OSI Pharmaceuticals Announces Notification of ANDA Filing for Tarceva
February 10 2009 - 6:30AM
Business Wire
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today receipt
of a Paragraph IV Certification Notice Letter advising that Teva
Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug
Application (ANDA) to the U.S. Food and Drug Administration (FDA)
requesting permission to manufacture and market a generic version
of Tarceva� (erlotinib).
OSI is currently reviewing the Notice Letter and has 45 days
from the date of receipt to commence a patent infringement lawsuit
against Teva and expects to file suit in that time frame. Tarceva
is currently protected by three patents that are listed in the
FDA�s Approved Drugs Products List (Orange Book). A lawsuit brought
with respect to one or more of those patents would restrict the FDA
from approving Teva�s ANDA until May 18, 2012 (the statutory stay
period), unless an adverse court ruling occurs prior to such
time.
About the Paragraph IV / ANDA
Process
Under the Hatch-Waxman Act of 1984, generic companies have the
opportunity to file an ANDA after the fourth anniversary of the FDA
approval of an innovator�s New Drug Application (NDA) of a drug
with a new chemical entity, provided they allege (through a
Paragraph IV certification) that the Orange Book-listed innovator
patents are invalid and/or unenforceable or will not be infringed.
Recent examples of this include Teva's ANDA filings for a generic
form of Lilly's Alimta and Gilead's Truvada. An ANDA filing often
causes the filing and commencement of patent infringement
litigation by the innovator company, which results in a prohibition
of FDA approval of that ANDA before the statutory stay period has
expired.
About OSI
Pharmaceuticals
OSI Pharmaceuticals is committed to "shaping medicine and
changing lives" by discovering, developing and commercializing
high-quality and novel pharmaceutical products designed to extend
life and/or improve the quality of life for patients with cancer
and diabetes/obesity. The Company�s oncology programs are focused
on developing molecular targeted therapies designed to change the
paradigm of cancer care. OSI�s diabetes/obesity efforts are
committed to the generation of novel, targeted therapies for the
treatment of type 2 diabetes and obesity. OSI's flagship product,
Tarceva� (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 in certain settings. OSI
markets Tarceva through partnerships with Genentech, Inc. in the
United States and with Roche throughout the rest of the world. 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, 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.
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