EXHIBIT 99
NEWS RELEASE
OSI PHARMACEUTICALS SUMMARIZES SURVIVAL BENEFITS IN KEY
PATIENT SUBSETS FROM THE BR.21 STUDY
MELVILLE, NEW YORK - June 8, 2004 -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP)
announced today a summary of data presented earlier at the 40th Annual Meeting
of the American Society of Clinical Oncology (ASCO) summarizing the treatment
benefit observed in various subsets of patients treated with the investigational
drug Tarceva(TM) (erlotinib HCl) in the BR.21 study. The study, presented on
Monday, June 7, was a Phase III trial of Tarceva(TM) versus placebo in second
and third-line patients with relapsed non-small cell lung cancer.
"The results of the BR.21 trial were noteworthy in that they demonstrated a
survival benefit in essentially all subsets of lung cancer patients that we
examined," stated Colin Goddard, Ph.D., Chief Executive Officer of OSI
Pharmaceuticals. "Previous research on other EGFR inhibitors had suggested that
any Tarceva(TM) benefit may have been restricted to certain subsets of patients.
We believe that the observation of an improvement in survival in subsets
including smokers and patients with squamous cell carcinoma is of particular
interest to the lung cancer community."
The BR.21 trial of Tarceva(TM) met the pre-determined primary study endpoint of
improvement in overall survival and demonstrated significant effects in all
secondary endpoints including time to symptom deterioration, progression-free
survival and response rate.
Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to
4.7 months in patients who received placebo (a 42.5 percent improvement). A
hazard ratio of 0.72 and a p-value of 0.001 were determined for comparison of
overall survival (a hazard ratio (HR) of less than one indicates a reduction in
the risk of death and a p-value of less than 0.05 indicates statistical
significance). In addition, 31 percent of patients receiving Tarceva(TM) in the
study were alive at one year versus 22 percent in the placebo arm (a 41 percent
improvement).
As would be expected from historical data on the relative prognosis for survival
in different subsets of lung cancer patients, patients treated with Tarceva(TM)
who were female, had tumors with adenocarcinoma histology or were never smokers
lived longer than patients treated with Tarceva(TM) who were male, had tumors
with squamous cell carcinoma histology or were smokers, respectively. However,
importantly, Tarceva(TM) improved survival in essentially all subsets of
patients in the study including males, patients with squamous cell carcinoma and
smokers. Data summarizing the broad-based treatment benefit that was observed in
key subsets of patients in the BR.21 study is summarized in the table below.
Median Survival in Months Hazard Ratio
Tarceva(TM) Placebo
Never Smokers 12.2 5.6 0.42
Current or Former Smokers 5.5 4.6 0.87
Adenocarcinoma 7.8 5.4 0.71
Squamous Cell Carcinoma 5.6 3.6 0.67
Female 8.4 6.2 0.80
Male 5.7 4.5 0.76
Note: OSI Pharmaceuticals, Inc. statistical analysis
of data from the BR.21 trial
A total of 731 patients were enrolled in BR.21, a randomized, international,
double-blinded controlled study comparing the use of 150mg/day Tarceva(TM)
versus placebo for the treatment of patients with advanced NSCLC following
failure of first or second-line chemotherapy. The study randomized patients with
a 2:1 ratio in favor of Tarceva(TM) to receive either Tarceva(TM) or placebo.
Safety
The safety profile observed for Tarceva(TM) in the study was consistent with
observations made in prior Tarceva(TM) studies. Seventy-six percent of patients
receiving Tarceva(TM) exhibited rash (versus 17 percent in the placebo group)
and 55 percent of patients receiving Tarceva(TM) experienced diarrhea (versus 19
percent for placebo). Most of these were mild or moderate. Dose reductions
occurred for rash and diarrhea only in the Tarceva(TM) arm, 12 percent and five
percent respectively. In this large, placebo-controlled study, severe pulmonary
events including potential cases of interstitial lung events were rare and
generally equally distributed between treatment arms.
About Tarceva(TM)
Tarceva(TM), an investigational small molecule, is designed to block tumor cell
growth by inhibiting the tyrosine kinase activity of the HER1/EGFR receptor
thereby blocking the HER1/EGFR signaling pathway inside the cell. Tarceva(TM) is
currently being evaluated in an extensive clinical development program together
with the Company's alliance partners at Genentech and Roche. The study was
conducted by the National Cancer Institute of Canada Clinical Trials Group based
at Queen's University in collaboration with OSI Pharmaceuticals.
About OSI Pharmaceuticals
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery,
development and commercialization of high-quality, next-generation oncology
products that both extend life and improve the quality-of-life for cancer
patients worldwide. OSI has a balanced pipeline of oncology drug candidates that
includes both novel mechanism-based, gene-targeted therapies focused in the
areas of signal transduction and apoptosis and next-generation cytotoxic
chemotherapy agents. OSI's most advanced drug candidate, Tarceva(TM), a
small-molecule inhibitor of the HER1 gene, has successfully completed Phase III
clinical trials for lung cancer and is subject to an ongoing rolling submission
of an NDA. OSI has a commercial presence in the U.S. oncology market where it
exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for
approved oncology indications and Gelclair(R) for the relief of pain associated
with oral mucositis.
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, and other
factors described in OSI Pharmaceuticals' filings with the Securities and
Exchange Commission. Tarceva(TM) is an investigational compound and has not yet
been determined safe or efficacious in humans for its ultimate intended use.
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Contact: OSI Pharmaceuticals, Inc. Burns McClellan (representing OSI)
Kathy Galante Kathy Nugent, Ph.D. (media)
Director Johnathan Nugent (investors)
Investor & Public Relations (212) 213-0006
(631) 962-2000