Key Developments For OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals, Inc. (OSIP.O) (Nasdaq)
OSI Pharmaceuticals, Inc. Announces Tarceva To Be Reviewed By FDA's Oncologic Drugs Advisory Committee For Use As First Line Maintenance Therapy In Advanced Non Small Cell Lung Cancer
OSI Pharmaceuticals, Inc. announced that the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, 2009 meeting. The ODAC panel is a committee of external experts, formed by the U.S. Food and Drug Administration (FDA), to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer. In June 2009, the FDA accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva as a first-line maintenance treatment for patients with advanced NSCLC who have not progressed following first-line treatment with platinum-based chemotherapy. In addition, the overall survival data was included in an update to the U.S. sNDA. The FDA Prescription Drug Fee Act (PDUFA) review date for the Tarceva application is on or about January 18, 2010. Tarceva is the only oral, non-chemotherapy agent shown to provide a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) in the NSCLC maintenance setting.
OSI Pharmaceuticals, Inc. Reaffirms FY 2009 Revenue Guidance-Conference Call
OSI Pharmaceuticals, Inc. reaffirmed fiscal 2009 guidance for revenue of approximately $425 million.
Simcere Pharmaceutical Group Announces Collaboration With OSI Pharmaceuticals, Inc.
Simcere Pharmaceutical Group announced an agreement with OSI Pharmaceuticals, Inc., to develop, manufacture, and market its KDR/Kit inhibitor OSI-930 in China. OSI-930 is designed to target both cancer cell proliferation and blood vessel growth (angiogenesis) in selected tumors. In preclinical studies, OSI-930 shows broad efficacy in tumor models representative of small cell lung cancer, glioblastoma, colorectal, renal, head and neck, non-small cell lung cancer and gastric cancers. The company completed a phase I dose escalation study of OSI-930 in healthy volunteers. A phase I single agent dose escalation study in cancer patients has identified a recommended phase II dose and a phase Ib dose escalation study with erlotinib has also identified a recommended dose for the combination. Both phase I studies in cancer patients have been reported at recent ASCO meetings.
U.S. Patent and Trademark Office Issues Notice of Allowance In OSI Pharmaceuticals, Inc.'s Reissue Application On Tarceva Composition Of Matter Patent
OSI Pharmaceuticals, Inc. announced that the U.S. Patent & Trademark Office has issued a Notice of Allowance in OSI`s reissue application for U.S. Patent No.5,747,498 (the 498) composition of matter patent for Tarceva (erlotinib). The reissued patent will replace the original 498 patent and have the same November 2018 expiration date.
OSI Pharmaceuticals, Inc. Initiates Phase III Registration-Oriented Study for OSI-906 in Adrenocortical Carcinoma and Phase I/II Study in Ovarian Cancer
OSI Pharmaceuticals, Inc. announced the initiation of two clinical trials with OSI-906, the Company`s potential first-in-class, oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The first study is a Phase III, multi-center study that will evaluate the use of OSI-906 for patients with locally advanced or metastatic adrenocortical carcinoma (ACC). The study is designed to determine overall survival for patients receiving single-agent OSI-906 versus placebo and will also evaluate progression free-survival, disease control rate, overall response rate as well as safety. The second study is a Phase I/II trial evaluating OSI-906 in combination with the chemotherapy paclitaxel (Taxol), primarily in patients with recurrent epithelial ovarian cancer.
