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 November, 2003
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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| STUDY IN NEW ENGLAND JOURNAL OF MEDICINE SHOWS EXTENDING RAPTIVA(TM) |
| TREATMENT PROVIDES RAPID AND CONTINUOUS BENEFIT |
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GENEVA, SWITZERLAND - NOVEMBER 20, 2003 - Serono S.A. (virt-x: SEO and NYSE:
SRA) announced today results of a study published in the New England Journal of
Medicine in which patients with moderate-to-severe plaque psoriasis who extended
treatment from 12 to 24 weeks both improved and maintained response with
continuous Raptiva (efalizumab) therapy.
Raptiva is designed to provide continuous control of chronic moderate-to-severe
plaque psoriasis and can be self-administered by patients as a single,
once-weekly, subcutaneous injection. The results published today are from one of
four randomized, placebo-controlled Phase III studies that were included in the
Serono's application to market Raptiva in the EU and other countries.
"Psoriasis is a life-long, chronic disease that requires continuous control of
symptoms," said Dr. Mark Lebwohl, chairman, Department of Dermatology, Mt. Sinai
School of Medicine. "These data support Raptiva's effectiveness in treating
psoriasis and its ability to deliver rapid and sustained improvement of symptoms
in patients."
77 PERCENT OF PATIENTS SUSTAINED RESPONSE WITH CONTINUED TREATMENT
The study reported today is based on a Phase III randomized, double-blind,
parallel-group, placebo-controlled, multi center study, involving 597 patients
aged 18 to 75 with moderate-to-severe plaque psoriasis. Patients were randomized
to receive subcutaneous Raptiva (1 or 2 mg/kg/wk) or placebo for 12 weeks. Based
upon response after 12 weeks, patients either received an additional 12 weeks of
Raptiva or placebo. Treatment was discontinued at 24 weeks and patients were
followed for a further 12 weeks.
At week 12, more than half of Raptiva-treated patients experienced a clinically
meaningful benefit, with some patients achieving clinical benefit as early as
four weeks. After 12 weeks of Raptiva therapy, 22 percent of patients receiving
1 mg/kg of Raptiva and 28 percent of patients receiving 2 mg/kg of Raptiva
reached the primary efficacy endpoint of 75 percent or greater improvement in
Psoriasis Area and Severity Index (PASI) scores compared to five percent of
placebo-treated patients. Over this same interval, 52 percent and 57 percent of
patients receiving 1 or 2 mg/kg Raptiva, respectively, achieved 50 percent or
greater improvement in PASI compared to 16 percent of placebo-treated patients.
Of the Raptiva-treated patients with 75 percent or greater PASI scores at week
12, 77 percent who were continued on Raptiva
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maintained improvement through week 24 compared with 20 percent of patients
switched to placebo. Approximately 90 percent of these patients maintained a 50
percent PASI improvement score at Week 24.
"The strength of these results clearly illustrates the benefit of continuous
therapy with Raptiva and supports the efficacy seen in over 3,000 patients
treated with Raptiva," said Frank Latrille, Serono's Senior Executive Vice
President Global Product Development.
ABOUT RAPTIVA(TM)
As a targeted T-cell modulator, Raptiva is designed to block the activation of
T-cells that cause psoriasis without destroying them.
Raptiva has been studied as a once-weekly therapy for the continuous treatment
of moderate-to-severe plaque psoriasis. In clinical trials, Raptiva was
administered via subcutaneous injection and in several of the trials was
self-administered by some patients in their homes.
Serono has the rights to develop and market Raptiva(TM) 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).
On October 27, 2003, Raptiva was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of moderate-to-severe plaque psoriasis in
adults age 18 or older who are candidates for systemic therapy or phototherapy.
Raptiva is not yet approved outside of the US.
More than 3,000 patients have been treated with Raptiva to date, creating the
largest existing database of patients treated with a biologic therapy for
psoriasis.
ABOUT PSORIASIS
Psoriasis occurs when new 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 six recombinant
products on the market, Gonal-F(R) (follitropin alfa for injection), Luveris(R)
(lutropin alfa), Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa for
injection), Rebif(R) (interferon beta-1a), Serostim(R) [somatropin (rDNA origin)
for injection] and Saizen(R) [somatropin (rDNA origin) for injection].
(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
over 30 projects in development.
Serono was awarded the International James D. Watson 2003 Helix Award from the
Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
In 2002, Serono achieved worldwide revenues of US$1.538 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. The Company operates in 44 countries, and its products are sold in 94
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)
November 20, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer