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New Drug Application for Erlotinib Submitted to FDA

MELVILLE, N.Y. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 2, 2004 -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - News) and Genentech, Inc. (NYSE: DNA - News) announced today that OSI completed the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Tarceva(TM) (erlotinib HCl), as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) for whom chemotherapy has failed.

"This submission completes the Tarceva(TM) NDA filing and is a major milestone in our commitment to providing relapsed lung cancer patients with this potential new treatment option as quickly as possible," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We are proud of the efforts of our internal clinical and regulatory teams in completing our first NDA in a timely manner and we appreciate the support of the Genentech team in this process. We will continue to work closely with the FDA as it reviews the Tarceva(TM) application."

"The improvement in survival observed in the Tarceva(TM) pivotal trial represents an important medical advance in the treatment of non-small cell lung cancer," said Hal Baron, M.D., Genentech's senior vice president, development and chief medical officer. "Of note, Tarceva(TM) showed improvement in survival across a broad spectrum of patients in the pivotal study and we believe, if approved, it will provide an important potential treatment option."

The NDA has been granted Pilot 1 Status under the FDA's Pilot 1 Program for Continuous Marketing Applications, a new program designed for investigational products that have been given Fast Track status, such as Tarceva(TM), and that have demonstrated significant promise in clinical trials as a therapeutic advance over available therapy for a disease or condition.

The NDA filing is based on a pivotal Phase III double-blind, placebo-controlled trial that included 731 patients and that compared Tarceva(TM) to placebo in the treatment of patients with relapsed non-small cell lung cancer who had previously received chemotherapy. Tarceva(TM) demonstrated a 42 percent improvement in median survival and improved one-year survival by 45 percent. The study also demonstrated statistically significant improvement in all secondary endpoints of the trial including time to symptom deterioration, progression-free survival and response rate. The study results make Tarceva(TM) the first and only targeted therapy to demonstrate an improvement in survival for non-small cell lung cancer patients. Detailed results of the trial were presented in June at the 40th Annual American Society of Clinical Oncology (ASCO) meeting in New Orleans, LA. The global study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University in collaboration with OSI Pharmaceuticals.

In line with previous clinical studies, adverse events that occurred more often with patients treated with Tarceva(TM) in the pivotal trial included rash and diarrhea, which were generally mild to moderate in severity. Seventy-five percent of patients receiving Tarceva(TM) exhibited rash (versus 17 percent in the placebo group) and 54 percent of patients receiving Tarceva(TM) experienced diarrhea (versus 18 percent for placebo). Dose reductions occurred for rash and diarrhea only in the Tarceva(TM) arm, 10 percent and four percent respectively. In the pivotal study, severe pulmonary events including potential cases of interstitial lung events were infrequent and were equally distributed between treatment arms.

About Tarceva(TM)
Tarceva(TM) is designed to block tumor cell growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva(TM) is currently being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech, and Roche.

About Non-Small Cell Lung Cancer
According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the United States and is responsible for nearly 30 percent of cancer deaths in the country. NSCLC is the most common form of lung cancer and accounts for almost 80 percent of cases.

Source: OSI Pharmaceuticals, Inc. & Genentech, Inc.

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