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 December, 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-______)
SERONO
[GRAPHIC OMITTED]
Media Release
FOR IMMEDIATE RELEASE
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FDA APPROVES SERONO'S ZORBTIVE(TM) FOR USE IN PATIENTS WITH
SHORT BOWEL SYNDROME
USE OF RECOMBINANT HUMAN GROWTH HORMONE IN PATIENTS WITH SHORT BOWEL SYNDROME
PROVIDES BENEFIT TO PEOPLE WITH THIS RARE CONDITION
ROCKLAND, MA, DECEMBER 2, 2003 - Serono, Inc., the US affiliate of Serono S.A.
(virt-x: SEO and NYSE: SRA), announced today that the U.S Food and Drug
Administration (FDA) has approved Zorbtive(TM)(1) [somatropin (rDNA origin) for
injection] for use in the treatment of short bowel syndrome (SBS).
"We are delighted that the FDA has approved Zorbtive(TM) for treatment of short
bowel syndrome," said James Sapirstein, Executive Vice President, Metabolic
Endocrinology, Serono, Inc. "There has been a substantial clinical need for
additional effective treatment options for patients with this rare condition.
We are pleased that continued discussions with the FDA following an Advisory
Committee meeting in June have resulted in our being able to bring this product
to patients."
SBS is a rare, serious and potentially life-threatening condition that follows
extensive surgical removal of portions of the small intestine as a treatment for
acute or chronic disorders of the intestine. Removal of a large portion of the
bowel results in impaired absorption of nutrients. Currently the standard
treatment for SBS involves careful management of dietary intake and hydration,
or where appropriate, a process referred to as parenteral nutrition in which
patients are fed through an intravenous tube. On rare occasions, surgical
transplant of the intestine may also be performed for this condition. There are
an estimated 10,000-20,000 patients in the United States who are receiving
intravenous parenteral nutrition for SBS.
In a randomized double-blind, controlled, parallel group Phase III clinical
study, Serono's recombinant human growth hormone administered with specialized
nutritional support was shown to significantly reduce patient dependence on
total parenteral nutrition as measured by total volume, total calories and
frequency of
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(1) Zorbtive(TM) [somatropin (rDNA origin) for injection] is a new trade name
for Serono's recombinant human growth hormone.
infusion. Serono's recombinant human growth hormone was granted an orphan drug
designation for use in the treatment of patients with short bowel syndrome by
the FDA Office of Orphan Products Development.
ADDITIONAL PRODUCT INFORMATION
The most common adverse events associated with growth hormone 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. Some patients develop diabetic ketacidosis and diabetic coma. In
some patients, therapy with growth hormone necessitates initiation or adjustment
of anti-diabetic treatment. Patients with a history of hyperglycemia or other
risk factors for glucose intolerance should be monitored closely. 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.
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 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 $1.538 billion, and a net income
of $321 million, making it the third largest biotech company in the world. The
Company operates in 44 countries, and its products are sold in over 94
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
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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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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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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)
December 2, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer