FRAZER, Pa., April 24 /PRNewswire-FirstCall/ -- Cephalon, Inc.,
(Nasdaq: CEPH) today announced its receipt of a Paragraph IV Certification
Notice Letter relating to an Abbreviated New Drug Application (ANDA)
submitted to the U.S. Food and Drug Administration (FDA) by Watson
Laboratories, Inc., requesting approval to market and sell a generic
version of FENTORA(R) (fentanyl buccal tablet) [C-II]. In its Notice
Letter, Watson alleges that the U.S. Patent Numbers 6,200,604 and 6,974,590
covering FENTORA are invalid, unenforceable and/or will not be infringed by
Watson's manufacture, use or sale of the product described in its ANDA.
Cephalon currently is reviewing the Notice Letter and, by statute, has
45 days to initiate a patent infringement lawsuit against Watson. Such a
lawsuit would automatically prevent the FDA from approving the Watson ANDA
until the earlier of a district court decision or 30 months from the
company's receipt of the Notice Letter.
Cephalon has a three-year period of marketing exclusivity for FENTORA
that extends until September 2009. Additionally, the method of use patents
described above expire in 2019.
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:
PROVIGIL(R) (modafinil) Tablets [C-IV], TREANDA(R) (bendamustine
hydrochloride), FENTORA, TRISENOX(R) (arsenic trioxide) injection, AMRIX(R)
(cyclobenzaprine hydrochloride extended-release capsules), 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; prospects for regulatory
approval; manufacturing development and capabilities; legal matters,
including whether the company will initiate a patent infringement lawsuit
against Watson; market prospects for its products; sales, adjusted net
income and basic adjusted income per common share guidance; and other
statements regarding matters that are not historical facts. 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, Candace Steele, +1-610-727-6231,
csteele@cephalon.com; or Investors, Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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