SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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 April, 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).)
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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)(7).)
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(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- )
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SERONO
Media Release
FOR IMMEDIATE RELEASE
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POSITIVE RESULTS FOR RAPTIVA(R) (EFALIZUMAB) IN FIRST PSORIASIS STUDY
OUTSIDE OF THE UNITED STATES
Treatment response in line with previous studies
GENEVA, SWITZERLAND - APRIL 30, 2004 - Serono (virt-x: SEO and NYSE: SRA)
announced today the results from the CLEAR trial, the first randomized
placebo-controlled, study with Raptiva(R) (efalizumab) conducted outside of the
United States. The results of CLEAR demonstrate that Raptiva is safe and
efficacious. They are also consistent with the previous trials which formed the
basis for the approval of Raptiva for chronic moderate-to-severe plaque
psoriasis in the US and Switzerland.
In the 793 patient multi-center study, 31.4% of patients treated with Raptiva
once a week for a period of 12 weeks showed a 75% or greater improvement in
their Psoriasis Area and Severity Index (PASI 75) score versus 4.2% of patients
on placebo (p<0.0001). In addition 53.7% achieved 50 percent or greater PASI
score improvement (PASI 50), versus 14.4% in the placebo group (p<0.0001).
CLEAR is also the first prospective study with a biological treatment in
patients whose psoriasis cannot be controlled by, are intolerant to or are
contraindicated to other currently available systemic therapies. The results in
this sub-group of 526 patients are also consistent with the results in the
broader moderate-to-severe population.
In this sub-group, 29.5% of patients treated with Raptiva showed improvement in
their PASI 75 score after 12 weeks of therapy versus 2.7% on placebo (p<0.0001).
In addition 52% achieved 50 percent or greater PASI score improvement (PASI 50),
versus 12% in the placebo group (p<0.0001).
"These results confirm that Raptiva is effective in psoriasis patients,
including those whose needs are not met by current treatments," said Dr. Franck
Latrille, Senior Executive Vice President Global Product Development of Serono.
"This study broadens the knowledge of psoriasis and of the therapeutic impact of
Raptiva in this life-ruining disease."
The CLEAR study was randomized in a 2:1 ratio (Raptiva/placebo), with Raptiva
patients being treated with a weekly 1mg/kg subcutaneous injection. The study
was undertaken across Europe and in Canada, Australia, Israel and Mexico.
Full results will be presented for the first time to the scientific community at
the current EADV (European Academy of Dermatology and Venerology) Spring
Congress in Budapest at 11.00am tomorrow, Saturday 1st May.
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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. In
the U.S, 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 worldwide outside of the
United States and Japan. On March 16, 2004, Serono announced approval for
Raptiva in Switzerland for adult patients with moderate-to-severe plaque
psoriasis. Serono announced in February 2003 that it had submitted a Marketing
Authorization Application (MAA) to the European Agency for the Evaluation of
Medicinal Products (EMEA) for European Union Approval of RAPTIVA in psoriasis.
Serono anticipates a final decision during the second half of 2004.
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.
More than 3,500 patients have been studied with Raptiva to date, creating the
largest existing database of patients treated with an approved 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.
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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 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
http://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
3/3
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)
April 30, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary