More MS news articles for Dec 2001

Serono to Participate in FDA Advisory Committee on Rebif(R)

Updated: Thu, Dec 13 3:17 PM EST

GENEVA, and NORWELL, Mass., Dec. 13 /PRNewswire/ -- Serono, S.A. (NYSE: SRA and SWX Swiss Exchange: SEO) has received confirmation from the US Food and Drug Administration (FDA) that the agency will convene its Peripheral & Nervous System Drugs Advisory Committee regarding the pending Biologics License Application (BLA) from Serono for its multiple sclerosis drug Rebif(R) (interferon beta-1a). The Advisory Committee, which has reviewed all previously approved multiple sclerosis drugs in the US, is scheduled to meet on February 15, 2002.

"This is a very positive step forward in the review process for Rebif(R) and we welcome the opportunity to present important clinical data about Rebif(R) before the Advisory Committee," commented Ernesto Bertarelli, CEO of Serono. "We continue to work closely with the FDA in order to bring Rebif(R) to people with multiple sclerosis in the US."

Serono submitted additional clinical data to the FDA during Q3 2001 as an amendment to its original BLA seeking US marketing approval for Rebif(R) for the treatment of relapsing remitting multiple sclerosis.

Rebif(R) is approved in over 70 countries outside the US, including Canada, Germany, Spain, Switzerland and France. Rebif(R) is currently not approved in the US where 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).

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