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Aptosyn, Taxotere Combination Does Not Meet Endpoints in Advanced Non-Small Cell Lung Cancer

MELVILLE, N.Y.--(BUSINESS WIRE)--June 11, 2004--OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - News) today announced that a Phase III study of Aptosyn® (exisulind) in combination with Taxotere® (docetaxel), did not meet its primary endpoint of improving overall survival in patients with advanced non-small cell lung cancer (NSCLC). The trial also did not meet its secondary endpoints of improvement in one-year survival, progression-free survival and response rate. Aptosyn® is being developed by OSI and is part of the Selective Apoptotic Anti-Neoplastic Drug (SAANDs) platform acquired from Cell Pathways, Inc. in June 2003.

Survival in the Taxotere® plus Aptosyn® arm was essentially indistinguishable from that in the Taxotere® plus placebo arm. Median and one-year survival rates in the Aptosyn® plus Taxotere® arm were 6.9 months and 30.7 percent respectively, compared with 6.9 months and 29.5 percent in the Taxotere® plus placebo arm. Median progression-free survival was 13 weeks in the Taxotere® plus Aptosyn® arm and 12 weeks in the Taxotere® plus placebo arm and the respective response rates were 9.2 percent and 7.2 percent.

"Although we have previously communicated our view that this was a high-risk study we are nonetheless disappointed for lung cancer patients that the outcome was not more positive," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We want to thank those patients and their families who volunteered for this study. We continue to believe that apoptosis is an important area of investigation in cancer research today and will continue with our efforts in developing pro-apoptotic anti-cancer drugs in appropriate disease settings."

About the Study
OSI assumed management of this fully enrolled randomized double-blind Phase III study upon completion of the acquisition of the apoptosis technology platform from Cell Pathways in June 2003. The multi-center, Phase III study evaluated Aptosyn® in combination with Taxotere® versus Taxotere® plus placebo in NSCLC patients after failure of prior platinum-based chemotherapy. Taxotere® is an approved chemotherapeutic agent used in the second-line treatment of locally advanced or metastatic non-small cell lung cancer. A total of 610 patients with locally advanced (Stage IIIb) or metastatic (Stage IV) NSCLC were enrolled in the trial. Approximately 90 percent of patients in the study were ECOG performance status 0-1 and approximately 10 percent were performance status 2. The Eastern Cooperative Oncology Group (ECOG) ranks performance status from 0 to 5 according to level of daily activity and symptoms of disease with 0 representing normal activity.

Safety Data
The addition of Aptosyn® to Taxotere® did not introduce any new toxicities beyond those typically associated with the use of Taxotere®. The frequency and severity of febrile neutropenia, diarrhea, nausea, and vomiting and other non-hematological toxicities were comparable in the two arms.

About Aptosyn® and the SAANDs Platform
Aptosyn® is a cGMP phosphodiesterases (cGMP-PDEs) inhibitor which leads to the activation of the intracellular signaling protein, Protein Kinase G (PKG), and subsequent stimulation of apoptosis through the c-Jun kinase pathway. Aptosyn® belongs to a new class of drugs termed Selective Apoptotic Anti-neoplastic Drugs (SAANDs) and is part of the technology platform which OSI acquired from Cell Pathways in June 2003. Cell Pathways had initiated the current Phase III trial based upon pre-clinical data in orthotopic rat models and the combined safety database of successive clinical programs that had originally focused on the pre-cancerous condition familial adenomatous polyposis (FAP). OSI had previously communicated that the lack of supporting Phase II data in advanced NSCLC made the prospects for success in the current study relatively low. However, the SAANDs platform, particularly in early stage and pre-cancerous conditions, remains an area of investigation at OSI.

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. It is estimated that more than 173,000 people will be diagnosed with lung cancer in the United States in 2004. 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. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 percent of all lung cancer.

Source: OSI Pharmaceuticals

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