-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OZbKF9ot37VHwN0tt360SkxTgSz5MUp669XnuZVYhyYQPK1hVev5fEfcV+X9H/vS qO9MOFMbFzqb+quPQPj2hg== 0001104659-03-028774.txt : 20031218 0001104659-03-028774.hdr.sgml : 20031218 20031217215939 ACCESSION NUMBER: 0001104659-03-028774 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031217 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031218 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMYLIN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000881464 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330266089 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19700 FILM NUMBER: 031061123 BUSINESS ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6195522200 MAIL ADDRESS: STREET 1: 9360 TOWNE CENTRE DR STREET 2: SUITE 110 CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a03-6386_18k.htm 8-K

 

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):  December 17, 2003

 

AMYLIN PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

 

 

0-19700

 

33-0266089

(Commission File No.)

 

(IRS Employer Identification No.)

 

 

 

9360 Towne Centre Drive
San Diego, California 92122

(Address of principal executive offices and zip code)

 

 

 

Registrant’s telephone number, including area code:  (858) 552-2200

 

 



 

ITEM 5. OTHER EVENTS.

 

On December 17, 2003, Amylin Pharmaceuticals, Inc. (the “Company”) announced that the United States Food and Drug Administration has issued a second approvable letter for SYMLIN® (pramlintide acetate), the Company’s lead drug candidate being studied for the treatment of people with type 1 and insulin-using type 2 diabetes.  A copy of the Company’s press release dated December 17, 2003, relating to the letter is attached hereto as Exhibit 99.1.

 

ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.

 

(C)          EXHIBITS.

 

Number

 

Description

 

 

 

99.1

 

Press release issued by the Company on December 17, 2003.

 

2



 

SIGNATURE

 

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.

 

 

AMYLIN PHARMACEUTICALS, INC.

 

 

Dated:    December 17, 2003

By:

/s/ Lloyd A. Rowland

 

 

 

Lloyd A. Rowland

 

 

Vice President, Legal, Secretary and General
 Counsel

 

3



 

INDEX TO EXHIBITS

 

99.1

 

Press release issued by the Company on December 17, 2003.

 

4


EX-99.1 3 a03-6386_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Amylin Pharmaceuticals Receives Second Approvable Letter for SYMLIN(R)

 

SAN DIEGO, Dec. 17 /PRNewswire-FirstCall/ — Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) 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 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).

 

SOURCE 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

 

http://www.prnewswire.com

 

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding Amylin Pharmaceuticals, Inc.’s business which are not historical facts are “forward-looking statements” that involve risks and uncertainties. For a discussion of such risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the Company’s Annual Report or Form 10-K for the most recently ended fiscal year.

 


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