GENEVA, Switzerland, September 21 /PRNewswire-FirstCall/ -- Serono
(virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been
designated a Fast Track product by the US Food and Drug Administration
(FDA). This designation covers patients with relapsing forms of multiple
sclerosis.
    Serono's proprietary oral formulation of cladribine for the treatment
of multiple sclerosis is currently being evaluated in a multi-center,
multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS
OrallY) . It is a two-year, double-blind, placebo-controlled study
involving over 1,200 patients. Patient enrollment into this pivotal trial
is planned to be completed by the end of 2006.
    "We are very pleased that oral cladribine has been designated a Fast
Track product," said Ernesto Bertarelli, CEO of Serono. "As a leader in
multiple sclerosis, we are committed to providing new treatment options
that can further improve the quality of the lives of people with this
serious disease and our objective is to bring to them the first oral
disease modifying treatment."
    "Thanks to decades of research, there are injectible drugs available to
treat some forms of MS, but there is certainly a need for more and even
better therapies to treat all forms of the disease. Having an effective
oral therapy for MS would be a major step forward in improving quality of
life for people with MS," said Dr. John Richert, Vice President, Research
and Clinical Programs, at the National Multiple Sclerosis Society.
    Fast Track programs are designed to facilitate the development and
expedite the review of new drugs that are intended to treat serious or
life-threatening conditions and that demonstrate the potential to address
unmet medical needs. Under Fast Track designation oral cladribine is
eligible for Priority Review and FDA may consider for review portions of
the marketing application before the New Drug Application (NDA) is
completed.
    About cladribine
    Cladribine is a purine nucleoside analogue that interferes with the
behavior and the proliferation of certain white blood cells, particularly
lymphocytes, which are involved in the pathological process of multiple
sclerosis. Through its differentiated mechanism of action, oral cladribine
may offer an alternative option to patients with multiple sclerosis.
    About multiple sclerosis
    Multiple sclerosis is a chronic, inflammatory condition of the nervous
system and is the most common, non-traumatic, neurological disease in young
adults. Multiple sclerosis affects approximately two million people
worldwide. While symptoms can vary, the most common symptoms of multiple
sclerosis include blurred vision, numbness or tingling in the limbs and
problems with strength and coordination. The relapsing forms of multiple
sclerosis are the most common.
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    Forward-looking statements
    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 February 28, 2006. 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, the outcome of any government
investigations and litigation. Serono is providing this information as of
the date of this press release, and 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 eight
biotechnology products, Rebif(R), Gonal-f(R), Luveris(R), Ovidrel(R
)/Ovitrelle(R), Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In
addition to being the world leader in reproductive health, Serono has
strong market positions in neurology, metabolism and growth and has
recently entered the psoriasis area. The Company's research programs are
focused on growing these businesses and on establishing new therapeutic
areas, including oncology and autoimmune diseases.
    In 2005, Serono, whose products are sold in over 90 countries, achieved
worldwide revenues of US$2,586.4 million. Reported net loss in 2005 was
US$106.1 million, reflecting a charge of US$725 million taken relating to
the settlement of the US Attorney's Office investigation of Serostim.
Excluding this charge as well as other non-recurring items, adjusted net
income grew 28.4% to US$565.3 million in 2005. 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).

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