WEST CHESTER, Pa., Feb. 5 /PRNewswire-FirstCall/ --
Cephalon, Inc. (Nasdaq: CEPH) reported today that the U.S. Food and Drug
Administration (FDA) has accepted an abbreviated new drug application (ANDA)
for a generic form of modafinil, the active ingredient found in the company's
PROVIGIL(R) Tablets [C-IV].
Even if an ANDA application eventually is approved by the FDA, it will be
years before a generic equivalent modafinil product can be sold in the United
States. PROVIGIL is protected in the United States by a patent that does not
expire until 2014 and that covers the pharmaceutical composition of the form
of modafinil contained in PROVIGIL. PROVIGIL also was granted orphan drug
exclusivity that prevents the approval of any ANDA for a modafinil product
prior to June 2006, provided the FDA grants the company a six-month extension
to the December 2005 orphan drug exclusivity upon completion of a pediatric
study.
"We have anticipated the possibility of a filing for some time, and we
believe that our patent position for this product is strong," said John E.
Osborn, Senior Vice President and General Counsel of Cephalon. "We will
thoroughly evaluate any filing when it becomes available to us, and we are
prepared to vigorously protect our intellectual property rights."
PROVIGIL was approved by the FDA for the treatment of excessive daytime
sleepiness associated with narcolepsy in December 1998 and was launched in the
United States by Cephalon in February 1999. In December 2002, the company
filed a Supplemental New Drug Application with the FDA seeking to expand its
U.S. labeling to cover the treatment of excessive sleepiness associated with
disorders of sleep and wakefulness in adults.
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products to treat sleep and neurological disorders, cancer and pain.
Cephalon currently employs approximately 1,500 people in the United States
and Europe. U.S. sites include the company's headquarters in West Chester,
Pennsylvania, and offices and manufacturing facilities in Salt Lake City,
Utah. Cephalon also has European operations in the United Kingdom, France and
Germany.
The company currently markets three proprietary products in the United
States: PROVIGIL, GABITRIL(R) (tiagabine hydrochloride) and ACTIQ(R) (oral
transmucosal fentanyl citrate) [C-II] and more than 20 products
internationally. Further information about Cephalon and 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 potential generic competition
and our responses thereto, the strength of the PROVIGIL patent position,
anticipated scientific progress on its research programs, development of
potential pharmaceutical products, interpretation of clinical results,
prospects for regulatory approval, manufacturing development and capabilities,
market prospects for its products, sales and earnings 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
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/134563.html
CONTACT:
Media: Robert Grupp, +1-610-738-6402 or
rgrupp@cephalon.com; or Investors: Robert S. (Chip) Merritt,
+1-610-738-6376 or cmerritt@cephalon.com, both of Cephalon
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