Amylin Pharmaceuticals Withdraws Swiss Regulatory Application for SYMLIN(R)
January 07 2004 - 4:45PM
PR Newswire (US)
Amylin Pharmaceuticals Withdraws Swiss Regulatory Application for
SYMLIN(R) SAN DIEGO, Jan. 7 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. today announced receipt of correspondence
from the Swiss Agency for Therapeutic Products (Swissmedic)
indicating that SYMLIN(R) could not be approved for marketing in
Switzerland based on data received to date. The Swissmedic
indicated that they require additional clinical information to
demonstrate the benefits of SYMLIN(R) therapy relative to risks
associated with adverse events, including nausea and hypoglycemia.
Amylin submitted the original application in August 2001, and in
March 2003 submitted a response to the original inquiries from the
Swissmedic, which included an interim analysis of a SYMLIN(R)
dose-titration study. The Swiss regulatory procedure does not allow
for another supplemental submission of data at this stage,
therefore, the Company has decided to withdraw its application. "We
are currently evaluating our SYMLIN(R) regulatory options in
markets in other countries, including resubmission in Switzerland.
However, at this time our priority is to gain regulatory approval
in the U.S.," said Joann L. Data, MD, PhD, Senior Vice President of
Regulatory Affairs and Quality Assurance for Amylin
Pharmaceuticals, Inc. "Currently, Amylin's primary focus is to work
with the FDA to answer questions posed in the SYMLIN(R) approvable
letter received in December 2003." The revision in Amylin's Swiss
regulatory strategy for SYMLIN(R) does not affect regulatory
strategies being pursued in the U.S. In December 2003, Amylin
received a second Approvable Letter from the Food and Drug
Administration (FDA) for both type 1 and insulin-using subjects
with type 2 diabetes. Final approval is subject to the outcome of
further discussions with the FDA. Amylin Pharmaceuticals is
committed to improving the lives of people with diabetes and other
metabolic disorders through the discovery, development and
commercialization of innovative, cost-effective medicines. Further
information on Amylin Pharmaceuticals and its pipeline in
metabolism is available at http://www.amylin.com/ . This press
release contains forward-looking statements about Amylin, which
involve risks and uncertainties. The Company's actual results could
differ materially from those forward-looking statements discussed
in this press release, due to a number of risks and uncertainties,
including risks and uncertainties in the ability of the current
clinical studies to satisfy the FDA's requirements for SYMLIN(R)
approval in the United States, risks and uncertainties in the FDA's
review of NDAs generally, risks and uncertainties in FDA
requirements for SYMLIN(R) approval, risks and uncertainties that
approval by the FDA if any, may be withheld, delayed and/or limited
by indications, risks and uncertainties regarding the drug
discovery and development process, and uncertainties regarding the
Company's ongoing clinical studies of its drug candidates.
Additional risks and uncertainties are described more fully in the
Company's most recently filed SEC documents, such as its Annual
Report on Form 10-K for the fiscal year ended December 31, 2002
under the heading "Risk Factors," its Quarterly Reports on Form
10-Q, and in its recently filed registration statement on Form S-3
(#333-111086). DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT:
Mark G. Foletta, Vice President of Finance and Chief Financial
Officer of Amylin Pharmaceuticals, Inc., +1-858-552-2200 Web site:
http://www.amylin.com/
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