FRAZER, Pa., June 18 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that it has received approval from the U.S. Food and
Drug Administration to market NUVIGIL(TM) (armodafinil) Tablets [C- IV], a
non-amphetamine wake-promoting agent for the treatment of excessive
sleepiness associated with obstructive sleep apnea/hypopnea syndrome
(OSAHS), narcolepsy, and shift work sleep disorder (SWSD). In OSAHS,
NUVIGIL is indicated as an adjunct to standard treatment(s) for the
underlying obstruction. NUVIGIL is the single-isomer formulation of
modafinil, the active pharmaceutical ingredient contained in PROVIGIL(R)
(modafinil) Tablets [C-IV], which was approved by FDA in 1998 to improve
wakefulness.
"FDA approval of NUVIGIL is a major accomplishment and the result of
collaborative efforts with the scientific and regulatory communities," said
Dr. Lesley Russell, Executive Vice President, Worldwide Medical and
Regulatory Operations. "We are excited about the future of NUVIGIL and we
have initiated additional clinical work to explore its potential in a wide
range of medical disorders."
Cephalon's clinical program will evaluate the use of NUVIGIL as a
treatment for serious medical conditions such as bipolar depression,
cognition associated with schizophrenia, excessive sleepiness in medical
conditions such as Parkinson's disease, and fatigue in patients who are
being treated for cancer. The company currently plans a commercial launch
of NUVIGIL once additional clinical data has been amassed.
"The approval of NUVIGIL allows us to preserve our current leadership
position in the area of wakefulness," said Frank Baldino, Jr., Ph.D.,
Chairman and CEO, Cephalon. "More importantly, we now have a longer-term
opportunity to further characterize the utility of this compound beyond
wakefulness." NUVIGIL is protected by a U.S. patent expiring in 2023.
The agency has approved final labeling for NUVIGIL, including a bolded
warning, which is consistent with the draft labeling received by the
company in March 2007. Full prescribing information will be available on
the FDA website or on the company's website at:
http://www.cephalon.com/newsroom/assets/Nuvigil_Prescribing_Information.pdf
. As expected, the agency also has indicated that it will request similar
language in the label for PROVIGIL.
About NUVIGIL
The active pharmaceutical ingredient in NUVIGIL, armodafinil, is the
longer-lived r-enantiomer of modafinil, the active ingredient in PROVIGIL.
The approval of NUVIGIL 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.
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 has delivered a seven-year compound annual
growth rate (CAGR) greater than 75% and 2006 revenue of $1.760 billion. 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. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:
PROVIGIL, FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic
trioxide) injection, VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), 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, including any additional clinical programs with respect to
NUVIGIL; interpretation of clinical results, particularly with respect to
the NUVIGIL clinical trials; manufacturing development and capabilities;
market prospects for its products, including the timing of the commercial
launch of NUVIGIL, the clinical utility of NUVIGIL and the longer-term
opportunities with NUVIGIL beyond its current indication; sales and
earnings guidance; and other statements regarding matters that are not
historical facts, including the protection afforded by any patents covering
NUVIGIL. 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.
 back to top
Related links:
http://www.cephalon.com/
http://www.prnewswire.com/comp/134563.html /
CONTACT:
Media: Jenifer Antonacci, +1-610-738-6674,
jantonacci@cephalon.com, or Investors: Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, both of Cephalon, Inc.
|
