- Current report filing (8-K)
March 26 2009 - 4:55PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
March 26, 2009
AMYLIN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
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0-19700
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33-0266089
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(State or Other
Jurisdiction of
Incorporation)
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(Commission File
Number)
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(I.R.S. Employer
Identification No.)
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9360 Towne Centre Drive
San Diego, California 92121
(Address of principal executive offices and zip code)
Registrants telephone number, including area
code:
(858)
552-2200
Check the appropriate box below if the Form 8-K is
intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (
see
General
Instruction A.2. below):
¨
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CRF 240.13e-4(c))
Item 8.01. Other Events.
On March 26, 2009, Amylin
Pharmaceuticals, Inc. issued a press release announcing that a
meta-analysis of primary cardiovascular events across controlled clinical
studies of three months or greater, from the BYETTA® (exenatide) injection
database, showed no increased risk of cardiovascular events associated with
exenatide use. The press release also
stated that the analyses to demonstrate comparability necessary for the
regulatory submission of exenatide once weekly have been successfully completed
and will be part of the exenatide once weekly New Drug Application which is on
track to be filed with U.S. Food and Drug Administration by the end of the
second quarter of 2009. Amylin also announced in the press release that it has
initiated a new phase 3b study designed to show superiority of exenatide once
weekly compared to BYETTA. A copy of the
press release is attached as Exhibit 99.1 and is incorporated herein by
reference.
Item 9.01. Financial Statements
and Exhibits.
(d)
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Exhibits.
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Number
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Description
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99.1
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Press release
issued by Amylin on March 26, 2009.
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2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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AMYLIN
PHARMACEUTICALS, INC.
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Dated: March 26,
2009
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By:
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/s/ LLOYD A.
ROWLAND
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Lloyd A. Rowland
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Vice
President, Governance and Compliance, and Secretary
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3
EXHIBIT
INDEX
Number
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Description
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99.1
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Press release
issued by Amylin on March 26, 2009.
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4
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