SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
________
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of March, 2004
Serono S.A.
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(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
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(Address of Principal Executive Offices)
1-15096
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(Commission File No.)
(Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.)
Form 20-F X Form 40-F
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(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(1).) ______
(Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101 (b)(7).) ______
(Indicate by check mark whether the registrant by furnishing the
information contained in this form is also thereby furnishing the information to
the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes No X
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(If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g3-2(b): 82-______)
[GRAPHIC OMITTED]
Serono
Media Release
FOR IMMEDIATE RELEASE
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RAPTIVA(R) (EFALIZUMAB) RECEIVES APPROVAL FOR MODERATE-TO-SEVERE PLAQUE
PSORIASIS IN SWITZERLAND
First approval of Raptiva for Serono
GENEVA, SWITZERLAND - MARCH 16, 2004 - 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: www.spvg.ch)
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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).
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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.
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FOR MORE INFORMATION, PLEASE CONTACT:
SERONO IN GENEVA, SWITZERLAND:
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 30 85 Fax: +41-22-739 30 22
http://www.serono.com Reuters: SEOZ.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel. +1 781 681 2340 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
http://www.seronousa.com
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
SERONO S.A.
a Swiss corporation
(Registrant)
March 16, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer