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 August, 2003
Serono S.A.
--------------
(Registrant's Name)
15 bis, Chemin des Mines
Case Postale 54
CH-1211 Geneva 20
Switzerland
-----------------------------------
(Address of Principal Executive Offices)
1-15096
----------
(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
--- ---
(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
--- ---
(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
-----------------------
SERONO'S SEROSTIM(R) RECEIVES FULL APPROVAL FROM FDA FOR TREATMENT OF AIDS
WASTING
SEROSTIM(R) GRANTED ACCELERATED APPROVAL IN 1996 AS TREATMENT FOR AIDS PATIENTS
WITH WASTING OR CACHEXIA, A SERIOUS AND LIFE THREATENING DISEASE
CONFIRMATORY MULTI-CENTER, PLACEBO-CONTROLLED STUDY SUBSTANTIATES PREVIOUS
FINDINGS OF INCREASED LEAN BODY MASS AND IMPROVEMENT IN PHYSICAL ENDURANCE
ROCKLAND, MA, AUGUST 29, 2003 - Serono, Inc. announced today that the US Food
and Drug Administration (FDA) has granted full approval for Serostim(R)
[somatropin (rDNA origin) for injection] which is indicated for the treatment of
HIV patients with wasting or cachexia to increase lean body mass and body
weight, and improve physical endurance.(1)
Serostim(R) received accelerated approval in 1996, a special regulatory status
granted by the FDA for approval of a drug that is used to treat patients with
serious or life-threatening illnesses, and provides meaningful therapeutic
benefit over any existing treatments. Under the terms of the accelerated
approval, Serono conducted a multi-center, confirmatory placebo-controlled study
with Serostim(R). Data from this trial substantiate previous study findings of
increased lean body mass and improvement in physical endurance with Serostim(R).
In addition, patients in this study perceived an improvement in their wasting
symptoms with Serostim(R) treatment.
"We are very pleased that the FDA has granted full approval for Serostim(R),"
said James Sapirstein, Executive Vice President, Metabolic Endocrinology,
Serono, Inc. "Wasting continues to be a major concern in the management of HIV
and AIDS treatment, even with the benefits of highly active antiretroviral
therapy. Serostim(R) makes an important and positive difference in the physical
endurance of people experiencing HIV wasting."
HIV-associated wasting is a chronically debilitating and potentially
life-threatening condition. 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
_______________
(1) Concomitant antiretroviral therapy is necessary.
body's stored fat. Loss of lean body mass, which consists of muscle tissue,
important body organ tissue and blood cells, can lead to increased risk of
opportunistic infections, illness, and extreme fatigue and can profoundly
diminish a person's quality of life. Serostim(R) was granted orphan drug
designation by the FDA in 1991 for this condition.
CLINICAL STUDY OF SEROSTIM IN AIDS WASTING
The full approval of Serostim(R) is based upon a randomized, double-blind,
dose-ranging study that confirmed the clinical efficacy of Serostim(R) in the
treatment of HIV wasting. The study treated 757 patients with HIV-associated
wasting at US, European and other international trial sites. Participants were
treated with placebo, Serostim(R) on alternate days (0.1 mg/kg) or Serostim(R)
on a daily basis (0.1mg/kg).
The result on the study's primary endpoint of cycle work output was
statistically significant for the Serostim(R) daily dose group as compared to
the placebo group (p<0.0001). Positive results were also 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<0.0001). In addition, patient perception of the impact of
treatment on their wasting symptoms was positive with both doses of Serostim(R).
All study participants completing the 12-week placebo-controlled phase of the
trial (n=646) continued treatment into an extension phase; 548 of these patients
completed an additional 12 weeks of active treatment. In these patients,
positive results in cycle work output and lean body mass either improved further
or were maintained with continued treatment with Serostim(R).
ADDITIONAL PRODUCT INFORMATION
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.
Serostim(R) is generally well tolerated. The most common adverse events
associated with Serostim(R) therapy are mild to moderate muscle and joint pain
and swelling/edema, 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.
----------------
ABOUT SERONO
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a global
biotechnology leader. The Company has six recombinant products on the worldwide
market, Gonal-F(R) (follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa for injection), Rebif(R)
(interferon beta-1a), Serostim(R) [somatropin (rDNA origin) for injection] and
Saizen(R) [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 over 30 projects in
development.
Serono was awarded the International James D. Watson 2003 Helix 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 $1.546 billion, and a net income
of $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).
###
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
_______________________________
(2) Package inserts for Serono's US marketed proucts are available at
www.seronousa.com or by calling 1-888-275-7376.
-----------------
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.
###
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
http://www.seronousa.com
------------------------
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)
August 29, 2003 By: /s/ Allan Shaw
-----------------------------
Name: Allan Shaw
Title: Chief Financial Officer