-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, U9vKdfqUJ1Wm5jkfASuXfnzQ1VPbV9PR1SBSknCnzTDYprJdgo0o68lnP/Y42JeK IoagJWjfR9T+aLVcU9ij5Q== 0000950123-05-008364.txt : 20050712 0000950123-05-008364.hdr.sgml : 20050712 20050711184908 ACCESSION NUMBER: 0000950123-05-008364 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20050627 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050712 DATE AS OF CHANGE: 20050711 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000729922 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133159796 STATE OF INCORPORATION: DE FISCAL YEAR END: 1204 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 05949070 BUSINESS ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y10718ae8vk.txt 8-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 June 27, 2005 ------------------------------------------------ Date of Report (Date of earliest event reported) OSI PHARMACEUTICALS, INC. ----------------------------------------------------- (Exact name of registrant as specified in its charter) DELAWARE 0-15190 13-3159796 - ------------------------------- ---------- ------------------ (State or other jurisdiction of (Commission (I.R.S. Employer incorporation) File Number) Identification No.) 58 SOUTH SERVICE ROAD MELVILLE, NY 11747 -------------------------------------- (Address of principal executive offices) (631) 962-2000 --------------------------------------------------- (Registrant's telephone number, including area code) N/A ------------------------------ (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a- 12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) ITEM 8.01 OTHER EVENTS On June 27, 2005, OSI Pharmaceuticals, Inc. ("OSI") announced that its partner, Roche, received a positive opinion from the European Committee for Medicinal Products for Human Use recommending approval of Tarceva(R) (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Details regarding the opinion are set forth in OSI's press release dated June 27, 2005 which is attached as Exhibit 99.1 to this Current Report on Form 8-K (the "Form 8-K") and incorporated herein by reference. On June 30, 2005, OSI announced that its diabetes and obesity business unit, (OSI) Prosidion, has granted Merck & Co. Inc. a worldwide, non-exclusive license under U.S. Patent No. 6,890,898 and its foreign equivalents which claim combination therapy comprising administration of a Dipeptidyl Peptidase IV (DPIV) inhibitor and another therapeutic agent for the treatment of type 2 diabetes and related indications. Details regarding the license are set forth in OSI's press release dated June 30, 2005 which is attached as Exhibit 99.2 to this Form 8-K and incorporated herein by reference. On July 6, 2005, OSI announced that the U.S. Food and Drug Administration has accepted for filing and review the supplemental New Drug Application for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous treatment. Details regarding the acceptance are set forth in OSI's press release dated July 6, 2005 which is attached as Exhibit 99.3 to this Form 8-K and incorporated herein by reference. On July 7, 2005, OSI announced that (OSI) Prosidion has granted a worldwide non-exclusive license under its DPIV patent portfolio to a major Japanese pharmaceutical company. Details regarding the license are set forth in OSI's press release dated July 7, 2005 which is attached as Exhibit 99.4 to this Form 8-K and incorporated herein by reference. ITEM 9.01 EXHIBITS
EXHIBIT NO. DESCRIPTION - ----------- ---------------------------------- 99.1 Press release, dated June 27, 2005. 99.2 Press release, dated June 30, 2005. 99.3 Press release, dated July 6, 2005. 99.4 Press release, dated July 7, 2005.
SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: July 11, 2005 OSI PHARMACEUTICALS, INC. By: /s/ Michael G. Atieh -------------------------------- Michael G. Atieh Executive Vice President and Chief Financial Officer EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION - ----------- ----------------------------------- 99.1 Press release, dated June 27, 2005. 99.2 Press release, dated June 30, 2005. 99.3 Press release, dated July 6, 2005. 99.4 Press release, dated July 7, 2005.
EX-99.1 2 y10718aexv99w1.txt PRESS RELEASE EXHIBIT 99.1 OSI PHARMACEUTICALS ANNOUNCES THAT TARCEVA-R- RECEIVES POSITIVE OPINION IN EU FOR THE TREATMENT OF PATIENTS WITH ADVANCED LUNG CANCER MELVILLE, N.Y.--(BUSINESS WIRE)--June 27, 2005--OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) announced today that its ex-U.S. partner for Tarceva(R) (erlotinib), Roche, received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending approval of Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration and was approved in the U.S. for NSCLC in November 2004. Following the CHMP recommendation, an approval decision for Tarceva by the European Commission is anticipated within 90 days. "The CHMP recommendation is an important milestone toward making Tarceva available for lung cancer patients throughout the European Union," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. "We congratulate our colleagues at Roche on their progress and continue to project the launch of Tarceva in the EU during the final quarter of 2005." "This decision is proof of the impressive survival benefit that Tarceva offers patients with late stage lung cancer," said William M Burns, CEO Division Roche Pharmaceuticals. "This brings new hope to lung cancer patients who have currently very limited treatment options." The CHMP has recommended that Tarceva is indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with EGFR-negative tumors. The CHMP recommendation is based on data from a pivotal Phase III study, Trial BR.21, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. As in the U.S. label, no mandatory testing for EGFR is required in the CHMP recommendation. ABOUT NSCLC Lung cancer is the most common cancer worldwide with 1.2 million new cases annually with someone, somewhere dying of the disease every 30 seconds. NSCLC accounts for almost 80 percent of all lung cancer cases and there are few treatment options available. There are an estimated 370,000 people suffering with lung cancer each year in Europe. 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) and other solid tumors. 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 is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent. Tarceva was approved by the U.S. Food and Drug Administration 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. 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. TARCEVA SAFETY PROFILE In the pivotal NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9 and 6 percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of 1 percent of Tarceva-treated patients. Dose reduction for rash and diarrhea was needed for 6 and 1 percent of patients, 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 pivotal trial in NSCLC, 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 NSCLC studies was approximately 0.7 percent. ABOUT OSI PHARMACEUTICALS OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world. In addition to Tarceva, (OSI) Oncology exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for its approved oncology indications and markets Gelclair(R) Bioadherent Oral Gel for the relief of pain associated with oral mucositis. The research and development pipeline consists of novel molecularly targeted anti-cancer agents focused on signal transduction pathways involved in cell proliferation, apoptosis and angiogenesis. The most advanced of these programs, targeting the co-inhibition of c-kit and VEGFR, has two candidates in development. This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, OSI's and its collaborators' abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission. CONTACT: OSI Pharmaceuticals, Inc. Kathy Galante, 631-962-2000 SOURCE: OSI Pharmaceuticals, Inc. EX-99.2 3 y10718aexv99w2.txt PRESS RELEASE EXHIBIT 99.2 OSI PHARMACEUTICALS GRANTS LICENSE TO MERCK & CO., INC. UNDER PATENT COVERING COMBINATION THERAPY USING DIPEPTIDYL PEPTIDASE IV (DPIV) INHIBITORS AND OTHER ANTIDIABETIC AGENTS THROUGH ITS DIABETES BUSINESS UNIT, (OSI) PROSIDION MELVILLE, N.Y., Jun 30, 2005 (BUSINESS WIRE) -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP), announced today that its diabetes and obesity business unit (OSI) Prosidion, has granted Merck & Co. Inc. a worldwide, non-exclusive license under U.S. Patent No. 6,890,898 and foreign equivalents thereof which claim combination therapy comprising administration of a DPIV inhibitor and another therapeutic agent for the treatment of type 2 diabetes and related indications. OSI will receive upfront, milestone and royalty payments. Additional financial terms were not disclosed. (OSI) Prosidion acquired its DPIV technology platform, which includes a Phase II compound, PSN9301, and a portfolio of DPIV medical use patents from Probiodrug AG of Germany in July 2004. The DPIV medical use patents include issued patents and pending patent applications corresponding to U.S. 6,303,661, U.S. 6,890,898 and WO 01/72290, with claims covering DPIV as a target for anti-diabetes therapy and the use of combinations of DPIV inhibitors with other anti-diabetes drugs. The license to Merck supplements their existing non-exclusive license under part of this patent portfolio. A number of non-exclusive licenses to the patent estate have now been granted and (OSI) Prosidion expects to grant additional non-exclusive licenses in the future. "We believe that the Merck license further validates the strength of our DPIV related patent estate and the importance of this target to the development of innovative new medicines for the treatment of diabetes," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. ABOUT (OSI) OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world. (OSI) Prosidion is the diabetes and obesity business team within OSI Pharmaceuticals, dedicated to the discovery and development of novel drugs for the treatment of type 2 diabetes and obesity. (OSI) Prosidion's lead compound, PSN9301, is a Dipeptidyl Peptidase IV (DPIV) inhibitor currently in Phase II clinical trials. Other products targeting glycogen phosphorylase inhibition and glucokinase activation are scheduled to enter Phase I clinical trials in 2005. (OSI) Prosidion owns or has licensing rights to a portfolio of DPIV medical use patents with claims covering DPIV as a target for anti-diabetes therapy and the use of combinations of DPIV inhibitors with other anti-diabetes drugs such as metformin. A number of non-exclusive licenses to the patent estate have been granted to major pharmaceutical companies. (OSI) Prosidion operates through OSI's wholly-owned subsidiary, Prosidion Limited, in Oxford, U.K. This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, Prosidion's and OSI's and their collaborators' abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission. PSN9301, PSN105, PSN357 and PSN010 are investigational compounds and have not yet been approved as safe or efficacious in humans for their ultimate intended use. SOURCE: OSI Pharmaceuticals, Inc. OSI Pharmaceuticals, Inc. Kathy Galante, 631-962-2000 EX-99.3 4 y10718aexv99w3.txt PRESS RELEASE EXHIBIT 99.3 OSI PHARMACEUTICALS ANNOUNCES ACCEPTANCE OF A TARCEVA(R) SUPPLEMENTAL NEW DRUG APPLICATION IN PANCREATIC CANCER FOR REVIEW BY THE U.S. FOOD AND DRUG ADMINISTRATION; TARCEVA'S SNDA IS GRANTED PRIORITY REVIEW DESIGNATION BY THE FDA MELVILLE, N.Y.--(BUSINESS WIRE)--July 6, 2005--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for use of Tarceva(R) (erlotinib) plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received previous treatment. Tarceva is the only EGFR therapy shown to provide a statistically significant survival benefit in patients treated in first-line locally advanced or metastatic pancreatic cancer in combination with gemcitabine. In addition, Tarceva has been granted priority review classification by the FDA. Based on this priority review status, the FDA has six months from receipt of the sNDA data, or until November 2, 2005, to take action on the sNDA filing. "We look forward to continuing to work closely with the FDA through this review process in hopes of bringing a new therapeutic treatment option to pancreatic cancer patients," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. The acceptance of the sNDA filing satisfies provisions for a $7 million milestone payment by Genentech, Inc. to OSI. The milestone will be accounted in accordance with EITF 00-21 and therefore the revenues will be recognized over the life of the product. As such the milestone is not expected to materially impact 2005 earnings. ABOUT PANCREATIC CANCER The American Cancer Society predicts that in 2005 about 32,180 people in the United States will be diagnosed with pancreatic cancer and about 31,800 will die of the disease. Although pancreatic cancer accounts for 2 percent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths. 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) and other solid tumors. 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 is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent. 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. 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. TARCEVA SAFETY PROFILE In the pivotal NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9 and 6 percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of 1 percent of Tarceva-treated patients. Dose reduction for rash and diarrhea was needed for 6 and 1 percent of patients, 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 pivotal trial in NSCLC, 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 NSCLC studies was approximately 0.7 percent. ABOUT OSI PHARMACEUTICALS OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world. In addition to Tarceva, (OSI) Oncology exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for its approved oncology indications and markets Gelclair(R) Bioadherent Oral Gel for the relief of pain associated with oral mucositis. The research and development pipeline consists of novel molecularly targeted anti-cancer agents focused on signal transduction pathways involved in cell proliferation, apoptosis and angiogenesis. The most advanced of these programs, targeting the co-inhibition of c-kit and VEGFR, has two candidates in development. This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, OSI's and its collaborators' abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission. CONTACT: OSI Pharmaceuticals, Inc. Kathy Galante, 631-962-2000 Director, Investor & Public Relations SOURCE: OSI Pharmaceuticals, Inc. EX-99.4 5 y10718aexv99w4.txt PRESS RELEASE EXHIBIT 99.4 OSI PHARMACEUTICALS GRANTS LICENSE UNDER DIPEPTIDYL PEPTIDASE IV (DPIV) PATENTS; FIFTH MAJOR PHARMACEUTICAL COMPANY LICENSEE MELVILLE, N.Y.--(BUSINESS WIRE)--July 7, 2005--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that its diabetes and obesity business unit, (OSI) Prosidion, has granted a worldwide non-exclusive license under its DPIV patent portfolio to a major Japanese pharmaceutical company. The estate covers the use of DPIV inhibitors for the treatment of type 2 diabetes and related indications. OSI will receive upfront, milestone and royalty payments. Additional financial terms were not disclosed. "This is the fifth major pharmaceutical company and the first major Japanese company that has taken a non-exclusive license under our DPIV patent estate further validating the importance of this patent estate," stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. (OSI) Prosidion acquired its DPIV technology platform, which includes a Phase II compound, PSN9301, and a portfolio of DPIV medical use patents from Probiodrug AG of Germany in July 2004. The DPIV medical use patents, the subject of the license, include issued patents and pending patent applications corresponding to U.S. 6,303,661, U.S. 6,890,898 and WO 01/72290, with claims covering DPIV as a target for anti-diabetes therapy and the use of combinations of DPIV inhibitors with other anti-diabetes drugs. A number of non-exclusive licenses to the patent estate have now been granted and (OSI) Prosidion expects to grant additional non-exclusive licenses in the future. ABOUT (OSI) OSI Pharmaceuticals is committed to "shaping medicines and changing lives" by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI's flagship product, Tarceva(R) (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world. (OSI) Prosidion is the diabetes and obesity business team within OSI Pharmaceuticals, dedicated to the discovery and development of novel drugs for the treatment of type 2 diabetes and obesity. (OSI) Prosidion's lead compound, PSN9301, is a Dipeptidyl Peptidase IV (DPIV) inhibitor currently in Phase II clinical trials. Other products targeting glycogen phosphorylase inhibition and glucokinase activation are scheduled to enter Phase I clinical trials in 2005. (OSI) Prosidion owns or has licensing rights to a portfolio of DPIV medical use patents with claims covering DPIV as a target for anti-diabetes therapy and the use of combinations of DPIV inhibitors with other anti-diabetes drugs such as metformin. A number of non-exclusive licenses to the patent estate have been granted to major pharmaceutical companies. (OSI) Prosidion operates through OSI's wholly-owned subsidiary, Prosidion Limited, in Oxford, U.K. This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review process and other governmental regulation, Prosidion's and OSI's and their collaborators' abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products and other factors described in OSI Pharmaceuticals' filings with the Securities and Exchange Commission. PSN9301, PSN105, PSN357 and PSN010 are investigational compounds and have not yet been approved as safe or efficacious in humans for their ultimate intended use. CONTACT: OSI Pharmaceuticals, Inc. Kathy Galante, 631-962-2000 SOURCE: OSI Pharmaceuticals, Inc. -----END PRIVACY-ENHANCED MESSAGE-----