More MS news articles for November 2000

Serono Sets the Record Straight Regarding Rebif(R)
Updated 1:00 AM ET November 15, 2000
GENEVA, Nov. 15 /PRNewswire/ -- Serono S.A. (NYSE:SRA) (SWX Swiss Exchange: SEO) wants to correct the facts following Biogen's incorrect and misleading statements in its press-release dated November 9, 2000: Serono is committed to fulfilling all the necessary regulatory requirements in order to make Rebif(R) available to patients in the US and offer them another treatment option for multiple sclerosis (MS). Serono's clinical development program is the largest and most comprehensive to date in relapsing-remitting multiple sclerosis (RRMS). To demonstrate the clinical superiority of Rebif(R) and satisfy the US Orphan Drug Act requirements, Serono is conducting a head-to-head clinical trial comparing Rebif(R) 44mcg three times a week versus Avonex(R) 30mcg once a week. This trial is progressing as planned. In Europe and many other countries, the PRISMS study is the basis for approval of Rebif(R). This comprehensive Phase III study demonstrates that Rebif(R) is the only treatment for RRMS to offer patients benefits on all recognized endpoints: it delays the progression of disability, reduces the number and severity of relapses and clearly reduces burden of disease and MS activity as shown on brain scans(1).
Rebif(R) is registered in 60 countries worldwide and is currently the most frequently selected treatment for newly diagnosed MS patients in the world outside the US. Year-to-date sales for Rebif(R) outside the US were $179.7 million, compared to an estimated $155 million for Avonex(R). Rebif(R) is also the fastest growing treatment for MS.

In respect to the preliminary injunction in the Netherlands, Serono denies that its press release of November 8, 2000 contained any defamatory statements against Biogen or Avonex(R).

Between one and two million people worldwide are living with multiple sclerosis, which is a chronic, debilitating disease of the central nervous system that affects mainly young adults. At present, there is no cure for MS and treatments aim to delay progression of the disease, relieve symptoms, and control the morbidity. Treating patients with high doses of interferon, at an early stage of their disease, is showing great promise in the relief of this highly incapacitating condition. By delaying the progression of disability and reducing the number and severity of attacks, quality of life is preserved.

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 the Company to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on the Company's current expectations and assumptions, which may be affected by a number of factors, including those discussed below and more fully described in the Company's prospectus filed with the U.S. Securities and Exchange Commission on July 26, 2000. These factors include any failure or delay in the Company'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. The Company 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.

Serono, headquartered in Geneva, Switzerland, is a global biotechnology leader. The Company has four recombinant products on the market, Gonal-F(R), Rebif(R), Serostim(R) and Saizen(R). 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 seven products in development including six recombinant proteins.

In 1999, Serono achieved worldwide sales of US$1.054 billion and a net income of US$183.7 million, making it the third largest biotech company 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).

(1) PRISMS Study Group, Randomized Double-Blind Placebo-Controlled Study of Interferon Beta-1a in Relapsing- Remitting Multiple Sclerosis. The Lancet. Vol. 352. Nov 7, 1998. 1498-1504.

Reuters: SEOZ.S/SRA.N
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