Cladribine Targeted to Become First Oral Therapy for Multiple Sclerosis
GENEVA and MIAMI, March 23 /PRNewswire-FirstCall/ -- Serono (virt-x: SEO
and NYSE: SRA) and IVAX Corporation (Amex: IVX and LSE: IVX.L) announced today
positive results from two clinical trials with a new proprietary oral
formulation of cladribine, a potential new treatment for multiple sclerosis
(MS). The study results showed that the formulation of oral cladribine which
has been developed by Serono and IVAX has met the targets for an orally
administered product, with blood levels of cladribine in the expected
therapeutic range. Efficacy studies of oral cladribine in MS patients are
planned to start late 2004.
Previous Phase II and Phase III clinical trials have demonstrated the
positive effect of injectable cladribine in patients with MS. In these
trials, cladribine caused a dramatic reduction in new lesion development in
the brain as seen on magnetic resonance imaging (MRI) scans. Patients with
relapsing remitting MS receiving cladribine also experienced clinical
benefits.
"As the originator of Rebif(R), a current reference treatment for multiple
sclerosis, Serono has a long-term commitment to patients with multiple
sclerosis," said Ernesto Bertarelli, CEO of Serono. "This is a major step in
the development of the first oral disease modifying treatment for multiple
sclerosis."
Dr. Phillip Frost, CEO and Chairman of IVAX commented, "We are very
pleased to report the important progress which has been made with our partner
Serono in the development of cladribine as a novel oral therapy for multiple
sclerosis. With the successful completion of these clinical trials, another of
our products advances in its clinical development."
Cladribine is being developed by Serono and IVAX under a worldwide
agreement signed in October 2002.
About cladribine
Cladribine is a purine nucleoside analogue that disrupts the proliferation
of certain white blood cells, particularly lymphocytes, which are involved in
the pathological process of 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.
For Serono
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 17, 2003. 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.
For IVAX
This press release contains certain forward-looking statements regarding
product development efforts and product performance and other non-historical
facts which are being are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. These statements involve
risks and uncertainties that cannot be predicted or quantified and,
consequentially, actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and uncertainties
include, among others, that development efforts for Cladribine may fail, may
not achieve the expected results or effectiveness and/or may not generate data
that would support the approval or marketing of this product for the
indications being studied or for other indications; that IVAX' patents
pertaining to this product may be invalidated or that additional patents may
not be issued, and in either case may not succeed in preventing other
products; and that others may develop product formulations that are superior
to IVAX' formulation. In addition to the risk factors set forth above, IVAX'
forward looking statements may also be adversely affected by general market
factors, competitive product development, product availability, federal and
state regulations and legislation, the regulatory process for new products and
indications, manufacturing issues that may arise, trade buying patterns,
patent positions and litigation, among other things. For further details and
discussion of these and other risks and uncertainties, see IVAX' Annual Report
on Form 10-K and other filings with the Securities and Exchange Commission.
About Serono
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (Luveris(R) is 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 approximately 30 ongoing
development projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a
net income of US$390.0 million, making it the third largest biotech company in
the world. Its products are sold in over 90 countries. 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).
About Ivax
IVAX is a multinational pharmaceutical company. The company discovers,
develops, manufactures and markets branded and brand-equivalent (generic)
drugs and veterinary products in the U.S. and abroad. Headquartered in Miami,
Florida, IVAX has operations in over 30 countries and its products are sold in
more than 80. The company is strategically focused on product diversification
and geographic expansion in key pharmaceutical markets in North America;
Western, Central and Eastern Europe; Latin America; and Asia. IVAX has more
than 700 scientists and researchers involved in research and development.
SOURCE Serono; IVAX Corporation
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Related links:
http://www.seronousa.com
http://www.ivax.com
CONTACT:
Serono in Geneva, Switzerland: Media
Relations - Tel: +41-22-739-36-00, Fax: +41-22-739-30-85, or
Investor Relations - Tel: +41-22-739-36-01, Fax:
+41-22-739-30-22; or Serono, Inc. in Rockland, MA: Media
Relations - Tel. +1-781-681-2340, Fax: +1-781-681-2935, or
Investor Relations - Tel. +1-781-681-2552, Fax: +1-781-681-2912;
or IVAX investor relations, Tel: +1-305-575-6043
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