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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 15, 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 15, 1999, the Company announced that they have expanded their
collaboration for Nutropin Depot, an injectable sustained release formulation of
Genentech's human growth hormone based on Alkermes' ProLease(R) drug delivery
system. The terms of the collaboration include the immediate purchase by
Genentech of $35 million of newly issued redeemable convertible exchangeable
preferred stock of Alkermes with a conversion price of at least $45 per share.
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 15, 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 21, 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 15, 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
FOR IMMEDIATE RELEASE
GENENTECH AND ALKERMES ANNOUNCE EXPANDED COLLABORATION FOR
NUTROPIN DEPOT /TM/
SOUTH SAN FRANCISCO, CA AND CAMBRIDGE, MA, APRIL 15, 1999 -- Genentech, Inc.
(NYSE: GNE) and Alkermes, Inc. (NASDAQ: ALKS) announced today that they have
expanded their collaboration for Nutropin Depot, an injectable sustained release
formulation of Genentech's human growth hormone based on Alkermes' ProLease(R)
drug delivery system. Pursuant to their collaborative arrangement initially
entered into in 1995, the companies have completed a Phase III clinical trial of
Nutropin Depot for the treatment of pediatric growth hormone deficiency and are
preparing to submit a New Drug Application with the U.S. Food and Drug
Administration. Under the agreement announced today, the companies will conduct
expanded development activities, including clinical trials in an additional
indication, process and formulation development, and manufacturing. The terms of
the collaboration include the immediate purchase by Genentech of $35 million of
newly issued redeemable convertible exchangeable preferred stock of Alkermes
(the "1999 Preferred Stock") with a conversion price of at least $45 per share.
The Agreement includes potential milestone payments to Alkermes of approximately
$40 million.
Alkermes will use the funding from the preferred stock for the activities
described above and will receive payments based on product sales. Genentech and
its partners will be responsible for worldwide sales and marketing.
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The 1999 Preferred Stock will be junior to Alkermes' outstanding $115 million of
convertible exchangeable preferred stock that was issued by Alkermes in March
1998. Dividends on the 1999 Preferred Stock will be paid at a floating
three-month LIBOR. Alkermes has the option to redeem the 1999 Preferred Stock in
cash or in common stock at any time.
"Genentech's goal is to continue to drive innovation in the growth hormone
marketplace for the benefit of patients, their families and caregivers," said
Arthur D. Levinson, Ph.D., Chief Executive Officer of Genentech. "We have had a
long-standing and productive relationship with Alkermes for the development of
Nutropin Depot and look forward to expanding our joint development activities."
Genentech, Inc. is a leading biotechnology company that discovers, develops,
manufactures and markets human pharmaceuticals for significant unmet medical
needs. Twelve of the currently marketed biotechnology products stem from
Genentech science. Genentech markets seven products directly in the United
States. The company has headquarters in South San Francisco and is traded on the
New York Stock Exchange and the Pacific Exchange under the symbol GNE.
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 and Medisorb(R) technologies; (ii) the
delivery of drugs into the brain past the blood-brain barrier, utilizing its
Cereport(TM) technology; (iii) oral delivery of drugs using its RingCap(TM) and
DST technologies; and (iv) the development of pharmaceutical products based on
proprietary pulmonary drug delivery technologies utilizing its 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 Alkermes believes that such statements are based on reasonable
assumptions within the bounds of its knowledge of its business and operations,
the Alkermes' business is subject to significant risks and there can be no
assurance that actual results of Alkermes' development activities and its
results of operations will not differ materially from its expectations. Factors
which could cause actual results to differ from expectations
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include, among others: (i) the Alkermes' collaborators could elect to terminate
or delay development programs; and (ii) even if product candidates appear
promising at an early stage of development, product candidates could fail to
receive necessary regulatory approvals, not reach anticipated milestones, be
difficult to manufacture on a large scale, be uneconomical, fail to achieve
market acceptance, be precluded from commercialization by proprietary rights of
third parties or experience substantial competition in the marketplace. For
additional information with respect to factors which could cause actual results
to differ from expectations, reference is made to the reports filed by Alkermes
with the Securities and Exchange Commission under the Securities Exchange Act of
1934, as amended.
CONTACT: Investor Relations: Genentech:
Richard F. Pops Lisa Burns Paul Laland/Corporate Communications
Alkermes, Inc. Burns McClellan (650) 225-2742
(617) 494-0171 (212) 213-0006 Susan Bentley/Investor Relations
(650) 225-1034
