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 September, 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-______)
Serono
Media Release
FOR IMMEDIATE RELEASE
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SERONO RECEIVES MARKETING AUTHORISATION FROM THE EUROPEAN COMMISSION FOR NEW
BIOLOGICAL PSORIASIS PRODUCT RAPTIVA(R)
Product launches to commence in the EU during fourth quarter of 2004
GENEVA, SWITZERLAND - SEPTEMBER 23, 2004 - Serono (virt-x: SEO and NYSE: SRA)
announced today that it has received European Commission Marketing Authorisation
for its product Raptiva(R) (efalizumab) for people with moderate-to-severe
chronic plaque psoriasis for whom other systemic treatments or phototherapy have
been inadequate or inappropriate.
Raptiva is the first new biological treatment for psoriasis to be authorised for
marketing in the 25 countries of the European Union (EU). Serono plans to
launch the treatment in several countries including Germany and the United
Kingdom before the end of the year and throughout the rest of the EU during
2005.
"The approval of Raptiva provides an effective therapy for those psoriasis
patients in the EU whose needs are not met by current treatments," said Ernesto
Bertarelli, Chief Executive Officer of Serono. "With other approvals in
Switzerland, Argentina, Mexico and Brazil, our new, fourth therapeutic area of
Dermatology has made a very strong start."
According to Prof. Saurat, Chairman of the Dermatology Department at the
University Hospital of Geneva and President of EADV (European Academy of
Dermatology and Venerology), "a new era is opening in the treatment of
psoriasis."
"Biological treatments such as Raptiva give us new hope of providing patients
with improved therapies that will be easier to manage and will provide effective
and safe, long-term control of their condition," he added.
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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. Raptiva is designed to be
administered once weekly via subcutaneous injection and can be self-administered
by patients at home after training by a healthcare professional.
Raptiva received EU approval for the 'Treatment of adult patients with moderate
to severe chronic plaque psoriasis who have failed to respond to, or who have a
contraindication to, or are intolerant to other systemic therapies including
cyclosporine, methotrexate and PUVA'.
Serono has already launched Raptiva(R) in Switzerland and Argentina, has
recently received approval in Mexico and Brazil and a positive recommendation
for approval in Australia. Raptiva(R) has also been available since November
2003 in the U.S., where it is marketed by Genentech for the treatment of
moderate to severe chronic plaque psoriasis in adults aged 18 or older who are
candidates for systemic therapy or phototherapy.
Serono has the rights to develop and market Raptiva 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).
More than 3,500 patients in the U.S. and Europe have been included in Raptiva
trials to date, creating the largest existing database of patients taking part
in studies with a biological therapy for psoriasis, with about 200 of these
treated continuously for more than 2-and-a-half years.
Adverse events observed with Raptiva include headache, non-specific infection
(e.g., common colds), chills, pain, nausea, asthenia (weakness), and fever, all
of which diminished after the first 1-2 doses. Further, there was no evidence of
accumulation or cumulative toxicity. At 30-months, the occurrence of serious
adverse events was infrequent which is consistent with data from previous
Raptiva Phase III studies.
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.
BACKGROUND MATERIAL
For free B-roll, video and other content about Raptiva, psoriasis and Serono,
please visit the Serono Media Center www.thenewsmarket.com/Serono. You can
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download print-quality images and receive broadcast-standard video digitally or
by tape from this site. Registration and video is free to the media.
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) (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 and has
recently entered the psoriasis area. 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 March 25, 2004. 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:
CORPORATE MEDIA RELATIONS: CORPORATE 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
www.serono.com Reuters: SEO.VX / SRA.N
-------------- Bloomberg: SEO VX / SRA US
INVESTOR RELATIONS, USA
Tel: +1 781 681 2552
Fax: +1 781 681 2912
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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)
September 23, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary