More MS news articles for Oct 2001

Serono Confirms Submission of Rebif(R) BLA Amendment to FDA

http://news.excite.com/news/pr/011008/ma-serono-rebif

Mon, Oct 08 1:01 AM EDT

GENEVA, Switzerland and NORWELL, Mass., Oct. 8 /PRNewswire/ -- Serono S.A. (NYSE: SRA and SWX Swiss Exchange: SEO) confirmed that during the third quarter ending September 30, 2001 it submitted an amendment to its original Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking U.S. marketing approval for Rebif(R) (interferon beta - 1a) for the treatment of relapsing remitting multiple sclerosis.

This submission includes clinical data from the EVIDENCE (EVidence for Interferon Dose-effect: European-North American Comparative Efficacy) Study, a direct, head-to-head comparative study of Rebif(R) (44 mcg 3 times per week) and Avonex(R) (30 mcg 1 time per week) in the treatment of relapsing remitting multiple sclerosis.

"The submission to the FDA of the EVIDENCE data represents another step forward in bringing Rebif(R), an important therapy for relapsing remitting multiple sclerosis, to patients in the United States," said Ernesto Bertarelli, CEO of Serono.

Rebif(R)

Rebif(R) is registered in 72 countries worldwide and is currently the fastest growing interferon beta-1a treatment for MS outside the USA. In 2000, Rebif(R) achieved worldwide sales of $254.2m. Rebif(R) is currently not approved in the USA because another product holds Orphan Drug exclusivity.

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 Serono S.A. and affiliates to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on Serono's current expectations and assumptions, which may be affected by a number of factors, including those discussed in this press release and more fully described in Serono's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 23, 2001. These factors include any failure or delay in Serono'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. Serono 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.

About Serono

Serono is a global biotechnology leader. The Company has six recombinant products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R), Rebif(R), Serostim(R) and Saizen(R) (Rebif(R) and Luveris(R) are 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 fifteen new molecules in development.

In 2000, Serono achieved worldwide revenues of US$1.240 billion, and a net income of US$301 million, 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).