U.S. Patent & Trademark Office Issues a Notice of Allowance in OSI Pharmaceuticals’ Reissue Application on Tarceva® Compos...
September 17 2009 - 1:37PM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that
the U.S. Patent & Trademark Office has issued a “Notice of
Allowance” in OSI’s reissue application for U.S. Patent
No.5,747,498 (the ‘498) composition of matter patent for Tarceva®
(erlotinib). The reissued patent will replace the original ‘498
patent and have the same November 2018 expiration date.
“This decision by the PTO is encouraging as OSI, along with the
biopharmaceutical industry, recognizes that patent rights are an
important asset in protecting the extensive R&D investment
necessary to bring new drugs and therapeutics to patients. Today’s
action by the PTO is significant as we view this reissue grant as a
positive step in managing generic challenges to the Tarceva patent
estate,” stated Colin Goddard, Ph.D., Chief Executive Officer of
OSI Pharmaceuticals. “With a potential approval on the horizon
based on the SATURN data in the first-line maintenance setting for
non-small cell lung cancer; additional ongoing Phase III studies in
NSCLC for first-line EGFR mutation patients and in the stage I-IIIa
adjuvant setting; and, further Phase III studies in ovarian cancer
and hepatocellular carcinoma, we believe Tarceva will remain a
growing, anchoring asset for the Company over the next decade.”
Background
In February 2008, OSI filed with the U.S. Patent and Trademark
Office an application to reissue its composition of matter patent
for Tarceva in order to correct certain errors relating to the
claiming of compounds, other than Tarceva, which fall outside of
the scope of the main claim in the patent. OSI’s reissue
application looked to correct these errors by deleting surplus
compounds from the claims. Like most composition of matter patents,
the ‘498 patent claims many compounds in addition to Tarceva.
Tarceva itself is accurately described in the ‘498 patent.
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 cell, one of the critical growth
factors in NSCLC and pancreatic cancers. 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. Results from two multicenter, placebo-controlled,
randomized Phase III trials conducted in first-line patients with
locally advanced or metastatic NSCLC showed no clinical benefit
with the concurrent administration of Tarceva with platinum-based
chemotherapy (carboplatin and paclitaxel or gemcitabine and
cisplatin) and its use is not recommended in that setting.
In pancreatic cancer, Tarceva is indicated in combination with
gemcitabine 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.
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
non-small cell lung cancer 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.
For full prescribing information, please call 1-877-TARCEVA or
visit http://www.tarceva.com.
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. For additional information about OSI,
please visit http://www.osip.com.
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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