EXHIBIT 99
(OSI LOGO)
(GENENTECH LOGO)
NEWS RELEASE
(ROCHE LOGO)
CONTACTS:
OSI Contact: Kathy Galante (631) 962-2000
Genentech Media Contact: Kristina Becker (650) 467-6450
Genentech Investor Contact: Lisa Tuomi (650) 225-6554
TARCEVA(TM) EXTENDS SURVIVAL OF PATIENTS WITH
RELAPSED NON-SMALL CELL LUNG CANCER
- ONLY HER1/EGFR-INHIBITOR TO SHOW SURVIVAL BENEFIT
IN A RANDOMIZED, CONTROLLED PHASE III TRIAL -
MELVILLE, N.Y.; SOUTH SAN FRANCISCO, CALIF.; AND BASEL, SWITZERLAND,
(APRIL 26, 2004) -- OSI Pharmaceuticals, Inc. (Nasdaq:OSIP), Genentech, Inc.
(NYSE:DNA), and Roche (SWX Zurich) today announced that a Phase III study of
Tarceva(TM) (erlotinib HCl), an investigational HER1/EGFR-inhibitor agent in
previously treated patients with non-small cell lung cancer (NSCLC), met its
primary endpoint of improving overall survival, with patients receiving
Tarceva(TM) living longer than those in the placebo arm of the study. The trial
also met secondary endpoints including improving time to symptomatic
deterioration, progression-free survival and response rate. OSI will work with
the Food and Drug Administration (FDA) to complete the New Drug Application
(NDA) for Tarceva(TM) during the summer.
This international study, which was sponsored by OSI, was conducted by the
National Cancer Institute of Canada Clinical Trials Group at Queens University
in collaboration with OSI. Results of this Phase III trial will be presented at
the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology
(ASCO) in New Orleans, Louisiana from June 5 to 8.
"We are extremely pleased with the results of this trial. This is the
first controlled Phase III study of a HER1/EGFR-targeted agent which has shown
an improvement in survival in any disease setting," said Colin Goddard, Ph.D.,
Chief Executive Officer of OSI Pharmaceuticals. "Because Tarceva(TM) was granted
Fast Track designation from the FDA, we will work with the
agency to make Tarceva(TM) available as quickly as possible to patients."
"The results of this controlled trial of Tarceva(TM) represent a
significant advancement in treating patients with relapsed non-small cell lung
cancer because Tarceva(TM) was shown to both extend life and provide symptomatic
improvement," said Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung
Cancer Research at the Princess Margaret Hospital, Professor of Medicine at the
University of Toronto and principal investigator of the trial.
"Approximately 173,000 Americans will be diagnosed with lung cancer this
year," said Hal Barron, M.D., Genentech's senior vice president of Development
and chief medical officer. "We are excited that pending FDA approval, patients
with relapsed non-small cell lung cancer will have a new treatment alternative
that has clinically demonstrated the ability to prolong survival."
ABOUT THE STUDY
The multi-center, randomized, controlled Phase III study evaluated
Tarceva(TM) at 150 mg/day in patients with stage IIIB/IV recurrent NSCLC. The
study participants must have received at least one, but no more than two prior
chemotherapy regimens. The study randomized patients to receive either
Tarceva(TM) or placebo. This was an international study with sites in Canada,
Argentina, Australia, Brazil, Chile, Germany, Greece, Hong Kong, Israel, Mexico,
New Zealand, Romania, Singapore, South Africa, Sweden, Thailand and the United
States.
A preliminary analysis of safety data showed that the toxicities reported
were as expected in patients receiving Tarceva(TM) compared to those receiving
placebo. In line with previous clinical studies, events that occurred more often
with patients treated with Tarceva(TM) included mainly mild to moderate diarrhea
and rash.
ABOUT TARCEVA(TM)
Tarceva(TM) 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 many cancers. HER1, also known as EGFR, is a key component of the
HER signaling pathway, which plays a role in the formation and growth of
numerous cancers. Tarceva(TM) is designed to inhibit the tyrosine kinase
activity of the HER1 signaling pathway inside the cell, which may block tumor
cell growth. Results of a Phase III trial of Tarceva(TM) in pancreatic cancer
are expected in the second half of 2004. Early-stage trials of Tarceva(TM) are
being conducted in other solid tumors, such as ovarian, colorectal, head and
neck, renal cell carcinoma, glioma and gastrointestinal cancers.
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.
ABOUT THE COMPANIES
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 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. For additional information
about the company, please visit http://www.osip.com.
GENENTECH is committed to changing the way cancer is treated by
establishing a broad oncology portfolio of innovative, targeted therapies that
can improve patients' lives. The company is the leading provider of anti-tumor
therapeutics in the United States. Genentech has developed Rituxan(R),
Herceptin(R) and Avastin(TM) and markets all three products in the United States
either alone (Avastin and Herceptin) or with Biogen-IDEC (Rituxan). Genentech
has licensed Rituxan, Herceptin and Avastin to the Roche Group for sale outside
of the U.S. The company has a robust pipeline of potential oncology therapies,
including the small molecule therapy Tarceva(TM), and a therapeutic antibody
directed at the HER pathway in Phase II trials. To broaden Genentech's portfolio
of targeted cancer therapies, research programs leverage the company's expertise
in the HER and angiogenesis pathways, as well as pathways that instruct cancer
cells to die (i.e., apoptosis), and B-cell biology.
Genentech is a leading biotechnology company that discovers, develops,
manufactures and commercializes biotherapeutics for significant unmet medical
needs. Eighteen of the currently approved biotechnology products originated from
or are based on Genentech science. Genentech manufactures and commercializes 13
biotechnology products in the United States. The company has headquarters in
South San Francisco, California and is traded on the New York Stock Exchange
under the symbol DNA. For additional information about the company, please visit
http://www.gene.com.
Within the last five years THE ROCHE GROUP has become the world's leading
provider of anti-cancer treatments, supportive care products and diagnostics.
Its oncology business includes an unprecedented four marketed products with
survival benefit: Herceptin, MabThera, Xeloda and Avastin which has been
launched in the US recently, treat a range of malignancies such as breast
cancer, non-Hodgkin's lymphoma and colorectal cancer. Other key products include
NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of
skeletal events in breast cancer and bone metastases patients, hypercalcemia of
malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting)
and Roferon-A (leukaemia, Kaposi's sarcoma,
malignant melanoma, renal cell carcinoma). Roche's cancer medicines generated
sales of more than 6 billion Swiss francs in 2003.
Roche is developing new tests which will have a significant impact on
disease management for cancer patients in the future. With a broad portfolio of
tumour markers for prostate, colorectal, liver, ovarian, breast, stomach,
pancreas and lung cancer, as well as a range of molecular oncology tests, we
will continue to be the leaders in providing cancer focused treatments and
diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan)
and four Headquarter Development sites (two in the U.S., UK and Switzerland).
CONFERENCE CALL INFORMATION
OSI PHARMACEUTICALS will host a conference call today, Monday, April 26,
2004 at 11:00AM Eastern Time. Dr. Colin Goddard will host the conference call to
discuss today's announcement. To access the live call or the seven-day archive
via the Internet, log on to www.osip.com. Please connect to the Company's
website at least 15 minutes prior to the conference call to ensure adequate time
for any software download that may be needed to access the webcast.
Alternatively, please call 1-800-915-4836 (US) or 1-973-317-5319 (international)
to listen to the call. Telephone replay is available approximately two hours
after the call through May 3, 2004. To access the replay, please call
1-800-428-6051 (US) or 1-973-709-2089 (international). The conference ID number
is 353362.
GENENTECH will be offering a live webcast of a discussion by Genentech
management of the Tarceva results on Monday, April 26, 2004, at 9:00 a.m.
Pacific Time (PT). The live webcast may be accessed on Genentech's website at
http://www.gene.com. This webcast will also be available after the call via the
website until 5:00 p.m. PT on May 3, 2004. An audio replay of the webcast will
be available beginning at 12:00 noon PT on April 26, 2004 through 5:00 p.m. PT
on May 3, 2004. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada)
and 1-706-645-9291 (international); Conference ID number is 7108002.
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 successful
marketing of products, product pricing and third-party reimbursement, 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 the companies' 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.
The statements made in this press release relating to the expected timeframes
for NDA filing and for data availability from the Phase III trial in pancreatic
cancer are forward-looking and actual results could differ materially. Among
other things, the timeframes could be affected by safety or efficacy concerns,
manufacturing issues, additional time requirements to achieve study endpoints
or for data analysis or NDA preparation, discussions with the FDA, the need for
additional clinical studies, or FDA actions or delays.
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