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 February, 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
[GRAPHIC OMITED]
MEDIA RELEASE
FOR IMMEDIATE RELEASE
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LOW DOSE MAINTENANCE THERAPY WITH RECOMBINANT HUMAN GROWTH HORMONE MAY SUSTAIN
PREVIOUS SEROSTIM(R) TREATMENT IN HIV POSITIVE PATIENTS WITH HARS
NEW DATA PRESENTED AT A RECENT MEDICAL MEETING ON HIV AND INFECTIOUS DISEASES
ROCKLAND, MA, FEBRUARY 12, 2004 - Serono, Inc., the US affiliate of Serono
(virt-x: SEO and NYSE: SRA), announced new clinical data on Serostim(R)
[somatropin (rDNA origin) for injection] as a potential maintenance therapy to
sustain reductions in excess visceral fat accumulation in patients with
HIV-associated adipose redistribution syndrome (HARS) who had previously
received Serostim(R)(1) induction therapy. The data was recently presented at a
medical meeting on HIV and infectious diseases. HARS is a debilitating medical
condition experienced by people being treated for HIV and for which there is
currently no medical treatment. The visceral adipose tissue accumulation seen in
HARS may be associated with an adverse risk profile.
"Based on its efficacy and safety profile, a low dose of Serostim(R) merits
additional investigation as a maintenance therapy for HIV patients with HARS,"
said study lead investigator, Donald P. Kotler, M.D., St. Luke's Roosevelt
Hospital, New York.
A prospective, multi-center, randomized, dose-finding extension trial evaluated
the safety and efficacy of Serostim(R) maintenance therapy, administered at a
dose of 1 or 2 mg daily, to sustain reductions in excess trunk fat in patients
with HARS following treatment with Serostim(R) at a higher dose. Laboratory
measurements of potential metabolic conditions occurring with HARS, such as
lipid profiles, were also included.
Serono has previously reported positive findings of 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
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1 Serostim(R) is currently not approved for the treatment of HARS.
(p<0.001). A significant decline in total and non-HDL cholesterol as compared
to placebo was also observed (p<0.005).
The present trial was an extension of the STARS study. The maintenance phase
involved 142 HIV positive patients with HARS and demonstrated significant
reductions (p<0.01) in trunk fat, non-HDL cholesterol and total cholesterol from
the trial baseline to week 60 in patients taking either 1 mg or 2 mg of
Serostim(R) as a maintenance therapy.
"Serono is committed to continuing research aimed at resolving metabolic
complications associated with HIV, including HARS," commented Paul Lammers, MD,
MSc, Chief Medical Officer, Serono, Inc.
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 or may develop a fat pad 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 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, Serostim(R) has a generally manageable
side effect profile. 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 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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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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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: SEOZ.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
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)
February 12, 2004 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer