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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 7, 1999
(Date of earliest event reported)
ALKERMES, INC.
(Exact name of Registrant as specified in its charter)
PENNSYLVANIA 0-19267 23-2472830
(State of incorporation) (Commission file number) (IRS employer
identification
number)
64 SIDNEY STREET, CAMBRIDGE, MASSACHUSETTS 02139
(Address of principal executive offices, zip code)
AREA CODE (617) 494-0171
(Telephone number)
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ITEM 5. OTHER INFORMATION.
As reported in the press release of Alkermes, Inc. (the "Company")
published April 7, 1999, the Company announced its plans to discontinue study
ALK01-040, a Phase III clinical trial of Cereport(TM) (RMP-7) and the
chemotherapeutic agent carboplatin for the treatment of newly diagnosed brain
tumor patients. The entire text of the Company's press release is incorporated
by reference herein and a copy has been filed as an exhibit to this report.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits
99 Press Release, dated April 7, 1999
2
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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 8, 1999 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
Sequentially
Exhibit No. Exhibit Numbered Page
- ----------- ------- -------------
99 Press Release, dated April 7, 1999
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Exhibit 99
64 Sidney Street Telephone News Release
Cambridge (617) 494-0171
Massachusetts Facsimile
02139 4136 USA (617) 494-9263
ALKERMES [Logo]
FOR IMMEDIATE RELEASE
ALKERMES TO DISCONTINUE PHASE III BRAIN TUMOR STUDY
CAMBRIDGE, MA, APRIL 7, 1999 - Alkermes, Inc. (NASDAQ:ALKS) today announced its
plans to discontinue study ALK01-040, a Phase III clinical trial of Cereport(TM)
(RMP-7) and the chemotherapeutic agent carboplatin for the treatment of
newly-diagnosed brain tumor patients. The discontinuation of the study is not
based on any issues related to the safety or potential efficacy of Cereport and
carboplatin in this indication. Based on the company's experience to date it has
determined that elements of the study design are no longer appropriate and that
the probability of successful completion is low. The company does not plan to
initiate another study in this indication in the near future. Other clinical
trials of Cereport and carboplatin are ongoing and will continue, and include
Phase II trials in adult patients with brain metastases from lung cancer
(conducted by Alkermes) and in pediatric patients with brain tumors (conducted
by the National Cancer Institute).
ALK01-040 began patient enrollment in March 1998. The study was designed to
enroll patients with high grade primary brain tumors (glioblastoma multiforme)
following surgical resection of the tumor and prior to the initiation of
radiotherapy. Patients enrolled in the study will be provided the opportunity to
complete their course of treatment pursuant to the protocol and at the
investigator's discretion.
Cereport is designed to improve the passage into the brain of pharmaceutical
compounds by transiently increasing the permeability of the blood-brain barrier.
Cereport's safety, tolerability in combination with other drugs and preliminary
efficacy have been tested in a series of clinical trials in over 600 human
subjects. Alkermes has focused its development of Cereport on improving the
therapeutic utility of the chemotherapeutic agent carboplatin in the treatment
of patients with primary and metastatic brain tumors.
-more-
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Alkermes, Inc. is a leader in the development of products based on sophisticated
drug delivery technologies. The Company has several areas of focus: (i)
controlled, sustained release of injectable drugs lasting several days to
several weeks, utilizing its ProLease(R) and Medisorb(R) technologies; (ii) the
delivery of drugs into the brain past the blood-brain barrier, utilizing its
Cereport technology; (iii) oral delivery of drugs using the RingCap(TM) and DST
technologies; and (iv) the development of pharmaceutical products based on
proprietary pulmonary drug delivery technologies utilizing the recently acquired
AIR technology. In addition to its Cambridge, Massachusetts headquarters,
Alkermes operates manufacturing facilities in Massachusetts and Ohio and a
medical affairs office in Cambridge, England.
Certain statements set forth above may constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
Although the Company believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and operations,
the Company's business is subject to significant risks and there can be no
assurance that actual results of the Company's development activities and its
results of operations will not differ materially from its expectations. For
information with respect to factors which could cause actual results to differ
from expectations, reference is made to the reports filed by the Company with
the Securities and Exchange Commission under the Securities Exchange Act of
1934, as amended.
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CONTACT: Investor Relations:
Richard F. Pops Burns McClellan
Alkermes, Inc. Lisa Burns/Investor Relations
(617) 494-0171 (212) 213-0006
