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 March, 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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[GRAPHIC OMITED]
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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SERONO'S SEROSTIM(R) IMPROVES LEAN BODY MASS AND PHYSICAL PERFORMANCE IN
PATIENTS WITH HIV-ASSOCIATED WASTING
RESULTS OF LARGEST STUDY OF RECOMBINANT HUMAN GROWTH HORMONE IN
HIV-ASSOCIATED WASTING PUBLISHED IN CURRENT ISSUE OF THE JOURNAL OF AIDS
ROCKLAND, MA, MARCH 31, 2004-SERONO (VIRT-X: SEO AND NYSE: SRA)-Serono's
Serostim(R) [somatropin (rDNA origin) for injection] improves lean body mass and
physical performance in patients with HIV-associated wasting, according to study
data published in the current edition of the Journal of AIDS ("Growth Hormone
Improves Lean Body Mass, Physical Performance, and Quality of Life in Subjects
with HIV-Associated Weight Loss or Wasting on Highly Active Antiretroviral
Therapy").(1)
HIV-associated wasting is a chronically debilitating and potentially
life-threatening condition. It is a metabolic disorder that causes the loss of
lean body mass, which includes muscle tissue, important body organ tissue and
blood cells, and can lead to increased risk of opportunistic infections,
illness, and extreme fatigue and can profoundly diminish a person's quality of
life.
The present study, the largest randomized, double-blind placebo-controlled study
of recombinant human growth hormone in HIV-associated wasting, confirmed the
efficacy, safety and tolerability of Serostim(R). The study treated 757 patients
with HIV-associated wasting at US, European and other international trial sites.
Participants were treated with placebo, 0.1 mg/kg Serostim(R) on alternate days,
or 0.1mg/kg of Serostim(R) on a daily basis.
Over the 12-week course of therapy, Serostim(R) was superior to placebo in
improving physical function, lean body mass and body weight and had a positive
effect on patient perception of the benefits of therapy.
"People with HIV still involuntarily lose both weight and lean body mass,
despite the adoption of highly antiretroviral therapy," said Joseph M. Gertner,
MD, Vice President of Medical Affairs, Metabolic Endocrinology, Serono, Inc. "As
demonstrated by these study results, Serostim(R) is the only therapy shown
clinically to build body mass and improve physical function in people with
HIV-associated wasting."
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1 Moyle, G, Daar, E, Gertner JM, et al. Growth Hormone Improves Lean Body Mass,
Physical Performance, and Quality of Life in Subjects with HIV-Associated Weight
Loss or Wasting on Highly Active Antiretroviral Therapy. Journal of AIDS 2004,
Volume 35, Number 4, April 1 2004, pp. 367 - 375.
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The result on the study's primary endpoint of cycle work output was
statistically significant for the Serostim(R) as compared to the placebo group
(p<0.001). Greater improvement was seen for the secondary endpoint of change in
lean body mass for the Serostim(R) daily dose group as compared to the
Serostim(R) alternate day group (p=0.017) and as compared to the placebo group
(p<0.001). In addition, patient perception of the impact of treatment on their
wasting symptoms was positive with both doses of Serostim(R) (p=0.002 for the
alternate day group and p=0.0004 for the daily dose group) as compared to
placebo. Bodily pain increased in a dose dependent manner for both treatment
groups, but the pain did not interfere with the subjects' normal work.
This study also provides long-term efficacy and safety information for up to 48
weeks of Serostim(R) treatment in a subset of participants. When treatment was
extended from 12 to 24 or 48 weeks, positive results in cycle work output and
lean body mass either improved further or were maintained with continued
treatment with Serostim(R) at both the daily and alternate day dosing.
Adverse reactions reported during this clinical trial were consistent with those
included in the current product labeling.
ABOUT SEROSTIM
Serostim(R) [somatropin (rDNA origin) 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 new onset impaired glucose
intolerance, new onset Type 2 diabetes mellitus and exacerbation of preexisting
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.)(2) 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:
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
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
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2 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)
March 31, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer