To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Raptiva (Efalizumab) Receives Approval for Moderate-to-Severe Plaque Psoriasis in Switzerland URL: http://www.pslgroup.com/dg/243A86.htm Doctor's Guide March 16, 2004
GENEVA, SWITZERLAND -- March 16, 2004 -- Serono (virt-x: SEO and NYSE: SRA) announced today that Raptiva® (efalizumab) has been approved by Swissmedic, the Swiss regulatory authority, for the treatment of adult patients with moderate-to-severe plaque psoriasis. Raptiva is the first biological therapy for psoriasis that is approved in Switzerland. It is designed to provide continuous control of the disease and can be self-administered by patients as a single, once-weekly, subcutaneous injection. "We are delighted that our home territory of Switzerland is the first country outside of the US to give approval to Raptiva," said Ernesto Bertarelli, Chief Executive Officer of Serono. "We look forward to bringing Raptiva to other patients, who deserve a new treatment for this serious condition." "Dermatologists and patients have been frustrated with the treatments that we have had available to us," said Prof Jean-Hilaire Saurat, Chairman, Dermatology Department, University Hospital of Geneva and current President of the European Academy of Dermatology and Venerology (EADV). "The new biological agents enable a new age in treatment for people with psoriasis. These give us new hope for providing patients with improved therapies that will be easier to manage and will provide effective and safe, long-term control of their condition." "Since there is no cure for psoriasis, people have to manage their disease over their lifetime. That means that amongst the two percent of the population affected by psoriasis, many patients suffer from reduced daily activities and quality of life, even up to a total inability to work. It is a major challenge to find a treatment that works, has a favorable track record for safety and can be easily integrated into a patient's life," said Kurt Scherrer, President of the Swiss Psoriasis and Vitiligo Association (SPVG)*. "Biological treatments like Raptiva offer a new treatment option for psoriasis which successfully meet this challenge and give patients, especially in more severe cases, a chance to live a more normal life." Serono plans to launch Raptiva in Switzerland during the second quarter of 2004. * (For more information you can visit the new SPVG-homepage: http://www.spvg.ch) About Raptiva® Raptiva® is a humanized therapeutic antibody designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis symptoms. In clinical studies, Raptiva demonstrated a rapid onset of action in the reduction of symptoms associated with psoriasis, in some patients within four weeks of initiating treatment. Raptiva is administered once weekly via subcutaneous injection and can be self-administered by patients at home. Serono has the rights to develop and market Raptiva worldwide outside of the United States and Japan. Development and marketing rights in the United States remain with Genentech Inc. (NYSE: DNA) and its U.S. partner XOMA (Nasdaq: XOMA). Raptiva has been available since November 2003 in the U.S. for the treatment of moderate-to-severe chronic plaque psoriasis in adults aged 18 or older who are candidates for systemic therapy or phototherapy. Switzerland is the first country outside of the U.S. to approve Raptiva. More than 3,000 patients have been studied with Raptiva to date, creating the largest existing database of patients treated with a biologic therapy for psoriasis. About Psoriasis Psoriasis is a T-cell mediated disease which occurs when skin cells grow abnormally, resulting in thick, red, scaly, inflamed patches. Plaque psoriasis, the most common form of the disease is characterized by inflamed patches of skin ("lesions") topped with silvery white scales. Psoriasis can be limited to a few spots or involve extensive areas of the body, appearing most commonly on the scalp, knees, elbows and trunk. Although it is highly visible, psoriasis is not a contagious disease. While there are a number of medications that may help control the symptoms of psoriasis, there currently is no known cure. SOURCE: Serono International S.A. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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