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Improvement Seen in Overall Survival for Patients Receiving Erlotinib, Gemcitabine Combination Compared to Patients Receiving Gemcitabine, Placebo

HOLLYWOOD, Fla.--(BUSINESS WIRE)--Jan. 27, 2005-- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - News), Genentech, Inc. (NYSE: DNA - News), and Roche (SWX Zurich) announced today that a randomized Phase III clinical study of Tarceva(TM) (erlotinib) plus gemcitabine chemotherapy in patients with locally advanced or metastatic pancreatic cancer met its primary endpoint by demonstrating a statistically significant 23.5 percent improvement in overall survival when compared to patients receiving gemcitabine plus placebo. The data were presented at the Second Annual Gastrointestinal Cancers Symposium in Hollywood, Fla. Tarceva is the first drug shown in a Phase III trial to prolong survival when added to the standard of care (gemcitabine) in the treatment of patients with previously untreated advanced pancreatic cancer.

Results from the Pancreatic Cancer Study
The study data demonstrated an improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to patients receiving gemcitabine plus placebo (hazard ratio = 0.81, p-value = 0.025; a hazard ratio of less than one indicates a decreased risk of death and a p-value of less than 0.05 indicates statistical significance). Twenty-four percent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 percent of patients receiving gemcitabine plus placebo. Median survival in the Tarceva plus gemcitabine arm was 6.4 months compared to 5.9 months in the gemcitabine plus placebo arm. An exploratory analysis of survival by pre-treatment characteristics also showed that patients with metastatic disease and patients with poor performance status derived a survival benefit. Progression-free survival in the Tarceva plus gemcitabine arm also was significantly improved (hazard ratio = 0.76, p-value = 0.003), although there was virtually no difference in tumor response (9 percent in patients receiving Tarceva plus gemcitabine versus 8 percent in the gemcitabine plus placebo arm).

The international study was a multi-center, randomized, double-blind, placebo-controlled Phase III trial evaluating Tarceva at 100 mg/day or 150 mg/day in patients with locally advanced or metastatic pancreatic cancer. The study randomized patients to receive either gemcitabine plus concurrent Tarceva or gemcitabine plus placebo. Gemcitabine was dosed at 1,000 mg/m2 IV once weekly. A total of 569 patients were randomized in the study, 521 patients were randomized to receive 100 mg/day of Tarceva plus gemcitabine or gemcitabine plus placebo, and 48 patients received 150 mg/day of Tarceva plus gemcitabine or gemcitabine plus placebo. Approximately 75 percent of the patients in the study had metastatic disease and 25 percent had locally advanced disease. The study had sites in the United States, Asia, Canada, Europe, Australia and South America. The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University, Ontario in collaboration with OSI Pharmaceuticals.

A preliminary analysis of the safety data did not reveal any unexpected safety signals beyond that seen in previous studies of Tarceva in both monotherapy and combination settings. As expected, rash and diarrhea were the principal Tarceva related side effects seen in the study. Rash was reported by 72 percent of patients who received Tarceva plus gemcitabine and by 28 percent of patients who received gemcitabine plus placebo. Diarrhea was reported by 51 percent of patients who received Tarceva plus gemcitabine and by 36 percent of patients who received gemcitabine plus placebo.

"The results of this trial underscore the importance and potential utility of Tarceva in combination with gemcitabine in the treatment of patients with pancreatic cancer," stated Malcolm Moore, M.D., Study Chair and Medical Oncologist at Princess Margaret Hospital in Toronto, Canada and Chair of the Gastrointestinal Disease Site, NCIC Clinical Trials Group. "These Tarceva results represent an important medical advance in the treatment of patients with pancreatic cancer and we hope will open the door to a completely new approach to treating the disease."

"The positive outcome of this trial is great news for pancreatic patients and their families. OSI is working closely with the FDA to complete a Supplemental New Drug Application (sNDA) which we hope to file in the first half of 2005," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "Tarceva has now shown a survival benefit in two cancers that are widely recognized among the most difficult to treat, pancreatic cancer and lung cancer."

About Pancreatic Cancer
According to the World Health Organization more than 216,000 people worldwide are diagnosed each year with pancreatic cancer. The American Cancer Society estimates that in 2005 approximately 32,180 people in the United States will be diagnosed with pancreatic cancer and approximately 31,800 will die of the disease. Most pancreatic tumors originate in the exocrine duct cells or in the cells that produce digestive enzymes (acinar cells). Called adenocarcinomas, these tumors account for nearly 95 percent of pancreatic cancers.

"Historically, few therapies have been proven to significantly extend survival in patients diagnosed with pancreatic cancer. We hope the encouraging data announced today will provide promising therapies for pancreatic cancer patients in the future," said Julie Fleshman, president and CEO, PanCAN (Pancreatic Cancer Action Network).

About Tarceva
Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in non-small cell lung cancer (NSCLC). HER1, also known as EGFR, is a component of the HER signaling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva was approved by the FDA in November 2004 and is an oral tablet indicated for daily administration for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Tarceva is the only EGFR inhibitor to have demonstrated a survival benefit in NSCLC. Results from two earlier large, randomized, placebo-controlled clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting. Additional early-stage trials of Tarceva are being conducted in other solid tumors. For Tarceva full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com/patient/.

About Tarceva Safety
In the pivotal NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade three/four rash and diarrhea occurred in nine and six percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of one percent of Tarceva-treated patients. Six and one percent of patients needed dose reduction for rash and diarrhea, respectively. Historically, there have been infrequent reports of serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. In the Phase III trial, severe pulmonary reactions, including potential cases of interstitial lung disease, were infrequent (0.8 percent) and were equally distributed between treatment arms. The overall incidence of ILD in Tarceva-treated patients from all studies was approximately 0.6 percent.

Source: OSI Pharmaceuticals, Inc.

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