Amylin Pharmaceuticals Submits Complete Response to FDA for SYMLIN(R)
September 20 2004 - 8:15AM
PR Newswire (US)
Amylin Pharmaceuticals Submits Complete Response to FDA for
SYMLIN(R) SAN DIEGO, Sept. 20 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ:AMLN) today announced the submission
of a complete response to the U.S. Food and Drug Administration's
second approvable letter for SYMLIN(R) (pramlintide acetate).
Resubmission of a complete response after receipt of an approvable
letter is intended to answer all of the questions that need to be
addressed prior to approval. The FDA is expected to respond to this
new submission within six months. "Based on numerous discussions
with the FDA, we believe that data generated since our last
SYMLIN(R) submission in June 2003 and additional analyses of
earlier studies, including the pivotal studies, answer the
questions raised in the second approvable letter," said Ginger L.
Graham, President and CEO of Amylin Pharmaceuticals, Inc. Amylin
will host a conference call to discuss recent SYMLIN(R) activities
on Monday, September 20, 2004 at noon Eastern (9 a.m. Pacific). The
call will be webcast live through Amylin's corporate website, and a
recording will be made available following the close of the call.
To access the webcast, please log on to http://www.amylin.com/
approximately fifteen minutes prior to the call to register,
download and install any necessary audio software. A recording will
be available by phone for 24 hours beginning approximately one hour
after the close of the call and can be accessed at (888) 286-8010
(domestic) or (617) 801-6888 (international), passcode 61201960.
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 SYMLIN may not be approved
by the FDA, 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, risks and uncertainties inherent in the drug discovery and
development process, and uncertainties regarding the company's
ongoing clinical studies of its drug candidates, including SYMLIN.
Additional risks and uncertainties are described more fully in the
Company's recently filed registration statement on Form S-3 under
the heading "Risks Related to Our Business" and our other recently
filed SEC documents. DATASOURCE: Amylin Pharmaceuticals CONTACT:
Mark G. Foletta, Vice President, Finance and Chief Financial
Officer of Amylin Pharmaceuticals, +1-858-552-2200 Web site:
http://www.amylin.com/
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