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

To: Harold Engstrom who wrote (650)	5/8/1998 9:05:00 AM
From: Harold Engstrom	Read Replies (1) \| Respond to of 1686

ARES-SERONO ANNOUNCES EUROPEAN APPROVAL OF REBIF FOR MULTIPLE SCLEROSIS Rebif to offer important new treatment option for 350,000 Europeans living with MS; Company will seek fast approval of additional claims from regulators GENEVA, SWITZERLAND, May 5, 1998 -- Ares-Serono announced today that Rebif (recombinant interferon beta-la) has been granted approval by the European Commission for treatment of relapsing-remitting multiple sclerosis (MS), applicable throughout its 15 member states. This month the company will launch Rebif in Germany, Austria, the UK, Portugal, Sweden, Denmark and Finland and expects to bring it to the other 8 countries by the end of 1998. ?We are pleased that Rebif has been approved by the European regulators,? said Ernesto Bertarelli, Chief Executive Officer of Ares-Serono. ?We believe it is of paramount importance that this treatment be available to the hundreds of thousands of Europeans living with multiple sclerosis as soon as possible.? In February, Ares-Serono filed a Biologics License Application for relapsing-remitting and Transitional Multiple Sclerosis (TMS) with the U.S. Food and Drug Administration (FDA). This file was accepted by the FDA for full review on April 27, 1998. The TMS category refers to patients who progress fairly rapidly from a relapsing to a secondary progressive stage of MS with an increased risk of fixed disability. The European Commission?s approval is for a liquid, ready-to-use syringe of 22 mcg dose subcutaneously administered three times a week for reduction in relapsing- remitting MS. This approval differs from the one granted earlier this year by Canada Health. The Canadian authority approved dosage at 22 and 44 mcg subcutaneously three times a week for reducing relapses and for slowing the progress of disability in relapsing-remitting multiple sclerosis. The company will shortly file additional data which has become available since the original submission in Europe. This data supports the higher dosage, disability claim and Transitional Multiple Sclerosis (TMS). The company?s pivotal trial, PRISMS (Prevention of Relapses and Disability by Interferon beta-1a, Subcutaneously in Multiple Sclerosis) was the largest-ever controlled clinical trial completed in the field of MS -- conducted in 22 MS centers in nine countries on three continents. The double-blind, randomized study followed 560 MS patients who self-administered 22 and 44 mcg doses of Rebif or placebo, subcutaneously three times a week for two years. Participants? clinical status was monitored every three months and MRI scans were conducted at least twice a year. ?The PRISMS trial has shown effectiveness on all major outcomes measures,? said Professor Otto Hommes, Chairman of the European Charcot Foundation and a leading European investigator of the PRISMS trial. ?In addition to very impressive clinical results, disease activity and burden of disease on Magnetic Resonance Imaging were also markedly decreased.? According to Dr. Andrew Galazka, Senior Vice President for Medical Affairs at Ares-Serono, PRISMS was the most comprehensive study ever conducted in relapsing-remitting multiple sclerosis. ?We are proud to make this contribution to the treatment of individual patients and to the understanding of this debilitating disease. O PRISMS also clearly demonstrated that Rebif was safe and well-tolerated. The most common adverse events reported among Rebif-treated patients were headache, flu-like symptoms and fever. Local site injection reactions were generally transient and mild in nature and did not result in discontinuation of therapy. - MORE - ?In my judgment, the Rebif data represent a significant advancement in both the science and the treatment of MS,? said Prof. Jrg Kesselring, Secretary of the Medical Advisory Board of the International Federation of Multiple Sclerosis Societies and President of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). ?Moreover, the availability of Rebif in a liquid formulation makes treatment more convenient for patients and is an important milesone in patient care.? More than one million people worldwide are living with multiple sclerosis. MS is a chronic, debilitating disease of the central nervous system that affects mainly young adults. It is associated with periods of disability (relapse) alternating with periods of recovery (remission). MS has an unpredictable clinical course and several distinct clinical patterns, the most common of which is relapsing-remitting multiple sclerosis. The Ares-Serono Group is a leading developer and marketer of pharmaceutical products with headquarters in Geneva, Switzerland. World leader in the treatment of infertility, Ares-Serono is also active in the fields of growth, wasting and multiple sclerosis/immunology. With nine recombinant products under development, Ares-Serono is one of today?s leading biotechnology companies. Four of these products are already marketed for various indications. Ares-Serono operates subsidiaries in 36 countries and its products are sold in over 90 countries. Shares of Ares-Serono S.A., the holding company of the group, are traded on the Swiss stock exchange. For more information, please contact: Christophe Lamps Corporate Affairs & Investor Relations Tel: ++41 22 739.32.35 Fax: ++41 22 739.30.33 E-Mail:christophe.lamps.ch_gva01@serono.com