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): April 26,
1996
Biogen, Inc.
(Exact name of Registrant as specified in its charter)
Massachusetts 0-12042 04-3002117
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
14 Cambridge Center
Cambridge, MA 02142
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617)
679-2000
Exhibit Index on page 4.
Item 5. Other Events.
On April 26, 1996, the Registrant publicly disseminated
a press release discussing a suit filed by Berlex
Laboratories, Inc. against the United States Food and Drug
Administration. In the suit, Berlex seeks a temporary
restraining order, preliminary and permanent injunctive
relief and a declaratory judgment to prevent the FDA from
approving the Registrant's product license application and
establishment license application for the Registrant's AVONEX
TM interferon beta - 1a. 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.
(c) Exhibits.
99.1 The Registrant's Press Release dated April 26,
1996.
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.
By: /s/ Michael J. Astrue
Michael J. Astrue
Vice President - General
Counsel
Date: April 26, 1996
EXHIBIT INDEX
Exhibit Sequential
Number Description Page Number
99.1 The Registrant's Press Release 5
dated April 26, 1996
Media Contact:
Kathryn R. Bloom
Director of Communications
Biogen, Inc.
tel: (617) 679-2851
Investment Community Contact:
Richard E. N. Lundberg
Manager, Investor Relations
Biogen, Inc.
tel: (617) 679-2822
Internet: Rick_Lundberg@mail.Biogen.com
FOR IMMEDIATE RELEASE
BIOGEN SAYS BERLEX SUIT AGAINST FDA WITHOUT MERIT
Cambridge, MA (April 26, 1996) -- Biogen, Inc. (NASDAQ/BGEN)
said today it considers a suit filed today by Berlex
Laboratories, Inc., the U.S. subsidiary of Schering A.G.,
headquartered in Berlin, Germany, against the United States
Food and Drug Administration to be completely without merit.
Biogen said it expects that the FDA will follow the unanimous
recommendation of the Advisory Committee on December 4, 1995,
and grant a license to market AVONEX TM (Interferon beta-1a)
in a timely fashion.
Biogen stated: Berlex has known for some time the
competitive challenge AVONEX TM will pose to its Betaseron R
product. Apparently they have chosen 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 TM available to multiple sclerosis patients,
and we are fully confident that the FDA will prevail in court
and we will prevail in the market.
The claims by Berlex that the FDA's grant of a license to
market AVONEX TM would violate the orphan drug status of
Betaseron R and that the FDA would violate its own procedures
in licensing our product are spurious. The Orphan Drug Law
was designed so that truly different products -- such as
AVONEX TM and Betaseron R -- could both be available to
patients. We believe the clinical and safety profiles of
AVONEX TM, which were fully reviewed by the FDA Advisory
Committee, demonstrate clearly that these are two different
products. AVONEX TM is the only MS drug that has been proven
to slow progression of disability in MS patients and reduce
the frequency of neurological attacks. It has once-a-week
dosing and a more moderate side-effect profile that does not
include injection-site reactions and skin necrosis associated
with Betaseron R. AVONEX TM and Betaseron R have different
molecular structures, are manufactured in different ways,
have different dosing regimens and are administered
differently.
Page 2 Biogen Says Berlex Suit Against FDA Without Merit
With regard to the allegations that FDA violated their own
procedures regarding manufacturing changes, Biogen provided
the FDA with extensive data, and the FDA stated their
satisfaction with, and conclusions about, this data at the
Advisory Committee meeting on December 4, 1995. Furthermore,
the existing FDA administrative procedures are unambiguous
regarding the FDA's authority on this subject.
We believe the Berlex strategy is very much against the best
interests of MS patients and their physicians and would deny
these patients a clinically superior treatment option. We
are confident Berlex will not be successful."
Biogen, Inc., headquartered in Cambridge, MA, is a
biopharmaceutical company principally engaged in developing
and manufacturing drugs for human healthcare through genetic
engineering. The company's revenues are generated 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 and testing products for the treatment of multiple
sclerosis, inflammatory and respiratory diseases, and certain
viruses and cancers.
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