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 January, 2005
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 COMPLETION OF PATIENT ENROLLMENT IN PHASE III TRIAL OF
SEROSTIM(R) (SOMATROPIN [RDNA ORIGIN] FOR INJECTION) IN HIV-ASSOCIATED ADIPOSE
REDISTRIBUTION SYNDROME (HARS)
GENEVA, SWITZERLAND AND ROCKLAND, MA, JANUARY 24, 2005 - Serono Inc., the US
affiliate of global biotechnology leader Serono (virt-x: SEO and NYSE: SRA),
announced today that it has completed enrollment in its second multi-center,
phase III trial of Serostim(R) (somatropin [rDNA origin] for injection) in the
treatment of HIV-Associated Adipose Redistribution Syndrome (HARS).
The primary goal of this randomized, double-blind, placebo-controlled trial is
to assess whether Serostim(R) induction therapy significantly reduces the marked
abnormal accumulation of visceral adipose tissue (intra-abdominal fat) and fat
maldistribution which characterize HARS, and whether low-dose maintenance
therapy prevents the abnormalities from returning during a continued course of
therapy.
"We are pleased to have reached this major milestone for this very important
study," said James Sapirstein, Executive Vice President of Metabolic
Endocrinology at Serono, Inc. "An unmet need clearly exists in this patient
population. Serono is committed to ensuring rapid completion of the trial and a
US registration submission for Serostim as a treatment for this orphan
indication."
"More than 300 patients were enrolled in the study in only six months. The
dedication of the clinical investigators, all study site personnel and our
in-house study team coupled with the need and enthusiasm for this project in the
HIV community led to speedy enrollment of this study," said Paul Lammers, Chief
Medical Officer at Serono, Inc. "The results of this pivotal Phase III clinical
trial are eagerly awaited."
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ABOUT HARS
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, e.g., glucose
intolerance.
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.
ABOUT SERONO
Serono is a global biotechnology leader. The Company has eight biotechnology
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the
world leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth and has recently entered the psoriasis area.
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, GENEVA, SWITZERLAND:
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 3085 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:
Stacie Madden Tel: +1 781 681 2552
Tel: +1 781 681 2496 Fax: +1 781 681 2912
stacie.madden@serono.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)
January 24, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer