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Oct 10
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Infinity Announces Promising Phase 1 Data of IPI-926 in Patients With Advanced or Metastatic Solid Tumors

By Infinity, Press Release
Press Release.

 

First Demonstration of Clinical Activity of IPI-926 Observed in Patients With Basal Cell Carcinoma

 

MILAN, Italy — Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced promising preliminary results from a Phase 1 study of IPI-926, its novel, oral small molecule that targets the Hedgehog pathway. In the study, IPI-926 was well tolerated and resulted in clinical activity in patients with basal cell carcinoma (BCC). These data demonstrate the ability of IPI-926 to inhibit the Hedgehog pathway, further supporting the Phase 1b/2 study of IPI-926 in combination with Gemzar® (gemcitabine) in patients with previously untreated, metastatic pancreatic cancer, which is enrolling patients. These data were described in a poster presentation at the European Society for Medical Oncology (ESMO) Congress in Milan, Italy.

“This study provides important information about the tolerability and anti-tumor activity of IPI-926 in patients with solid tumors and confirms our hypothesis that inhibition of the Hedgehog pathway may be an important new approach to treating the broad range of cancers in which this pathway is implicated,”

said Antonio Jimeno, M.D., Ph.D., Associate Professor, University of Colorado School of Medicine, and a lead investigator in this study.

“I look forward to further exploration of the clinical potential of IPI-926 in multiple indications.”

“We are encouraged by the clinical data of IPI-926 showing a pharmacokinetic profile that supports once daily dosing as well as activity in patients with basal cell carcinoma. We look forward to following the numerous patients who remain on study and reporting the full set of data in the future,”

stated Julian Adams, Ph.D., president of research and development at Infinity.

“Having demonstrated that IPI-926 has on-target activity against the Hedgehog pathway, these results further support our Phase 1b/2 trial in pancreatic cancer. We are currently evaluating additional indications in which to advance IPI-926.”

 

Trial Design and Results
The Phase 1 study of IPI-926 was designed as an open-label, dose-escalation study in patients with advanced and/or metastatic solid tumor malignancies. Patients received IPI-926 administered orally once-daily on 28 day cycles at doses ranging from 20 mg to 200 mg. In addition to the initial dose escalation phase, several expansion cohorts were enrolled at the 130 mg dose level, including a cohort of patients with locally advanced or metastatic BCC. Trial endpoints include safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity. Further dose escalation in this study is ongoing to determine the maximum tolerated dose of IPI-926.

At the time of the data presentation, 60 patients have been enrolled, including 24 patients with BCC. IPI-926 has been well tolerated. The most common adverse events observed were Grade 1 and 2 fatigue and nausea. Grade 3 transaminitis was observed in four patients; however, all events of transaminitis were asymptomatic and reversible. No Grade 4 or 5 related AEs were observed. Steady state exposure to IPI-926 was achieved after three weeks on study, confirming the potential for once daily dosing.

In the BCC cohort, 17 patients were enrolled who were naïve to treatment with a Hedgehog pathway inhibitor. To date, four clinical partial responses have been observed in this group of patients. As the majority of patients with BCC have undergone treatment for less than 24 weeks, more time on study will be required to fully assess the clinical activity of IPI-926 in patients with BCC. Only one patient with BCC naïve to treatment with a Hedgehog pathway inhibitor has discontinued from the study due to progression of disease, and this patient was on trial for more than 18 months. Among patients with non-BCC solid tumors enrolled in the study, three patients have shown stable disease for at least six months.

Information regarding clinical trials for IPI-926, including participating clinical trial sites, is available at www.clinicaltrials.gov.

About the Hedgehog Pathway and IPI-926
Malignant activation of the Hedgehog pathway is responsible for a broad range of cancers through three distinct mechanisms: signaling to the tumor microenvironment, signaling to tumor progenitor cells, and genetic activation of the Hedgehog pathway in tumor cells. IPI-926 is a small molecule that inhibits Smoothened (Smo), a key component of the Hedgehog pathway. Smo inhibition represents a significant anti-cancer opportunity for addressing a number of difficult-to-treat cancers by disrupting malignant activation of the pathway.

IPI-926 is currently being evaluated in a Phase 1 study in solid tumors as well as a Phase 1b/2 study in combination with Gemzar® (gemcitabine) in patients with previously untreated, metastatic pancreatic cancer. These clinical trials build upon a robust set of supporting preclinical data that provide a strong rationale for evaluating the potential of IPI-926 for treatment of a broad range of cancers.

About Infinity Pharmaceuticals, Inc.
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hsp90 chaperone system, the Hedgehog pathway, fatty acid amide hydrolase and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at www.infi.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements 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. Such forward-looking statements include those regarding the utility of Hedgehog pathway inhibition, the reporting of clinical data and the potential of IPI-926 to treat a broad range of cancers. Such statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that IPI-926 will successfully complete necessary preclinical and clinical development phases or that Infinity’s strategic alliance with Mundipharma International Corporation Ltd. will continue for its expected term or that it will fund Infinity’s programs as agreed. Management’s expectations could also be affected by risks and uncertainties relating to: results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures, including in connection with business development activities; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2010. Any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Gemzar® is a registered trademark of Eli Lilly and Company.

CONTACT:
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden
617-453-1336
Cell: 617-780-7432
Jaren.Madden@infi.com
http://www.infi.com

Oct 06
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Amsterdam Molecular Therapeutics successfully raised €14.3m through an Equity Issue

By Press Release

Press Release.

Amsterdam – Amsterdam Molecular Therapeutics (AMT) Holding N.V. (Euronext: AMT) announces today that it has successfully raised € 14.3 m in gross proceeds through a private placement of new shares with institutional investors, other qualifying investors who subscribed forat least € 50,000 per investor in various jurisdictions and the members of the Board of Management (the “Private Placement”). Pursuant to the Private Placement AMT will issue 8,435,294 new ordinary shares with a nominal value of € 0.04 each for an offer price of € 1.70 per share.

The net proceeds of the Private Placement will increase AMT’s financial flexibility and will be used to fund Glybera® through its regulatory and commercial development and to continue the development of the hemophilia and other pipeline programs.

The payment and delivery of the new shares is expected to take place on October 11, 2010, at which date the new shares are also expected to be admitted to listing on NYSE Euronext in Amsterdam.

Immediately after the closing of the Private Placement, AMT’s issued and outstanding share capital will amount to 23,504,022 ordinary shares.

Pricing Statement
The prospectus that was prepared in relation to the admission to listing and trading of the shares was made generally available on 5 October 2010. Today, AMT deposited a pricing statement with the Authority of the Financial Markets (Stichting Autoriteit Financiële Markten) mentioning amongst others the number of new shares to be issued and the issue price of the new shares. The prospectus and the pricing statement are available via AMT’s website.

Kempen & Co and Petercam Nederland N.V. have acted as joint global coordinators and bookrunners for the Private Placement.

About Amsterdam Molecular Therapeutics
AMT is a leader in the development of human gene based therapies. Using adeno-associated viral (AAV) derived vectors 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 proprietary platform 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, Duchenne Muscular Dystrophy, Acute Intermittent Porphyria, and Parkinson’s Disease at different stages of research or development. AMT was founded in 1998 and is based in Amsterdam.

Not for release, publication or distribution in whole or in part, directly or indirectly, in or into the United States, Australia, Canada, Japan or South Africa or to US persons. This announcement is not a prospectus and is not an offer for sale of securities in the United States, Canada, South Africa, Australia, Japan or any other jurisdiction.

The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “”Securities Act””), and may not be offered or sold in the United States absent registration under the Securities Act or an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act.

In connection with the admission of the shares in the capital of Amsterdam Molecular Therapeutics (AMT) Holding N.V. to listing and trading on NYSE Euronext in Amsterdam a prospectus has been made generally available (the “”Prospectus””). The Prospectus is available at no cost through the website of AMT, and is also available via the website of NYSE Euronext (Dutch residents only) and by sending a request in writing to AMT (P.O. Box 22506, 1100 DA Amsterdam, The Netherlands).

For further enquiries:

Ellen Roest
AMT Communications
Tel : +31 6 2900 6179
e.roest@amtbiopharma.com

Mike Sinclair
Halsin Partners
Tel : +44 20 7318 2955
msinclair@halsin.com

Jörn Aldag
CEO
Tel +31 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 AMT 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.

AMT expressly disclaims any intent or obligation to update any forward-looking statements herein except as required by law. For a more detailed description of the risk factors and uncertainties affecting AMT, reference is made to the Prospectus and AMT’s public announcements made from time to time.

Oct 06
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Pathwork Diagnostics Completes $30M Series C Round

By Pathwork Diagnostics, Press Release
Press Release.

 

Capital to Accelerate Commercialization and Market Share for FDA-cleared Tissue of Origin Test

 

REDWOOD CITY, Calif., – Pathwork Diagnostics, Inc, a privately held molecular diagnostics company focused on oncology, today announced the closing of its $30 million Series C financing. Led by Alta Partners, the financing included participation from the company’s existing investors: Abingworth, Advent Venture Partners, Novus Ventures, Prospect Venture Partners and Venrock. David Mack, Ph.D., Director at Alta Partners, joined Pathwork Diagnostics’ board of directors in connection with the financing.

The Pathwork® Tissue of Origin Test identifies the source of cancers that are difficult to classify and increases oncologists’ confidence in their treatment approaches. The test works on formalin-fixed, paraffin-embedded (FFPE) tissues, which is the most common clinical specimen type. The accurate and reproducible results are evaluated by the physician in the context of the patient’s clinical history and complementary diagnostics.

Breaking new ground in the field of molecular diagnostics, the Tissue of Origin Test recently received U.S. Food and Drug (FDA) clearance. Pathwork has the only FDA-cleared molecular diagnostic test for tissue of origin. Pathwork also recently signed a diagnostic discovery partnership in oncology with Novartis.

“2010 has been an exciting and productive year at Pathwork Diagnostics,”

said CEO Deborah J. Neff.

“We are pleased to have Alta Partners join our outstanding syndicate of investors, and look forward to working with our team to accelerate our efforts to build adoption and market share for the Tissue of Origin Test. This financing provides the resources to support our commercial activities and expand our product offerings.”

“Pathwork Diagnostics is developing compelling technology that is changing the way oncologists diagnose and treat challenging tumors,”

said new board member David Mack.

“We believe the company’s technology is best in class and are excited about the company’s commercial growth opportunities.”

When the tumor’s tissue of origin cannot be identified, patients may not receive the most appropriate tissue specific standard-of-care treatment.

“Our approach allows physicians to have more certainty in diagnosing and managing their cancer patients,”

said Deborah J. Neff.

“Pathwork looks forward to working directly on new molecular diagnostic tests and in collaboration with pharmaceutical companies to provide physicians with better diagnostics that will help improve patient care.”

 

About Pathwork Diagnostics
Pathwork Diagnostics Inc. is a privately held company based in Redwood City, Calif., that develops and commercializes high-value molecular diagnostics for oncology. The company’s flagship Tissue of Origin Test is the only FDA-cleared molecular test of its kind. For more information call toll-free 1(877) 808-0006 or visit www.pathworkdx.com.

About Alta Partners
Alta Partners is a San Francisco-based venture capital firm focused on life sciences investing. Founded in 1996, the firm currently manages $2 billion in committed capital through eight venture fund programs. Alta invests in life sciences companies across the development continuum, from company formation to later-stage opportunities, and has funded more than 120 companies in the sector to date. www.altapartners.com

Oct 04
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Avila Initiates Phase 1 Clinical Study of AVL-292, a Targeted Covalent Drug and Novel Potential Treatment for B Cell Cancers and Autoimmune Diseases

By Avila, Press Release
Press Release.

 

WALTHAM, Mass. – Avila Therapeutics™, Inc., a biotechnology company developing targeted covalent drugs, announced today that it has initiated a phase 1 clinical trial to assess the safety, tolerability and pharmacokinetic profile of AVL-292, a novel, orally available, covalent drug that targets Bruton’s tyrosine kinase (Btk). AVL-292 is the first product candidate to enter clinical evaluation from Avila’s proprietary covalent drug platform, Avilomics™.

“Initiating clinical development of AVL-292 is an important milestone in our development of a new generation of rationally-designed, targeted covalent drugs,”

said Katrine Bosley, Chief Executive Officer of Avila.

“By addressing a target that has been difficult for others to address successfully AVL-292 has the potential to help patients in need of new therapies for B cell cancers and autoimmune diseases like rheumatoid arthritis.”

B cells are implicated in multiple diseases, and Btk plays a critical role in the signaling and proliferation of B cells. Potent, selective inhibition of Btk has the potential to be therapeutically important in the treatment of B cell-related hematological cancers such as non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as autoimmune diseases such as rheumatoid arthritis. In preclinical studies, AVL-292 selectively and potently inhibited Btk in vitro and was efficacious in a variety of different animal disease models.

The first clinical study of AVL-292, which is being conducted in the U.S., is a double-blind, placebo-controlled, single ascending dose study and will evaluate the safety, tolerability, and pharmacokinetic profile of AVL-292 in healthy volunteers. In addition, this study will use Avila’s unique covalent probe technology to evaluate quantitatively the relationships among dose level, systemic exposure and occupancy of the target by AVL-292. This combination of analyses is designed to provide a powerful and rigorous understanding of AVL-292 action at the molecular and cellular levels and may serve to guide future clinical development.

“The Leukemia & Lymphoma Society is very excited about AVL-292 moving into clinical evaluation. There remains a great need for therapies that work by new mechanisms to treat patients who are fighting blood cancers, and we believe that targeting Bruton’s tyrosine kinase may be an important new approach to benefit the patients we serve,”

said Louis DeGennaro, Ph.D., Chief Mission Officer of The Leukemia & Lymphoma Society, with whom Avila established a collaboration in March 2010.

 

About Avila Therapeutics
Avila focuses on design and development of targeted covalent drugs to achieve best-in-class 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 cancer, autoimmune disease, and hepatitis C infection. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.

Aug 03
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Algeta concludes agreements for the manufacture and supply of Alpharadin for future commercial sale

By Algeta, Press Release
Press Release.

 

Oslo, Norway – Algeta ASA (OSE: ALGETA), the focused oncology company, today has announced it has concluded two agreements for the manufacture and supply of Alpharadin for future commercial sale. Alpharadin (radium-223) is a novel, targeted alpha-pharmaceutical in clinical trials for treating bone metastases in cancer patients.

The signing of these agreements triggers a EUR 5 million milestone payment from Bayer Schering Pharma (“Bayer”), Algeta’s development and commercial partner for Alpharadin.

The first agreement, with Bayer, provides that Algeta will be the exclusive supplier of Alpharadin for future commercial sale.

The second agreement sees Algeta significantly extend its collaboration with Oslo’s Institute for Energy Technology (IFE), which currently manufactures Alpharadin for Algeta/Bayer’s ongoing ALSYMPCA phase III study and clinical trials in other cancer indications. Under the terms of this second agreement, IFE, in conjunction with Algeta, will commence an expansion of the existing Alpharadin production facility at IFE. The upgrade, which will be paid for by Algeta, will create a state-of-the-art manufacturing facility to supply the expected commercial demand around the world following approval and launch.

Andrew Kay, Algeta’s President and CEO said:

“IFE has proved to be an excellent manufacture and supply partner of Alpharadin for all our clinical trials to date. We look forward to continuing our work together with IFE to secure the future clinical and commercial supply of Alpharadin.”

He added:

“Algeta and IFE have developed world-leading expertise in the production of the alpha-emitters that underpin our alpha-pharmaceutical platform. As a consequence, the new, state-of-the-art facility will also provide an important advantage to Algeta as it looks to advance its Thorium platform. The conclusion of these agreements, therefore, is a very positive development for Algeta.”

 

For further information, please contact:

For Algeta
Andrew Kay, CEO
Oystein Soug, CFO
+47 2300 7990 / +47 4840 1360 (mob)
+47 2300 7990 / +47 9065 6525 (mob)
post@algeta.com

International media enquiries:
Mark Swallow/Helena Galilee/David Dible,
Citigate Dewe Rogerson
+44 207 638 9571,
mark.swallow@citigatedr.co.uk

US investor enquiries:
Jessica Lloyd, The Trout Group
+1 646 378 2928,
jlloyd@troutgroup.com

About Algeta
Algeta is a focused oncology company developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.

Algeta’s lead product Alpharadin (based on radium-223) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.

The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring in up to 90% of certain late-stage cancers, e.g. prostate, breast and lung.

Alpharadin is partnered with Bayer Schering Pharma AG, a major pharmaceutical company, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from hormone-refractory (castration-resistant) prostate cancer. Alpharadin is also under investigation in phase II clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients.

Algeta also aims to develop a future pipeline of tumor-targeting alpha-pharmaceutical candidates based on the alpha particle emitter thorium-227, through selective in-licensing and/or acquiring innovative technologies and tumor-targeting molecules.

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.

About IFE (Institute for Energy Technology) ife.no
IFE is an international research institute for energy and nuclear technology. IFE’s mandate is to undertake research and development, on an ideal basis and for the benefit of society, within the energy and petroleum sector, and to carry out assignments in the field of nuclear technology for the nation.

The Isotope Laboratories at IFE are a national centre of expertise for radiopharmaceuticals. The Institute was founded in 1948, and is today an independent foundation. The annual turnover is approximately NOK 650 M, and IFE has approximately 600 employees.

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. These 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.

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)

Aug 02
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Pathwork Diagnostics Partners with Leading Pharmaceutical Company to Discover Molecular Diagnostics for Cancer

By Pathwork Diagnostics, Press Release
Press Release.

 

REDWOOD CITY, California – Pathwork Diagnostics Inc., a molecular diagnostics company focused on oncology, today announced that it has entered into a research collaboration with Novartis.

The parties intend to discover clinically meaningful biomarker signatures that can serve as the basis for diagnostics across a range of cancer types. Under the terms of the agreement, both parties have rights to develop and commercialize the diagnostic products.
Financial terms were not disclosed.

“There is no question that the future of cancer treatment will require and depend on molecular diagnostics,”

said Richard Klausner, M.D., former director of the National Cancer Institute and member of Pathwork Diagnostics Board of Directors.

“The collaboration between Pathwork and Novartis has the potential to yield diagnostic products that improve the quality of cancer care worldwide.”

 

About Pathwork Diagnostics
Pathwork Diagnostics Inc. develops and commercializes high-value molecular diagnostics for oncology and is a privately held company based in Redwood City, Calif. The company’s Tissue of Origin Test is the only FDA-cleared molecular test that assists in the determination of the tissue of origin. The test uses microarray-based RNA profiling to compare the patient’s specimen to a database of known tumor types. The accurate and reproducible results are evaluated by the physician in the context of the patients’ clinical history and complementary diagnostics, such as immunohistochemistry.

Jul 19
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MediGene sells full European rights for Eligard to Astellas for EUR 25 million and ongoing royalties

By Press Release
Press Release.

 

MediGene sells full European rights for Eligard to Astellas for EUR 25 million and ongoing royalties

Astellas to make one-off payments totaling EUR 25 million
•  MediGene to remain entitled to royalties
•  No further costs to MediGene
•  Sale price reflects the full NPV of all future Eligard® revenues while allowing MediGene to benefit from continued Eligard® growth
•  Analyst and press conference call and webcast tomorrow, July 20, at 11 a.m. (CEST)

Martinsried/Munich – MediGene AG (Frankfurt, Prime Standard, MDG, TecDAX) announces the sale of full European marketing and distribution rights to Eligard® (leuprolide acetate, for the treatment of hormone-dependent prostate cancer) to Astellas Pharma Europe Ltd. (London, “Astellas”), previously MediGene’s European marketing partner for Eligard®. MediGene acquired these rights from TOLMAR Therapeutics Inc. (formerly Atrix Laboratories Inc.) in 2001. In return for the Eligard® license, MediGene will receive EUR 25 million in cash from Astellas as well as royalties on future product sales. For MediGene, all future costs, obligations and risks associated with the supply of Eligard® to Astellas, as well all future procurement costs and license payments to TOLMAR, will cease within the next months.

This agreement will strengthen MediGene’s financial situation and provide the opportunity for MediGene to profit from future growth of Eligard® sales. This would not be possible under the former deal structure since MediGene’s net margin decreased once net sales by Astellas exceeded a certain threshold, capping royalty receipts.

MediGene will now receive a low single-digit royalty on net sales of Eligard® generated by Astellas in Europe. In 2009, MediGene’s net participation in Eligard® sales by Astellas totalled about 6%. In future, MediGene will receive about one third of this margin on Eligard® in-market sales. According to the contract, Astellas will pay EUR 25 million in three tranches as the steps of transfer of the rights are concluded over the next six to twelve months (EUR 5 million upon signature, EUR 15 million anticipated within six to eight months, EUR 5 million anticipated within six to twelve months).

Arnd Christ, MediGene’s CFO, commented: “This is an excellent deal for MediGene, both in financial and strategic terms. It not only reflects the full NPV of all future Eligard® revenues according to the previous deal structure, but also provides us with significant and non-dilutive financing in a very tough capital markets environment. Furthermore, the structure of the deal allows MediGene to continue to benefit from the increasing revenue from Eligard® which was not possible under the previous structure. The significant improvement of our balance sheet and the simplification of the Eligard® deal structure allow us to fund growth opportunities and thus strengthening the future pipeline of the company.”

“We are delighted to have reached this agreement with MediGene which confirms our strong commitment to meeting the needs of patients in the fields of urology and oncology,” added Masao
Yoshida, President and CEO of Astellas Pharma Europe Ltd. “We have a strong track record in urology and look forward to continuing applying our proven expertise to all aspects of the marketing and distribution of this important treatment throughout Europe.”

Analyst and press conference call and webcast: An analyst and press conference call in English will take place tomorrow, July 20, at 11 a.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.

About Astellas: Astellas Pharma Europe Ltd. is a subsidiary of Astellas Pharma Inc. which is located in Tokyo, Japan. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. For more information on Astellas Pharma Europe Ltd., please visit the website at http://www.astellas.eu.

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 forward-looking statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene® is a registered trademark of MediGene AG. Eligard® is a registered trademark of Tolmar Therapeutics, Inc. These trademarks may be owned or licensed in select locations only.

– ends –

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 focus on oncology.

Contact MediGene AG
Email: 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

Jun 15
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Micromet’s Blinatumomab Induces Durable Remissions in Patients with Relapsed Non-Hodgkin’s Lymphoma

By Micromet, Press Release
Press Release.

 

Durable responses ranging up to 30 months observed

 

BETHESDA, Md., – Micromet, Inc. (Nasdaq: MITI) today announced the presentation of updated results from a Phase 1 trial of the Company’s lead product candidate blinatumomab (MT103) in patients with relapsed non-Hodgkin’s lymphoma (NHL). A high objective response rate was maintained among patients treated with blinatumomab using an adapted schedule, comparable to that previously reported in patients receiving constant dosing. Blinatumomab is the first in a new class of agents called BiTE(R) antibodies, designed to harness the body’s T cells to kill cancer cells.

The findings were presented on June 12, 2010 in an oral presentation (abstract # 0559) at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

“Blinatumomab continues to demonstrate a long duration of response in heavily pre-treated non-Hodgkin’s lymphoma patients,”

said Professor Ralph Bargou, Division of Hematology and Oncology, Department of Internal Medicine II, Wuerzburg University Hospital, and the study’s principal investigator.

“Results of the expanded Phase 1 experience suggest that blinatumomab has the potential to alter the clinical course of disease in patients with a variety of NHL sub-types.”

Phase 1 Study Design
This multi-center Phase 1 study evaluates the safety and tolerability of blinatumomab in adult patients with relapsed non-Hodgkin’s lymphoma (NHL). The key objectives of the study are to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and anti-lymphoma activity. Patient response is assessed using the Cheson criteria by independent radiologic review.

Patients initially received blinatumomab at dose levels ranging from 0.5 to 90 micrograms per meter squared per day over a four or eight week cycle. Based on findings in the ongoing study, a new dosing schedule was designed to mitigate the occurrence of neurological adverse events observed at the onset of treatment. Recently enrolled patients received a “step-dose approach” including a lower starting dose (5 or 15 micrograms per meter squared per day) of blinatumomab for one week, with subsequent escalation up to the target dose of 60 micrograms per meter squared per day.

Updated Phase 1 Results
The analysis presented at EHA included 52 patients, mainly with diagnoses of follicular lymphoma (FL) (42%) and mantle cell lymphoma (MCL) (42%). The majority of enrolled patients received three or more prior lines of chemotherapy. Of eight evaluable FL and MCL patients treated with constant dosing at a dose level of 60 micrograms per meter squared per day, 100% (8 of 8) achieved an objective response. The median response duration is 21 months. Three patients currently have ongoing responses ranging from 24 up to 30 months.

Among patients treated using constant dosing, the most common clinical adverse events were pyrexia, headache and fatigue. The most common adverse events were early, transient, fully reversible and did not require discontinuation of treatment. The clinically most relevant cause of treatment discontinuation was neurologic events. These were observed in a sub-group of patients with an identified prognostic factor. All events resolved without sequelae following treatment discontinuation.

Data presented on six patients with an identified risk factor for neurologic events who were treated with blinatumomab using a “step-dose approach” indicates that the new treatment schedule appears to mitigate neurological events and maintain clinical activity. There was no occurrence of grade 3 or higher neurological events and five objective responses were achieved among the six patients treated.

“Our goal is to safely and effectively treat indolent and mantle cell lymphomas using a uniform treatment schedule irrespective of patient characteristics,”

said Jan Fagerberg, M.D., Ph.D., Micromet’s SVP, Chief Medical Officer.

“We look forward to continuing to advance enrollment in the on-going study using the adapted treatment schedule and broadening the eligible patient population to include other non-Hodgkin’s lymphoma subtypes.”

Conference Call and Webcast
Micromet management will host a conference call on Tuesday, June 15 at 8:30 AM EDT to review the data presented at EHA. To participate in the conference call, please dial 866-770-7120 (domestic) or 617-213-8065 (international) and reference the access code 28465583.

A replay of the call will be available from 11:30 AM ET on June 15, 2010 until midnight on June 22, 2010. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 87529369. The archived webcast will be available for 30 days in the Investor Relations section of the Micromet website at www.micromet-inc.com.

About Blinatumomab
Blinatumomab (MT103) is a novel, next-generation monoclonal antibody designed to direct the body’s cell destroying T-cells against CD19, a protein expressed on the surface of B-cell derived acute lymphoblastic leukemias and non Hodgkin’s lymphomas. Micromet received orphan drug designation from the European Medicines Agency for blinatumomab for the treatment of acute lymphoblastic leukemia, mantle cell lymphoma and chronic lymphatic leukemia and from the Food and Drug Association for the treatment of acute lymphoblastic leukemia, chronic lymphocytic leukemia, indolent B cell lymphoma, hairy cell leukemia and prolymphocytic leukemia.

About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) technology, as well as conventional monoclonal antibodies. Two of Micromet’s BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including sanofi-aventis, Bayer Schering Pharma, Merck Serono, Boehringer Ingelheim, MedImmune and Nycomed. Additional information can be found at www.micromet-inc.com

Safe Harbor
This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the development of blinatumomab and its use in the treatment of cancer. 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 our preclinical data is not confirmed in clinical trials with our product candidates. This factor and others are more fully discussed in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2010. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

SOURCE Micromet, Inc.

Jun 04
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Amsterdam Molecular Therapeutics reports Positive New Clinical Data from Glybera Study

By Press Release
Press Release.

 

Amsterdam, The Netherlands, June 4, 2010 – Amsterdam Molecular Therapeutics (Euronext: AMT) a world leader in gene therapy, today reports new data showing that it’s lead product Glybera results in break-down of chylomicrons in lipoprotein lipase deficient (LPLD) patients.  The data will be presented on June 5 at the Second International Symposium on Chylomicrons in Disease, Sint Franciscus Gasthuis, Rotterdam, The Netherlands.

Glybera is a gene therapy product that induces functional lipoprotein activity. New data from an ongoing Canadian clinical study indicate that a single administration of Glybera in LPLD patients results in a remarkable improvement in the ability to break down the chylomicrons that transport dietary fat (triglycerides).  Lipoprotein-lipase-deficient (LPLD) patients are incapable of clearing chylomicrons which are responsible for causing significant morbidity and mortality.

“The long-term improvement in chylomicron handling following Glybera administration is very impressive”

said Dr. André Carpentier, co-investigator from the University of Sherbrooke, Quebec, Canada, who designed and analyzed the chylomicron sub-study.

“These data are important, because the major complications observed in LPLD patients, including pancreatitis, are a consequence of chylomicron overload. They also constitute evidence for a long term clinically relevant lipoprotein lipase activity induced by Glybera”

noted the principal investigator, Prof. Daniel Gaudet, from the University of Montreal, and ECOGENE-21 clinical study center, Chicoutimi, Quebec, Canada.

These new data provide a basis for explaining the mechanism of action of Glybera in LPLD patients, and in general for continued pharmacologic activity after one time gene therapy.

About  LPLD
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 LPL activity in patients. LPL activity is needed in order to break down Chylomicrons, large fat-carrying particles that are formed in the gut and enter the circulation after each meal.  When such particles are not adequately broken down they 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.

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

Jun 01
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Advent Sells Respivert to J&J for Significant Cash Return

By Press Release, Respivert
Press Release.

 

Advent Venture Partners was instrumental in the development of RespiVert, a true example of a classic venture investment and a case study of Advent‘s ability to find strong innovation at the early stage and develop it to a strong and early exit.

 

Advent backed an exceptional Founding team at Respivert,  helped refine the business plan, assembled an international venture capital syndicate, and placed Rudi Pauwels (former Advent Venture Partner and current CEO of portfolio company Biocartis) as chairman of the board. Advent has remained the largest shareholder of the company throughout.

The sale of RespiVert represents a further validation of Advent’s strategic approach to portfolio building, which is designed to produce earlier cash returns to our LPs than typically associated with venture funds. RespiVert is the third profitable exit from the Life Science element of the APEF IV portfolio following successful exits for Thiakis and Algeta. Each of these three companies received a single round of finance and in each case an exit has been achieved within four years of the initial investment.

 

Press Release

Centocor Ortho Biotech Inc. Acquires Respivert Ltd, Strengthens Pulmonary Focus

 

Acquisition Bolsters Pulmonary Portfolio and Capabilities, Accessing Promising Pipeline of First-in-Class Compounds and Renowned Team of Respiratory Scientists

Horsham, Pa., June 1, 2010 – Centocor Ortho Biotech Inc. today announced that it has acquired RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases.  The company’s lead compounds, RV-568 and RV-1088, narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities, are progressing into clinical development as potential first-in-class treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).  The clinical development of RV-568 and RV-1088 will be led by RespiVert in collaboration with scientists at Centocor Research and Development, Inc.  The company is not disclosing financial terms.

“The RespiVert compounds offer the potential for a new class of medicines for patients with severe lung disease that are insensitive to inhaled corticosteroids,”

said Susan Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Centocor Research and Development, Inc.

“The addition of RespiVert’s expert scientific team and discovery platforms for inhaled medicines strengthens our capabilities and further builds our pipeline of novel oral and biologic therapies for serious pulmonary diseases.”

With the acquisition of RespiVert, Centocor Ortho Biotech gains a portfolio of first-in-class, early-stage inhaled treatments for serious lung diseases.  RespiVert will continue to maintain its research and discovery presence in London from the Imperial BioIncubator, which is based at the campus of Imperial College London.  RespiVert employees will continue to lead ongoing research and drug discovery efforts.

Dr. Garth Rapeport, Chief Executive Officer of RespiVert, who is remaining with RespiVert following the acquisition, said,

“We believe that our focused discovery efforts in pulmonary disease offer a unique opportunity to bring completely new treatment options to patients who suffer from severe, chronic respiratory diseases including Chronic Obstructive Pulmonary Disease, severe asthma and Cystic Fibrosis.”

 

About Asthma, COPD, and CF
Severe or uncontrolled asthma is associated with significant morbidity, resulting in missed work and school days, and substantial limitation of activity, adversely impacting quality of life in asthmatics.  Severe asthma represents a particular societal burden, with sources suggesting that half of the total cost of asthma in the United States is attributable to severe disease.  Asthma is the cause of over 4,000 deaths each year in the U.S. and over 12,000 in Europe.

COPD is an umbrella term for a group of lung diseases which include chronic bronchitis, emphysema and small airways disease.  COPD is a serious, chronic disorder characterized by a slowly progressive decline in lung function with symptoms such as chronic cough and dyspnoea significantly impacting quality of life.  COPD is estimated to cause 130,000 deaths per year in the U.S.

CF is an inherited life-threatening disease involving a genetic mutation that disrupts the cystic fibrosis transmembrane regulator (CFTR) protein, resulting in poorly hydrated, thickened mucous secretions in the lungs and digestive tract.  Due to these changes, the lungs of individuals with cystic fibrosis are colonized and infected by bacteria from an early age.  This leads to progressive and severe lung inflammation which is difficult to treat.

About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology.  The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc.  Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options.  Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.  For more information about Centocor Ortho Biotech, visit www.CentocorOrthoBiotech.com.  Centocor Ortho Biotech Inc. and Centocor Research and Development Inc. are wholly-owned subsidiaries of Johnson & Johnson.

About RespiVert
RespiVert is a small molecule drug discovery company working towards the identification of new treatments for patients with Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF) and severe asthma.  The more severe forms of these diseases are poorly responsive to existing therapies such as inhaled corticosteroids and new disease modifying treatments are urgently required.

RespiVert has been financed by Advent Venture Partners, Fidelity Biosciences, Imperial Innovations and SV Life Sciences.

Forward-looking statements
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.  These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Centocor Ortho Biotech Inc.’s and/or Johnson & Johnson’s expectations and projections.  Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Centocor Ortho Biotech Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)