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Infinity and MedImmune Announce Issuance of U.S. Patent for Proprietary Heat Shock Protein 90 Inhibitors
Wednesday, October 24, 2007
Companies Also Granted European Orphan Drug Designation for IPI-504 for the Potential Treatment of Gastrointestinal Stromal Tumors
Cambridge, MA and Gaithersburg, MD -- Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) and MedImmune, Inc. today announced that the United States Patent and Trademark Office issued a patent on October 16, 2007 for the companies' heat shock protein 90 (Hsp90) inhibitors, including investigational drug candidate IPI-504. U.S. Patent No. 7,282,493 includes composition of matter, pharmaceutical composition, method of treatment, and synthetic method claims directed to IPI-504 and other hydroquinone-containing ansamycin analogues. IPI-504, the companies' lead Hsp90 inhibitor, is currently being evaluated in two separate multi-center clinical trials in patients with gastrointestinal stromal tumors (GIST) and other soft tissue sarcomas, and in patients with non-small cell lung cancer. The patent is owned by Infinity and is co-exclusively licensed to MedImmune pursuant to the terms of the parties' collaboration agreement.
Infinity and MedImmune also announced today that the European Medicines Agency's (EMEA) Committee for Orphan Medicinal Products has granted IPI-504 orphan drug designation for the treatment of GIST. Orphan drug designation is granted by the EMEA to promote the development of products that may offer therapeutic benefits for diseases affecting fewer than five in 10,000 people in the European Union. Orphan drug designation provides opportunities for free protocol assistance, fee reductions for access to centralized community procedures before and after marketing authorization, and 10 years of market exclusivity following drug approval. On September 17, 2007, the companies announced that the U.S. Food and Drug Administration's Office of Orphan Products Development granted IPI-504 orphan drug designation for the treatment of GIST.
IPI-504 is a small molecule drug candidate being developed jointly by Infinity and MedImmune. IPI-504 has been well-tolerated in its ongoing Phase 1 studies and has shown promising biological activity in a Phase 1 clinical trial in patients with relapsed, refractory Gleevec®-resistant GIST. IPI-504 is also being evaluated in a Phase 1/2 clinical trial in patients with advanced non-small cell lung cancer. In preclinical studies, IPI-504 has been shown to inhibit Hsp90 potently and selectively, thereby affecting cancer cells. IPI-504 has also demonstrated, in preclinical studies, broad potential to treat certain cancers as both a single agent as well as in combination with existing anti-cancer drugs. The water-based formulation of IPI-504 is delivered as an intravenous infusion. Infinity and MedImmune are currently developing and evaluating two oral Hsp90 inhibitors, which have both demonstrated potent and selective inhibition of Hsp90 in preclinical models.
About Gastrointestinal Stromal Tumors (GIST) and Hsp90
The American Cancer Society (ACS) reports that GIST is the most frequent form of gastrointestinal sarcoma, a life-threatening disease highly resistant to traditional cytotoxic chemotherapy or radiation treatment. The ACS estimates that between 4,500 and 6,000 Americans develop GIST each year. In the majority of GIST cases, specific mutations in cellular signaling enzymes ("kinases") called KIT or PDGFRA cause the growth and survival signal of the cell to become permanently active, leading to cancer. Both KIT and PDGFRA are client proteins of Hsp90, suggesting that inhibition of Hsp90 in GIST is an attractive area for clinical study.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. For more information on Infinity, please refer to the company's website at http://www.ipi.com.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc LSE:AZN) (NYSE:AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular statements related to the research and development of IPI-504 and other compounds targeting Hsp90. Such statements reflect the current views of MedImmune and/or Infinity management and are based on certain assumptions. MedImmune is a member of the AstraZeneca Group of companies. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the reports and other documents filed by AstraZeneca plc with the Securities and Exchange Commission and in Infinity's quarterly report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission on August 9, 2007. There can be no assurance that such development efforts will succeed, that the products will receive required regulatory clearance or, even if such regulatory clearance is received, that the subsequent products will ultimately achieve commercial success. Further, any forward-looking statements contained in this announcement speak only as of the date hereof, and AstraZeneca and Infinity expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise may be required by applicable law or regulation.
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