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 January, 2005
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 THE AVAILABILITY OF SAIZEN(R) FOR ADULT GROWTH HORMONE
DEFICIENCY (AGHD) IN THE UNITED STATES
NEEDLE-FREE DELIVERY OPTION EXCLUSIVE TO SAIZEN(R) AVAILABLE FOR PATIENTS
GENEVA, SWITZERLAND AND ROCKLAND, MA, JANUARY 10, 2005 - Serono Inc., the US
affiliate of Serono (virt-x: SEO and NYSE: SRA), announced today the
availability of Saizen(R) [somatropin (rDNA origin) for injection] for use in
the treatment of patients with adult growth hormone deficiency (AGHD), following
its FDA approval.
"This new indication for Saizen(R) represents the evolution of our growth
hormone portfolio and further demonstrates our commitment to the metabolic
franchise," said James Sapirstein, executive vice president of Metabolic
Endocrinology at Serono, Inc. "Patients with AGHD who are treated with Saizen(R)
therapy can use our easy-to-use drug delivery devices such as cool.click(R), a
needle-free device that is preferred by pediatric patients and is now available
for use by adults taking Saizen(R)."
Adult Growth Hormone Deficiency (AGHD) can be effectively treated with
Saizen(R). With the U.S. approval, patients who were growth hormone deficient
during childhood and have growth hormone deficiency as an adult, may continue to
use Saizen(R). In addition, adult patients who have adult onset growth hormone
deficiency either alone, or associated with multiple hormone deficiencies, now
have access to Saizen(R) and its line of devices.
Saizen(R) can be administered using a needle-free device, cool.click(R), the
only FDA approved needle-free device for the administration of growth hormone.
It can also be administered with a recently launched autoinjector pen device,
one.click(R), or by traditional needle and syringe. Serono's portfolio of
innovative devices gives patients the choice they want in growth hormone
delivery.
Patients can learn more about Saizen(R) and Serono's growth hormone delivery
devices by talking with their physician, or by calling Serono Connections for
Growth(R) toll-free at 1-800-582-7989. The full prescribing information for
Saizen(R) can be found online at www.seronousa.com.
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About Adult Growth Hormone Deficiency (AGHD)
Growth hormone deficiency can be a significant problem for adults even though
they no longer get taller. AGHD is recognized as a specific clinical syndrome
with numerous physiological consequences, with effects on:
- Changes in body composition, including central obesity;
- Lipids in the blood;
- Muscle strength;
- Bone composition;
- Exercise capacity and energy;
- Cardiovascular risk; and
- Psychological well-being (social isolation and depression).
There are also studies indicating that patients with AGHD have an increased risk
of mortality from cardiovascular disease, possibly attributable to their growth
hormone (GH) deficiency.
GH deficiency in adults can result from a pituitary or peri-pituitary tumor or
as a direct result of the surgery/radiation used to manage these conditions.
Less commonly, GH deficiency in adults arises from a deficiency acquired in
childhood.
ABOUT SAIZEN(R)
Saizen(R) [somatropin (rDNA origin) for injection] is a human growth hormone
produced by recombinant DNA technology. The recommended dose for adults at the
start of therapy is .005 mg/kg daily. The dosage may be increased to not more
than .01 mg/kg daily after four weeks depending upon the patient's tolerance of
treatment.
Saizen(R) is indicated for the long-term treatment of children with growth
failure due to inadequate secretion of endogenous growth hormone. It is
indicated for replacement of endogenous growth hormone in adults with growth
hormone deficiency that meets the criteria of adult onset or childhood onset.
In patients with AGHD, the most common adverse events with associated growth
hormone therapy are joint and muscle pain, edema, carpal tunnel syndrome, and
tingling.
Growth hormone should be used with caution in patients with insulin resistance,
glucose intolerance, diabetes, hypothyroidism, intracranial hypertension, and in
women who are pregnant or nursing. GH should not be used in patients with
Prader-Willi syndrome who are severely obese or have severe respiratory
impairment; in the presence of active neoplasia; and in patients with
proliferative or preproliferative diabetic retinopathy; or in patients
hospitalized with acute critical illnesses.
Full prescribing information for Saizen(R), including important safety
information, is available at www.seronousa.com.
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ABOUT SERONO CONNECTIONS FOR GROWTH(R)
Connections for Growth(R) provides reimbursement support and educational
materials for practitioners and families. They offer educational materials,
reconstitution and dosage information, reimbursement support, access to
cool.click(R) supplies, and contact information for local nurses in the Serono
Nurse Network.
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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 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 eight biotechnology
products, Rebif(R), Gonal-F(R), Luveris(R), Ovidrel(R)/Ovitrelle(R),
Serostim(R), Saizen(R), Zorbtive(TM) and Raptiva(R). In addition to being the
world leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth and has recently entered the psoriasis area.
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, GENEVA, SWITZERLAND:
MEDIA RELATIONS: INVESTOR RELATIONS:
Tel: +41-22-739 36 00 Tel: +41-22-739 36 01
Fax: +41-22-739 3085 Fax: +41-22-739 30 22
http://www.serono.com Reuters: SEO.VS/SRA.N
--------------------- Bloomberg: SEO VX/SRA US
SERONO, INC., ROCKLAND, MA
MEDIA RELATIONS: INVESTOR RELATIONS:
Stacie Madden Tel: +1 781 681 2552
Tel: +1 781 681 2496 Fax: +1 781 681 2912
stacie.madden@serono.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)
January 10, 2005 By: /s/ Stuart Grant
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Name: Stuart Grant
Title: Chief Financial Officer