Rebif® Approved in Europe for Treatment of Multiple Sclerosis
Rebif® Accepted for Review by U.S. Food and Drug Administration.
GENEVA, SWITZERLAND, MAY 15, 1998 -- Ares-Serono announced today that Rebif® (interferon beta 1a) has been granted approval by the European Commission for treatment of Relapsing Remitting Multiple Sclerosis (RRMS), in each of the 15 European member states. This month, the company will launch Rebif in Germany, Austria, the U.K., Portugal, Sweden, Denmark and Finland and expects to launch Rebif in the other eight European countries by the end of 1998. Rebif was also launched in Canada in February 1998.
"The European approval of Rebif and its recent launch in Canada demonstrate the value of this product to the MS community, and we are hopeful that Rebif will be brought to U.S. market as well. We reached our first milestone when the FDA formally accepted our BLA filing for full review on April 27," said Hisham Samra, M.D., president of Serono Laboratories, Inc., the U.S. subsidiary of The Ares-Serono Group.
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. Transitional MS patients have relatively severe disability with a higher EDSS score and decline rapidly towards the Secondary Progressive form of MS (SPMS). Up to 50 percent of RRMS patients become progressive within ten years of diagnosis and as many as 90 percent become progressive over the course of their disease.
The Ares-Serono Group is a leading developer and marketer of pharmaceutical products with headquarters in Geneva, Switzerland. Serono Laboratories, Inc., headquartered in Norwell, MA, is the U.S. member of The Ares-Serono Group. 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.