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, 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 INITIATES PHASE III TRIAL OF SEROSTIM(R) IN
HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME
STUDY AIMED AT ASSESSING BENEFITS OF RECOMBINANT HUMAN GROWTH HORMONE AS
POTENTIAL TREATMENT AND MAINTENANCE THERAPY FOR HIV METABOLIC COMPLICATION
GENEVA, SWITZERLAND AND ROCKLAND, MA, JUNE 1, 2004- Serono, Inc., the US
affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today that the
company has initiated a Phase III clinical trial of Serostim(R) [somatropin
(rDNA origin) for injection] as a potential treatment and maintenance therapy to
reduce excess visceral fat accumulation in patients with HIV-associated adipose
redistribution syndrome (HARS). HARS is a potentially debilitating medical
condition experienced by people being treated for HIV for which there is
currently no medical treatment. The visceral adipose tissue accumulations seen
in HARS may also be associated with an adverse risk profile.
This multi-center, randomized, double-blind, placebo-controlled study of the
safety and efficacy of Serostim(R) in HARS will include approximately 300
patients at 30 clinical trial sites. The study will evaluate the effectiveness
of Serostim(R) 4mg administered daily for 12 weeks compared to placebo in
reducing abdominal visceral adipose tissue while assessing, among other
endpoints, patient reported outcomes. This trial will also evaluate the effect
of Serostim(R) 2mg administered on alternate days as a maintenance therapy to
sustain reductions in visceral adipose tissue attained during the first 12 weeks
of active therapy.
"This trial will build upon Serono's extensive experience with Serostim(R),"
said Paul Lammers, MD, MSc, Chief Medical Officer, Serono, Inc. "We are hopeful
that it will demonstrate the effectiveness of recombinant human growth hormone
for this metabolic complication of HIV."
The results of previous studies suggest that Serostim(R) may be an effective
treatment for this indication. Serono has previously reported positive findings
of the Serostim(R) for the Treatment of Adipose Redistribution Syndrome (STARS)
study, a double-blind, placebo-controlled study, designed to evaluate
Serostim(R) as a potential HARS therapy. The study results showed that
Serostim(R) 4mg administered daily for 12 weeks decreased visceral adipose
tissue and trunk fat as compared to placebo (p<0.001). A significant decline in
total and non-HDL cholesterol as compared to placebo was also observed
(p<0.005).
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HIV-associated adipose redistribution syndrome or HARS is a subset of HIV
lipodystrophy. HIV-associated lipodystrophy is characterized by a variety of
metabolic disturbances and body shape abnormalities that may present
individually or in combination.
Patients with HARS experience abnormal, pathological accumulation of adipose
tissue, which may be present with or without fat depletion and/or metabolic
abnormalities. In general, HARS patients accumulate excess visceral adipose
tissue in the abdomen and may develop a fat pad of on the upper back commonly
known as a "buffalo hump."
ABOUT SEROSTIM(R)
Serostim(R) [somatropin (rDNAorigin) for injection] is the only growth hormone
approved by the US Food and Drug Administration for the treatment of
HIV-associated wasting or cachexia. The recommended dose is 0.1 mg/kg daily (6
mg/day for patients > 55 kg). Serostim(R) 0.1 mg/kg every other day should be
considered as a starting dose in patients thought to be at risk of certain
adverse effects, i.e., glucose intolerance.
In patients with HIV-associated wasting, the most common adverse events
associated with Serostim(R) therapy are mild to moderate muscle and joint pain
and swelling, which occur in a dose-related manner and often subside with
continued treatment or dose reduction. Cases of impaired glucose intolerance,
Type 2 diabetes mellitus and exacerbation of pre-existing diabetes mellitus have
been reported in patients receiving Serostim(R). Some patients develop diabetic
ketacidosis and diabetic coma. In some patients, therapy with Serostim(R)
necessitated initiation or adjustment of anti-diabetic treatment. Patients with
a history of hyperglycemia or other risk factors for glucose intolerance should
be monitored closely during treatment with Serostim(R). Transient increases in
glucose levels occur early in treatment and should be monitored.
Use of growth hormone is contraindicated in treatment of patients in intensive
care units due to complications following open-heart surgery or abdominal
surgery, multiple accidental trauma or acute respiratory failure; patients with
active neoplasia; and patients with known hypersensitivity to growth hormone.
Serostim(R) must be used in conjunction with antiretroviral therapy.
Full prescribing information for Serostim(R), including important safety
information, is available at www.serostim.com.
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ABOUT SERONO
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global
biotechnology leader headquartered in Geneva, Switzerland. The Company has seven
recombinant products Rebif(R) (interferon beta-1a), Gonal-F(R) (follitropin alfa
for injection), Luveris(R) (lutropin alfa), Ovidrel(R)/Ovitrelle(R)
(choriogonadotropin alfa injection), Serostim(R) [somatropin (rDNA origin) for
injection], Saizen(R) [somatropin (rDNA origin) for injection] and Zorbtive(TM)
[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.
In 2003, Serono achieved worldwide revenues of US$ 2,018.6 million, and a net
income of US$390 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:
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: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel. +1 781 681 2486 Tel. +1 781 681 2552
Fax: +1 781 681 2935 Fax: +1 781 681 2912
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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 1, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary