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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (2814)	2/5/2001 1:28:58 AM
From: Jibacoa	Read Replies (1) \| Respond to of 52153

New higher dose of Rebif for MS: GENEVA, Feb. 5 /PRNewswire/ -- Serono S.A. (NYSE: SRA - news), Worldwide, Multiple Sclerosis (MS) is the most common disease of the central nervous system in young adults with up to two million people affected (450,000 in Europe alone). The European Commission has approved the highest available dose of Rebif® (44mcg 3 times per week) and recommends it as first line therapy for the treatment of patients with relapsing-remitting multiple sclerosis, the most common form of MS. This is a milestone in the treatment of relapsing-remitting multiple sclerosis confirming the findings of the increased efficacy of a higher dose of interferon beta-1a. The CPMP(1) approval is based on the assessment of the 4-year data from the PRISMS(2) study. The study provides clinical evidence that a high dose of interferon beta-1a, administered as early as possible in the course of the disease, significantly improves the long-term outlook for the patient. Rebif® is the only interferon beta product granted full approval by the European Commission. All previous approvals in the EU for interferon products for the treatment of MS have been subject to annual reassessment of their risk/benefit profile. Early treatment with the highest possible dose of interferon beta-1a has been proven to significantly slow down the disease and is believed to reduce the destruction of nerve fibers (axons) in the central nervous system. The patient will have a better long-term prognosis. To maximize its benefit, interferon beta-1a needs to be administered three times per week and with the highest tolerable dose. Currently, Rebif® 44mcg x 3 is the only therapy that can be given at such a high dose, whilst maintaining a good safety profile. Rebif® is currently the only MS treatment that has been recognized by the CPMP to have a significant positive impact on all major clinical aspects(3) in relapsing-remitting multiple sclerosis: -- Progression of disability is delayed. Patients remain longer on their current EDSS(4) level, which means that they are less likely to get severely disabled and, therefore can live a better quality life. -- The number of relapses is significantly reduced and patients are more likely to be able to remain professionally and socially active. -- The severity of relapses is reduced, which means fewer hospitalizations are needed. Rebif® is registered in 60 countries worldwide and is currently the most frequently selected treatment for newly diagnosed MS patients in the world outside the US. Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on the Company's current expectations and assumptions, which may be affected by a number of factors, including those discussed below and more fully described in the Company's prospectus filed with the U.S. Securities and Exchange Commission on July 26, 2000. These factors include any failure or delay in the Company's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. The Company has no responsibility to update the forward- looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release. Serono, headquartered in Geneva, Switzerland, is a global biotechnology leader. The Company has five recombinant products on the market, Gonal-F®, Ovidrel(le)®, Rebif®, Serostim® and Saizen®. In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are nine molecules in development. In 2000, Serono achieved worldwide sales of US$ 1.147 billion, making it the third largest biotech company in the world based on revenues. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA). (1) The CPMP is the committee responsible for providing scientific advice and opinions to the European Medicines Evaluation Agency (EMEA), within the framework of the European centralized approval procedure. (2) Long-term efficacy of interferon beta-1a (Rebif(r)) in relapsing- remitting MS: 4-year results of the PRISMS study. Presented by M Freedman at the American Academy of Neurology 52nd Annual Meeting, San Diego, USA, 29 April - 6 May, 2000. (3) EPAR (European Public Assessment Report) : Rebif®: CPMP/022/98; Avonex®: CPMP/1063/96; Betaferon®: CPMP/590/95 (4) EDSS = Expanded Disability Status Scale is the official method to measure the level of disability and its changes in the course of the disease. For more information, please contact: Serono International S.A., Geneva, Switzerland: Media Relations: Investor Relations: Noonan/Russo Communications: Tel: +41-22-739-36-00 Tel: +41-22-739-36-01 Tel: +44-207-726-4452 Fax: +41-22-739-30-85 Fax: +41-22-739-30-22 Fax: +44-207-726-4453 serono.com Reuters: SEOZ.S/SRA.N noonanrusso.com Bloomberg: SEO SW/SRA US