FRAZER, Pa. and PHILADELPHIA, Oct. 21 /PRNewswire-FirstCall/ --
Cephalon, Inc. (Nasdaq: CEPH) and Eurand NV (Nasdaq: EURX) today announced
receipt of a Paragraph IV Certification Notice Letter on October 20, 2008
regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S.
Food and Drug Administration (FDA) by Mylan Pharmaceuticals, Inc.,
requesting approval to market and sell a generic version of the 15 mg and
30 mg strengths of AMRIX(R) (Cyclobenzaprine Hydrochloride Extended-Release
Capsules). In the Notice Letter, Mylan alleges that the U.S. Patent Number
7,387,793, entitled "Modified Release Dosage Forms of Skeletal Muscle
Relaxants," issued to Eurand is invalid, unenforceable and/or will not be
infringed by Mylan's manufacture, use or sale of the product described in
Mylan's ANDA submission. The Eurand patent covers extended-release
formulations containing the muscle relaxant cyclobenzaprine and expires on
February 26, 2025. Cephalon has a three-year period of marketing
exclusivity for AMRIX that extends until February 2010.
Eurand, the developer of AMRIX, and Cephalon, the exclusive licensee
and marketer of AMRIX in the United States, currently are reviewing the
Notice Letter. By statute, if Eurand initiates a patent infringement
lawsuit against Mylan within 45 days of the Notice Date, then the FDA would
be automatically precluded from approving the Mylan ANDA until the earlier
of a district court decision finding the patent invalid or not infringed or
30 months from the receipt of the Notice Letters by Eurand and Cephalon.
The companies will work together to determine the most appropriate course
of action.
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(R) (fentanyl buccal tablet) (C-II), TRISENOX(R)
(arsenic trioxide) injection, AMRIX, 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.
About Eurand
Eurand is a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies. Eurand has had four partnered products approved by the FDA
since 2001 and has a pipeline of product candidates in development for
itself and its collaboration partners. Eurand's technology platforms
include bioavailability enhancement of poorly soluble drugs, customized
release, taste-masking/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the U.S. and Europe. For
more information, visit Eurand's website at http://www.eurand.com.
Cephalon Forward-Looking Statement
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 Mylan; 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.
Eurand Forward-Looking Statement
This release, and oral statements made with respect to information
contained in this release, constitutes forward-looking statements. Such
forward-looking statements include those which express plan, anticipation,
intent, contingency, goals, targets or future development and/or otherwise
are not statements of historical fact including whether the company will
initiate a patent infringement lawsuit against the paragraph IV filer. Any
forward- looking statements are based upon management's current
expectations and are subject to risks and uncertainties, known and unknown,
which could cause actual results and developments to differ materially from
those expressed or implied in such statements. Forward-looking statements
contained in this press release are made as of this date, and we undertake
no obligation to publicly update any forward-looking statement, whether as
a result of new information, future events or otherwise. Actual events
could differ materially from those anticipated in the forward-looking
statements.
SOURCE Cephalon, Inc.
 back to top
Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media: Sheryl Williams, +1-610-738-6493 or
cell +1-610-457-5257, swilliam@cephalon.com, or Investor
Relations: Chip Merritt, +1-610-738-6376, cmerritt@cephalon.com,
both of Cephalon, Inc.; or Bill Newbould of Eurand
Pharmaceuticals, Inc., +1-267-759-9335 or cell +1-610-203-7663,
bill.newbould@eurand.com; or Nick Laudico, +1-646-536-7030,
nlaudico@theruthgroup.com, or Sara Ephraim, +1-646-536-7002,
sephraim@theruthgroup.com, both of The Ruth Group for Eurand
Pharmaceuticals, Inc.
|
