brian,
ceph to resubmit nda, i believe this to be positive since it does give a chance for approval short term stock may take a hit.
gw
WEST CHESTER, Pa., and EMERYVILLE, Calif., Nov. 11 /PRNewswire/ --
Cephalon, Inc. (NASDAQ:CEPH) and Chiron Corporation (Nasdaq: CHIR) announced
today that they have withdrawn and resubmitted to the U.S. Food and Drug
Administration the companies' new drug application (NDA) to market
MYOTROPHIN(R) (mecasermin) Injection in the United States for the treatment of
ALS. By withdrawing and resubmitting the NDA, the companies will enable the
FDA to continue its review. Under the Prescription Drug User Fee Act, which
establishes performance goals for FDA reviews of new product applications, the
FDA's review of the MYOTROPHIN NDA was expected to be completed by
November 11, 1997.
The FDA informed the companies that information submitted in support of
the MYOTROPHIN NDA requires more in-depth analysis by the agency before a
final decision on the NDA can be made.
Cephalon President Frank Baldino, Jr., Ph.D., and Chiron Technologies
President Lewis T. Williams, M.D., Ph.D., stated: "Although this action is
unusual, it provides the FDA adequate time to evaluate all the data submitted
in support of the NDA. We have been advised that the FDA will complete its
review of the data and reach a decision on the NDA promptly."
Cephalon and Chiron are developing MYOTROPHIN Injection in North America
and Europe for the treatment of ALS and other neuromuscular disorders.
Chiron Corporation, headquartered in Emeryville, Calif., is a healthcare
company that combines diagnostic, vaccine and therapeutic strategies for
controlling disease.
Cephalon, Inc., headquartered in West Chester, Pa., is an international
biopharmaceutical company that discovers, develops and markets products to
treat neurological disorders. The company is developing products for the
treatment of amyotrophic lateral sclerosis, narcolepsy, peripheral
neuropathies, Alzheimer's disease and stroke. Cephalon currently copromotes
three products in the United States for the treatment of neurological
conditions.
This news release may contain forward-looking statements that involve
risks and uncertainties. A full discussion of Cephalon's and Chiron's
operations and financial condition, including factors that may affect the
companies' business and future prospects, is contained in documents the two
companies file with the SEC, such as form 10-Q and 10-K reports. These
documents identify important factors that could cause their actual performance
to differ from current expectations.
NOTE: Cephalon's press releases are available by fax 24 hours a day at no
charge by calling PR Newswire's Company News On-Call at 800-758-5804,
extension 134563. They we also posted on the Internet at
prnewswire.com. |
