Serono's Oral Cladribine for the Treatment of Multiple Sclerosis Awarded Fast Track Status by FDA
September 21 2006 - 2:00AM
PR Newswire (US)
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. Background material For
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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). DATASOURCE: Serono International S A CONTACT: For
more information, please contact: Corporate Media Relations: Tel:
+41-22-739-36-00, Fax: +41-22-739-30-85, http://www.serono.com/;
Corporate Investor Relations: Tel: +41-22-739-36-01, Fax:
+41-22-739-30-22; Media Relations, USA: Tel: +1-781-681-2340, Fax:
+1-781-681-2935; Investor Relations, USA: Tel: +1-781-681-2552,
Fax: +1-781-681-2912, http://www.seronousa.com/
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