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 June, 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 ANNOUNCES RESULTS OF FDA ADVISORY COMMITTEE ON SEROSTIM(R) FOR USE IN
PATIENTS WITH SHORT BOWEL SYNDROME
ROCKLAND, MA, JUNE 25, 2003 - Serono, Inc. announced that the Gastrointestinal
Drugs Advisory Committee for the U.S Food and Drug Administration (FDA) did not
recommend approval at this time of Serostim(R) [somatropin (rDNA origin) for
injection] for use in the treatment of short bowel syndrome (SBS) in patients
receiving specialized nutritional support.
The committee's view was based, in part, on the fact that the majority of study
patients were treated in a single specialty treatment center.
"Serono is disappointed with the recommendation of the Advisory Committee," said
Dr. Joseph Gertner, Vice President and Head of Metabolic Endocrinology Clinical
Development, Serono, Inc. "There is a substantial clinical need to provide more
effective treatments to patients with short bowel syndrome, a rare orphan
condition. We will evaluate our next steps and will continue to work closely
with the FDA to fully understand and address the outstanding issues."
The Advisory Committee recommendation is considered by the FDA in making its
decision. This committee recommendation does not impact the current use of
Serostim(R) in the approved indication of AIDS wasting.
SBS is a rare, serious and potentially life-threatening condition that follows
extensive surgical removal 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, or where appropriate, a
process referred to as parenteral nutrition in which patients are fed through an
intravenous tube. 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 long-term intravenous parenteral nutrition for SBS.
At the committee meeting, Serono presented data from a pivotal study to evaluate
the change in total parenteral nutrition requirements in adult patients with SBS
who are dependent on parenteral nutrition. In the double-blind, controlled,
parallel group Phase III study, 41 patients were randomly assigned to
one of three study arms: a specialized diet supplemented with oral glutamine
alone; Serostim(R) with a specialized diet alone; or Serostim(R) with a
specialized diet with glutamine.
The results of the study were positive with total parenteral nutrition volume,
total parenteral nutrition calories, and frequency of infusion decreasing
significantly more in the Serostim(R) plus specialized diet group as compared to
the glutamine supplemented specialized diet group (p values 0.043, 0.005, and
0.025 respectively). The corresponding reductions in the Serostim(R) plus
glutamine supplemented diet group as compared to the glutamine supplemented
specialized diet group were larger and all were highly significant (p values
less than 0.001).
Serostim(R) was granted an orphan drug designation for use alone or in
combination with glutamine in the treatment of patients with short bowel
syndrome by the FDA Office of Orphan Products Development.
Serostim(R) is currently approved by the FDA for the treatment of AIDS wasting
or cachexia.
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 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 12 countries.
Serostim(R), when taken as currently 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. Elevations in mean blood glucose levels can also
occur. Patients with other risk factors for glucose intolerance should be
monitored closely. When used in patients with HIV disease, Serostim(R) must be
used in conjunction with antiretroviral therapy. Full prescribing information
for Serostim(R) is available at www.aidswasting.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 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).
###
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.
###
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
--------------------- 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
------------------------
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)
June 26, 2003 By: /s/ Allan Shaw
---------------
Name: Allan Shaw
Title: Chief Financial Officer