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 April, 2003
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-______)
[GRAPHIC OMITTED
SERONO]
Media Release
FOR IMMEDIATE RELEASE
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SERONO DISAGREES WITH CPMP OPINION FOR SEROSTIM IN AIDS WASTING IN EUROPEAN
UNION
GENEVA, SWITZERLAND, APRIL 30, 2003 - Serono S.A. (virt-x: SEO and NYSE: SRA)
Serono disagrees with the opinion issued by the Committee for Proprietary
Medicinal Products (CPMP) on April 25, 2003 that recommends not granting initial
marketing authorization for Serostim(R) for the treatment of AIDS wasting in the
European Union. In contrast with the CPMP opinion, Serono believes that the data
submitted confirm the safety and efficacy of Serostim(R) in the rare condition
of AIDS wasting and that the data do justify the therapeutic benefits
for patients who have no alternative treatment.
AIDS wasting was designated as a rare condition based on the published criteria
of the US Centers for Disease Control and Prevention (CDC)(1). In August 2000
the European Commission granted Serostim(R) orphan designation based on the
opinion of the Committee for Orphan Medicinal Products (COMP). This Committee
confirmed that the indication of AIDS wasting in the EU should also be in
agreement with the CDC disease definition.
The Serostim(R) AIDS Wasting Confirmatory Study (GF9037) was designed to include
patients meeting the agreed and official definition of AIDS wasting. The results
of this confirmatory trial were positive and demonstrate a highly significant
increase of both work output and lean body mass as well as an improvement in
quality of life for the patients treated with Serostim(R) as compared to
patients treated with placebo. The results of this study were presented at the
International AIDS Conference in Barcelona in July 2002.
It is unfortunate that the current CPMP view of AIDS wasting is not aligned with
the definition of the orphan drug designation granted in Europe. The CPMP
opinion reflects the difficulties in the understanding of rare and continuously
evolving diseases and in the assessment of appropriate treatments. The full
implementation of the EU Orphan Regulation needs to be improved to ensure access
to innovative treatments for rare diseases in Europe. Serono will continue to
work with the European Commission, the EMEA and all interested parties to
improve the policy continuity from the orphan designation, through clinical
development and marketing authorization, to meet patients' unmet medical needs.
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(1) An involuntary weight loss of greater than 10% with intermittent or
constant fever and chronic diarrhea, or chronic weakness and fever for more
than 30 days in the absence of other causes than HIV that may explain the
condition
The CPMP negative opinion marks a sad day for the European patient community
suffering from rare diseases, and for all other interested parties. Serono wants
to reassure European AIDS wasting patients currently under Serostim(R) therapy
both in clinical programs and in national compassionate use schemes, that Serono
will continue to work with authorities and patient associations to ensure access
to the product in compliance with local regulations.
Serono will review the full details of the current CPMP opinion, and is
considering the appropriate next steps.
BACKGROUND
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SEROSTIM (R) AIDS WASTING CONFIRMATORY TRIAL
The Serostim(R) AIDS wasting confirmatory trial included more than 700 patients
at US, EU and other international trial sites. Following the accelerated
approval of Serostim(R) by the FDA, Serono conducted this study to confirm the
safety and efficacy of Serostim(R). Patients were randomized into three
treatment groups to receive Serostim (R) 6 mg daily, Serostim(R) 6 mg on
alternate days or placebo for a 12-week treatment period.
The primary endpoint of the study was to confirm the clinical efficacy of
Serostim(R) compared with placebo, based on exercise function change as assessed
by cycle ergometer work output from baseline to week 12. The results of the
primary endpoint were positive and demonstrated a highly significant increase of
work output of 9.9% in the group treated with Serostim(R) 6 mg daily and a
decrease of 1% in the placebo group (p<0.0001).
The secondary endpoint was the change in lean body mass as measured by
bioimpedance spectroscopy (BIS) from baseline to week 12. Findings demonstrate a
dose-response relationship. The quantity of lean tissue gained in the group
treated with Serostim(R) 6mg daily (median gain in lean body mass 5.2 kg) and in
the group treated with Serostim(R) 6 mg on alternate days (median gain in lean
body mass 3.3 kg) was significantly greater compared to the placebo group
(median gain in lean body mass 0.6 kg) (p<0.0001 for both Serostim(R) doses).
Furthermore, patients receiving Serostim(R) 6 mg daily had a significantly
greater effect in terms of median gain in lean body mass than those patients
receiving Serostim(R) 6 mg on alternate days (p=0.017). Adverse reactions
reported during this clinical trial were consistent with those expected within
the current approved indication for Serostim(R).
The study used two Quality of Life scales to assess patients' response to
treatment with Serostim(R) for AIDS wasting. Results were favorable. When asked
the question 'Do you think this treatment has been of benefit to you?'
Serostim(R) treated patients responded significantly more favorably than those
treated with placebo (p<0.0001). In addition, patients receiving Serostim(R) 6
mg daily responded significantly more favorably than those treated with
Serostim(R) 6 mg every other day (p=0.004)
ABOUT AIDS WASTING AND SEROSTIM
AIDS wasting is a chronically debilitating and potentially life-threatening
condition. In spite of the introduction of highly active antiretroviral therapy
(HAART), which extends the lives of people with HIV, AIDS wasting remains a
concern and an independent predictor of mortality (JAIDS 2002; 31:230-236). It
is a metabolic disorder that causes the body to use vital muscle and organ
tissue, which is critical for survival, for energy instead of primarily using
the body's stored fat. People with AIDS wasting usually experience a loss of 10%
or more of body weight, mainly due to loss of lean body mass, which consists of
muscle tissue, important body organ and blood cells, including red cells and
functioning white cells. The result can lead to increased risk for
opportunistic infections and illness, extreme fatigue and can profoundly
diminish a person's quality of life.
Serostim(R) is the only growth hormone approved by the US Food and Drug
Administration (FDA) for the treatment of AIDS wasting or cachexia. Serostim(R)
received FDA accelerated approval in 1996 based upon the analysis of changes in
body weight and lean body mass in surrogate endpoints in clinical studies up to
12 weeks in duration. Serostim(R) is now on the market in 13 countries.
Serostim,(R) when taken as prescribed in 6mg doses over 12 weeks, is generally
well tolerated. The most common adverse reactions to Serostim(R) are increased
tissue turgor (generally swelling of hands and feet) and musculoskeletal
discomfort (pain, swelling or stiffness). Generally mild to moderate in
severity, these symptoms usually resolve spontaneously with continued treatment
or are effectively managed with analgesic therapy or after reducing the weekly
dose. Serostim(R) must be used in conjunction with antiretroviral therapy.
Elevations in mean blood glucose levels can also occur. Patients with other risk
factors for glucose intolerance should be monitored closely. Full prescribing
information for Serostim(R) is available at www.aidswasting.com
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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.
###
ABOUT SERONO
Serono is a global biotechnology leader. The Company has six recombinant
products on the market, Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Rebif(R), Serostim(R) and Saizen(R) (Luveris(R) is not approved in the USA). 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.
Serono was awarded the International James D. Watson Helix 2003 Award from the
Biotechnology Industry Organization (BIO) in recognition of the Company's
outstanding leadership and highest standards of scientific and product
achievement.
In 2002, Serono achieved worldwide revenues of US$1.546 billion, and a net
income of US$321 million, making it the third largest biotech company in the
world. The Company operates in 45 countries, and its products are sold in over
100 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:
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
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Bloomberg: SEO VX / SRA US
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
http://www.seronousa.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)
April 30, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer