-----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, ANPC9gBOsixuKOoUrMMX8GvDB3dvBEa+z6gNErpq6b7Xal/QBuTnDI6l6UnmRIVt xbAWMnfuLMlIW5IRwFKX4w== 0000950135-03-001388.txt : 20030224 0000950135-03-001388.hdr.sgml : 20030224 20030224160125 ACCESSION NUMBER: 0000950135-03-001388 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030220 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030224 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: 03577667 BUSINESS ADDRESS: STREET 1: 14 CAMBRIDGE CTR CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: 6176792000 MAIL ADDRESS: STREET 1: 14 CAMBRIDGE CTR CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: BIOGEN NV DATE OF NAME CHANGE: 19880622 8-K 1 b45747bie8vk.txt BIOGEN, INC. ================================================================================ 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): FEBRUARY 20, 2003 BIOGEN, INC. (EXACT NAME OF REGISTRANT AS SPECIFIED IN CHARTER) MASSACHUSETTS 0-12042 04-3002117 (STATE OR OTHER JURISDICTION (COMMISSION (I.R.S. EMPLOYER OF INCORPORATION) FILE NUMBER) IDENTIFICATION NO.) FOURTEEN CAMBRIDGE CENTER CAMBRIDGE, MASSACHUSETTS 02142 (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) ------------------ (617) 679-2000 (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) ------------------ ================================================================================ ITEM 5. OTHER EVENTS AND REGULATION FD DISCLOSURE. On February 20, 2003, the Registrant publicly disseminated a press release announcing that the Registrant has decided to withdraw its application for approval of AMEVIVE(R) (alefacept) for psoriasis in the European Union because the Committee for Proprietary Medicinal Products, the scientific advisory body of the European Medicines Evaluation Agency, determined that more clinical information is needed to approve the product. 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 February 20, 2003. 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/ Anne Marie Cook ----------------------------------------- Anne Marie Cook Vice President,Chief Corporate Counsel Dated: February 24, 2003 EXHIBIT INDEX
- --------------- --------------------------------------------------------- Exhibit Number Description - --------------- --------------------------------------------------------- 99.1 The Registrant's Press Release dated February 20, 2003 - --------------- ---------------------------------------------------------
EX-99.1 3 b45747biexv99w1.txt PRESS RELEASE DATED FEBRUARY 20, 2003 EXHIBIT 99.1 EUROPEAN APPROVAL OF AMEVIVE(R) DELAYED Committee Requests Additional Clinical Information Cambridge, MA (February 20, 2003) - Biogen, Inc. (NASDAQ/BGEN) announced today that the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA), requested more information relating to its application for AMEVIVE(R) (alefacept) for psoriasis. In the final assessment received this week, the CPMP determined that more clinical information is needed to approve the product. Biogen has withdrawn its application and plans to develop the additional clinical information necessary to obtain approval of AMEVIVE for psoriasis patients in Europe. Developing the data and re-filing the application to gain approval could take several years. This action should have no impact on the company's 2003 financial guidance. Biogen will be evaluating the impact on guidance for 2004 and beyond, considering the delay of European revenue as well as sales and marketing expense, and updating this outlook in its quarterly earnings call. ABOUT BIOGEN Biogen is the world's oldest independent biotechnology company and a leader in biologics research, development and manufacturing. A pioneer in leading edge research in immunology, neurobiology and oncology, Biogen brings novel therapies to improve patients' lives around the world through its global marketing capabilities. For press releases and additional information about the company, please visit http://www.biogen.com. SAFE HARBOR In addition to historical information, this press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to plans for the development of additional clinical data in response to the determination of the Committee for Proprietary Medicinal Products (CPMP) and the Company's expectations regarding the impact of the decision on financial results. These statements are based on the Company's current beliefs and expectations as to such future outcomes. There is no assurance that the Company will be able to generate data satisfactory to the CPMP. There are also a number of risks and uncertainties that could cause actual financial results to differ materially from our expectations. For example, financial results may be affected by the impact of competitive products on AVONEX (interferon beta-1a) sales, any slowing of growth of the multiple sclerosis market, any change in market acceptance of AVONEX in key markets worldwide, the level of success in launching AMEVIVE in the United States and the impact on expenses of development, sales and marketing activities and in-licensing and product opportunities as well as the other risks and uncertainties described from time to time in the Company's periodic reports filed with the Securities and Exchange Commission. CONFERENCE CALL AND WEBCAST The company will host a call for investors at 9:00 a.m. EST on February 20, 2003, and will be accessible through the investor relations section of Biogen's homepage, http://www.biogen.com.
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