FRAZER, Pa., March 30 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that it has received an approvable letter, together
with draft labeling, from the U.S. Food and Drug Administration (FDA) for
its new drug application (NDA) for NUVIGIL(TM) (armodafinil) Tablets [C-IV]
for the treatment of excessive sleepiness associated with narcolepsy,
obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep
disorder (SWSD).
The draft labeling includes a proposed bolded warning section that
characterizes the potential occurrence of skin rash and hypersensitivity in
patients taking modafinil and armodafinil. As expected, the agency also has
indicated that it will request similar language in the label for
PROVIGIL(R) (modafinil) Tablets [C-IV]. The proposed labeling is subject to
final approval by the FDA.
"We have worked diligently with the FDA over the past six months on
this issue, and they have now informed us that their review is complete. We
are very pleased that the proposed warning language appropriately describes
the product's safety profile," said Dr. Lesley Russell, Executive Vice
President, Worldwide Medical and Regulatory Operations.
Among other things, the agency has requested that the company provide a
standard safety update from clinical trials conducted since the last update
in June 2006, and introductory promotional materials to be used for the
product. The company's response will be submitted within 30 days and will
be considered a Class I response; the agency is expected to complete its
review within 60 days thereafter. The agency has not requested any
additional studies prior to final approval of NUVIGIL.
"While we fully appreciate that this regulatory review has been
difficult and lengthy for stockholders and others interested in the
outcome, we are convinced that in this unusual situation where multiple
products may be affected, the final result will prove to be worth the
investment of time and effort," said Frank Baldino Jr., Ph.D., Chairman and
CEO of Cephalon.
About NUVIGIL
NUVIGIL is a single-isomer formulation of modafinil, the active
pharmaceutical ingredient contained in PROVIGIL which is FDA-approved for
the treatment of excessive sleepiness associated with narcolepsy, OSAHS and
SWSD. The NUVIGIL NDA is based on positive results of four double-blind,
randomized, placebo-controlled studies in patients with excessive
sleepiness associated with either narcolepsy, SWSD or OSAHS. In these
studies, NUVIGIL was generally well tolerated. The most common side effects
were mild to moderate in intensity and included nausea, headaches,
dizziness, diarrhea, decreased appetite and upset stomach.
The company submitted its NDA for NUVIGIL to FDA in March 2005 and
received an initial approvable letter in April 2006.
Cephalon also plans to conduct clinical trials evaluating the use of
NUVIGIL as a treatment for serious medical conditions such as bipolar
depression, cognition associated with schizophrenia, and excessive
sleepiness and fatigue in conditions such as Parkinson's disease and
cancer.
NUVIGIL is protected by a U.S. patent expiring in 2023 that claims the
Form 1 polymorph of armodafinil.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development and marketing of innovative
products in four core therapeutic areas: central nervous system, pain,
oncology and addiction. Cephalon currently employs approximately 3,000
people in the United States and Europe. Cephalon's U.S. headquarters are
located in Frazer, Pennsylvania, with offices, laboratories and
manufacturing facilities in West Chester, Pennsylvania, Salt Lake City,
Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company currently markets six proprietary products in the United
States: PROVIGIL, FENTORA(R) (fentanyl buccal tablet) [C-II], ACTIQ(R)
(oral transmucosal fentanyl citrate) [C-II], GABITRIL(R) (tiagabine
hydrochloride), TRISENOX(R) (arsenic trioxide) injection, and VIVITROL(R)
(naltrexone for extended-release injectable suspension). 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, including future clinical development plans for NUVIGIL;
interpretation of clinical results, particularly with respect to the
NUVIGIL Phase 3 trials; prospects for regulatory approval of NUVIGIL,
including the likelihood of receiving final approval from FDA and the
characterization of serious skin rash, among other things, in the final
approved labeling for NUVIGIL; 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/
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Media: Jenifer Antonacci, +1-610-738-6674,
jantonac@cephalon.com; Investors: Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
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