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 July, 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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NEW DATA SUPPORT RAPTIVA(TM) AS A POTENTIAL LONG-TERM TREATMENT FOR
MODERATE-TO-SEVERE PLAQUE PSORIASIS
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GENEVA, SWITZERLAND - JULY 26, 2003 - Serono S.A. (virt-x: SEO and NYSE: SRA)
today announced positive results from two clinical studies evaluating the
long-term safety and efficacy of treatment with Raptiva(TM) (efalizumab) in
adults with moderate-to-severe plaque psoriasis. Study investigators will
present data from these studies on Monday, July 28 from 2- 5 p.m. during a
peer-reviewed session at the American Academy of Dermatology ACADEMY 2003
meeting in Chicago.
Findings highlighted during the session will include data at 24 weeks from an
open-label, extended treatment period following the first-time treatment with
Raptiva in a randomized, double blind, placebo-controlled Phase III study. By
the end of the extended treatment , 44 percent (161/368) of patients treated
continuously with 1mg/kg Raptiva for up to 24 weeks achieved a 75 percent or
greater improvement in Psoriasis Area and Severity Index (PASI) scores (PASI
75).
Additionally, 21-months (84 weeks) of data from an open-label study evaluating
the long-term safety and tolerability of continuous Raptiva will be presented.
The 21-month data analysis showed that 67 percent (130/194) of patients
achieving a PASI 75 score with weekly Raptiva therapy.
"These data further support the sustained and potentially increased clinical
benefit of Raptiva when administered continuously for the treatment of
moderate-to-severe plaque psoriasis," said Dr Andrew Galazka, Serono's Senior
Vice President Scientific Affairs.
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NEW EFFICACY DATA AT 24 WEEKS OF TREATMENT
Data evaluating efficacy at 24 weeks from an open-label, extended treatment
period following 12 weeks of treatment with Raptiva in a randomized, double
blind, placebo-controlled Phase III study will be presented. In this study a
total of 368 patients received at least one dose of Raptiva during the first 12
weeks of the study and were eligible to receive once-weekly 1mg/kg doses of
Raptiva for an additional 12 weeks.
At week 24, 44 percent (161/368) of patients who had received at least one dose
of Raptiva during the first 12 weeks achieved PASI 75 response. As previously
reported, at week 12, 27 percent (98/369) of the patients receiving Raptiva had
achieved PASI 75, suggesting an improvement in the reduction of symptoms with
continued treatment. Furthermore, at week 24, 67 percent of patients (245/368)
achieved a 50 percent or greater PASI improvement (PASI 50) versus 59 percent of
patients (216/369) at week 12. Furthermore, 15 percent (55/368) of patients
achieved a 90 percent or greater PASI improvement (PASI 90).
No new adverse events emerged during the extended 12 weeks of Raptiva treatment.
The most common events that were reported in greater than or equal to five
percent of patients included non-specific infection, headache, and arthritis.
"These results show a high percentage of patients experiencing a clinically
meaningful response to Raptiva with 24 weeks of continuous therapy," said
Kenneth Gordon, M.D., associate professor of Medicine, Division of Dermatology
at Loyola University in Chicago, Illinois. "Further, Raptiva continued to be
well-tolerated by patients suggesting a positive overall clinical profile."
LONG-TERM STUDY SUGGESTS CONTINUED BENEFIT WITH 21-MONTHS OF TREATMENT
Preliminary results from 21 months (84 weeks) of an open-label, multicenter
trial evaluating the long-term safety and tolerability of continuous Raptiva
treatment will be presented.
In this study, patients received 2 mg/kg Raptiva weekly for an initial 12 weeks
and subsequently received a once-weekly dose of 1mg/kg Raptiva starting at week
13. For each successive three-month period of treatment, dropouts during that
period were analyzed using their last available PASI assessment, but were
excluded from the subsequent cohorts. Among the 194 patients who remained in the
trial through Week 84, 67 percent (130/194) of patients achieved a PASI 75
response and 86 percent (167/194) of patients achieved a PASI 50 response.
Further, 34 percent of patients (66/194) achieved a 90 percent or greater PASI
improvement (PASI 90).
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The most common adverse events during the first 12 weeks of treatment were
headache, non-specific infection (e.g., common colds), chills, pain, nausea,
asthenia (weakness), and fever of which headache, chills, nausea, and fever are
protocol-defined acute adverse events that mostly occurred following the first
two injections of Raptiva. During continuous therapy, the incidence of adverse
events decreased over time from 57 percent during Weeks 13-24 to 47.9% during
Weeks 73-84. The occurrence of serious adverse events was infrequent, which is
consistent with data from previous Raptiva Phase III studies.
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).
The two companies filed a Biologics License Application (BLA) with the U.S. Food
and Drug Administration in December 2002 for Raptiva for the treatment of
moderate-to-severe plaque psoriasis in patients 18 years or older. More than
2,700 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$1.546 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. The Company operates in 45 countries, and its products are sold in over
100 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
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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)
July 28, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer