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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): JULY 3, 1996
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BIOGEN, INC.
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(Exact name of registrant as specified in its charter)
MASSACHUSETTS 0-12042 04-3002117
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
14 CAMBRIDGE CENTER, CAMBRIDGE, MASSACHUSETTS 02142
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 679-2000
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ITEM 5. OTHER EVENTS.
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On July 3, 1996, the Registrant publicly disseminated a press release
concerning (i) a patent suit filed by Berlex Laboratories against the
Registrant, (ii) the current status of legal proceedings among the FDA, Berlex
Laboratories and the Registrant regarding the FDA's approval of the Registrant's
drug AVONEX[Trademark] and (iii) a filing by ASTA Medica Aktiengesselschaft of
Dresden, Germany for an arbitration against the Registrant with the
International Chamber of Commerce. The information contained in the press
release is incorporated herein by reference and filed as Exhibit 99.1 hereto.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
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(c) Exhibit.
99.1 The Registrant's Press Release dated July 3, 1996.
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SIGNATURES
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.
BIOGEN, INC.
(Registrant)
Date: July 5, 1996 /s/ Michael J. Astrue
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Michael J. Astrue, Esquire
Vice President and General Counsel
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EXHIBIT INDEX
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Exhibit
Number Description
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99.1 The Registrant's Press Release
dated July 3, 1996.
T3/633161.1
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EXHIBIT 99.1
Media Contact:
Kathyrn R. Bloom
Director of Communications
Biogen, Inc.
tel:(617)679-2837
Internet:[email protected]
Investment Community Contact:
Richard E.N. Lundberg
Manager of Investors Relations
Biogen, Inc.
tel:(617)679-2822
FOR IMMEDIATE RELEASE
BIOGEN SAYS BERLEX PATENT SUIT IS WITHOUT MERIT AND WILL
NOT AFFECT MARKET LAUNCH OF AVONEX[Trademark]
Cambridge, MA (July 3, 1996) -- Biogen, Inc. (NASDAQ/BGEN) said today it
considered the suit filed by Berlex Laboratories on the so-called "McCormick"
patent to be completely without merit and another desperate attempt to keep
AVONEX[Trademark] off the market. AVONEX[Trademark] is the only drug proven to
slow the progression of disability in people with multiple sclerosis.
Seperately Biogen announced that, due to Berlex's past threats, it was not
surprised by this action and sued Berlex Laboratories on May 3, 1996, in the
United States District Court of Massachusetts, for a declaratory judgement that
the McCormick patent is invalid and that Biogen does not infringe it in any
case.
Biogen Chairman James L. Vincent said, "Berlex has known for some time the
competitive challenge AVONEX[Trademark] will pose to the Berlex product. They
continue to try to substitute the courtroom for the marketplace as the
competitive arena. We do not expect this action will in any way impede our
making AVONEX[Trademark] available to the multiple sclerosis community, and we
are fully confident that we will prevail both in court and in the marketplace."
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Page 2 Biogen Says Berlex Patent Suit Is Without Merit
With regard to an earlier suit by Berlex against the FDA and Biogen, alleging
that FDA had violated its own procedure and the Orphan Drug Law in approving
AVONEX[Trademark], the FDA today asked Judge James Robertson of the United
States District Court for the District of Columbia to dismiss the case. In
asking for the dismissal, the FDA stated, "Allowing this type of lawsuit to go
forward does nothing but encourage companies to use the courts to stifle
competition and second-guess a highly scientific regulatory decision". Biogen
indicated that it will be supporting and expanding upon the FDA's motion next
week, and that it expects a prompt and successful hearing on the merits.
In addition, Biogen announced that it has been notified that ASTA Medica
Aktiengesselschaft of Dredsen, Germany, has filed for an arbitration against
Biogen with the International Chamber of Commerce (ICC) in Paris. In its
complaint, ASTA alleges that Biogen's 1993 termination of a 1989 agreement
licensing ASTA to market recombinant interferon beta in certain European
territories was ineffective. This Agreement also included Bioferon, a Biogen
joint venture that declared bankruptcy in 1993.
The ASTA complaint asks that an ICC panel declare that the 1989 license is
still in force and, in the alternative, seeks approximately five million
dollars in damages. The territories included in the 1989 license were Austria,
Belgium, Denmark, Finland, France, Greece, Iceland, Ireland, Luxembourg, The
Netherlands, Norway, Portugal, Sweden, Switzerland and the United Kingdom. The
arbitration will take place in Zurich under Swiss law. Biogen said it considers
the ASTA claims to be without merit.
Biogen, Inc., headquartered in Cambridge, MA, is a biopharmaceutical company
principally engaged in discovering and developing novel drugs for human
healthcare through genetic engineering. The Company's revenues are generated
from U.S. sales of AVONEX[Trademark] (Interferon beta-1a) for treatment of
relapsing forms of multiple sclerosis, and from the worldwide sales by
licensees of a number of products, including alpha interferon and hepatitis B
vaccines and diagnostic products. Biogen is focused primarily on developing,
testing and marketing products for multiple sclerosis, inflammatory and
respiratory diseases, and certain viruses and cancers.
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