I think it is the time for FDA to schedule the advisary meetting for
modafinil. See the following news for detail. It should give CEPH a good lift. Thus, I personally think it is the bottom for CEPH. The stock will be back soon.
Tuesday December 31 8:01 AM EDT
Cephalon Submits New Drug Application For Modafinil
to U.S. Food and Drug Administration
WEST CHESTER, Pa., Dec. 31 /PRNewswire/ -- Cephalon Inc announced today that the company
has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for
clearance to market modafinil for use in treating excessive daytime sleepiness associated
with narcolepsy.
The NDA contains results of 14 clinical studies with modafinil conducted by Cephalon,
including two double-blind, placebo-controlled multicenter Phase 3 trials involving 558
patients with narcolepsy. The Phase 3 studies were conducted at 39 sleep centers in the
United States and were designed to assess the patient's ability to stay awake using a
number of laboratory and clinical measures. The studies also measured the patient's
overall well-being, as assessed by an independent clinician, and the patient's quality of
life.
"As our first NDA submission, this event marks an important milestone for Cephalon," said
Frank Baldino, Jr., Ph.D., Cephalon's president and chief executive officer. "To our
knowledge, this is the most comprehensive clinical investigation ever undertaken in the
study of narcolepsy. We are grateful to the patients who participated in these studies,
and appreciate the dedication of the physicians and Cephalon employees who are working to
improve the lives of patients with this chronic and debilitating disease."
Modafinil is a novel oral medication that is approved and marketed in France for the
treatment of narcolepsy and idiopathic hypersomnia. Cephalon received exclusive rights to
market modafinil in the United States, Japan, the United Kingdom, Ireland and Mexico from
Laboratoire L. Lafon, the French pharmaceutical company which developed and currently
markets the drug in France. If approved in the United States, modafinil would be the first
new chemical entity available to treat narcolepsy in more than 20 years.
Narcolepsy is a chronic, lifelong sleep disorder afflicting approximately 125,000 people
in the United States. The most common symptom is excessive daytime sleepiness. Narcolepsy
generally begins in young adulthood. Therapies to treat the excessive daytime sleepiness
associated with the disease have been limited to amphetamine and other stimulants. The FDA
designated modafinil an orphan drug in March 1993 for the treatment of excessive daytime
sleepiness in narcolepsy.
Cephalon is an international biopharmaceutical company that discovers, develops and
markets products to treat neurological disorders. The company is developing products for
the treatment of ALS, narcolepsy, peripheral neuropathies, Alzheimer's disease, head and
spinal injury, and stroke, and currently copromotes two products in the United States for
the treatment of neurological conditions.
This news release may contain forward-looking statements that involve risks and
uncertainties. The results of the modafinil clinical trials have not been reviewed by the
FDA and there can be no assurance that the FDA will consider that these results
demonstrate sufficient safety and efficacy data to allow the filing of an NDA to obtain
marketing clearance or if the filing is allowed, to obtain marketing clearance. A full
discussion of Cephalon's operations and financial condition, including factors that may
affect the company's business and future prospects, is contained in documents the company
files with the SEC, such as form 10-Q and 10-K reports. These documents identify important
factors that could cause the company's actual performance to differ from current
expectations. SOURCE Cephalon, Inc. |
