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): October 31, 1994
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 October 31, 1994, the Registrant publicly disseminated a
press release announcing the results of the Registrant's
preliminary analysis of the data from its Phase III trial of its
Hirulog(TM) thrombin inhibitor in angioplasty and the Registrant's
decision to discontinue its major activities associated with
Hirulog(TM) development. In the press release, the Company also
announced that, as a result of its decision to discontinue the
Hirulog(TM) program, the Company was taking a pretax charge to
earnings of $25 million in the third quarter of 1994. 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 October 31, 1994.
<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: November 8, 1994
<PAGE>
EXHIBIT INDEX
Exhibit Sequential
Number Description Page Number
99.1 The Registrant's Press Release 5
dated October 31, 1994
<PAGE>
Exhibit 99.1
Media Contact
Kathryn R. Bloom
Director of Communications
Biogen, Inc.
Tel: (617) 679-2851
Investment Community Contact
Amy S. Hedison
Director, Investor Relations
Biogen, Inc.
BIOGEN ANNOUNCES PHASE III TRIAL RESULTS WITH HIRULOG*
Cambridge, MA (October 31, 1994) -- Biogen (NASDAQ/BGEN) today
announced it has completed the preliminary analysis of its Phase
III trial of Hirulog* thrombin inhibitor in angioplasty and does
not intend to file for regulatory approval at this time. The
company said that, although patients treated with Hirulog* had a
more than 50 percent lower incidence of major bleeding
complications compared to the heparin control, and that Hirulog*
appeared to demonstrate efficacy equivalent to the control, the
trial did not achieve its primary efficacy endpoint. As a result,
Biogen is discontinuing its major activities associated with
Hirulog* development and will seek a marketing partner for the
drug.
The trial was designed to show a reduction in the overall rate of
adverse events associated with angioplasty procedures. The
composite endpoint included death, myocardial infarctions,
emergency bypass surgery and repeat angioplasty procedures.
Although positive efficacy benefits were seen in selected patient
populations, the trial results failed to demonstrate a
statistically significant effect compared to heparin on the primary
endpoint in the overall patient population.
Jim Vincent, Biogen's chairman and chief executive officer, said,
"Although we are encouraged by the safety profile of the drug, we
are obviously disappointed in the overall trial outcome. As a
result, we don't see a market opportunity that will support our
continued development of the drug and direct marketing by Biogen as
we had envisioned. We believe Hirulog* may be attractive to other
companies and will begin looking for a marketing partner."
Biogen also announced that as a result of its decision to
discontinue the Hirulog* program, it was taking a pretax charge to
earnings of $25 million in the third quarter of 1994. The reserve
relates entirely to third-party expenses associated with the
manufacturing of drug supplies and wind-down of clinical trial
activities. The decision will not result in any layoffs or
terminations of personnel.
Mr. Vincent said, "Biogen will benefit in a number of ways from our
decision to act decisively on the Hirulog* program. We will
immediately redeploy internal resources onto the beta interferon
launch effort. We will improve our near-term profit-and-loss
outlook, which, in combination with our significant cash position,
assures that we will have the financial resources to be competitive
in the multiple sclerosis market."
The double-blinded, placebo controlled Phase III trial included
approximately 4,675 patients and was conducted in 113 hospitals in
the U.S. and Europe. The trial's principal investigator is
expected to report preliminary findings at the 10th International
George Washington University Workshop on "Thrombolysis and
Interventional Therapy in Acute Myocardial Infarction" at the
American Heart Association meeting in Dallas on November 13. The
final analysis by the company and the clinical investigators will
take several months to complete.
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 five 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, cardiovascular disease,
inflammatory diseases, and certain viruses and cancers.
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