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 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 COMPLETES PATIENT ENROLLMENT IN
REBIF(R) VERSUS COPAXONE(R) COMPARATIVE CLINICAL TRIAL
HEAD-TO-HEAD TRIAL WILL PROVIDE DATA ON THE COMPARATIVE EFFICACY AND SAFETY OF
REBIF(R) AND COPAXONE(R) IN TREATMENT OF PATIENTS WITH MULTIPLE SCLEROSIS
GENEVA, SWITZERLAND, JANUARY 5, 2005 - Serono (virt-x: SEO and NYSE: SRA)
announced today that patient enrollment has been completed in a multi-national
Rebif(R) (interferon beta-1a) versus Copaxone(R) (glatiramer acetate)
comparative clinical trial. This two-year trial is designed to compare the
efficacy of the two therapies in patients with relapsing remitting multiple
sclerosis (RRMS), who were previously untreated with disease modifying
therapies.
Over 700 patients have been enrolled and are being treated either with
Rebif(R) 44 mcg administered three times per week by subcutaneous injection or
Copaxone(R) 20 mg administered daily by subcutaneous injection. The primary
outcome of the trial is time to first relapse. Secondary outcomes include
assessments of MRI (magnetic resonance imaging) brain scans and disability
progression. Physicians performing the neurological examinations and
radiologists assessing the MRI scans do not know what treatment each patient has
been allocated to.
"We believe that a head-to-head trial is necessary to provide scientific data
that can be used to compare different therapeutic options. In the past, we have
provided such data, comparing Rebif(R) with Avonex(R) in the landmark EVIDENCE
trial, which allowed Rebif(R) to gain market approval in the U.S. under the
terms of the Orphan Drug Act," said Paul Lammers, Chief Medical Officer of
Serono, Inc. "The ongoing Rebif(R) versus Copaxone(R) trial will provide
comparative data that will support an evidence-based approach for rational
treatment decisions in multiple sclerosis, and we expect the data to support
Rebif(R) as the foundation therapy for treatment of multiple sclerosis."
Rebif(R) is the only approved MS therapy proven in a four-year clinical study in
all three key measures of treatment effectiveness: reducing MRI lesion area and
activity(1), reducing relapses and delaying the progression of disability.
Rebif(R) is the most prescribed MS disease modifying drug outside the US and is
the fastest growing one in the US.
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1 The exact relationship between MRI findings and the clinical status of
patients is unknown.
1/3
ABOUT EVIDENCE
In the EVIDENCE study, Rebif(R) was shown to be superior over Avonex(R) in
reducing relapses and MRI measures at 24, 48 weeks and at trial completion
(average of 64 weeks)(1). The study involved 677 patients with relapsing
remitting multiple sclerosis (RRMS), and was designed to compare the proportion
of patients who were treated with either Rebif(R) (44 mcg three times weekly,
subcutaneously) or Avonex(R) (30 mcg once weekly, intramuscularly) who remained
relapse-free after 24 weeks (primary endpoint) and 48 weeks of therapy. The
results showed that patients treated with Rebif(R) were significantly more
likely to remain relapse free at 24 and 48 weeks than were patients treated with
Avonex(R). In addition, patients taking Rebif(R) had fewer active lesions per
MRI scan for all studied activity measures and there was an approximate
one-third relative difference in favor of Rebif(R) for measures of MRI lesion
activity. A comparison of safety based on the EVIDENCE study 48-week results
indicates that both Rebif(R) and Avonex(R) are associated with a similar overall
side effect profile, including flu-like symptoms, headache, fatigue and muscle
ache that occur in about half of the patients treated. Adverse events reported
more frequently with Rebif(R) were injection site reactions, asymptomatic liver
function test changes and white blood cell abnormalities. Flu-like symptoms were
reported in significantly more patients treated with Avonex(R) than with
Rebif(R).
ABOUT REBIF(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the body's immune
system, fight disease and reduce inflammation.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. In the United States, Rebif(R)
is co-marketed by Serono, Inc. and Pfizer Inc. Rebif(R) has been proven to
reduce MRI lesion activity and area(1), reduce the frequency of relapses, and
delay the progression of disability. Rebif(R) is available in a 22 mcg and 44
mcg ready-to-use pre-filled syringe and can be stored at room temperature for up
to 30 days if a refrigerator is not available.
Most commonly reported side effects are injection site disorders, flu-like
symptoms, elevation of liver enzymes and blood cell abnormalities. Patients,
especially those with depression, seizure disorders, or liver problems, should
discuss treatment with Rebif(R) with their doctors.
ABOUT MULTIPLE SCLEROSIS
Multiple sclerosis is a chronic, inflammatory condition of the nervous system
and is the most common, non-traumatic, neurological disease in young adults.
Multiple sclerosis may affect approximately two million people worldwide. While
symptoms can vary, the most common symptoms of multiple sclerosis include
blurred vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of multiple sclerosis are the most common.
_______________
1 The exact relationship between MRI findings and the clinical status of
patients is unknown.
2/3
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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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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).
FOR MORE INFORMATION, PLEASE CONTACT:
CORPORATE MEDIA RELATIONS: CORPORATE 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
MEDIA RELATIONS, USA: INVESTOR RELATIONS, USA:
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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3/3
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 5, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer