Serono and IVAX Announce Positive Outcome of Pharmacokinetic Trials With Oral Cladribine
March 23 2004 - 12:00AM
PR Newswire (US)
Serono and IVAX Announce Positive Outcome of Pharmacokinetic Trials
With Oral Cladribine 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 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 advancesin 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 productdiversification 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.
DATASOURCE:Serono; IVAX Corporation 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 Web site:
http://www.seronousa.com/ http://www.ivax.com/
Copyright
Ivax Diagnostics (AMEX:IVX)
Historical Stock Chart
From May 2024 to Jun 2024
Ivax Diagnostics (AMEX:IVX)
Historical Stock Chart
From Jun 2023 to Jun 2024