Use of recombinant human growth hormone in patients with short bowel syndrome
provides benefit to people with this rare condition
ROCKLAND, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Serono, Inc., the US
affiliate of Serono S.A. (NYSE: SRA and virt-x: SEO), announced today that the
U.S Food and Drug Administration (FDA) has approved Zorbtive(TM)(1)
[somatropin (rDNA origin) for injection] for use in the treatment of short
bowel syndrome (SBS).
"We are delighted that the FDA has approved Zorbtive(TM) for treatment of
short bowel syndrome," said James Sapirstein, Executive Vice President,
Metabolic Endocrinology, Serono, Inc. "There has been a substantial clinical
need for additional effective treatment options for patients with this rare
condition. We are pleased that continued discussions with the FDA following
an Advisory Committee meeting in June have resulted in our being able to bring
this product to patients."
SBS is a rare, serious and potentially life-threatening condition that
follows extensive surgical removal of portions 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
and hydration, or where appropriate, a process referred to as parenteral
nutrition in which patients are fed through an intravenous tube. On rare
occasions, 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 intravenous parenteral nutrition for SBS.
In a randomized double-blind, controlled, parallel group Phase III
clinical study, Serono's recombinant human growth hormone administered with
specialized nutritional support was shown to significantly reduce patient
dependence on total parenteral nutrition as measured by total volume, total
calories and frequency of infusion. Serono's recombinant human growth hormone
was granted an orphan drug designation for use in the treatment of patients
with short bowel syndrome by the FDA Office of Orphan Products Development.
Additional Product Information
The most common adverse events associated with growth hormone therapy are
mild to moderate muscle and joint pain and swelling/edema, which occur in a
dose-related manner and often subside with continued treatment or dose
reduction. Cases of new onset impaired glucose intolerance, new onset type 2
diabetes mellitus and exacerbation of preexisting diabetes mellitus have been
reported. Some patients develop diabetic ketacidosis and diabetic coma. In
some patients, therapy with growth hormone necessitates initiation or
adjustment of anti-diabetic treatment. Patients with a history of
hyperglycemia or other risk factors for glucose intolerance should be
monitored closely. Transient increases in glucose levels occur early in
treatment and should be monitored.
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.
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
worldwide market, Gonal-F(R) (follitropin alfa for injection), Luveris(R)
(lutropin alfa), Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa 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.)(2) 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 $1.538 billion, and a net
income of $321 million, making it the third largest biotech company in the
world. The Company operates in 44 countries, and its products are sold in
over 94 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.
(1) Zorbtive(tm) [somatropin (rDNA origin) for injection] is a new trade
name for Serono's recombinant human growth hormone.
(2) Package inserts for Serono's US marketed products are available at
http://www.seronousa.com or by calling 1-888-275-7376.
SOURCE Serono, Inc.
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Related links:
http://www.serono.com
http://www.seronousa.com
CONTACT:
Serono in Geneva, Switzerland: Media
Relations: +41-22-739-36-00, or fax: +41-22-739-30-85, or
http://www.serono.com, or Investor Relations: +41-22-739-36-01,
or fax: +41-22-739-30-22, or Reuters: SEOZ.VX - SRA.N, or
Bloomberg: SEO VX - SRA US; or Serono, Inc., Rockland, MA, Media
Relations: +1-781-681-2340, or fax: +1-781-681-2935, or Investor
Relations: +1-781-681-2552, or fax: +1-781-681-2912, or
http://www.seronousa.com
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