FRAZER, Pa., June 3 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that it and its wholly-owned subsidiary CIMA LABS
INC. have filed a lawsuit in U.S. District Court in Delaware against Watson
Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories,
Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which
cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal
tablet) [C-II]. The 6,200,604 and 6,974,590 patents do not expire until
2019. FENTORA was approved by the U.S. Food and Drug Administration (FDA)
in September 2006 for the management of breakthrough pain in patients with
cancer who are already receiving and who are tolerant to opioid therapy for
their underlying persistent cancer pain.
The lawsuit is based upon an Abbreviated New Drug Application (ANDA)
filed by Watson seeking FDA approval for a generic equivalent of fentanyl
buccal tablets to be sold in the United States. Watson alleges that the
above two FENTORA patents are invalid, unenforceable and/or will not be
infringed by Watson's manufacture, use or sale of the product described in
its ANDA.
"We believe that the proposed Watson ANDA product infringes our
patents," said Jerry Pappert, Executive Vice President and General Counsel.
"The FENTORA patents were approved by the United States Patent and
Trademark Office based on the results of extensive research by CIMA LABS.
We continue to believe that our patent position for this product is strong
and intend to vigorously defend our intellectual property."
The filing of this lawsuit is provided for by the Hatch-Waxman Act, a
federal statute governing certain aspects of generic drug approvals. Under
that statute, the filing of the lawsuit stays any FDA approval of the
Watson ANDA until the earlier of a district court judgment in favor of
Watson or 30 months from the company's April 2008 receipt of a Paragraph IV
certification letter from Watson.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and commercialization of
innovative products in four core therapeutic areas: central nervous system,
pain, oncology and addiction. A member of the Fortune 1000, Cephalon
currently employs approximately 3,000 people in the United States and
Europe. U.S. sites include the company's headquarters in Frazer,
Pennsylvania, and offices, laboratories or manufacturing facilities in West
Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis,
Minnesota. The company's European headquarters are located in
Maisons-Alfort, France.
The company's proprietary products in the United States include:
TREANDA(R) (bendamustine hydrochloride) for injection, AMRIX(R)
(Cyclobenzaprine Hydrochloride Extended-Release Capsules), PROVIGIL(R)
(modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide)
injection, VIVITROL(R) (naltrexone for extended-release injectable
suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM)
(armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl
citrate) [C-II]. The company also markets numerous products
internationally. Full prescribing information on its U.S. products is
available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products; interpretation of clinical results; manufacturing development and
capabilities; market prospects for its products; sales and earnings
guidance; and other statements regarding matters that are not historical
facts, including statements regarding whether the Watson ANDA product
infringes the FENTORA patents, the strength of Cephalon's patent position
for FENTORA or Cephalon's intention to defend the FENTORA intellectual
property. You may identify some of these forward-looking statements by the
use of words in the statements such as "anticipate," "estimate," "expect,"
"project," "intend," "plan," "believe" or other words and terms of similar
meaning. Cephalon's performance and financial results could differ
materially from those reflected in these forward-looking statements due to
general financial, economic, regulatory and political conditions affecting
the biotechnology and pharmaceutical industries as well as more specific
risks and uncertainties facing Cephalon such as those set forth in its
reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and
Exchange Commission. Given these risks and uncertainties, any or all of
these forward-looking statements may prove to be incorrect. Therefore, you
should not rely on any such factors or forward-looking statements.
Furthermore, Cephalon does not intend to update publicly any
forward-looking statement, except as required by law. The Private
Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE Cephalon, Inc.
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Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media, Sheryl Williams, +1-610-738-6493,
swilliam@cephalon.com, or Investors, Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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