-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FT+usLLv04wl8SRDpd0lT/EPzK8/KKGAW/GA5GkrEORE0NPMzjJVx+srju3Efdnv P0U2GByT9V97l5Pyqes/zA== 0000714655-96-000021.txt : 19961202 0000714655-96-000021.hdr.sgml : 19961202 ACCESSION NUMBER: 0000714655-96-000021 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19961121 ITEM INFORMATION: Other events FILED AS OF DATE: 19961126 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOGEN INC CENTRAL INDEX KEY: 0000714655 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 043002117 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-12042 FILM NUMBER: 96672287 BUSINESS ADDRESS: STREET 1: 14 CAMBRIDGE CTR CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 6176792000 MAIL ADDRESS: ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: BIOGEN NV DATE OF NAME CHANGE: 19880622 8-K 1 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): November 21, 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 November 21, 1996, the Registrant publicly disseminated a press release discussing the issuance by the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) of a positive opinion for the Registrant's recombinant interferon beta for the treatment of relapsing multiple sclerosis. The CPMP's opinion represents the EMEA's scientific evaluation of the Registrant's product. The positive opinion of the CPMP now will be forwarded to the European Commission for final review and approval. Approval by the European Commission will allow the Registrant to market and sell its product in 15 member states of the European Union. The Registrant's product was approved for marketing and sale within the United States in May 1996. 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 November 21, 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/ Thomas J. Bucknum Thomas J. Bucknum Associate General Counsel - Chief Corporate Counsel Date: November 26, 1996 EXHIBIT INDEX Exhibit Sequential Number Description Page Number 99.1 The Registrant's Press Release 5 dated November 21, 1996 Media Contact: Kathryn R. Bloom Director of Communications Biogen, Inc. Tel: (617) 679-2851 Angela Kirkman Manager of Communications Biogen Europe Tel: 33-1-41-37-96-02 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 ANNOUNCES MAJOR STEP TOWARD EUROPEAN APPROVAL OF INTERFERON BETA-1a Cambridge, MA (November 21, 1996) -- Biogen, Inc. (NASDAQ/BGEN) today announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion for Biogen's interferon beta-1a for the treatment of relapsing multiple sclerosis. Upon final approval, the product will be marketed in Europe under the brand name AVONEXTM. It is also marketed in the U.S. under the brand name AVONEX. The CPMP's opinion represents the Agency's scientific evaluation of the product. According to the European procedure, the positive opinion will now be forwarded to the European Commission for final review and approval. Final Commission action grants a Marketing Authorization that is effective in all 15 member states of the European Union. Jim Vincent, Biogen's Chairman and Chief Executive Officer, said, "This is a major step toward European market approval, and another strong sign of the potential for this drug. AVONEXTM continues to grow at a significant rate in the U.S., where we expect to be the market leader in the foreseeable future. The CPMP recommendation, combined with U.S. sales growth and the additional approvals anticipated in other markets, underscores the major potential market for AVONEXTM throughout the world." AVONEXTM was licensed for the U.S. market in May 1996. Biogen has also applied for market approval in a number of other countries, including Australia, Canada, New Zealand, Switzerland and Norway. 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 U.S. sales of AVONEXTM (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 and testing novel products for multiple sclerosis, inflammatory and respiratory diseases, and certain viruses and cancers. # # # chard\corporat\8kCPMP96 -----END PRIVACY-ENHANCED MESSAGE-----