Serono Submits Application for European Union Approval of Raptiva(TM) for Psoriasis
Wednesday February 26, 1:00 am ET
GENEVA, Feb. 26 /PRNewswire-FirstCall/ -- Serono S.A. (virt-x: SEO and NYSE: SRA) Serono announced today that it has submitted a Marketing Authorization Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) for Raptiva(TM) (efalizumab) for the treatment of adults with moderate-to-severe psoriasis. The EMEA has confirmed that the application is valid, and that the regulatory procedure has commenced.
"With the filing of Raptiva in Europe, Serono is one step nearer to entering a new therapeutic area, " said Ernesto Bertarelli, Serono's Chief Executive Officer. "The treatment advance represented by Raptiva will address many of the unmet needs of people with psoriasis."
This submission is based on efficacy and safety studies in more than 2,100 patients with psoriasis. In these clinical trials, Raptiva(TM) showed fast onset of clinical response -- as early as two weeks -- and control of plaque psoriasis over a one year period of treatment.
The company plans to submit the applications for the marketing authorization of Raptiva(TM) with Canadian, Australian and Swiss authorities by the end of this quarter.
Serono has the rights to develop and market Raptiva(TM) worldwide outside of the United States and Japan. Development and marketing rights in the United States remain with Genentech Inc. (NYSE: DNA - News) and its U.S. partner XOMA (Nasdaq: XOMA - News), who filed a Biologics License Application (BLA) with the FDA in December 2002.
About Raptiva(TM)
Raptiva(TM), a recombinant humanized monoclonal antibody, is designed to inhibit the adhesion of T-lymphocytes to other cell types by inhibiting the binding of LFA-1 to ICAM-1. This mechanism of action has a number of effects depending upon the cell type, which include: (1) inhibition of T-lymphocyte interactions with tissue-specific cells, (2) inhibition of T-lymphocyte migration, (3) inhibition of T-lymphocyte activation, proliferation and cytokine release. In the clinical Phase III studies, Raptiva(TM) was given as a once-a-week subcutaneous injection. Raptiva(TM) is currently in Phase II trials in Rheumatoid Arthritis and is being also evaluated for the treatment of Psoriatic Arthritis.
About Serono
Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F®, Luveris®, Ovidrel®/Ovitrelle®, Rebif®, Serostim® and Saizen® (Luveris® is not approved in the USA). 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 over 30 projects in development.
In 2002, Serono achieved worldwide revenues of US$1.546 billion, and a net income of US$321 million, making it the third largest biotech company in the world. 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 virt-x (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA). |
