Showing posts with label biopharmaceutical. Show all posts
Showing posts with label biopharmaceutical. Show all posts

Monday, April 9, 2007

Sirion Therapeutics Completes $45 Million Series B Financing

Sirion Therapeutics, Inc., an ophthalmic-focused biopharmaceutical company, announced today that it has raised $45 million in a Series B private equity financing led by Aisling Capital. In addition to Aisling, the financing included new investors Investor Growth Capital, Atlas Venture, Advent International and Bear Sterns Healthcare Value Partners. Previous Series A investor NovaQuest also participated in the Series B round.

Andrew Schiff, MD, Managing Director of Aisling Capital commented, "Sirion's experienced management team has put together an impressive portfolio of products. We are pleased with the company's progress to date. It is extraordinary to have achieved so much in such a short period of time and we appreciate the opportunity to support them at a crucial time in the company's development."

Curt LaBelle, MD, Vice President of Investor Growth Capital, Inc. added "IGC is pleased to make this investment in Sirion. We think ophthalmology is an exciting area and the management team at Sirion has the experience to continue building an excellent ophthalmic company."

Barry Butler, President and CEO of Sirion Therapeutics, said that the proceeds from this raise will be used to advance the company's pipeline of products. "We are obviously delighted to be partnered with such high caliber investors and appreciate their confidence in our technology, management team and strategic direction. This investment will allow us to reach critical milestones in several of our development programs."

Sirion currently has four products in various stages of development:

ST-601. ST-601 is a potent ophthalmic steroid emulsion for the treatment of steroid responsive inflammatory diseases. A Phase III program was initiated in January 2007.

ST-602. ST 602 is a product aimed at reducing the accumulation of lipofuscin in the eye by inhibiting the formation of serum retinol. It is theorized that the accumulation of lipofuscin in the eye is responsible for vision loss in such diseases as dry age-related macular degeneration, geographic atrophy and Stargardt's disease. A Phase II trial commenced in December 2006.

ST-603. ST-603 is a topical preparation of cyclosporine A in the patented Sophisen ophthalmic delivery system. A clinical program commenced in Q1 2007.

ST-605. ST-605 is a topical ophthalmic gel containing ganciclovir for the treatment of certain viral and superficial eye infections. The product is currently marketed by Laboratoires Thia in Europe under the brand name of Virgan®.

About Sirion Therapeutics, Inc. Sirion Therapeutics is a Tampa, FL based biopharmaceutical company, with additional offices in La Jolla, California, dedicated to the development and commercialization of innovative ophthalmic products. For more information regarding Sirion, please visit Sirion's website at http://www.siriontherapeutics.com

Friday, March 23, 2007

Marketing Authorisation Application for Ambrisentan Validated by European Medicines Agency


Gilead Sciences, Inc. (Nasdaq: GILD) today announced that GlaxoSmithKline's Marketing Authorisation Application (MAA) for ambrisentan for the treatment of pulmonary arterial hypertension (PAH) was validated by the European Medicines Agency (EMEA) following a review by the Committee for Medicinal Products for Human Use (CHMP). Following the validation of an MAA, the dossier is distributed to members of the CHMP for formal review. As a result of this validation, Gilead will receive a milestone payment from GlaxoSmithKline.

About Ambrisentan

Ambrisentan is a non-sulfonamide, propanoic acid-class, endothelin receptor antagonist that is selective for the endothelin type-A (ET(A)) receptor. Activation of the ET(A) receptor by endothelin, a small peptide hormone, leads to vasoconstriction and cell proliferation. PAH is associated with elevated endothelin blood levels. Ambrisentan has been granted orphan drug designation for the treatment of PAH in both the United States and European Union.

The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted a Priority Review for Gilead's New Drug Application (NDA) for marketing approval of ambrisentan (5 mg and 10 mg) for the once-daily treatment of PAH. The FDA has established a target review date, under the Prescription Drug User Fee Act (PDUFA), of June 18, 2007.

As an investigational compound, ambrisentan has not yet been determined safe or efficacious in humans.

GlaxoSmithKline holds rights to commercialize ambrisentan in territories outside of the United States.

About Pulmonary Arterial Hypertension

PAH is a debilitating disease characterized by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. These high pressures make it difficult for the heart to pump blood through the lungs to be oxygenated. Patients with PAH suffer from shortness of breath as the heart struggles to pump against these high pressures causing such patients to ultimately die of heart failure. PAH can occur with no known underlying cause, or it can occur secondary to diseases such as connective tissue disease, congenital heart defects, cirrhosis of the liver and HIV infection. PAH afflicts approximately 200,000 patients worldwide.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. For more information on Gilead Sciences, please visit the company's website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Thursday, March 22, 2007

Eisai to Acquire Morphotek, Eisai's Dramatic Leap towards Biologic Therapeutics Evidenced by the Acquisition

Eisai Co., Ltd. (Tokyo, "Eisai," President and CEO: Haruo Naito), Eisai Corporation of North America (Woodcliff Lake, NJ, "ECA," President: Hajime Shimizu) and Morphotek® Inc. (Exton, PA, "Morphotek," CEO: Nicholas Nicolaides) today announce that ECA has signed a definitive agreement to acquire Morphotek for US$325 million after excess net cash.

Morphotek develops therapeutic monoclonal antibodies through the use of proprietary human antibody technologies, including Human MORPHODOMA® and LibradomaTM. The company is leveraging these technologies to enrich its pipeline that already includes therapeutic antibody leads for the treatment of cancer, rheumatoid arthritis, and infectious disease. Two of its programs are currently in early stage clinical trials for the treatment of ovarian cancer and pancreatic cancer, respectively, with several others in preclinical development.

Eisai currently has an extensive global oncology research program for discovering small molecule anti-cancer agents, and upon completion of the acquisition, will expand its capabilities into the biologic therapeutics field. With this unique and strategic antibody technology acquisition, Eisai can meet a variety of medical needs of cancer patients, through the development of therapeutic antibodies, small-molecule anti-cancer drugs, and potential combinations of both.

Mr. Naito said, "I sincerely respect Dr. Nicolaides' innovative and courageous endeavor in developing human monoclonal antibody therapeutics. He has made a tremendous contribution to that effort. By combining Morphotek's proprietary technologies and promising therapeutic antibodies with Eisai's existing research programs and infrastructure, we will be able to meet our goal of addressing the unmet medical needs of patients, especially cancer patients, all around the world. Morphotek's rich pipeline, unique and proprietary antibody generation technology platform, and highly skilled management and scientific team will become the core of our R&D efforts in biologics."

Dr. Nicolaides said, "Eisai's substantial intellectual and managerial resources will enable us to accelerate the development of our current therapeutic antibody pipeline as well as develop a number of additional clinical compounds to targets accessed from our broad network of research collaborations and to those discovered by Eisai researchers globally."

Dr. Ivor Royston, Chairman of Morphotek and Managing Partner of Forward Ventures added, "This is an excellent opportunity for Morphotek to join the Eisai organization and to further its founding mission of becoming a global leader in the development of innovative immunotherapies to treat serious diseases and to establish solutions for the health and well-being of people worldwide."

Upon completion of the transaction, Morphotek will become part of Eisai's growing global discovery and development research network, which is comprised of research laboratories in Japan, Europe and the U.S. The addition of Morphotek further extends Eisai's research presence in the U.S., which includes the Eisai Research Institute of Boston, Inc., a discovery operation based in Andover, Massachusetts, Eisai Medical Research Inc., for clinical development, located in Ridgefield Park, New Jersey, and RTP laboratory for formulation research, North Carolina.

"Morphotek will enjoy its autonomy in Eisai's discovery network but I will encourage close collaboration among all Eisai R&D member companies. We very much look forward to welcoming Morphotek to the Eisai family of companies," Mr. Naito concluded.

This planned expansion of Eisai's discovery, research and clinical capabilities complements Eisai's establishment of its oncology sales and marketing operations in the U.S. under ECA. Aided in part through its recent acquisition of four oncology-related products from Ligand Pharmaceuticals in October 2006, which included the retention of key oncology personnel and expertise including a sales force, Eisai has developed its commercial oncology infrastructure and is well positioned to market new oncology products that originate from Eisai's research and discovery efforts or through future acquisition, co-promotion or in-licensing opportunities.

The Morphotek acquisition, which has been approved by the boards of directors of ECA and Morphotek, is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. It is expected to close sometime during Eisai's first fiscal quarter of 2007.

Mitsubishi UFJ Securities Co., Ltd. and Montgomery & Co. LLC are acting as financial advisors and Sullivan & Cromwell LLP is acting as legal counsel to Eisai in this transaction.

Lehman Brothers Inc. is acting as financial advisor and Cozen O'Conner LLP is acting as legal counsel to Morphotek in this transaction.

About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: Integrative neuroscience including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 9,000 people worldwide and forecasts the group sales of ¥668 billion in FY2006. More than 50% of the group sales is derived from overseas business. For more information, visit www.eisai.co.jp

About Eisai Corporation of North America
Eisai Corporation of North America is a wholly owned subsidiary of Eisai Co., Ltd. and supports the activities of its operating companies in North America. These operating companies include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Eisai Medical Research Inc., for clinical development; Eisai Inc. for manufacturing and marketing/sales functions; and Eisai Machinery U.S.A. for marketing and maintenance of pharmaceutical manufacturing machinery.

About Morphotek
Morphotek®, which was founded in 2000 and is located in Exton, Pennsylvania, and employs 45 people, is a privately held biopharmaceutical company which discovers and develops monoclonal antibodies for oncology, inflammatory and infectious diseases through the use of a proprietary human antibody technology called Human MORPHODOMA®. The company has assembled a strong pipeline of lead products in the area of cancer, inflammation and infectious diseases. Morphotek's most advanced programs are MORAb-003, in Phase I/II for ovarian cancer, and MORAb-009, in Phase I for pancreatic cancer. There are several programs in preclinical stage moving towards IND filing. Its partners to date have included world-renowned research laboratories and leading biopharmaceutical companies. For further information, visit www.morphotek.com