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 June, 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
Media Release
FOR IMMEDIATE RELEASE
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SERONO ANNOUNCES PROMISING RESULTS FOR EMFILERMIN, A NEW DRUG FOR IMPROVING
IMPLANTATION OF EMBRYOS
GENEVA, SWITZERLAND - JUNE 30TH, 2003 - SERONO S.A. (VIRT-X: SEO AND NYSE: SRA)
Serono announced today at the ESHRE (European Society for Human Reproduction and
Embryology) Congress in Madrid positive results of a first proof of concept
study of emfilermin (r-hLIF) for improving embryo implantation in women with
recurrent implantation failure (RIF).
"This study indicates that emfilermin has good prospects of increasing pregnancy
rates in those women in whom embryos have previously failed to implant, helping
more couples to fulfill their dream of having a child," said Peter Brinsden,
Medical Director of Bourn Hall in Cambridgeshire, England. "The results of this
exploratory study confirmed that those patients who had a suspected problem with
purely embryo implantation may benefit most from emfilermin."
Amongst this group, which is characterized by patients requiring normal in-vitro
fertilization (IVF) rather than intra cytoplasmic sperm injection, (ICSI) none
of the eight patients on placebo achieved a clinical pregnancy compared with
eight of the 17 (47%) treated with LIF.
The results of this trial were based on a relatively small sample size; Serono
is undertaking a larger proof of concept study focusing on recurrent
implantation failure in IVF. This study started this year in Europe and
Australia using this protein which was developed by Australian company AMRAD and
has been exclusively licensed to Serono.
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FURTHER INFORMATION
1. One in six couples worldwide experience some form of infertility problems.
2. LIF is a substance that is produced in the female reproductive tract and is
naturally secreted by the endometrium during the secretory phase (time of
embryo implantation). There is good evidence that if LIF is not secreted
properly during the time of implantation, the embryo may not implant and
the pregnancy may fail. Since LIF appears to play an important role during
embryo implantation, it is thought that giving recombinant human LIF to
infertile women for several days from embryo transfer might increase their
chances of successful implantation.
3. The study participants were all pre-menopausal women aged between 21 and 36
years who required treatment by IVF or ICSI. All had a history of at least
three implantation failures, defined as failure of at least three transfers
of at least two fresh or frozen/thawed morphologically normal embryos, and
with no other known cause of previous IVF failure.
4. In the overall population from the placebo-controlled study, 11 out of 39
patients on emfilermin (28%) achieved clinical pregnancies. This compared
with 4 out of 20 patients on placebo (20%).
5. Emfilermin was generally safe and well-tolerated when co-administered with
paracetamol administration. Most adverse events were mild in severity and
no serious adverse events with possible / probable causal relationship with
emfilermin were observed. Some mild, asymptomatic, transient and reversible
laboratory changes which are related to the cytokine-induced acute phase
response were observed. Most injection site reactions were mild in
severity.
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ABOUT SERONO
Serono is a global biotechnology leader. The Company has six recombinant
products on the 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). 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 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).
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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.
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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
--------------------- 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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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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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 30, 2003 By: /s/ Allan Shaw
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Name: Allan Shaw
Title: Chief Financial Officer