SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
DATE OF REPORT - APRIL 29, 2003
(Date of earliest event reported)
ALKERMES, INC.
(Exact name of Registrant as specified in its charter)
PENNSYLVANIA 1-14131 23-2472830
(State of incorporation) (Commission file number) (IRS employer
identification
number)
88 SIDNEY STREET, CAMBRIDGE, MASSACHUSETTS 02139
(Address of principal executive offices, zip code)
AREA CODE (617) 494-0171
(Telephone number)
ITEM 5. OTHER INFORMATION.
Alkermes, Inc. announced that its partner, Johnson & Johnson
Pharmaceutical Research & Development (J&JPRD), has submitted additional data
and analyses to the U.S. Food and Drug Administration (FDA) to fulfill a
complete response to the "non-approvable" letter issued by the FDA regarding the
New Drug Application (NDA) for Risperdal Consta(TM) long-acting injection. The
specific data and analyses provided were generated following discussions with
the FDA, particularly related to the agency's questions pertaining to aspects of
the preclinical data presented in the NDA for the long-acting injection form of
the atypical antipsychotic, risperidone. It is anticipated, based on criteria
set forth in the Prescription Drug User Fee Act (PDUFA), that the FDA will issue
a formal response to the submission in the fourth quarter of calendar year 2003.
A copy of the press release issued by Alkermes on April 29, 2003, is attached
hereto as Exhibit 99.1 and is incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits
99.1 Press Release issued by Alkermes, Inc., dated April 29, 2003.
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SIGNATURES
Pursuant to requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
Dated: April 29, 2003 Alkermes, Inc.
By: /s/ James M. Frates
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James M. Frates
Vice President, Chief Financial
Officer, and Treasurer
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ALKERMES, INC.
CURRENT REPORT ON FORM 8-K
EXHIBIT INDEX
Exhibit No. Exhibit
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99.1 Press Release issued by Alkermes, Inc., dated April 29, 2003.
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