CHMP issues positive opinion recommending approval of Tarceva as monotherapy for NSCLC

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its international partner for Tarceva^® (erlotinib), Roche, informed OSI that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Tarceva as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with stable disease following four cycles of standard platinum-based first-line chemotherapy. A final decision is expected from the European Commission within 45 days.

“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of patients deteriorates rapidly. By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we could help more people live longer without their disease getting worse”

“Advanced lung cancer is an aggressive disease and when the cancer grows or spreads the health of patients deteriorates rapidly. By giving Tarceva earlier after chemotherapy, instead of waiting for the disease to progress, we could help more people live longer without their disease getting worse,” said Professor Federico Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital, Italy and principal investigator of the SATURN trial.

The CHMP positive opinion is based on a review of data from the pivotal Phase III SATURN study which showed a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS)- the study’s primary and secondary endpoints, respectively- with Tarceva compared to placebo across a broad range of patients with advanced NSCLC in the maintenance setting. The magnitude of the benefit was greater in patients with stable disease following first-line chemotherapy compared to patients achieving a complete or partial response. Data for patients with stable disease will be presented at a forthcoming scientific meeting.

The U.S. Food and Drug Administration (FDA) recently extended the review period for the supplemental New Drug Application (sNDA) for Tarceva as a first-line maintenance therapy in advanced NSCLC by 90 days, and the agency is now expected to make a decision by April 18, 2010.

Sales of Tarceva outside the U.S. represent an important component of the Company's revenues. In 2009, $146 million (or 41%) of the Company's $359 million in Tarceva-related revenues were derived from royalty payments received from Roche for sales outside the U.S. market.