First Approval of Raptiva for Serono
GENEVA, March 16 /PRNewswire-FirstCall/ -- Serono
(virt-x: SEO and NYSE: SRA) announced today that Raptiva(R) (efalizumab) has
been approved by Swissmedic, the Swiss regulatory authority, for the treatment
of adult patients with moderate-to-severe plaque psoriasis. Raptiva is the
first biological therapy for psoriasis that is approved in Switzerland. It is
designed to provide continuous control of the disease and can be
self-administered by patients as a single, once-weekly, subcutaneous
injection.
"We are delighted that our home territory of Switzerland is the first
country outside of the US to give approval to Raptiva," said Ernesto
Bertarelli, Chief Executive Officer of Serono. "We look forward to bringing
Raptiva to other patients, who deserve a new treatment for this serious
condition."
"Dermatologists and patients have been frustrated with the treatments that
we have had available to us," said Prof Jean-Hilaire Saurat, Chairman,
Dermatology Department, University Hospital of Geneva and current President of
the European Academy of Dermatology and Venerology (EADV). "The new
biological agents enable a new age in treatment for people with psoriasis.
These give us new hope for providing patients with improved therapies that
will be easier to manage and will provide effective and safe, long-term
control of their condition."
"Since there is no cure for psoriasis, people have to manage their disease
over their lifetime. That means that amongst the two percent of the
population affected by psoriasis, many patients suffer from reduced daily
activities and quality of life, even up to a total inability to work. It is a
major challenge to find a treatment that works, has a favorable track record
for safety and can be easily integrated into a patient's life," said Kurt
Scherrer, President of the Swiss Psoriasis and Vitiligo Association (SPVG)*.
"Biological treatments like Raptiva offer a new treatment option for psoriasis
which successfully meet this challenge and give patients, especially in more
severe cases, a chance to live a more normal life."
Serono plans to launch Raptiva in Switzerland during the second quarter of
2004.
* (For more information you can visit the new SPVG-homepage: http://www.spvg.ch)
About Raptiva(R)
Raptiva(R) is a humanized therapeutic antibody designed to selectively and
reversibly block the activation, reactivation and trafficking of T-cells that
lead to the development of psoriasis symptoms. In clinical studies, Raptiva
demonstrated a rapid onset of action in the reduction of symptoms associated
with psoriasis, in some patients within four weeks of initiating treatment.
Raptiva is administered once weekly via subcutaneous injection and can be
self-administered by patients at home.
Serono has the rights to develop and market Raptiva(R) worldwide outside
of the United States and Japan. Development and marketing rights in the United
States remain with Genentech Inc. (NYSE: DNA) and its U.S. partner XOMA
(Nasdaq: XOMA). Raptiva has been available since November 2003 in the U.S. for
the treatment of moderate-to-severe chronic plaque psoriasis in adults aged 18
or older who are candidates for systemic therapy or phototherapy. Switzerland
is the first country outside of the U.S. to approve Raptiva.
More than 3,000 patients have been studied with Raptiva to date, creating
the largest existing database of patients treated with a biologic therapy for
psoriasis.
About Psoriasis
Psoriasis is a T-cell mediated disease which occurs when skin cells grow
abnormally, resulting in thick, red, scaly, inflamed patches. Plaque
psoriasis, the most common form of the disease is characterized by inflamed
patches of skin ("lesions") topped with silvery white scales. Psoriasis can be
limited to a few spots or involve extensive areas of the body, appearing most
commonly on the scalp, knees, elbows and trunk. Although it is highly visible,
psoriasis is not a contagious disease. While there are a number of medications
that may help control the symptoms of psoriasis, there currently is no known
cure.
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).
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.
Reuters: SEOZ.VX / SRA.N
Bloomberg: SEO VX / SRA US
SOURCE Serono International S.A.
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http://www.serono.com
http://www.seronousa.com
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CONTACT:
Geneva, Switzerland - Serono, Media
Relations, +41-22-739-36-00, Fax - +41-22-739-30-85, or Investor
Relations - +41-22-739-36-01, Fax - +41-22-739-30-22; or
Rockland, MA - Serono, Inc., Media Relations, +1-781-681-2340,
Fax- +1-781-681-2935, or Investor Relations - +1-781-681-2552,
Fax - +1-781-681-2912
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