Amylin Pharmaceuticals Receives Second Approvable Letter for SYMLIN(R)
December 17 2003 - 6:44PM
PR Newswire (US)
Amylin Pharmaceuticals Receives Second Approvable Letter for
SYMLIN(R) SAN DIEGO, Dec. 17 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug
Administration (FDA) has issued a second approvable letter for
SYMLIN(R) (pramlintide acetate), Amylin's lead drug candidate being
studied for the treatment of people with type 1 and insulin-using
type 2 diabetes. The FDA has requested additional clinical data to
identify a patient population and method of use for SYMLIN(R) where
there is no increased risk of significant hypoglycemia or where
there is an added benefit that clearly counterbalances any
potential for increases in episodes of hypoglycemia. The Company
believes that existing data generated since the submission of the
amendment to the SYMLIN New Drug Application in June 2003 could
provide the necessary data requested by the FDA. This includes data
from the open-label extension of the dose-titration study included
in the amendment and a large open-label study initiated earlier
this year. Amylin has requested a discussion with the agency
regarding specific requirements for approval. Amylin
Pharmaceuticals is a biopharmaceutical company dedicated to
developing innovative medicines to improve the lives of people with
metabolic diseases. Further information on Amylin 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 that existing SYMLIN clinical
data may not be satisfactory to the FDA, risks and uncertainties in
the FDA's review process generally, risks and uncertainties that
approval by the FDA, if any, may be withheld, delayed and/or
limited by indications or other label limitations, risks and
uncertainties regarding the drug discovery and development process,
and uncertainties regarding the company's ongoing clinical studies
of its drug candidates, including SYMLIN(R), exenatide and
exenatide LAR. 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 its recently filed registration statement
on Form S-3 (#333-111086). DATASOURCE: Amylin Pharmaceuticals, Inc.
CONTACT: Mark G. Foletta, Vice President, Finance and Chief
Financial Officer of Amylin Pharmaceuticals, Inc., +1-858-552-2200
Web site: http://www.amylin.com/
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