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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 12, 2010
ALKERMES, INC.
(Exact Name of Registrant as Specified in its Charter)
         
PENNSYLVANIA   1-14131   23-2472830
(State or Other Jurisdiction of Incorporation)   (Commission
File Number) 		  (I.R.S. Employer
Identification No.)
     
88 Sidney Street
Cambridge, Massachusetts
(Address of principal executive offices) 		  02139
(Zip Code)
Registrant’s telephone number, including area code: (617) 494-0171
     Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o      Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 

 

Item 7.01.   Regulation FD Disclosure
On March 12, 2010, Alkermes, Inc. (“Alkermes”), Amylin Pharmaceuticals, Inc. (“Amylin”), and Eli Lilly and Co. (“Lilly”) received a complete response letter from the U.S. Food and Drug Administration (“FDA”) in response to the exenatide once weekly New Drug Application (“NDA”) submission. A copy of the press release is attached hereto as Exhibit 99.1. This information, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
     
Exhibit No.   Description
99.1
  Press release issued by Alkermes, Amylin and Lilly, dated March 15, 2010, announcing receipt of complete response letter from FDA for exenatide once weekly NDA submission.

 

 

SIGNATURE
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  ALKERMES, INC.
 		  
Date: March 15, 2010  By:   /s/ James M. Frates   
    James M. Frates   
    Senior Vice President, Chief Financial Officer and Treasurer   

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Exhibit Index
     
Exhibit No.   Description
99.1
  Press release issued by Alkermes, Amylin and Lilly, dated March 15, 2010, announcing receipt of complete response letter from FDA for exenatide once weekly NDA submission.

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