OSIP Osi Pharmaceuticals Inc. (MM)

OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Food and Drug Administration (FDA) approved the daily pill Tarceva® (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.

“We are delighted that lung cancer patients and their physicians will have the option of beginning Tarceva therapy in the first-line maintenance setting. We believe that Tarceva, as the only medicine approved in the maintenance setting for the squamous and non-squamous forms of NSCLC, offers a valuable treatment option for these patients,” said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “We remain committed to a strategy of maximizing the value of Tarceva as an important therapy for cancer patients and are pursuing the study of additional uses for Tarceva, including as a first-line treatment for lung cancer patients with an activating EGFR mutation, as an adjuvant therapy in NSCLC, and in other tumor types such as ovarian cancer and hepatocellular carcinoma.”

The new approval for Tarceva was based on data from the pivotal Phase III SATURN study. SATURN showed that Tarceva given as a maintenance therapy immediately after first-line chemotherapy significantly extended overall survival (OS) and significantly improved the time people with advanced NSCLC lived without the disease getting worse (progression-free survival, PFS) in a broad patient population, including squamous and non-squamous histology, compared with placebo. The goal of maintenance therapy, a new approach in lung cancer, is to provide an active treatment for patients whose disease either responded to, or was stable, following initial chemotherapy before their cancer worsens. Many people are unable to receive further treatment after their cancer grows or spreads because of rapid cancer growth and worsening symptoms.

Tarceva is already FDA-approved for people with advanced NSCLC whose cancer has grown or spread after receiving at least one course of chemotherapy. Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the United States and approximately 159,000 Americans died from the disease in 2009. NSCLC is the most common type of lung cancer. Most people are diagnosed with advanced stage disease and only one to five percent of people with advanced stage (IIIB/IV) NSCLC survive five years.

About SATURN

SATURN was an international, placebo-controlled, randomized, double-blind, Phase III study that enrolled 889 patients with advanced NSCLC at approximately 160 sites worldwide. Patients were treated with four cycles of standard first-line platinum-based chemotherapy and then randomized to Tarceva or placebo if the cancer did not progress. PFS was defined as the length of time from randomization to disease progression or death from any cause.

• OS was significantly improved by 23 percent with Tarceva compared to placebo (hazard ratio=0.81, 19 percent reduction in the risk of death, p=0.0088).
• People who received Tarceva had a 41 percent improvement in the likelihood of living without the disease getting worse (PFS, the primary endpoint) compared to placebo (hazard ratio=0.71, 29 percent reduction in the risk of cancer progression or death, p

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