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 May, 2004
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 OMITED]
Media Release
FOR IMMEDIATE RELEASE
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SERONO ANNOUNCES LAUNCH OF REBIJECT II(TM) DEVICE
FOR MULTIPLE SCLEROSIS PATIENTS ON REBIF(R) THERAPY
REBIJECT II(TM) MAKES SELF-INJECTION OF REBIF(R) EVEN MORE CONVENIENT
GENEVA, SWITZERLAND, MAY 6, 2004 - Serono (virt-x: SEO and NYSE: SRA), announced
today the launch of its new Rebiject II(TM) auto-injector, a device specifically
designed to make self-injection of Rebif(R) (interferon beta-1a) more convenient
for multiple sclerosis (MS) patients on Rebif(R) therapy.
"Rebiject II(TM) is another example of Serono's commitment to improving the
quality of life of people with multiple sclerosis," said Franck Latrille, Head
of Product Development at Serono. "Rebiject II(TM) should make Rebif(R)
administration easier and help to support treatment compliance for multiple
sclerosis patients."
A study conducted in 115 patients with MS on Rebif(R) therapy showed that 71% of
these patients found the new Rebiject II(TM) was better than their previous
injection method. Patient feedback indicated that injections using Rebiject
II(TM) were less painful, and that the new Rebiject II(TM) was easier to use
than the previous Rebiject mini(TM) auto-injector or manual injection.
Rebiject II(TM) is specifically designed for use with the Rebif(R) pre-filled
syringe. It provides several advantages compared to the previous auto-injector.
These advantages are:
- Fewer steps are needed to inject - no need to remove the plunger from
the pre-filled syringe
- An adjustable needle depth regulator to allow the injector be tailored
to each patient
- A visual signal to show patients that the injection has been fully
delivered
- A safety mechanism to minimize the chance of accidental activation
that could result in loss of medication
- Better design making it easier to handle for patients suffering of MS,
with a square, non-rolling, non-slip rubber grip.
Serono was the first company to introduce an auto-injector for MS patients with
the introduction of Rebiject mini(TM). Now, with Rebiject II(TM), Serono
continues to lead the way in developing patient-friendly injection devices, with
advanced functionality.
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The Rebiject II(TM) auto-injector, combined with the recently announced
availability of the new 29 gauge needle Rebif(R) pre-filled syringe (the
thinnest needle available on a ready-to-use pre-filled syringe), provides
patients with state-of-the-art technology that is designed to maximize the
benefits of Rebif(R) therapy.
The new Rebiject II(TM) auto-injector is currently being launched in Europe and
Canada as well as in certain countries of Asia, Latin America and the Middle
East. Rebiject II(TM) is expected to be available worldwide by the end of 2004.
ABOUT REBIF(R)
Rebif(R) (interferon beta-1a) is a disease-modifying drug used to treat
relapsing forms of multiple sclerosis and is similar to the interferon beta
protein produced by the human body. Interferon helps modulate the body's immune
system, fight disease and reduce inflammation.
Rebif(R), which was approved in Europe in 1998 and in the US in 2002, is
registered in more than 80 countries worldwide. In the United States, Rebif(R)
is co-marketed by Serono, Inc. and Pfizer Inc. Rebif(R) has been proven to
reduce MRI lesion activity and area, reduce the frequency of relapses, and delay
the progression of disability. Rebif(R) is available in a 22 mcg and 44 mcg
ready-to-use pre-filled syringe and can be stored at room temperature for up to
30 days if a refrigerator is not available.
ABOUT MULTIPLE SCLEROSIS
Multiple sclerosis is a chronic, inflammatory condition of the nervous system
and is the most common, non-traumatic, neurological disease in young adults.
Multiple sclerosis may affect approximately two million people worldwide. While
symptoms can vary, the most common symptoms of multiple sclerosis include
blurred vision, numbness or tingling in the limbs and problems with strength and
coordination. The relapsing forms of multiple sclerosis are the most common.
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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 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 March 25, 2004. 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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ABOUT SERONO
Serono is a global biotechnology leader. The Company has seven recombinant
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R) and Zorbtive(TM) (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 approximately 30 ongoing development
projects.
In 2003, Serono achieved worldwide revenues of US$2,018.6 million, and a net
income of US$390.0 million, making it the third largest biotech company in the
world. Its products are sold in over 90 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: SEO.VX / SRA.N
--------------------- Bloomberg: SEO VX / SRA US
SERONO, INC., ROCKLAND, MA:
INVESTOR RELATIONS:
Tel. +1 781 681 2552
Fax: +1 781 681 2912
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)
May 6, 2004 By: /s/ Francois Naef
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Name: Francois Naef
Title: Secretary