-----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, L617ClryGbQyXmfw8jEDI5aNGVygVZwUNM4U6h4wvD9pCwrFfGKDRYKQT6y3wGkV LkOGPSJ7FaqdnUWAeQwRrg== 0000950135-96-002991.txt : 19960709 0000950135-96-002991.hdr.sgml : 19960709 ACCESSION NUMBER: 0000950135-96-002991 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19960703 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 19960708 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: 96591645 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 BIOGEN, INC. 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): JULY 3, 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, MASSACHUSETTS 02142 - -------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (617) 679-2000 -------------- 2 ITEM 5. OTHER EVENTS. - ------- ------------ 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. - ------- ---------------------------------- (c) Exhibit. 99.1 The Registrant's Press Release dated July 3, 1996. 2 3 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 ---------------------- Michael J. Astrue, Esquire Vice President and General Counsel 3 4 EXHIBIT INDEX ------------- Exhibit Number Description - ------- ----------- 99.1 The Registrant's Press Release dated July 3, 1996. T3/633161.1 4 EX-99.1 2 PRESS RELEASE DATED JULY 3, 1996 1 EXHIBIT 99.1 Media Contact: Kathyrn R. Bloom Director of Communications Biogen, Inc. tel:(617)679-2837 Internet:Kathryn_Bloom@mail.Biogen.com 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." 2 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. ### ### ### -----END PRIVACY-ENHANCED MESSAGE-----