8-K

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

July 26, 2001
Date of Report (date of earliest event reported)

AMYLIN PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in charter)

Delaware	0-19700	33-0266089
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

9373 Towne Centre Drive
San Diego, California 92122
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 552-2200

N/A

(Former name or former address, if changed since last report)

TABLE OF CONTENTS

	Item 5. Other Events.
	Item 7. Financial Statements and Exhibits.
SIGNATURE
INDEX TO EXHIBITS
Exhibit 99.1

Item 5. Other Events.

     On July 26, 2001, Amylin Pharmaceuticals, Inc., a Delaware corporation (“Amylin”), issued a press release announcing that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration has voted not to recommend approval of Amylin’s New Drug Application for SYMLIN™ (pramlintide acetate).

     A copy of the press release is attached as Exhibit 99.1 hereto and incorporated herein by this reference.

Item 7. Financial Statements and Exhibits.

     (c)  99.1 Press Release issued on July 26, 2001 by Amylin.

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.
By:	/s/ Mark G. Foletta
	Mark G. Foletta, Vice President and Chief Financial Officer

Date: July 26, 2001

INDEX TO EXHIBITS

99.1. Press Release issued on July 26, 2001 by Amylin Pharmaceuticals, Inc.

EX-99.1 2 a74376ex99-1.txt EXHIBIT 99.1 1 EXHIBIT 99.1 CONTACT: Mark G. Foletta Vice President of Finance and Chief Financial Officer (858) 552-2200 www.amylin.com FOR IMMEDIATE RELEASE FDA ADVISORY COMMITTEE VOTES NOT TO RECOMMEND APPROVAL OF SYMLIN FOR USE IN TYPE 1 AND INSULIN-USING TYPE 2 DIABETES San Diego, CA - July 26, 2001 - The Endocrinologic and Metabolic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) today voted not to recommend approval at this time of Amylin Pharmaceuticals' SYMLIN(TM) (pramlintide acetate) for the treatment of type 1 and insulin-using type 2 diabetes. However, eight out of nine Committee members voted that the data presented were adequate to demonstrate efficacy of SYMLIN in both type 1 and insulin-using type 2 diabetes, which the FDA also acknowledged in their presentation. The majority of the Committee members voiced encouragement for the potential of SYMLIN therapy. Concerns expressed focused on safety issues, particularly upon the initiation of therapy. Committee members requested that the Company submit additional data to respond to safety concerns. "We believe the concerns highlighted by the Advisory Committee are clear and addressable," stated Joann L. Data, Senior Vice President of Regulatory Affairs and Quality Assurance. "Our next step is to meet with the FDA and develop an agreeable plan going forward." "We are obviously disappointed with the decision of the Advisory Committee, but we are heartened by the stated enthusiasm of the Committee on the potential of SYMLIN in the management of type 1 and insulin-using type 2 diabetes," said Joseph C. Cook, Jr., Chairman and CEO of Amylin Pharmaceuticals "We remain committed to the SYMLIN development program and to the opportunity it may present for people with diabetes who use insulin." The FDA's advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the FDA. Although the committees provide recommendations to the agency, final decisions are made by the FDA. The company will webcast a conference call for analysts and investors tomorrow morning, July 27, 2001, at 8:30 a.m., Eastern Time. 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 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 following the close of the call at 800-633-8284 (domestic) or 858-812-6440 (international), reservation number 19398229. 2 Amylin Pharmaceuticals is engaged in the discovery, development and commercialization of drug candidates for the treatment of metabolic disorders. The Company's lead drug candidate, SYMLIN(TM) (pramlintide acetate), is currently under review by the FDA as a treatment for people with diabetes who use insulin. Marketing Authorization Applications for SYMLIN were submitted in Europe in May 2001 and have since been accepted for filing by the EMEA. Amylin Pharmaceuticals' second diabetes drug candidate, AC2993, is in Phase 2 evaluation for the treatment of type 2 diabetes. A long-acting release formulation, AC2993 LAR, is in Phase 1 development, with study results expected in the third quarter of 2001. The Company's third drug candidate, AC3056, is currently in Phase 1 evaluation as a potential treatment for metabolic disorders relating to cardiovascular disease. The Company has adopted a commercialization plan for SYMLIN that includes establishment of an internal commercial organization. The Company continues to evaluate arrangements with companies that may add value to its commercialization efforts for SYMLIN in the US as well as in Europe, Japan and other markets. Amylin Pharmaceuticals is based in San Diego, California and has approximately 220 employees. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.com. This press release contains forward-looking statements about the Company which involve a number of risks and uncertainties, including statements regarding the Company's ability to address the safety concerns regarding SYMLIN highlighted by the Advisory Committee, the timing of public announcements of the results of the Company's current Phase 1 clinical trials for AC2993 LAR and the Company's commercialization plans for SYMLIN. 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 FDA's review of NDAs generally, risks and uncertainties that the FDA may require additional clinical testing of SYMLIN, risks and uncertainties that approval of SYMLIN, if any, may be delayed and/or limited to specific indications, uncertainties in the review of the Company's European Marketing Authorization Applications for SYMLIN, risks and uncertainties regarding the drug discovery and development process, uncertainties regarding the Company's ongoing clinical studies of its drug candidates and the ability of the Company to commercialize its drug candidates, whether through sales, distribution, marketing and/or corporate partnering agreements, on terms acceptable to the Company or otherwise. 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, 2000 under the heading "Risk Factors," and its subsequently filed Quarterly Reports on Form 10-Q. ### -----END PRIVACY-ENHANCED MESSAGE-----

EX-99.1

   1
                                                                    EXHIBIT 99.1



                                                  CONTACT:
                                                  Mark G. Foletta
                                                  Vice President of Finance and
                                                  Chief Financial Officer
                                                  (858) 552-2200
                                                  www.amylin.com

FOR IMMEDIATE RELEASE

  FDA ADVISORY COMMITTEE VOTES NOT TO RECOMMEND APPROVAL OF SYMLIN FOR USE IN
                    TYPE 1 AND INSULIN-USING TYPE 2 DIABETES

     San Diego, CA - July 26, 2001 - The Endocrinologic and Metabolic Drugs
Advisory Committee of the United States Food and Drug Administration (FDA) today
voted not to recommend approval at this time of Amylin Pharmaceuticals'
SYMLIN(TM) (pramlintide acetate) for the treatment of type 1 and insulin-using
type 2 diabetes.  However, eight out of nine Committee members voted that the
data presented were adequate to demonstrate efficacy of SYMLIN in both type 1
and insulin-using type 2 diabetes, which the FDA also acknowledged in their
presentation.  The majority of the Committee members voiced encouragement for
the potential of SYMLIN therapy.  Concerns expressed focused on safety issues,
particularly upon the initiation of therapy.  Committee members requested that
the Company submit additional data to respond to safety concerns.

     "We believe the concerns highlighted by the Advisory Committee are clear
and addressable," stated Joann L. Data, Senior Vice President of Regulatory
Affairs and Quality Assurance.  "Our next step is to meet with the FDA and
develop an agreeable plan going forward."

     "We are obviously disappointed with the decision of the Advisory Committee,
but we are heartened by the stated enthusiasm of the Committee on the potential
of SYMLIN in the management of type 1 and insulin-using type 2 diabetes," said
Joseph C. Cook, Jr., Chairman and CEO of Amylin Pharmaceuticals  "We remain
committed to the SYMLIN development program and to the opportunity it may
present for people with diabetes who use insulin."

     The FDA's advisory committees provide independent advice and
recommendations to the FDA on scientific and technical matters related to the
development and evaluation of products regulated by the FDA.  Although the
committees provide recommendations to the agency, final decisions are made by
the FDA.

     The company will webcast a conference call for analysts and investors
tomorrow morning, July 27, 2001, at 8:30 a.m., Eastern Time.  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 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 following the close of the call at 800-633-8284
(domestic) or 858-812-6440 (international), reservation number 19398229.
   2
 Amylin Pharmaceuticals is engaged in the discovery, development and
commercialization of drug candidates for the treatment of metabolic disorders.
The Company's lead drug candidate, SYMLIN(TM) (pramlintide acetate), is
currently under review by the FDA as a treatment for people with diabetes who
use insulin. Marketing Authorization Applications for SYMLIN were submitted in
Europe in May 2001 and have since been accepted for filing by the EMEA.  Amylin
Pharmaceuticals' second diabetes drug candidate, AC2993, is in Phase 2
evaluation for the treatment of type 2 diabetes.   A long-acting release
formulation, AC2993 LAR, is in Phase 1 development, with study results expected
in the third quarter of 2001. The Company's third drug candidate, AC3056, is
currently in Phase 1 evaluation as a potential treatment for metabolic disorders
relating to cardiovascular disease.  The Company has adopted a commercialization
plan for SYMLIN that includes establishment of an internal commercial
organization.  The Company continues to evaluate arrangements with companies
that may add value to its commercialization efforts for SYMLIN in the US as well
as in Europe, Japan and other markets.  Amylin Pharmaceuticals is based in San
Diego, California and has approximately 220 employees.  Further information on
Amylin Pharmaceuticals and its pipeline in metabolism is available at
www.amylin.com.

     This press release contains forward-looking statements about the Company
which involve a number of risks and uncertainties, including statements
regarding the Company's ability to address the safety concerns regarding SYMLIN
highlighted by the Advisory Committee, the timing of public announcements of the
results of the Company's current Phase 1 clinical trials for AC2993 LAR and the
Company's commercialization plans for SYMLIN.  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 FDA's review of NDAs generally, risks and uncertainties
that the FDA may require additional clinical testing of SYMLIN, risks and
uncertainties that approval of SYMLIN, if any, may be delayed and/or limited to
specific indications, uncertainties in the review of the Company's European
Marketing Authorization Applications for SYMLIN, risks and uncertainties
regarding the drug discovery and development process, uncertainties regarding
the Company's ongoing clinical studies of its drug candidates and the ability of
the Company to commercialize its drug candidates, whether through sales,
distribution, marketing and/or corporate partnering agreements, on terms
acceptable to the Company or otherwise. 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, 2000 under
the heading "Risk Factors," and its subsequently filed Quarterly Reports on Form
10-Q.

                                      ###