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): June 5, 2012

 

 

AMYLIN PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   0-19700   33-0266089

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

9360 Towne Centre Drive

San Diego, California 92121

(Address of principal executive offices and zip code)

Registrant’s 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 June 5, 2012, Amylin Pharmaceuticals, Inc. (“Amylin”) announced that it has received comments from the U.S. Food and Drug Administration (“FDA”) regarding Amylin’s pending regulatory submission package for the BYDUREON™ (exenatide extended-release for injectable suspension) pen delivery system, including a request for incremental device-related data. Amylin is committed to responding to the FDA’s requests in a timely fashion with the goal of making the BYDUREON pen delivery system available to patients during calendar year 2013.


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.

 

    AMYLIN PHARMACEUTICALS, INC.
Dated: June 5, 2012     By:  

/s/ Harry J. Leonhardt

      Harry J. Leonhardt
     

Senior Vice President, Governance and Compliance,

and Corporate Secretary