Serono Completes Second Phase III Trial of its Proprietary Recombinant Human Growth Hormone for HIV-Associated Adipose Redistrib
January 09 2006 - 1:01AM
PR Newswire (US)
Successful Completion of Trial Meets Pre-Specified Primary and
Major Secondary Endpoints GENEVA, Switzerland and ROCKLAND,
Massachusetts, January 9 /PRNewswire-FirstCall/ -- Serono (virt-x:
SEO NYSE: SRA) announced today the completion of its pivotal Phase
III double-blind, placebo-controlled trial of Serono's recombinant
human growth hormone in the treatment of HIV-associated Adipose
Redistribution Syndrome (HARS), which met all pre-specified primary
and major secondary endpoints. Serono plans to submit the file to
the FDA in the first half of 2006 and expects that the data will be
presented at upcoming scientific meetings. More than 300 patients
enrolled in the trial to determine if daily administration of r-hGH
as treatment for the abnormal fat accumulation and distribution
associated with HARS reduces Visceral Adipose Tissue (VAT) more
effectively than placebo. In the first phase of the study, patients
were randomly assigned to receive either r-hGH 4 mg daily, or
placebo. Growth hormone was administered for 12 weeks and all
patients were measured by CT scan to determine changes in VAT from
baseline. In the second placebo-controlled phase of the study,
r-hGH was administered as 2 mg on alternate days for 24 weeks to
assess the ability of a maintenance regimen to sustain improvements
in VAT. "The completion of this important research study of r-hGH
in HARS is a strategic milestone for Serono and may lead to an
important advance for patients living with this condition, that not
only affects their health but also their quality of life," said Dr.
Paul Lammers, Chief Medical Officer at Serono, Inc. "The rapid
enrollment in the study demonstrates the need for treatment for
this rare medical syndrome. We anticipate filing a supplemental New
Drug Application (sNDA) in the first half of 2006." About HARS
HIV-associated adipose redistribution syndrome or HARS is
characterized by fat maldistribution in HIV-infected patients.
Patients with HARS experience abnormal, pathological accumulation
of adipose tissue in the trunk, primarily in the form of visceral
adipose tissue located deep within the abdomen, underneath the
abdominal muscle wall. This fat accumulation may be present with or
without fat depletion (lipoatrophy) and/or metabolic abnormalities.
Recombinant human growth hormone is not approved by the FDA for the
treatment of HARS. About Recombinant Human Growth Hormone
Recombinant Human Growth Hormone (r-hGH) is human growth hormone
produced by recombinant DNA technology. Serono's r-hGH products are
indicated for the treatment of pediatric growth hormone deficiency,
adult growth hormone deficiency, HIV wasting or cachexia and for
the treatment of short bowel syndrome. Growth hormone should be
used with caution in patients with insulin resistance, glucose
intolerance, diabetes, and in women who are pregnant or nursing.
The most commonly reported adverse events include mild
injection-site reactions, moderate muscle and joint pain, and
edema/swelling. Patients with a history of hyperglycemia or other
risk factors for glucose intolerance or pancreatitis should be
monitored closely. 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. Full prescribing information for Serono's approved
indications, including important safety information, is available
at http://www.seronousa.com/. Background material For free B-roll,
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to the media. 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 16, 2005. 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. 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, including oncology. Currently,
there are approximately 30 ongoing development projects. In 2004,
Serono achieved worldwide revenues of US$2,458.1 million, and a net
income of US$494.2 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). Package inserts for Serono's US
marketed products are available at http://www.seronousa.com/ or by
calling 1-888-275-7376. DATASOURCE: Serono International S.A.
CONTACT: For more information, please contact: Serono, Geneva,
Switzerland: Media Relations: Tel: +41-22-739-3600, Fax:
+41-22-739-3085, http://www.serono.com/, Investor Relations: Tel:
+41-22-739-3601, Fax: +41-22-739-3022, Serono, Inc., Rockland, MA,
Media Relations: Stacie Madden, Tel: +1-781-681-2496,
http://www.seronousa.com/ Investor Relations: Tel: +1-781-681-2552,
Fax: +1-781-681-2912
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