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 June, 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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SERONO ANNOUNCES POSITIVE RESULTS FOR ONERCEPT IN PSORIASIS AND PSORIATIC
ARTHRITIS IN PHASE II TRIALS
PHASE III IN PSORIASIS TO BE INITIATED LATER THIS YEAR
GENEVA, SWITZERLAND, JUNE 22, 2003 - SERONO S.A. (VIRT-X: SEO AND NYSE: SRA)
Serono today announced positive Phase II results for onercept (r-hTBP-1) in both
psoriasis and psoriatic arthritis. Onercept is a recombinant, unmodified, fully
human soluble type I TNF receptor (p55), which acts as an anti TNF agent. The
data were presented at the 9th International Psoriasis Symposium in New York.
In a multi-center double-blind placebo-controlled study for psoriasis, patients
treated with onercept at a dose of 150mg, subcutaneously, three times a week for
a period of 12 weeks, showed a significant improvement in their Psoriasis Area
and Severity Index (PASI) score. PASI is the globally accepted measure of
treatment efficacy in this indication.
After 12 weeks of therapy, 54% (23/43) of patients receiving onercept 150mg
demonstrated 75 percent or greater PASI score improvement (PASI 75) versus 12%
(5/43) of patients on placebo (p<0.001). In addition, 74% (32/43) achieved 50
percent or greater PASI score improvement (PASI 50), versus 26% (11/43) in the
placebo group (p<0.001). In the study, patients treated with onercept showed
significant improvement in PASI after two weeks of treatment compared with
placebo (p<0.05). Side effects for onercept-treated patients were similar to
those observed in the placebo group. Injection site reactions were more frequent
in the onercept group.
Over the 12-week treatment period patients treated with onercept 150mg
experienced a significant improvement in quality of life, based on the standard
measurements of Short Form 36 (SF-36) and Dermatology Life Quality Index (DLQI).
In an earlier multi-center double-blind placebo-controlled study of onercept in
psoriatic arthritis, doses of 50mg and 100mg were given subcutaneously three
times a week for a period of 12 weeks. The improvement in the psoriatic
arthritis response criteria (PsARC) was more favorable at the 100mg dose. After
12 weeks of treatment at 100mg, 86% (36/42) of patients on onercept met the
PsARC primary endpoint compared with 45% (19/42) on placebo (p<0.001). The
secondary endpoint of ACR20 was achieved by 67% (28/42) of onercept patients
compared to 31% (13/42) on placebo (p=0.001). Side effects for onercept-treated
patients were similar to those observed in the placebo group. Injection site
reactions were more frequent in the onercept groups.
"Onercept's efficacy and safety data from these studies are very encouraging for
people with psoriasis and psoriatic arthritis," said Franck Latrille, Serono's
Senior Executive Vice President Global Product Development. "As a result of
these positive data we plan to initiate Phase III with onercept in psoriasis
later this year."
Additional Study Details
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ONERCEPT IN PSORIASIS
In the 12-week, multicenter double-blind placebo controlled study for psoriasis,
130 patients were treated with either placebo (n=43), 150mg three times a week
(n=43) or 100mg seven times a week (n=44). The study included patients with
moderate-to-severe psoriasis, which was defined as a baseline PASI of 12 or more
and body surface involvement of 10% or more. The primary endpoint was the
percentage of patients achieving a PASI 75 response at week 12. Onercept was
generally well-tolerated. The most common adverse events (occurring in more than
5% of patients) in patients receiving onercept at 150mg tiw were comparable to
those observed in the placebo group. Injection site reactions were more frequent
in onercept treated patients. One serious adverse event (hemorrhage in an
ovarian cyst) was reported. Rate of infections was similar between the placebo
and onercept groups. In addition to the significant improvement in PASI, a Clear
or Almost Clear rating in the Physician Global Assessment was achieved in 52% of
patients treated with onercept 150 mg three times a week compared to 12% in
patients treated with placebo (p<0.001). Patients on onercept also had a mean
percentage improvement in SF-36 of 29% compared to 7% in placebo (p<0.05) and a
mean percentage improvement in DLQI of 30% against 2% in placebo (p<0.001).
ONERCEPT IN PSORIATIC ARTHRITIS
The 12-week, multicenter double-blind placebo controlled trial for psoriatic
arthritis included 126 patients divided between placebo (n=42), onercept at 50mg
three times a week (n=42), and onercept at 100mg three times a week (n=42). At
baseline, patients were required to have a PASI of 8 or more, a body surface
involvement of 5% or more, and at least three active joints. The primary
articular endpoint was the percentage of patients achieving a PsARC response at
the end of the 12-week treatment period. Onercept was generally well-tolerated.
The most common adverse events (occurring in more than 5% of patients) in
patients receiving onercept were comparable to those observed in the placebo
group. Injection site reactions were more frequent in the onercept-treated
groups. Two serious adverse events (hypokalemia and angle closure glaucoma) were
reported at the 50mg dose. Rate of infections was similar between the placebo
and onercept groups.
ABOUT PSORIASIS
Psoriasis is a chronic skin disease that affects approximately 4.5 million
people in the US and 5.7 million people in Europe. 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. Psoriatic arthritis is the manifestation of this disease in the
joints.
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)(1). 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
--------------------- 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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(1) Package inserts for Serono's US marketed products are available at
www.seronousa.com or by calling 1-888-275-7376.
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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)
June 23, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer