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Apr 12
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Biocartis raises €30 million in Series B’ financing round

By Biocartis, Press Release
Press Release.

 

Lausanne, Switzerland – Biocartis SA, a biotech company active in the field of personalized medicine and focused on fast, multiplexed and fully integrated molecular diagnostics based on its proprietary micro-technology and sample preparation platforms, today announced the successful closing of a Series B equity financing round. The Company raised EUR 30 million (~ USD 41.3 million) from its current shareholder base of leading life science investors and two new strategic investors from the pharmaceutical/diagnostic industry.

The new investors are the Debiopharm GroupTM (Debiopharm) (Lausanne, Switzerland) and Johnson & Johnson Development Corporation (JJDC), each thus obtaining a minority stake in Biocartis.

This financing round was also underwritten by Aescap, Biocartis’ original lead-investor (The Netherlands), Biovest (Belgium), Advent Venture Partners (United Kingdom), several Biocartis employees and Benaruca, the family investment vehicle of Biocartis’ co-founder Rudi Pauwels.

Biocartis has developed and licensed a series of new technologies to build a broadly applicable new diagnostics platform for low to highly multiplexed detection, quantification, and amplification of molecular-based biomarkers, including nucleic acids, proteins, and small molecules. Following its recent acquisition of the Philips’ technology for rapid and fully automated DNA/RNA molecular diagnostic testing, Biocartis will use the proceeds of this round to accelerate its plans to finalize the development and validation of the first version of its proprietary new platform.

“Debiopharm recognized some time ago that companion diagnostics would play an increasingly important role in personalized medicine and the cost-effectiveness of healthcare in general”

said Thierry Mauvernay, executive vice-president of Debiopharm Group, who added:

“we are extremely happy to have started a new financial partnership with a dynamic start up company that has all the necessary strengths and management know-how to become a leading player in the field of in-vitro-diagnostics. Its potential combined with the various disruptive technologies it has created and licensed is perfectly in line with Debiopharm’s own efforts at the frontline of innovation in life-sciences at large”.

Dr. Pietro Scalfaro, from Debiopharm has joined the board of directors of Biocartis, now chaired by Dinko Valerio from Aescap. Dr. Scalfaro holds an MD with a specialty in pediatric intensive care medicine and led several drug development projects at Debiopharm before focusing on the development of their companion diagnostics strategy within a newly created business unit.

Rudi Pauwels, founder of Biocartis, Director and CEO, commented

“This successful financing, within weeks after closing the acquisition of the Philips technology, is yet another important step in our plans to bring a novel and cost-effective diagnostic solution to the healthcare community. There is a global need to turn the many scientific advances in the understanding of the molecular basis of diseases and treatments into routine daily clinical practice. The commitment and support of the Biocartis Board members, shareholders and employees have been instrumental in Biocartis’ rapid progress on this mission. I am particularly pleased that two new investors have now joined Biocartis. Our vision is of a future for medicine whereby the classical isolated elements of diagnostics and pharmaceuticals become more aligned and increasingly part of a much more integrated solution designed to optimize the outcome for the individual patient. Biocartis plans to actively work together with pharmaceutical, diagnostic and biomarker groups who can and would like to contribute to the practical realization of these goals.”

 

About Biocartis
Biocartis is a privately owned biotech company that was founded in 2007 by Dr. Rudi Pauwels (Co-founder of Tibotec, Virco and Galapagos Genomics), Prof. Philippe Renaud (Prof. at EPFL), and Nader Donzel (Co-founder of Scitec laboratory Automation). Biocartis engages in the development of a novel diagnostics technology platform for low to highly multiplexed detection of molecular-based biomarkers. The Company is focused on the delivery of a versatile and compact molecular diagnostic platform whose ease of use and operational characteristics will lower the entry barrier to molecular diagnostic testing. Biocartis is based at the EPFL Science Park in Lausanne, Switzerland and at the High Tech Campus in Eindhoven, The Netherlands.

About Debiopharm – www.debiopharm.com
Debiopharm is a Swiss-based global biopharmaceutical group of companies with a focus on the development of innovative prescription drugs that target unmet medical needs, and which has embarked in the field of companion diagnostics with a view to progressing in the area of personalized medicine.

About Aescap Venture – www.aescap.com
Aescap Venture is a venture capital company investing in private medical companies in Europe. Aescap’s Partners have a proven track record of success and the skills to coach entrepreneurs in accelerating the growth of their companies.

About Biovest – Rudi Mariën
Rudi Mariën was co-founder, reference shareholder and Chairman of Innogenetics, and has been the founder, shareholder and Managing Director of several clinical reference laboratories.

About Advent Venture Partners
Advent Venture Partners is a long established European Venture Capital firm with a strong record of building successful companies.

For further information, please contact:
Rudi Pauwels
CEO
Phone: +41 21 693 90 51
Fax: +41 21 560 42 91

Mar 30
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The Leukemia & Lymphoma Society and Avila Therapeutics Enter Partnership to Accelerate Development of AVL-292 For Patients with Cell B Malignancies

By Avila, Press Release
Press Release.

 

White Plains, NY and Waltham, Mass. – The Leukemia & Lymphoma Society (LLS) and Avila Therapeutics, Inc., today announced they have established a collaboration to support development of one of Avila’s lead product candidates, AVL-292, for treatment of adults with B cell cancers.

Through the partnership, LLS will provide up to $3.2 million to support Avila’s clinical development of AVL-292. Avila anticipates the drug entering clinical trials in 2010.

B cells are an important component of the body’s immune system. B cells can become cancerous, leading to diseases such as non-Hodgkin lymphoma. Approximately 85 percent of non-Hodgkin lymphomas originate from B cells. AVL-292 is a targeted covalent drug designed to bind specifically to the protein target Bruton’s Tyrosine Kinase (Btk). Btk plays a critical role in B cell development and activation, and it is believed the inhibition of Btk will provide benefits in treating B cell cancers.

Taking an active role in accelerating development of novel therapies for patients, LLS has committed substantial, multi-year funding to support this collaboration as part of its Therapy Acceleration Program (TAP). TAP is LLS’s bold initiative designed to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers. By partnering directly with biotechnology companies, LLS is taking a results-oriented approach to more quickly identify potential breakthrough therapies and advance them along the FDA drug approval pathway.

“Avila, with its targeted covalent approach to Btk, hopes to develop, and ultimately deliver to patients, a cancer treatment with optimal efficacy and safety. We believe AVL-292 is a therapeutic candidate with significant opportunity to benefit the patients that we serve, and that Avila is an excellent partner for the LLS. Together the LLS and Avila hope to change the standard of care and improve the quality of life for patients suffering from blood cancer,”

said Louis DeGennaro, Ph.D., LLS’s chief mission officer.

“We are very honored that The Leukemia & Lymphoma Society recognizes the potential of AVL-292 and is making this substantial investment with Avila, which will significantly enhance the drug’s development,”

says Katrine Bosley, Avila’s chiefexecutive officer.

“In pursuing their mission, LLS is combining scientific advancement with connecting to doctors and patients – that ‘translational thinking’ helps companies like Avila cross the bridge from research into development much more effectively forpeople battling blood cancers.”

 

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world’s largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and theirfamilies. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org or contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9a.m. to 6 p.m. ET. www.lls.org.

About Avila Therapeutics™, Inc.
Avila focuses on design and development of targeted covalent drugs to achieve best-inclass outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Mar 24
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MediGene reports additional phase II results of EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer

By Press Release
Press Release.

 

Clinical trial objective achieved – data confirm positive efficacy trend of EndoTAGTM-1 combination therapy

 

Martinsried/Munich, June 24, 2010. The biotechnology company, MediGene AG (Frankfurt, Prime Standard, MDG, TecDAX) announces additional phase II clinical trial results of the drug candidate EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer. The extensive data analysis of the three-arm trial conducted in 140 patients confirms a positive efficacy trend of EndoTAGTM-1 in combination with paclitaxel for the treatment of this difficult to treat type of cancer. The objective of the trial was achieved, and the initial conclusion of the preliminary data published on May 6, 2010 was verified.

The primary endpoint was achieved with EndoTAGTM-1 combination therapy. In addition, the analysis of the secondary endpoints (median progression-free survival, non-progression rate, safety, and tolerability) shows further positive results for EndoTAGTM-1 combination therapy.

Trial design
The trial recruited 140 patients diagnosed with triple receptor-negative breast cancer. These patients were randomized into three treatment groups, receiving either EndoTAGTM-1 in combination with the cytotoxic drug, paclitaxel (55 patients), or EndoTAGTM-1 monotherapy (57 patients). The third group (28 patients) was treated with paclitaxel alone. The patients treated with combination therapy received 22 mg/m2 EndoTAGTM-1 plus 70 mg/m2 paclitaxel once per week. EndoTAGTM-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers across several European countries and India. According to the trial protocol, the trial results are based on centralized data analysis. The patient numbers whose data were eligible for the central analysis are shown in the following results.

Trial results
The trial objective of evaluating efficacy of EndoTAGTM-1 was achieved by the combination therapy with Paclitaxel.

Primary endpoint: The primary endpoint was a progression-free survival rate of the patients treated with either EndoTAGTM-1 monotherapy or EndoTAGTM-1 plus paclitaxel combination of at least 30% after 16 weeks of treatment. At the same time, the 95% confidence interval, which provides information about the potential error rate, also had to be above 30%. The group of patients treated with EndoTAGTM-1 and paclitaxel combination therapy showed a progression-free survival rate of 59% (26 of 44 patients). The group treated with EndoTAGTM-1 monotherapy achieved a rate of 34% (13/38). For the group treated with paclitaxel monotherapy, this rate was 48% (12/25). Regarding the set confidence interval, the primary trial endpoint was met by the EndoTAGTM-1 combination therapy arm only.

Secondary endpoints: Median progression-free survival time during the trial was 4.2 months in the EndoTAGTM-1 combination therapy arm (52 patients), 3.4 months in the EndoTAGTM-1 monotherapy arm (48), and 3.7 months in the paclitaxel monotherapy arm (25). The rate of patients whose tumors had not progressed further (clinical benefit rate) in treatment week 16 was 59% in the EndoTAGTM-1 combination therapy arm (26/44 patients), 34% in the EndoTAGTM-1 monotherapy arm (13/38), and 50% in the paclitaxel monotherapy arm (12/24). In 76% of the patients in the EndoTAGTM-1 combination therapy arm (38/50), the tumor was either stable or regressive at a certain point in time during the treatment period (best overall response). The corresponding rate was 58% for the EndoTAGTM-1 monotherapy arm (26/45), and 58% for the paclitaxel monotherapy arm (14/24). Safety and tolerability profile of EndoTAGTM-1 was confirmed during the trial. The combination of EndoTAGTM-1 with paclitaxel did not lead to additional toxicity.

Professor Dr. Ahmad Awada, Head of the Medical Oncology Clinic, Department of Medicine, Institut Jules Bordet, Brussels, and principal investigator of the trial, commented:

“These are promising results for a disease that is as difficult to treat as triple receptor-negative breast cancer. Since the trial demonstrated a clinical benefit combining EndoTAGTM-1 with paclitaxel, I am confident that this therapy may represent a novel treatment option in the future.”

Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented:

“Following the positive phase II clinical results obtained in pancreatic cancer indication, this trial conducted in another very difficult to treat type of cancer also shows clear indication of efficacy of EndoTAGTM-1. The data represent further clinical evidence of the therapeutic principle (proof-of-concept) of EndoTAGTM-1 combination therapies for indications with high medical need.”

 

About triple receptor-negative breast cancer: According to recent estimates by the American Cancer Society, approximately 193,000 newly diagnosed cases of breast cancer and 41,000 deaths associated with it occurred in the USA in 2009. Breast cancer is by far the most common type of cancer in women, accounting for 27% of cancer diagnoses. Malignant breast tumors that do not possess estrogen, progesterone or HER2 receptors are called “triple receptor-negative” breast cancer. About 15% of all breast cancers belong to this subgroup.1 Patients suffering from this type of breast cancer have a significantly poorer prognosis, and there are very few treatments available since conventional anti-hormonal treatments or treatments targeting HER2 are not appropriate. In case of recurrence following initial surgery, the only remaining treatment option is chemotherapy, and this also provides only a limited number of suitable therapeutics for this type of cancer.

About EndoTAG™-1: EndoTAGTM-1 represents an innovative therapeutic approach that unfolds its effect by both a targeted antivascular (against newly formed tumor blood vessels), and an anti-tumoral (directed against the tumor) mechanism. The drug candidate attaches itself selectively to newly developed, negatively charged tumor blood vessels, thus attacking only these blood vessels and not those in healthy tissue. Concurrently, EndoTAGTM-1 prevents the formation of new vessels, which is expected to suppress further tumor growth. EndoTAGTM-1 is a combination of positively charged liposomes with the therapeutic substance paclitaxel embedded therein.

EndoTAGTM-1 is MediGene’s first product candidate derived from the EndoTAGTM platform technology. MediGene obtained positive results with EndoTAGTM-1 in a controlled phase II clinical trial in pancreatic cancer. In Europe and the USA, EndoTAGTM-1 has been granted orphan drug designation which provides both cost and timeline benefits in the drug development process.

Analyst conference call and webcast: An analyst conference call in English will take place today at 2.30 p.m. (CEST), and will be webcast live. The webcast and synchronized presentation slides can be accessed at www.medigene.com. A recording of the live presentation will also be available thereafter.

1 Source: Cleator S, Heller W, Coombes R Ch. Triple-negative breast cancer: therapeutic options. Lancet Oncol 2007; 8:235-44

This press release contains forward-looking statements representing the opinion of MediGene as of the date of this release. The actual results achieved by MediGene may differ significantly from the statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene, EndoTAGTM, and EndoTAGTM-1 are trademarks of MediGene AG. These trademarks may be owned or licensed in select locations only.

MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG, TecDax) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company to have drugs on the market which are distributed by partner companies. It has several drug candidates in clinical development, and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs with emphasis on oncology.

Contact MediGene AG
E-mail: investor@medigene.com
Fax: ++49 – 89 – 85 65 – 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 – 89 – 85 65 – 3324
Dr. Georg Dönges, Investor Relations, Tel.: ++49 – 89 – 85 65 – 2946

Mar 16
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4-Antibody announces long-term collaboration with Boehringer Ingelheim with a maximum value of EUR 177.5m (CHF 266m) for 4-Antibody

By 4-Antibody, Press Release
Press Release.

 

Basel, Switzerland: 4-Antibody AG today announced a major long-term collaboration with Boehringer Ingelheim to discover and to develop fully human therapeutic antibodies for a number of targets in various disease indications.

4-Antibody will use its proprietary and unencumbered Hu-PAC™ and Retrocyte Display™ technologies for the discovery and development of fully human antibodies against novel targets nominated by Boehringer Ingelheim. 4-Antibody AG will receive payments of up to EUR 177.5 million (CHF 266 million) including upfront and milestone payments from Boehringer Ingelheim upon achievement of certain clinical development milestones.

 

About 4-Antibody AG

4-Antibody AG is a privately held Swiss Biotech company active in the area of therapeutic antibody drug development. 4-Antibody AG has developed a portfolio of powerful, proprietary antibody discovery and engineering platforms, including the Hu-PAC® and the Retrocyte Display® technologies. 4-Antibody AG owns four patent families related to therapeutic antibody discovery platforms and products, including more than a dozen of granted patents worldwide. The company has 40 employees working at its headquarter in Basel, Switzerland, and its subsidiary in Jena, Germany.

Feb 10
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Biocartis acquires Philips Technology Platform for Automated DNA/RNA Molecular Diagnostic Testing

By Biocartis, Press Release
Press Release.

 

Eindhoven, The Netherlands – Molecular diagnostics company Biocartis and Royal Philips Electronics (NYSE: PHG, AEX: PHI) today announced the signing of an agreement that will result in Biocartis acquiring Philips’ technology platform for rapid fully-automated DNA/RNA molecular diagnostic testing. The platform has been designed for applications in a wide range of patient sample testing, including oncology and infectious diseases. Financial details of this agreement were not disclosed.

Biocartis will develop and commercialize the platform, together with a menu of tests, through strategic partnerships and will finalize validation of the platform at its newly-established and wholly-owned Dutch subsidiary Biocartis BV. Biocartis BV is based on the High Tech Campus in Eindhoven, the Netherlands, where it will benefit from close access to the multi-disciplinary R&D facilities and services of Philips Corporate Technologies.

“This agreement is transformational for Biocartis as it accelerates our plans to bring innovative and cost-effective molecular diagnostic solutions that can turn personalized medicine into practice,”

says Rudi Pauwels, CEO of Biocartis.

“From our inception, we have been on a quest to integrate a clinical sample preparation and processing technology to complement our own developments. The platform developed by Philips clearly stood out as an impressive, integrated solution in terms of architecture choices, functionality, flexibility and bears the signature of a world-class engineering team.”

“We are extremely pleased that in Biocartis we have found a highly innovative and entrepreneurial partner that is committed to bringing a cutting-edge molecular diagnostics platform to market based on advanced technology developed by Philips,”

says Gottfried Dutiné, Executive Vice President of Philips and Global Head of Markets & Innovation.

“Biocartis’ vision of the future of molecular diagnostics, the technologies they have developed within the space of a few years and the proven track record of its key management in the pharmaceutical and diagnostic sector have convinced us of the value of this agreement.”

Under the terms of the agreement, all platform-related assets, including the relevant Philips patents and technology know-how, plus a number of existing Philips staff members, will be transferred to Biocartis. Biocartis will finance future developments and be responsible for commercialization of the platform. It will accelerate the development program by leveraging Philips’ expertise in product engineering and life science technologies through extensive collaborations.

DNA/RNA molecular diagnostic tests will become increasingly important in providing vital information on a patient’s state of health at every stage of the care cycle – from prevention and early diagnosis to treatment, monitoring and after care. To make effective use of existing and new DNA/RNA biomarkers and to fully realize the potential of personalized medicine, new solutions are needed to make the required tests more widely available. This will be the focus of Biocartis.

At the same time, it will be essential to integrate, analyze and present all the available patient data in an intelligent way. Philips will focus its research program in this area on the integration of molecular diagnostic information into clinical decision support systems with the objective to help clinicians to arrive at the correct diagnosis and choice of therapy. Through its ongoing technical collaboration with Biocartis, Philips will remain closely involved with technology innovation in this field, contributing to the development of optimized clinical informatics solutions that address the needs of both patients and care providers.

The Philips technology platform for DNA/RNA molecular diagnostic testing is the result of several years of development by the life science research and applied technology groups within Philips Corporate Technologies. It has been designed for fully integrated, random access, multiplexed DNA/RNA molecular diagnostic testing. The platform is characterized by ease-of-use, which is a prerequisite for making it suitable for all types of laboratory environments.

 

For further information, please contact:

Biocartis
Rudi Pauwels
Tel: +41 21 693 90 51
Mobile: +41 79 705 73 07
E-mail: rpauwels@biocartis.com

Philips
Steve Klink
Tel: +31 40 2743703
Mobile +31 6 10888824
E-mail: steve.klink@philips.com

 

About Biocartis
Biocartis is developing cost-effective solutions for the rapid & simultaneous detection and quantification of different biomarkers in a variety of laboratory & clinical settings, including the point-of-need. Biocartis has therefore developed and licensed a series of new technologies to build a broadly applicable diagnostics platform for low- to highly-multiplexed detection, quantification, and amplification of bio-analytes/biomarkers, including proteins, nucleic acids, and small molecules. Biocartis was founded in 2007 by Dr. Rudi Pauwels ((co)founder of Tibotec, Virco and Galapagos Genomics), Prof. Philippe Renaud (EPFL) and Nader Donzel (co-founder of Scitec Laboratory Automation) and is backed by a syndicate of investors that contain some of Europe’s most successful biotech entrepreneurs. Biocartis is headquartered at the Swiss Federal Institute of Technology (EPFL) Science Park in Lausanne, a world-leading university in the field of Technology and Science.

 

About Royal Philips Electronics
Royal Philips Electronics of the Netherlands (NYSE: PHG, AEX: PHI) is a diversified Health and Well-being company, focused on improving people’s lives through timely innovations. As a world leader in healthcare, lifestyle and lighting, Philips integrates technologies and design into people-centric solutions, based on fundamental customer insights and the brand promise of “sense and simplicity”. Headquartered in the Netherlands, Philips employs approximately 116,000 employees in more than 60 countries worldwide. With sales of EUR 23 billion in 2009, the company is a market leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as lifestyle products for personal well-being and pleasure with strong leadership positions in flat TV, male shaving and grooming, portable entertainment and oral healthcare. News from Philips is located at www.philips.com/newscenter.

Jan 19
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AMT submits its lead product Glybera® Application for Marketing Authorisation Application to EMA

By Press Release
Press Release.

 

Amsterdam, The Netherlands – Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, announced today that the Marketing Authorisation Application (MAA) for Glybera®, AMT’s proprietary lead product, for lipoprotein lipase deficient patients, has been submitted to the European Medicines Agency (EMA, formerly known as EMEA).

AMT has conducted two clinical studies for lipoprotein lipase deficiency (LPLD) in Europe and Canada and long term follow-up from these is ongoing, as is a further study in Canada. In these three studies Glybera® has shown a sizeable decrease in the incidence of pancreatitis, or acute inflammation of the pancreas, the most debilitating complication of LPLD. Moreover, these studies also indicate that Glybera® has an excellent safety profile.

“We are delighted to have submitted the Glybera® dossier to EMA. We believe that AMT will be the first to successfully develop a gene therapy for a disease caused by a genetic defect,”

said Jörn Aldag, Chief Executive Officer of AMT.

“Importantly, Glybera® also validates AMT’s adeno-associated viral (AAV) vector delivery platform, which can be used to deliver other gene therapy products for other indications.”

The MAA for Glybera® is now in the validation stage, and the formal review process is expected to begin later this month. The MAA for Glybera® will be reviewed via the centralised procedure which is the standard route for all advanced therapies.

 

About the Disease
LPLD is a seriously debilitating, and potentially lethal, orphan disease, for which no approved therapy exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels, which in turn can lead to pancreatitis. Recurrent pancreatitis in LPLD patients can result in difficult-to-treat diabetes. LPLD is associated with significant morbidity and mortality.

About Amsterdam Molecular Therapeutics
AMT, founded in 1998 and based in Amsterdam, is a leader in the development of human gene based therapies. Using AAV as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate what is probably the first stable and scalable AAV production platform. This safe and efficacious proprietary platform offers a unique manufacturing capability which can be applied to a large number of rare (orphan) diseases that are caused by one faulty gene. Currently, AMT has a product pipeline with several AAV-based gene therapy products in LPLD, Hemophilia B, DMD, Acute Intermittent Porphyria and Parkinson’s Disease at different stages of research or development.

Jörn Aldag
Chief Executive Officer
Tel +31 (0) 20 566 7394
j.aldag@amtbiopharma.com

Certain statements in this press release are “forward-looking statements” including those that refer to management’s plans and expectations for future operations, prospects and financial condition. Words such as “strategy,” “expects,” “plans,” “anticipates,” “believes,” “will,” “continues,” “estimates,” “intends,” “projects,” “goals,” “targets” and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of Amsterdam Molecular Therapeutics only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT’s business, including, but not limited to, the timely commencement and success of AMT’s clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (i.e. EMA, Health Canada), market acceptance of AMT’s products, effectiveness of AMT’s marketing and sales efforts, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet, conditions imposed for required governmental and regulatory approvals and consents. AMT expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting AMT, refer to the prospectus of AMT’s initial public offering on June 20, 2007, and AMT’s public announcements made from time to time.

Nov 24
Love0

Oxagen Limited Raises £16 Million in Series C Private Venture Capital Financing Led by Novartis Venture Funds

By Press Release
Press Release.

 

Abingdon, UK – Oxagen Limited, a drug discovery and development company specializing in inflammation, announced today the successful completion of a £16 Million ($26.7 Million) Series C round led by Novartis Venture Funds.

The proceeds of the funding will be used primarily to advance Oxagen’s CRTH2 antagonist programme in inflammatory and respiratory diseases. This will include the completion of an ongoing Phase IIb clinical study of the lead molecule OC000459 in moderate persistent asthma. This follows the successful completion of proof-of-concept (POC) studies in both asthma and allergic rhinitis. CRTH2, also known as DP2 is a cell surface receptor for prostaglandin D2 and is implicated in allergic inflammation.

The funds will also be used to expand the therapeutic indications for CRTH2 antagonists using the lead molecule as well as back-up compounds. The investment was led by Novartis Venture Funds, and joined by existing investors including MPM Capital, SV Life Sciences, Advent Ventures, Bessemer Venture Partners, Omega, Abingworth, IBT, Red Abbey and The Wellcome Trust.

Commenting on the fundraising, Mark Payton, Ph.D., Chief Executive Officer of Oxagen said,

“We are delighted to welcome Novartis Ventures as a new investor in Oxagen. We are excited by the potential shown to date by CRTH2 antagonists in general and by OC000459 in particular. This funding will allow us to both advance and broaden the therapeutic utility of our portfolio of molecules. We are delighted that this potential has been recognised both by our new lead investor, as well as by our strong base of existing investors.”

Anja König, Ph.D., Managing Director at Novartis Venture Funds commented

“We are looking forward to joining Oxagen in their exciting effort to deliver their first in class medicine to patients with asthma, a condition with significant unmet need. CRTH2 is a very promising new target in asthma and inflammation and Oxagen’s lead compound has the potential to become a blockbuster.”

Anja König will join the Oxagen Board of Directors.

Nov 03
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Avila presents data on its novel, orally-available protease inhibitor, AVL-181, demonstrating viral clearance of hepatitis C virus in preclinical models

By Avila, Press Release
Press Release.

 

BOSTON & WALTHAM, Mass. – Avila Therapeutics™, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181. Avila showed that AVL-181 promoted complete viral clearance in vitro when used at clinically-relevant concentrations in combination with other HCV therapies. Additionally, using an innovative technology for measuring the extent of covalent bond formation, Avila showed that AVL-181 bonds selectively and irreversibly to HCV protease in vivo in a novel rodent model, thus silencing a key protein necessary for successful viral replication and resulting in a prolonged duration of action in vivo. These new data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) international meeting in Boston, Massachusetts.

“Our clinical candidate, AVL-181, demonstrated inhibition across multiple genotypes and drug-resistant mutations of the HCV protease. In addition, the data showing complete viral clearance in conjunction with other cutting edge therapies are striking,”

said Katrine Bosley, Chief Executive Officer, Avila.

“These data provide additional support for the clinical evaluation of AVL-181, and we are on track to advance into clinical development next year.”

In one presentation, “Potential for Rapid and Prolonged Therapeutic Benefit in HCV through Protein Silencing of NS3 Protease with AVL-181”, the data show that the orally-available, novel HCV protease inhibitor, AVL-181:

selectively bonds the HCV NS3 protease to completely and irreversibly inactivate proteolytic activity, essentially silencing the HCV protease complex; forms a highly specific covalent bond across HCV genotypes and clinically-described drug-resistant mutant proteases; inhibits protease activity in cultured replicon cells for >48 hours after very brief exposure and removal of AVL-181; demonstrates prolonged pharmacodynamic activity for both wild-type and drug-resistant mutations (e.g. R155K); and; results in clearance of HCV RNA from replicon cells in conjunction with a non-nucleoside polymerase inhibitor, contributing to a profile that differentiates AVL-181 from clinically investigated agents.

In a second presentation, “AVL-181 Demonstrates Prolonged Inhibition of HCV NS3 Protease Activity In Vivo that Directly Correlates with Prolonged Molecular Target Occupancy”, the data demonstrate that the orally available, novel HCV protease inhibitor, AVL-181: potently and irreversibly silences HCV proteases, and that the level of protease inhibition is directly correlated with the extent of target bonding; durably inhibits the HCV protease for at least 10 hours in vivo after a single exposure as measured in a novel model in which NS3/4A is expressed in the mouse liver; and this duration of action coupled with the low plasma levels of AVL-181 at this late timepoint confirm that the covalent mechanism does not depend on the near-continuous drug exposure such as that required by the reversible HCV protease inhibitors currently in late-stage clinical trials.

 

About the Avilomics™ Platform and Covalent Drugs

The Avilomics platform is Avila’s powerful approach to design and develop covalent drugs that strongly, selectively, and resiliently bond to disease?causing proteins, thereby silencing their activity and producing superior pharmacological outcomes. Covalent drugs inherently provide prolonged duration of action through this silencing of the disease target, and they can solve the critical therapeutic challenges of drugging difficult targets and addressing resistance mutations. The three components of Avilomics are:

Compositions: Innovative chemical structures for forming highly selective, not indiscriminate, covalent bonds
Design: Proprietary informatics to uniquely identify sites amenable to selective covalent modification and target silencing
Testing: Empirical methods to demonstrate covalent specificity at both target and proteomic levels

Together, these components provide a platform for efficient design and testing of covalent drugs. Avilomics opens up the broad potential of covalent drugs across target classes and disease areas, as demonstrated with the company’s emerging pipeline of novel, protein silencing covalent drugs.

 

About Avila Therapeutics™, Inc.

Avila focuses on design and development of covalent drugs to achieve best-in-class outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company is developing a pipeline of novel, protein-silencing covalent drugs with a current focus on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Contact:
Yates Public Relations
Adriana Jenkins,
617-710-8350

Oct 29
Love0

Micromet and Sanofi-aventis Sign Global Collaboration and License Agreement for New Solid Tumor BiTE Antibody

By Press Release
Press Release.

 

BETHESDA, Md., Oct 29, 2009 (GlobeNewswire via COMTEX) — Micromet, Inc. (Nasdaq:MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, and sanofi-aventis (NYSE Euronext:SAN) (NYSE:SNY) announced today a global collaboration and license agreement to develop a BiTE(R) antibody against an antigen present at the surface of carcinoma cells. BiTE antibodies are novel therapeutic antibodies that activate a patient’s T cells to seek out and destroy cancer cells.

Under this agreement, Micromet will be mainly responsible for the discovery, research and development of the BiTE antibody through the completion of phase 1 clinical trials under the supervision of a Joint Steering Committee. Sanofi-aventis will then have the full responsibility for the further development, as well as for the worldwide commercialization of the BiTE antibody.

“Micromet’s BiTE antibodies represent a promising new approach to treating cancer,”

declared Marc Cluzel, Executive Vice-President R&D, sanofi-aventis.

“We believe BiTE antibodies have the potential to significantly expand the treatment options that we can offer to cancer patients in the future.”

“We are very pleased to start a new BiTE antibody program with sanofi-aventis,”

said Christian Itin, Micromet’s Chief Executive Officer.

“As we continue to make progress in the clinical development of our BiTE antibodies for hematological cancers and solid tumors, this collaboration with sanofi-aventis further validates the BiTE antibody technology and creates the opportunity to expand the pipeline of BiTE antibodies for the treatment of solid tumors.”

 

Under the terms of the agreement, sanofi-aventis agreed to pay Micromet an upfront cash payment of 8 million euros (approx. US$ 12 million) following signing of the agreement. Micromet is eligible for development and regulatory milestone payments of up to 162 million euros (approx. US$ 241 million), plus performance-based sales milestones of up to 150 million euros (approx. US$ 224 million) and royalties on worldwide product sales.

 

About BiTE Antibodies
BiTE(R) antibodies are designed to direct the body’s cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing a self-destruction process in the tumor cells referred to as apoptosis, or programmed cell death. In the presence of BiTE antibodies, T cells have been demonstrated to serially eliminate tumor cells, which explains the activity of BiTE antibodies at very low concentrations. Through the killing process, T cells start to proliferate, which leads to an increased number of T cells at the site of attack.

 

About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) antibody platform, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet’s preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. Micromet’s collaboration partners include sanofi-aventis, Bayer Schering Pharma, Merck Serono, MedImmune and Nycomed.

 

About Sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (NYSE Euronext:SAN) and in New York (NYSE:SNY).

 

Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the operation of the global collaboration with sanofi-aventis, the efficacy, safety and intended utilization of our product candidates, including the BiTE antibody that is the subject of the agreement with sanofi-aventis, the mode of action of BiTE antibodies, the conduct, timing and results of future clinical trials, expectations of the future expansion of our product pipeline and collaborations, and the future payment of milestone and royalty payments by sanofi-aventis. You are urged to consider statements that include the words “ongoing,” “may,” “will,” “believes,” “potential,” “expects,” “plans,” “anticipates,” “intends,” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that product candidates that appeared promising in early research, preclinical studies or clinical trials do not demonstrate safety and/or efficacy in subsequent clinical trials, the risk that encouraging results from early research, preclinical studies or clinical trials may not be confirmed upon further analysis of the detailed results of such research, preclinical study or clinical trial, the risk that additional information relating to the safety, efficacy or tolerability of our product candidates may be discovered upon further analysis of preclinical or clinical trial data, the risk that we or our collaborators will not obtain approval to market our product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborators, including sanofi-aventis, MedImmune, Merck Serono, TRACON and Nycomed, for the funding or conduct of further development and commercialization activities relating to our product candidates. These factors and others are more fully discussed in Micromet’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2009, filed with the SEC on August 6, 2009, as well as other filings by the company with the SEC.

 

CONTACT: Micromet, Inc.

US Media:
Andrea tenBroek
Chris Stamm
(781)-684-0770
micromet@schwartz-pr.com

European Media:
Ludger Wess
+49 (40) 8816 5964
ludger@akampion.com

US Investors:
Susan Noonan
(212) 966-3650
susan@sanoonan.com

European Investors:
Ines-Regina Buth
+49 (30) 2363 2768
ines@akampion.com