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8-K - OSI PHARMACEUTICALS INC | v170891_8k.htm |
EX-99.3 - PRESS RELEASE DATED DECEMBER 29, 2009. - OSI PHARMACEUTICALS INC | v170891_ex99-3.htm |
EX-99.2 - PRESS RELEASE DATED DECEMBER 22, 2009. - OSI PHARMACEUTICALS INC | v170891_ex99-2.htm |
Exhibit
99.1
NEWS
RELEASE
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OSI
Contacts:
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Media/Investor:
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Kathy
Galante
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(631)
962-2043
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Media:
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Kim
Wittig
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(631)
962-2135
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Genentech
Contacts:
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Media:
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Charlotte
Arnold
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(650)
467-6800
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Advocacy:
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Kristin
Olson
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(650)
467-9129
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Investor:
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Susan
Morris
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(650)
225-6334
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Karl
Mahler
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011
41 61 687 85 03
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FDA
ADVISORY COMMITTEE RECOMMENDS AGAINST APPROVING TARCEVA FOR FIRST-LINE
MAINTENANCE USE IN ADVANCED NON-SMALL CELL LUNG CANCER
Gaithersburg, Md. – December 16,
2009 – OSI Pharmaceuticals, Inc. (NASDAQ: OSIP)
and Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO,
ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending
against approval of the daily pill Tarceva®
(erlotinib) for first-line maintenance use in people with advanced or metastatic
non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or
spread) following first-line treatment with platinum-based
chemotherapy. The FDA is not bound by the recommendations of its
advisory committees and the agency is expected to make a decision whether to
approve Tarceva for this use by January 18, 2010.
“We are
disappointed with the Committee’s recommendation and will work diligently to
respond to the issues that arose today as quickly as possible,” said Colin
Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “We
continue to believe that having an oral, well-tolerated treatment option that
can maintain the initial benefit from cytotoxic chemotherapy would be an
important advance in treating advanced lung cancer and will explore further with
regulatory agencies how best to pursue this outcome.”
“We
continue to hope Tarceva may be an option that could help more people with
advanced non-small cell lung cancer live longer without the disease getting
worse,” said Hal Barron, M.D., executive vice president, Global Development and
chief medical officer, Genentech. “We will work closely with OSI to
carefully review and address the Committee’s comments.”
The ODAC
recommendation was based on a review of data from the pivotal Phase III SATURN
study which showed a statistically significant improvement in both
progression-free survival (PFS) and overall survival (OS) with Tarceva compared
to placebo in the NSCLC maintenance setting. There were no new or
unexpected safety signals in the study and adverse events were consistent with
those previously reported for Tarceva in NSCLC.
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People
who received Tarceva had a 41 percent improvement in the likelihood of
living without the disease getting worse (PFS, the primary endpoint)
compared to placebo (hazard ratio=0.71, 29 percent reduction in the risk
of cancer progression or death, p<0.0001; median
PFS 12.3 weeks vs. 11.1 weeks).
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People
whose tumors over-expressed the epidermal growth factor receptor (EGFR) as
assessed by Immunohistochemistry (IHC) who received Tarceva had a 45
percent improvement in PFS compared to placebo (the co-primary endpoint;
hazard ratio=0.69, 31 percent reduction in the risk of cancer progression
or death, p<0.0001; median PFS 12.3 weeks vs. 11.1
weeks).
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·
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OS,
a key secondary endpoint, was also significantly improved by 23 percent
with Tarceva compared to placebo (hazard ratio=0.81, 19 percent
reduction in the risk of death, p=0.0088; median OS 12.0 months vs. 11.0
months).
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·
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The
most commonly reported adverse events in patients who received Tarceva
were rash (49 percent) and diarrhea (20 percent). Grade 3 rash
and diarrhea were experienced by six percent and two percent of patients,
respectively. There were no cases of Grade 4 rash or
diarrhea.
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About
SATURN
SATURN
was an international, placebo-controlled, randomized, double-blind, Phase III
study that enrolled 889 patients with advanced NSCLC at approximately 160 sites
worldwide. Patients were treated with four cycles of standard
first-line platinum-based chemotherapy and then randomized to Tarceva or placebo
if the cancer did not progress. The co-primary endpoints were PFS in
all patients and PFS in patients whose tumors over-expressed EGFR as assessed by
IHC. PFS was defined as the length of time from randomization to
disease progression or death from any cause. Secondary endpoints
included OS, safety and an evaluation of exploratory biomarkers.
About Lung Cancer
According
to the American Cancer Society, lung cancer is the leading cause of cancer death
in the United States. In 2009, approximately 159,000 Americans will die from the
disease. Most people are diagnosed with advanced stage disease and
only 15 percent survive five years. NSCLC is the most common type of
lung cancer.
About Tarceva
Tarceva
is a once-a-day pill that targets the EGFR pathway. Tarceva is
designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway
inside the cancer cell, one of the critical growth factors in NSCLC and
pancreatic cancer. Tarceva is indicated as a monotherapy for patients
with locally advanced or metastatic NSCLC whose disease has progressed after one
or more courses of chemotherapy. Tarceva is not intended to be used
at the same time as chemotherapy for NSCLC.
In
pancreatic cancer, Tarceva is indicated in combination with gemcitabine
chemotherapy for the first-line treatment of patients with locally advanced
pancreatic cancer, pancreatic cancer that cannot be surgically removed or
pancreatic cancer that has spread to distant body organs.
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Tarceva Safety
There
have been infrequent reports of serious Interstitial Lung Disease (ILD)-like
events including deaths in patients taking Tarceva. Serious side
effects (including deaths) in patients taking Tarceva include liver and/or
kidney problems; gastrointestinal (GI) perforations (the development of a hole
in the stomach, small intestine, or large intestine); and severe blistering skin
reactions including cases similar to Stevens-Johnson
syndrome. Patients taking Tarceva plus gemcitabine were more likely
to experience bleeding and clotting problems such as heart attack or
stroke. Eye irritation and damage to the cornea have been reported in
patients taking Tarceva. Women should avoid becoming pregnant and
avoid breastfeeding while taking Tarceva. Patients should call their
doctor right away if they have these signs or symptoms: new or worsening skin
rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting or stomach
pain; new or worsening shortness of breath or cough; fever; eye
irritation. Rash and diarrhea were the most common side effects
associated with Tarceva in the NSCLC clinical study. Fatigue, rash,
nausea, loss of appetite and diarrhea were the most common side effects
associated with Tarceva plus gemcitabine therapy in the pancreatic cancer
clinical study.
About OSI Pharmaceuticals
OSI
Pharmaceuticals is committed to "shaping medicine and changing lives" by
discovering, developing and commercializing high-quality, novel and
differentiated targeted medicines designed to extend life and improve the
quality of life for patients with cancer and diabetes/obesity.
About
Genentech
Founded
more than 30 years ago, Genentech is a leading biotechnology company that
discovers, develops, manufactures and commercializes medicines to treat patients
with serious or life-threatening medical conditions. The company, a wholly owned
member of the Roche Group, has headquarters in South San Francisco,
California.
###
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, OSI's and its collaborators' abilities to effectively market and sell
Tarceva and to expand the approved indications for Tarceva, OSI’s ability to
protect its intellectual property rights, safety concerns regarding
Tarceva, competition to Tarceva and OSI’s drug
candidates from other biotechnology and pharmaceutical
companies, the completion of clinical trials, the effects of FDA and other
governmental regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other factors
described in OSI Pharmaceuticals' filings with the Securities and Exchange
Commission.
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