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 30, 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.
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Item 5. Other Events.
On April 30, 1996, the Registrant publicly disseminated a press release
discussing the decision by U.S. District Court Judge James Robertson to reject a
motion by Berlex Laboratories, Inc. for a temporary restraining order in
Berlex's suit against the United States Food and Drug Administration. Berlex
sought the temporary restraining order 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 30, 1996.
<PAGE>
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
Vice President
General Counsel
Date: April 30, 1996
<PAGE>
EXHIBIT INDEX
Exhibit Sequential
Number Description Page Number
99.1 The Registrant's Press Release 5
dated April 30, 1996
<PAGE>
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 at mail.Biogen.com
FOR IMMEDIATE RELEASE
BIOGEN COMMENTS ON COURT DENIAL OF BERLEX
ATTEMPT TO DELAY MARKETING OF AVONEX(TM)
Cambridge, MA (April 30, 1996) -- Biogen, Inc. (NASDAQ/BGEN) said today it is
pleased the Food and Drug Administration will be able to proceed without delay
to conclude its review of Biogen's application for a license to market
AVONEX(TM) (Interferon beta-1a). FDA action was cleared by U.S. District Court
Judge James Robertson, who rejected a motion for a temporary restraining order
in a lawsuit filed by Berlex Laboratories, Inc. against FDA, seeking to bar
approval of Biogen's AVONEX(TM) for the treatment of multiple sclerosis. Biogen
said it expects FDA will follow the unanimous recommendation of the Advisory
Committee on December 4, 1995, and grant a license to market AVONEX(TM) in a
timely fashion.
"We look forward to making AVONEX(TM) available to multiple sclerosis patients
as quickly as possible," Biogen stated. "AVONEX(TM) is the only MS drug that
has been proven to slow progression of disability in MS patients and reduce the
frequency of exacerbations. 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 the product marketed by Berlex. We believe any delay
in the availability of this treatment option would be contrary to the best
interests of MS patients."
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.
