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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

Oct 20
Love0

Privately held CardiacAssist reports record revenues for nine-month financial results

By CardiacAssist, Press Release
Press Release.

 

Company’s TandemHeart(R) extracorporeal circulatory support device continues to gain traction among cardiologists and cardiac surgeons

 

Privately held CardiacAssist Inc. announced today nine-month financial results for 2009. TandemHeart System revenues were at new record levels compared to results for the same period in 2008.

FDA-cleared and CE-Marked TandemHeart can be placed rapidly by both interventional cardiologists in a cath lab and by cardiac surgeons in an operating room to provide short-term circulatory support to patients requiring additional cardiac assistance. The device provides effective and reliable temporary circulatory support for critically ill patients. Hemodynamic support includes a high net blood-flow rate of up to five liters per minute in the catheterization lab or up to eight liters per minute in the OR — more than twice the amount of competing technologies — and is fully reimbursed by Medicare under existing DRG codes.

“We continue to grow our Company’s TandemHeart revenues because customers are able to see right through the ‘myths’ spread by our main competition,”

said Michael Garippa, CEO and President.

“Indeed, our record-setting revenues for the nine months of 2009 bear strong witness to the indisputable fact that TandemHeart represents a breakthrough model for treating cardiac patients quickly and aggressively.

“For example, one myth is that the Impella 2.5 can support patients in cardiogenic shock with 2.5 liters per minute of blood flow. This is not true. Patients in profound cardiogenic shock often have heightened vascular resistance, thus limiting the flow provided by any device by 50 percent or more. Consequently, the Impella 2.5 would provide less than 1.0 liter per minute of blood flow to patients in cardiogenic shock, which is not enough to sustain such very sick patients,”

said Garippa.

“There also have been claims that the Impella 2.5 completely unloads the left ventricle. Actually, published data has shown the contrary.

“Furthermore,” added Garippa, “the Impella 5.0 cannot be inserted percutaneously in the overwhelming majority of the population. The 5.0’s 21-French catheter cannot be placed in an artery–the artery simply cannot be dilated to accept a sheath of that size, and surgical placement is the most likely option.

“These are just some of the reasons why we remain confident that TandemHeart is destined to become standard of care in extracorporeal circulatory support,”

Garippa concluded.

***

About CardiacAssist

Headquartered in Pittsburgh, privately held CardiacAssist is a growing and profitable medical technology company that develops, manufactures and markets cardiac assist devices. The Company has developed the world’s first and only proprietary platform, FDA-cleared and CE-Marked TandemHeart(R)–which provides a short-term extracorporeal circulatory support system for both cardiologists and cardiac surgeons.

Oct 15
Love0

Biocartis raises €10 million in Series A financing round

By Biocartis, Press Release
Press Release.

 

Lausanne, Switzerland, October 15th 2009 – Biocartis SA, a diagnostics company focused on fast and low-cost, integrated molecular and immunodiagnostics based on its proprietary micro-technology platform, today announced the successful closing of a Series A equity financing round. The Company raised EUR 10 million (~ USD 14.6 million) from a syndicate of leading life science investors.

The deal was led by Aescap Venture (Amsterdam, The Netherlands). Other members of the syndicate are Advent Venture Partners (United Kingdom), existing shareholder Benaruca (Luxemburg), Biovest (Belgium), and KBC Private Equity (Belgium). Following the Series A financing, Dinko Valerio for Aescap Venture, Raj Parekh for Advent Venture Partners, Rudi Mariën for Biovest, Ruth Devenyns for KBC Private Equity, Peter Verhaeghe for Benaruca, and Rudi Pauwels constitute the Board of Directors of Biocartis.

Biocartis engages in the development of a new diagnostics technology platform for low to highly multiplexed detection, quantification, and amplification of bio-analytes, including proteins, nucleic acids, and small molecules. The company has developed and licensed a series of new technologies, both for the optimization of biological assays and the amplification of bio-analytes, and will use the proceeds to develop a commercial version of its proprietary platform and first prototype assays. Biocartis aims to ultimately deliver a versatile compact diagnostics platform, for use in various in vitro diagnostic settings that will drastically reduce the time and costs per value added data point.

“Biocartis has all the key ingredients necessary to become a world leader in diagnostics. It has groundbreaking new technology created with a clear vision of the end-product and the market in mind, exceptional management with a successful serial entrepreneur and an experienced and energetic team. This has now been complemented by a group of investors with highly relevant expertise in the various aspects required to build world class companies. We are delighted to be part of the team working towards the fulfillment of the great promise embedded in Biocartis”

said Dinko Valerio, General Partner from lead investor Aescap Venture.

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

“This successful financing is an important endorsement of the innovation and advances the Biocartis team has made and allows us to further accelerate the development, validation and industrialization of the new diagnostic platform and its various components. I am particularly pleased that we are joined and backed by life-science investors who have had a very strong track record in building and financing some of the most successful European biotech and diagnostic companies”.

Biocartis is based in Lausanne Switzerland, where it benefits from access to the Ecole Polytechnique Fédérale de Lausanne (EPFL), a leading European academic institution in Micro-&Nanotechnology and Life Sciences, with first-class clean room and laboratory facilities that can be accessed by the companies located in the university’s scientific park. Access to this multi-disciplinary environment has already been crucial to Biocartis’ rapid progress and will play an important role in its future development.

 

Note for the editor:

About Biocartis – www.biocartis.com
Biocartis S.A. 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 bio-analytes. The Company is focused on delivering a versatile compact diagnostics platform, for use in various in vitro diagnostic settings that will drastically reduce the time and costs per value added data point.

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 KBC Private Equity – www.kbcpe.be
The Life Sciences division of KBC Private Equity invests in early- to late-stage life-science companies, with a focus on pharmaceutical biotech. Investments include Ablynx, Devgen, Innogenetics, Movetis, and Tibotec-Virco.

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
e-mail: info@biocartis.com

Oct 12
Love0

New phase II data presented at ECCO 15 and 34th ESMO Congress reinforces exciting potential of Algeta’s Alpharadin as a new treatment for bone metastases in cancer patients

By Algeta, Press Release

Press Release.

Oslo, Norway, 22 September 2009 – Algeta ASA (OSE:ALGETA), the cancer therapeutics company, announces that new clinical data from three phase II clinical trials with Alpharadin have been presented at the joint 15th Congress of the European CanCer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) held in Berlin, Germany (20-24 September 2009).

Alpharadin is Algeta’s lead cancer therapeutic and has recently been partnered with Bayer for its future development and commercialization. It is the first in a new class of alpha-emitting pharmaceuticals (‘alpha-pharmaceutical’) and is based on radium-223. Alpharadin is in a global phase III clinical trial (ALSYMPCA) designed to confirm its overall survival benefit and safety as a targeted treatment for bone metastases in men with hormone-refractory prostate cancer (HRPC). Alpharadin is administered as a simple injection and has a unique mode of action whereby it targets bone metastases specifically and exerts a highly localized effect on tumor cells while minimizing damage to normal surrounding tissues.

The Alpharadin phase II efficacy and safety program comprised three trials (BC1-02, BC1-03 and BC1-04) and involved 286 individuals. It was designed to provide detailed information on the safety and therapeutic efficacy of different doses of Alpharadin in HRPC patients, as well as evaluating its ability to relieve pain caused by bone metastases in symptomatic patients. In all three phase II trials completed, the primary efficacy endpoints were met while providing compelling evidence of the benign safety profile of Alpharadin. The new data presented this week at the ECCO 15 – 34th ESMO congress confirm these key clinical characteristics of Alpharadin treatment and are outlined below in more detail.

Andrew Kay, Algeta’s President & CEO said,

“The clinical data from our comprehensive phase II program fully support our earlier findings and reinforce our confidence that Alpharadin represents an exciting potential new treatment for cancer patients with bone metastases. With our new partner Bayer, we are committed to progressing Alpharadin through the final stages of development and onto the market where we believe its use will offer significant clinical benefits to patients with bone metastases. I would like to thank all the researchers involved for their excellent work in developing Alpharadin thus far and for their continued support in the phase III trial.”

 

Clinical results

BC1-02

Two-year follow-up data from a 64-patient efficacy and safety study evaluating survival and long-term toxicity in HRPC patients with bone metastases (Alpharadin vs. placebo) were presented in a poster by Prof. Oyvind Bruland (Norwegian Radium Hospital, Oslo, Norway). Sub-group analyses based on disease status at inclusion and pre-treatment with external beam radiotherapy were also reported. Earlier results from this trial were published by Nilsson et al. in the Lancet Oncology (2007) 8: 587-594.

The key findings were that at 24 months, ten of 33 patients (30%) who received Alpharadin and four of 31 patients (13%) in the placebo group were alive. Median survival was 65 weeks compared with 46 weeks, respectively (on an Intent to treat (ITT) basis). The median survival was more than 40% longer in the Alpharadin group at all levels of extent of disease (EOD = number of “hot-spots” of bone metastasis identified on a bone scan: <6; 6-20; >20; super-scan (i.e. distributed throughout the entire skeleton)).

The largest absolute difference occurred in patients with lowest EOD; 107 weeks for Alpharadin and 68 weeks for placebo and, in general, the therapeutic benefit of Alpharadin treatment seems to be greater in fitter patients than for those with extensive bone metastases. However, the relative improvement in survival was maintained irrespective of extent of disease at the start of treatment.

Furthermore, a benign side effect profile was documented following repeated Alpharadin treatment, and no long term haematological toxicity was reported.

 

BC1-03

Final results from the 100-patient BC1-03 study investigating the pain-relieving effects and dose-response relationship after a single dose of Alpharadin were presented in a poster by Prof. Sten Nilsson (Karolinska Hospital, Stockholm, Sweden). Preliminary findings from this trial were first announced in August 2008.

The trial met its primary endpoint by showing that a single dose of Alpharadin alleviated pain in a dose-dependent manner, with the most prominent effects seen in patients receiving the highest dose. The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance. Again, Alpharadin was found to be well tolerated at all doses, confirming the benign side-effect profile seen in other clinical studies.

The BC1-03 trial involved 100 men with HRPC and painful bone metastases, who were randomized in a double-blind dose-ranging study to receive one of four dose levels: 5, 25, 50 or 100 kBq/kg b.w. of radium-223. Median age, baseline PSA (prostate cancer specific antigen) and baseline patients’ diary Visual Analogue Score (VAS) were 70 years, 149 µg/L and 42 mm, respectively. The primary efficacy endpoint was Pain Index (PI) based on a combination of the change in diary pain rating (VAS scale) and the change in analgesic consumption during a 16-week period. Pain and physical function were also measured using BPI (Brief Pain Inventory).

At eight weeks after injection there were 40, 63, 56 and 71% responders (including only pain responders with Pain Index 1-4, minimal to complete pain response) in the four dose levels: 5, 25, 50 or 100 kBq/kg b.w., respectively. Within each dose group, for the responders, a significant pain-relieving effect was observed in the patients’ diary VAS score. Median decreases were -15, -30, -26 and -22 mm (p values all highly significant) respectively. The pain response improved gradually from 2-8 weeks, with the best effects in the highest dose group. 33% of the patients in the 5 and 25 kBq/kg groups had increased use of analgesic compared to 10% of the patients in the two highest dose groups after four weeks. Improvements in BPI pain severity and functional interference index confirmed progressive improvements up to eight weeks. A significant reduction was seen in bone-ALP for the highest dose level (p<0.0001 at week 4). The haematological toxicity was generally mild and not clinically significant.

 

BC1-04

The results from the 122-patient BC1-04 efficacy and safety study were presented in an oral presentation by Dr. Chris Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK), who is principal investigator of the ALSYMPCA phase III study. The study was designed to compare the PSA response rate of three different repeat doses of Alpharadin, as well as the effect of dose on changes in PSA, b-ALP and toxicity. Preliminary results from this trial were first announced in January 2009.

The study met the primary endpoint, showing a significant dose response for % PSA responders. In addition to the biochemical evidence of efficacy, Alpharadin demonstrated a benign side-effect profile and was well tolerated at all doses. No patients stopped study treatment for toxicity and the most common adverse events were gastro-intestinal and musculo-skeletal, with no evidence of a dose-effect. Grade 3 or 4 neutropenia was not seen. Grade 3 or 4 thrombocytopenia occurred in two patients, one from each of the two lower dose groups.

The trial involved 122 men with HRPC and bone metastases but no evidence of metastases in other tissues, a castrate testosterone, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and PSA progression according to the PSA Working Group criteria. They were randomized to one of three Alpharadin dose groups: 25, 50 or 80 kBq/kg, given once every six weeks for three cycles. The main outcome was PSA response (defined as a 50% decline confirmed >19 days later).

121 eligible patients (median age 70 years, median baseline PSA 127.6 ng/ml) were analyzed by ITT. 37 (31%) had received prior chemotherapy. 107 (88%) received all three Alpharadin treatments over 12 weeks. Confirmed PSA response was seen in 0%, 6% and 13% in the 25, 50 and 80 kBq/kg groups, respectively (p=0.0297 test for dose response). The median change in PSA at week 16 was 71%, 42% and 24%, respectively (p=0.050), and in b-ALP was -34%, -58% and -61% (p<0.0001).

The results support the dose schedule being used in the ongoing ALSYMPCA phase III trial of 50 kBq/kg every four weeks for six cycles, and anticipated to be used in combination studies with docetaxel expected to begin in the first half of 2010.

 

For further information, please contact

Algeta
Andrew Kay, CEO
Gillies O’Bryan-Tear, CMO
Thomas Ramdahl, EVP & CTO

+47 2300 6742 / +47 4840 1360 (mob)
+47 23 00 7824 / +47 4804 1411 (mob)
+47 23 00 79 90 / +47 913 91 458 (mob)
post@algeta.com

Citigate Dewe Rogerson
Mark Swallow / Helena Galilee / David Dible +44 (0) 207 638 9571
mark.swallow@citigatedr.co.uk

About Algeta
Algeta ASA is a cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing a new generation of targeted cancer therapeutics (alpha-pharmaceuticals) that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta‘s lead alpha-pharmaceutical candidate, Alpharadin (based on radium-223), has blockbuster potential for treating bone metastases arising from multiple major cancer types, owing to its bone-targeting nature, potent efficacy (therapeutic and palliative) and benign, placebo-like safety profile. Development of Alpharadin is most advanced targeting bone metastases resulting from hormone-refractory prostate cancer (HRPC), and it entered an international phase III clinical trial (ALSYMPCA) in mid-2008 based on compelling clinical results from a comprehensive phase II program. This trial is currently open for recruitment.

In September 2009, Algeta entered into an global agreement with Bayer Healthcare AG for the development and commercialization of Alpharadin. As part of the agreement, Algeta retains an option to co-promote Alpharadin in the United States and to share profits from future sales.

Algeta is also developing other technologies for delivering alpha-pharmaceuticals. These include methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227. The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

 

Forward-looking Statement
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

 

Oct 05
Love0

Cellnovo Introduces First Wireless Touchscreen Insulin Micro-pumps

By Cellnovo, Press Release
Press Release.

 

Pumps Offer New Levels of Portability and Ease-of-Use for People Living with Diabetes

 

Cellnovo announces the first wireless touchscreen insulin micro-pumps – two compact, innovative pumps that offer greater freedom, easy-of-use and health management to people living with diabetes.

The pumps, which are being introduced at the EASD (European Association for the Study of Diabetes) conference in Vienna, are approximately 60% smaller than leading insulin pumps and include an extensive set of intuitive, touchscreen applications that help improve diabetes management and control.

“In the past, insulin pumps have been large and difficult to use,”

explains William McKeon, Cellnovo’s Chief Executive Officer.

“They also require extensive training. We wanted to create a pump that was friendly and incredibly easy to use, so that pump-based therapy could reach as many people with diabetes as possible.”

The pumps include a number of industry “firsts,” highlighted by the first touchscreen operation; the first fully integrated set of diabetes management applications, including programmable Basal and Bolus, built-in glucose monitoring, a Food Library, and automatic journaling; the first, real-time Activity Monitor, which registers and stores information on the user’s physical activity; and the first insulin pump designed exclusively for children.

Two Programmable Models with Handset, Micro-Pump, and Customizable Applications

The Cellnovo pump family, which will be commercially available throughout Europe at the start of 2010, includes two models:

The Cellnovo 150 pump – a three-day adult pump that holds 150 units of insulin
The Cellnovo 50 pump – a three-day pump for children that holds 50 units of insulin and the first product in the world designed for the insulin consumption needs of children.

Each pump offers:

A wireless touchscreen handset that resembles a small mobile phone and operates via a color Graphical User Interface. Users tap the screen to enter, access, store, monitor, and send information in either portrait or landscape mode.

A discreet IPX8-waterproof patch pump that can be worn on the body in a number of different areas and is easily applied, removed, and repositioned. The pump also includes a built-in accelerometer that registers and stores user activity data.

A full suite of customizable applications, including programmable Basal, adjustable Bolus, temporary Basal, an integrated blood glucose meter, real-time Activity Monitor, Food Library, and an automatic Personal Journal. Together, these applications provide a comprehensive view of an individual’s diabetes management, leading to better therapy decisions and improved diabetes control.
Disposable, three-day insulin cartridges, each with a unique serial number stored by the pump to ensure a cartridge is only used once. Unlike competitive patch pumps, users only dispose of the cartridge, not the entire pump case.

A back-up pump and multi-device charger that enable users to wear one pump while charging the other.

In addition, the pumps include alerts and alarms that indicate low battery, low insulin levels and line occlusion.

 

Wireless Communication and a Mobile Backbone

The handset and micro-pump each house an ultra-low-power radio that enables wireless communication within a 2-metre range. The pump sends a signal to the handset twice a second, around the clock. If out of range, the pump can store information for extended periods. Equally important, the pump is linked to a mobile backbone, which offers virtually unlimited potential for future communication advancements and information sharing.

“We have only begun to realize the potential of our pump’s advanced technology,”

continues McKeon.

“Because our pump is as easy to use as a mobile phone, but offers sophisticated applications, precise insulin delivery, and wireless communication, we hope to put greater diabetes management literally at the fingertips of patients everywhere.”

 

About Cellnovo

Cellnovo is a London-based biomedical device company committed to bringing new freedom and ease of use to people living with diabetes. Our innovative insulin micro-pumps combine breakthrough proprietary technology with the latest communication and application advancements. Smart and extremely portable, they offer precise control of insulin through simple, intuitive operation. People with diabetes can efficiently manage their therapy while enjoying greater independence. For further information, contact William F. McKeon, Cellnovo at +44 (0)203 0581 250, info@cellnovo.com

Aug 17
Love0

FDA Clears The Pathwork(R) Tissue Of Origin Test For Hard To Identify Tumors

By Pathwork Diagnostics, Press Release
Press Release.

 

Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, announced that the U.S. Food and Drug Supervision (FDA) has cleared its Pathwork(R) Tissue of Genesis Test concerning purchase in determining the origin of debatable tumors.

 

The assess analyzes a tumor’s gene wording diagram to help pinpoint the beginning of insensitive-to-relate to tumors and is the first test of its kind to walk off FDA clearance. Up to an estimated 200,000 newly diagnosed cancer patients annually in the U.S. may have a tumor for which the site of origin is uncertain after the initial diagnostic workup. The FDA’s clearance underscores the growing capacity that patients’ genomic information can drag one’s feet use in helping physicians make preferably decisions.

“Knowing the primary tumor plat with greater certainty enables more appropriate cancer treatment. The growing style in cancer nurse is the fritter away of therapies that target specific tissues and their genomic components, rather than relying on a one-size-fits-all treatment approach,”

said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.

“We believe the Pathwork Tissue of Creation Check up on will help purvey more certainty in tumor diagnosis, which will enable more patients to realize the benefits of this experimental times in genomics-based diagnostics.”

The FDA-cleared Pathwork Tissue of Commencement Test will be present as an in vitro diagnostic (IVD) kit, message that clinical laboratories can run the evaluate themselves. The test is currently within reach as a service through Pathwork’s CLIA-certified laboratory.

The Pathwork Tissue of Origin Prove uses a microarray to measure the expression pattern, comprising more than 1,500 genes, in the indecisive tumor and compares it to expression patterns of a panel of 15 known tumor types, representing 60 morphologies blanket, to help shape the tumor’s origin. In the in vitro diagnostics clinical validation study submitted to the FDA, the test demonstrated 89 percent auspicious agreement (akin to sensitivity) with close by diagnoses and 99 percent cool agreement (akin to specificity). The cram consisted of 545 metastatic, poorly differentiated and undifferentiated tumors that had been identified as sole of the 15 tumor types on the panel using existing methods. The assay demonstrated an as a rule 94 percent overall concordance across four laboratories in a cross-laboratory comparison scrutiny of 60 metastatic, inadequately differentiated and undifferentiated tissue specimens.

“Hard-to-identify tumors are a significant clinical problem,”

said Dr. James Abbruzzese, Professor of Medicine at M.D. Anderson Cancer Center.

“They are time-consuming and frustrating in requital for both physicians and patients. Accurately identifying a tumor’s origin — and ergo knowing what thoughtful of cancer the tenacious has — is necessary seeking dawn standard-of-care, cancer-proper to treatment per the National Comprehensive Cancer Network Clinical Practice Guidelines. Knowing the tumor’s origin can also enable patients to get into — and benefit from — appropriate clinical trials.”

Targeted cancer therapies can be clobber even with metastatic tumors and are typically tumor-specific (e.g., Herceptin® for breast cancer), requiring identification of the primary tumor purlieus or tissue of origination. Targeting therapy to clear-cut tumor types can allow patients to avoid the toxicity of broader chemotherapy.

“Traditional tools inured to to identify tumors of inconstant origin include imaging studies, such as CT scans and MRIs, as well as a thorough pathological appraisal with immunohistochemistry and other techniques,”

said Federico Monzon, M.D., Director of Molecular Diagnostics of The Methodist Hospital in Houston.

“However, seeking difficult cases the use of these complex iterative techniques can often chronicle b debase weeks, and in some cases they smooth do not definitively identify the tissue of origin. A gene expression probe of a piece with the Pathwork Tissue of Derivation Check provides unrivalled facts and, based on this text, it is reasoned to expect that it will promote the diagnosis of uncertain primary tumors.”

 

Pathwork Diagnostics

Pathwork Diagnostics, Inc., based in Sunnyvale, California, develops and commercializes high-value molecular diagnostics with a view oncology. The firm delivers FDA-cleared, microarray- ased tests to clinical laboratories and also provides diagnostic tests through its CLIA-certified laboratory. The company’s initial tests utilize Pathwork Diagnostics’ proprietary analytics and a companion Pathchip(R) microarray, which runs on the proven Affymetrix GeneChip(R) System. The company’s start test — the Pathwork Tissue of Fountain-head Study — is now FDA-cleared as an in vitro diagnostic kit. A functionally equivalent understanding of the check up on is also present through Pathwork(R) Diagnostics Laboratory. The test aids in determining a tumor’s origin so that model-of-care, cancer-specific treatment can set out.

www.pathworkdx.com