieve exactly this remodeling of allergic Th2-cells. Such remodeling will provide a powerful therapeutic approach to directly address the causes of allergic diseases instead of just treating the symptoms”.

Follow-on study to reduce development risk; data expected in July
“The encouraging results achieved with SG100 are a major milestone for S-TARget”, commented Christof Langer, MBA, Chief Executive Officer and Co-founder of S-TARget. “We look forward to conducting the follow-on study of SG100 as it will be highly predictive of its subsequent development in the clinic. We believe that this approach will facilitate the clinical development. Moreover, it will significantly reduce the development risk of this program, making S-TARget an attractive target for future investors.” S-TARget expects the results of this study to be available in July 2013.

 
About S-TARget
S-TARget therapeutics develops human specific therapeutic vaccines to cure and prevent allergic diseases. S‑TARget‘s vaccines are based on a unique, proprietary technology platform that addresses the cause of the disease and not only the symptoms. They are directed against major, widespread allergic diseases that currently cannot be cured, including severe forms of allergy.

Lead candidate SG100 targets allergic asthma induced by house dust mites (HDM), the major cause of allergy in the Western world.

S-TARget therapeutics was founded in 2010 by two senior pharma professionals with extensive experience in pharmaceutical research and development and in the management of multinational and start-up companies.

The company is privately held. It is based in Vienna, Austria (Europe).

For an overview of SG100 and the underlying technology platform, please see our video on youtube: www.youtube.com/watch?v=xO_NPiZLiiw .

Company contact:

Christof Langer, CEO
S-TARget therapeutics GmbH
Mooslackengasse 17
1190 Vienna, Austria
Phone: +43-664-5160032
christof.langer@s-target.com

Media contact:

Frank Butschbacher
Investor Relations & Communications
Phone: +43-650-7844940
office@butschbacher.net

Munich, Germany, April 9, 2013 / B3C newswire / - Proteros biostructures GmbH ("Proteros") today announced that the company entered into a Lead Discovery Collaboration with Priaxon AG to jointly develop lead compounds for high value protein-protein interaction (PPI) drug targets.

The combination of Proteros’ structure guided discovery with Priaxon’s PPI-directed drug discovery platforms will be focused on the identification of novel small molecule modulators for PPI targets. As part of this collaboration, Proteros will apply its integrated Lead Discovery expertise and technologies in the field of structural biology, biophysics and screening. Priaxon will apply its proprietary drug discovery platform  Priaxplore®, which combines a proprietary PPI focused chemical space with special tailor made chemoinformatic methods for the identification of potential PPI modulators.

“The combination of Proteros’ strength in structural biology and biophysics with the Priaxon’s PPI focused drug discovery platform Priaxplore® forms an excellent basis to make PPI targets of high interest addressable by small molecule modulators" said Dr. Juergen Kolb, CEO of Priaxon.

Dr. Torsten Neuefeind, CEO of Proteros, stated: "We are very pleased to have formed this relationship with Priaxon. Both companies have complementary platforms as well as an established track-record. PPIs are a big challenge in drug discovery and the use of structural information, computational chemistry and Priaxons’ validated chemistry approach allows us to respond to the industry demand for such targets in a unique manner”.

About Proteros
Proteros is a privately held company that provides services and proprietary technologies to support integrated drug discovery. Proteros uses its technical expertise, industrial processes and unique technologies for crystallography, kinetic and thermodynamic profiling and fragment-based lead discovery. The platform allows structure accelerated Lead Discovery. Proteros currently provides services to more than 80 pharmaceutical and biotechnology clients in North America, Europe and Asia.

About Priaxon
Priaxon is an emerging pharmaceutical company building a pipeline of novel drug candidates in different therapeutic fields, but focusing on protein-protein interactions in oncology. Priaxon uses its unique and proprietary drug discovery technology platform Priaxplore® which employs novel methods of chemical synthesis and computational design to discover and develop new chemical entities as candidates for hard-to-drug targets from the PPI field.

About PPIs
Protein-protein-interactions are relevant for a variety of targets (PPIs) in numerous indications and such targets could become successors of kinases as prime targets for a whole era. PPIs pertain to numerous therapeutic fields including cardiovascular and metabolic diseases or oncology. This class of targets has been regarded as un-drugable for a long time. Now, successful approaches to address PPIs together with their high relevance in cellular signaling pathways and regulation make them attractive potential targets for future developments. The chemistry and technology of Priaxon and Proteros are particularly suited for addressing PPIs.

Contact
Proteros biostructures GmbH
Dr. Neuefeind
Bunsenstrasse 7a
82152 Martinsried
Germany
Phone: +49 (0) 89 7007 61 0
E-Mail: business@proteros.de
www.proteros.com

Priaxon AG
Gmunder Strasse 37-37A
Dr. Kolb
81379 Munich
Germany
Phone: +49 (0) 89 4521 308 0
E-Mail: contact@priaxon.com
www.priaxon.com

Munich, Germany, April 9, 2013 / B3C newswire / - Definiens, the global leader of image and data analysis solutions for quantitative digital pathology, today announced it has appointed Merrilyn Datta, Ph.D., as Chief Marketing Officer. Dr. Datta brings a wealth of experience in marketing and her expertise will be critical as Definiens expands its leadership in the life sciences and tissue diagnostics industries.

“I am very excited to have Merrilyn join our leadership team. Merrilyn’s expertise will be key to leverage our leadership position in image and data analysis in Life Sciences into Tissue Diagnostics and Clinical Digital Pathology,“ said Definiens CEO Thomas Heydler. “Merrilyn’s great track record in understanding the marketplace and building businesses will be invaluable for driving Definiens’ Marketing and Commercialization activities.”

Prior to joining Definiens, Dr. Datta served as a senior marketing leader for Life Technologies, a global biotechnology company with customers in the fields of scientific research, genetic analysis and applied sciences, where she specialized in technology commercialization and strategy. Her professional background also includes positions as Chief Content Officer, Services Leader and Gene Regulation BU leader.

“Definiens will take tissue analysis into the 21st century by making the information on histological slides accessible to bioinformatics analysis,” said Dr. Datta. “I’m excited to be a part of the team which will not only provide valuable image understanding to accelerate drug discovery, but which also has a roadmap to fundamentally change clinical practice, advance personalized medicine and improve patient outcomes.”

Dr. Datta is based in southern California and will lead Definiens’ marketing activities from the company’s Carlsbad office.

About Definiens
Definiens is the leading provider of image analysis and data mining solutions for life sciences, tissue diagnostics and clinical digital pathology. Definiens software provides detailed cell-by-cell readouts from target structures on whole tissue slides, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy. Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives.

Definiens is headquartered in Munich, Germany and has a North American office in Carlsbad, California. Further information is available at www.definiens.com.

Media Contact
Definiens AG
Dr Florian Leiss
Manager Marketing Communications
+49 (89) 2311-8024
fleiss@definiens.com

Strasbourg, Dijon, France, April 9, 2013 / B3C newswire / - Inventiva and NovAliX announced today that they have entered into a strategic alliance dedicated to the discovery of clinical candidates, targeting nuclear receptors.

After several years of successful collaboration in the field of nuclear receptors and a proven track record with three programs having reached clinical stage, Inventiva and NovAliX are now officially teaming up to establish a solid alliance to further deliver on the therapeutic promises of the nuclear receptor target class.

Through this alliance, Inventiva and NovAliX offer pharmaceutical and biotech companies a unique set of fully integrated nuclear receptor drug discovery capabilities by combining their respective in-depth expertise in structural biology, medicinal chemistry, biology, DMPK, pharmacology and safety. This alliance will leverage Inventiva’s and NovAliX’s diversified proprietary libraries in combination with complementary screening technologies (multiple biophysical techniques combined with biochemical and bio-functional assays). For the first time, pharmaceutical and biotech companies will be able to entrust their entire nuclear receptor drug discovery program from target validation to IND stage to one single experienced partner.

Pierre Broqua, CSO and co-founder of Inventiva, stated “This is a great opportunity for pharmaceutical and biotech companies wishing to engage in discovery collaborations to address this major, therapeutically relevant, target class. Based on our unique drug-discovery platform, proven track record in nuclear receptors, and our experience in managing collaborations, I strongly believe in our ability to again deliver innovative drug development candidates to our partners”.

Denis Zeyer, CEO of NovAliX, stated, “Ten years ago we built the company on the academic legacy of Pierre Chambon and Dino Moras, world class scientists, who pioneered the field of structural biology and nuclear receptors. We have turned that academic excellence into promising pharmaceutical candidates and this alliance is the opportunity to further extend that success”.

About NovAliX
NovAliX is providing enabling chemistry and innovative biophysical technologies to support the pharmaceutical research needs for structure- and fragment based drug discovery. With its proprietary Graffinity SPR technology, X-ray protein crystallography, native mass spectrometry, proprietary NMR methodologies and chemistry expertise, NovAliX offers comprehensive integrated services for small molecule drug discovery. NovAliX Group, a team of 130 scientists, is located in Strasbourg-Illkirch (France) and Heidelberg (NovAliX’s Graffinity subsidiary in Germany).

About Inventiva
Inventiva is a first-class drug discovery organization dedicated to providing IND-ready drug development candidates in therapeutic areas of high unmet medical need. Over the past 10 years Inventiva’s team has develop a proprietary expertise in the biology and medicinal chemistry of liganded and orphan nuclear receptors, with a strong track-record in the discovery of clinical candidates. At its research centre based in Dijon (France), Inventiva’s team of 85 scientists with extensive pharmaceutical industry background offers a high quality and efficient one-stop-shop solution for drug discovery collaborations.

Contacts

Denis Zeyer, CEO
NovAliX
Bld Sébastien Brant, BP 30170
F-67405 Illkirch CEDEX FRANCE
info@novalix-pharma.com

Pierre Broqua, CSO
Inventiva
50 rue de Dijon
21121 Daix FRANCE
info@inventivapharma.com

April 10, 2013 / B3C newswire / - SARomics Biostructures, Prestwick Chemical and ProQinase together with the University of Turin, Italy, the Israel Structural Proteomics Center (ISPC) at the Weizmann Institute of Science, Israel, and the TechMedIll platform of the University of Strasbourg, France, announce today that they have created the Translational Kinase Tumor Inhibitor Discovery Consortium (TAKTIC), funded with €1.1 million by the EU 7th Framework Program “Research for the Benefit of SMEs”.

Targeting kinases has become one of the most important therapeutic opportunities for treating cancer, diabetes, inflammatory diseases and more. The TAKTIC Consortium brings together the unique and proprietary technologies of three SMEs and their knowhow in the field of drug discovery. To this are coupled the extensive expertise in medicinal chemistry, kinase biochemistry and biology of the University of Turin as well as the state-of-the-art high throughput platform for protein expression and crystallization of the Israel Structural Proteomics Centre. The merging of the highly complementary capabilities of the six partners within the TAKTIC Consortium enables an efficient and versatile kinase drug discovery platform that will target some challenging and medically important kinases.

“We are excited to coordinate a frontline project of these dimensions, which brings together companies and academic researchers with impressive track records within their respective fields.” says Prof. Salam Al-Karadaghi, project coordinator and Director of Business Development at SARomics Biostructures.

“This exciting project fits with our corporate strategy to generate future value through collaborations with top-tiered SMEs and academic groups” added Prof. Thierry Langer, CEO at Prestwick.

“ProQinase is very pleased to join this attractive project since it brings together complementary expertise from biotech industry and academia creating highly promising synergies in the development of novel anti-cancer drugs” explained Christoph Schächtele, Managing Director of ProQinase.

About SARomics
SARomics Biostructures is the leading Scandinavian provider of structural biology and in silico drug discovery services. We accelerate our customers’ drug discovery processes by providing structure-based drug design expertize and services, which include protein crystallization, X-ray protein structure determination, computational chemistry, protein modelling and NMR spectroscopy analyses. Our strategic location close to the MAX IV Laboratory synchrotron radiation facility provides us with instant access to beamlines. For further information please visit www.saromics.com or contact Dr. Björn Walse, CEO, at sales@saromics.com.

About Prestwick Chemical
Prestwick Chemical is a premium medicinal chemistry company that successfully identifies hits and optimizes these into clinical candidates. Prestwick has developed the capacity to integrate the whole drug research pipeline: Hit identification using smart screening libraries and/or large scale pharmacophore based virtual screening, hit validation, hit to lead expansion, lead optimization and profiling. Prestwick’s expertise has led to unprecedented success: seven compounds made by Prestwick are currently in clinical development, from Phase I to Phase III. More information can be found at www.prestwickchemical.com.

About ProQinase
ProQinase is a leading contract service provider dedicated to supporting pharmaceutical and biotech companies in the development of novel therapies for cancer treatment. The company offers a comprehensive portfolio of products and services, including biochemical high-throughput screening, cellular testing and in vivo studies, thus covering all stages of the drug discovery process in the field of cancer. ProQinase was founded in 2001 as a subsidiary of the Tumor Biology Center Freiburg, Germany, a privately owned hospital for cancer patients. To learn more about ProQinase, please visit the company’s web site on www.proqinase.com or contact us at info@proqinase.com.

About the University of Turin
The University of Turin is involved in TAKTIC with two groups:

• The Medicinal Chemistry Unit is coordinated by Dr. Marco L. Lolli and is based in the Department of Science and Drug Technologies (DSTF), founded in 1984. DSTF has established itself as a centre of strong expertise in Medicinal and Organic Chemistry at the University of Turin. To learn more please visit the Marco L. Lolli’s web site on www.personalweb.unito.it/marco.lolli or contact at marco.lolli@unito.it.
• The Biochemistry Unit is coordinated by Dr. Marco Piccinini, and is based in the Department of Oncology. The Department of Oncology is active in clinical and basic research and has a well-deserved international reputation. For more information please contact Dr. Marco Piccinini, marco.piccinini@unito.it.

About The Israel Structural Proteomics Center
The Israel Structural Proteomics Center (ISPC) at the Weizmann Institute of Science, directed by Prof. Joel L. Sussman, was founded in 2002 with the support of the Israel Ministry of Science and the Divadol Foundation. It serves as an Israeli National Center for protein production, biochemical/biophysical studies and structure determination. It is within the Structural Proteomics Unit, headed by Prof. Zvi Livneh, Dean of the Faculty of Biochemistry. The ISPC provides a service for the determination and analysis of protein structures for scientists both at the Weizmann and at other academic institutions and biotech/pharma companies in Israel and abroad. The ISPC is now one of the six core centers in the Integrated Structural Biology Infrastructure in Europe (Instruct) project. For more information please visit http://www.weizmann.ac.il/ISPC.

About TechMedIll of the University of Strasbourg
TechMedIll of the University of Strasbourg is an ISO 9001 certified academic platform of the University of Strasbourg, which provides services in preclinical ADME (absorption, distribution, metabolism, excretion) and toxicity. The platform offers determination of physicochemical properties of molecules (development of analytical methods, determination of solubility, ionization, partition coefficients, binding to plasma proteins etc.) as well as metabolic stability, plasma protein binding, permeability assays, cytochrome P450 sensitivity or inhibition, cellular toxicity of compounds or of their metabolites, distribution in tissues, pharmacokinetic measurements. For more information please contact Dr. Jean-Luc Galzi, galzi@unistra.fr.

 
Members of biosciences trade association will receive training discounts to improve skills and maintain regulatory compliance

Malvern, PA & Ann Arbor, MI, USA, April 10, 2013 / B3C newswire / - The Center for Professional Innovation and Education (CfPIE), the global leader of technical training across the life sciences industry and MichBio, the statewide biosciences industry association for Michigan, today announced a partnership that will offer MichBio members a 15% discount off CfPIE’s extensive training curriculum and certification programs.

“Our alliance with CfPIE extends both cost-savings and a quality resource for our members to meet professional development and compliance requirements, while capitalizing on personal career growth opportunities,” says Stephen Rapundalo, PhD, President and CEO of MichBio.

MichBio members will benefit from multiple training formats:

• Two and three-day classroom training that provides detailed topic coverage along with opportunities for one-on-one contact with industry-active course directors
• On-site training that delivers economies for groups, travel savings, content customized to corporate needs, and a consistent experience for all company employees in attendance
• Multi-course certification programs that enable individuals to tailor the qualifying courses of study, leading to certification according to their personal and professional needs

Specific bioscience training courses include:  cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices; CMC Regulatory Compliance for Biopharmaceuticals and Biologics; Preparation of FDA Submission and Communicating with the FDA; and Comprehensive Overview of FDA Regulatory Compliance.

MichBio members will learn how to:

• Better understand regulatory agency expectations and how to avoid pitfalls for development and validation of bioanalytical assays for biologics
• Ensure adherence to CMC regulatory compliance for biologics and biopharmaceuticals
• Appreciate the regulatory challenges of biosimilars, and the FDA, EMA and WHO perspectives on them
• An overview of the FDA’s procedures, guidances and regulatory pathways that affect review of potential products, and how to hold meetings with the agency

About CfPIE
The Center for Professional Innovation and Education (CfPIE) is the global leader in pharmaceutical, biotech, and medical device training within the life sciences industry. CfPIE offers more than 350 class sessions annually across 71 course titles. Multiple learning formats—classroom, customized on-site presentation and certification programs—provide individuals and companies versatile choices for improving personal skills, maintaining regulatory compliance, and creating opportunities for career advancement. Small class sizes and life science industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction.

About MichBio
MichBio is the trade association committed to driving growth in Michigan's biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations.

Media Contact:
Jaclyn Solick
TME Communications for CfPIE
610- 688-0659 x 114
jackies@tmecom.com