Use of Recombinant Human Growth Hormone Reduces Patient Dependence on
Parenteral Nutrition
GENEVA, Switzerland, and ROCKLAND, Mass., May 4 /PRNewswire-FirstCall/ --
Serono (virt-x: SEO and NYSE: SRA) -Serono, Inc., the US affiliate of
Serono, announced today the launch of Zorbtive(TM) [somatropin (rDNA origin)
for injection] for use in the treatment of patients with short bowel syndrome.
Short bowel syndrome (SBS) is a rare and potentially life-threatening
condition in which the ability of the small intestine to absorb the nutrition
a person needs from food is impaired. Short bowel syndrome can occur after
surgical removal of part of the intestine, due to trauma or because the
intestine is diseased.
"Many patients with SBS receive their basic nourishment by parenteral
nutrition, which means they can spend eight to ten hours a day hooked up to an
intravenous feeding line," says Kareem M. Abu-Elmagd, MD, PhD, FACS, Professor
of Surgery, Director of The Intestinal Rehabilitation and Transplant Center at
the Thomas E. Starzl Transplantation Institute in Pittsburgh, Pennsylvania.
"Reduction in dependence on parenteral nutrition is an important therapeutic
goal for patients. Treatment with Zorbtive(TM) may help to achieve this."
Results from a pivotal clinical trial showed that a four-week regimen of
Zorbtive(TM), Serono's brand of recombinant human growth hormone for use in
SBS given in conjunction with specialized nutritional support, could
significantly reduce a person's dependence on intravenous feeding as measured
by total volume, total calories and frequency of infusion. Patients taking
Zorbtive(TM) and a supplemented specialized diet reduced the average number of
days they had to use intravenous nutrition by 4.2 days per week versus
baseline, which was a significant reduction compared to the average reduction
seen in the control group. Additionally, the proportion of patients who were
able to completely discontinue intravenous feeding was greater among those who
received Zorbtive(TM). Results persisted at the 12-week post-treatment follow-
up assessment.
There are an estimated 10,000-20,000 people in the US who are receiving
intravenous parenteral nutrition for SBS who could potentially benefit from
Zorbtive(TM) treatment. Zorbtive(TM) was granted a seven-year orphan drug
exclusivity for use in the treatment of patients with SBS by the US Food and
Drug Administration.
Additional Product Information
Zorbtive(TM) is the only drug product approved by the US Food and Drug
Administration specifically for the treatment of SBS in patients receiving
specialized nutritional support. Optimal management of SBS may include
dietary adjustments, enteral feedings, parenteral nutrition, and fluid and
micronutrient supplements, as needed. The recommended dose is 0.1 mg/kg daily
up to a maximum of 8 mg per day for a treatment period of four weeks.
Zorbtive(TM) is available in an 8.8 mg vial and is administered by
subcutaneous injection.
The most commonly reported adverse events during the clinical trial
included mild injection-site reactions, gastrointestinal disturbances, muscle
and joint pain, and edema/swelling. 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.
More information about Zorbtive(TM) can be found in the full prescribing
information and Treatment Guideline available online at http://www.zorbtive.com or by
calling SeroCare at 1-800-714-2437. Patients should be instructed to read the
Patient Handbook and the patient package insert leaflet accompanying the
product.
About Serono
Serono, Inc., located in Rockland, MA, is the US affiliate of Serono, a
global biotechnology leader, headquartered in Geneva, Switzerland. Serono has
seven recombinant products, Rebif(R) (interferon beta-1a), Gonal-F(R)
(follitropin alfa for injection), Luveris(R) (lutropin alfa),
Ovidrel(R)/Ovitrelle(R) (choriogonadotropin alfa injection), Serostim(R)
[somatropin (rDNA origin) for injection], Saizen(R) [somatropin (rDNA origin)
for injection] and Zorbtive(TM) [somatropin (rDNA origin) for injection].
(Luveris(R) is not approved in the USA.)(1) In addition to being the world
leader in reproductive health, Serono has strong market positions in
neurology, metabolism and growth. Serono'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).
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.
(1) Package inserts for Serono's US marketed products are available at
http://www.seronousa.com or by calling 1-888-275-7376.
SOURCE Serono International S.A.
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Related links:
http://www.seronousa.com
http://www.serono.com
CONTACT:
Serono, Inc., Rockland, MA, Media,
+1-781-681-2481, Fax, +1-781-681-2935, or Investors,
+1-781-681-2552, or Fax, +1-781-681-2912; or Serono in Geneva,
Switzerland, Media, +41-22-739-36-00, or Fax, +41-22-739-30-85,
or Investors, +41-22-739-36-01, or fax, +41-22-739-30-22
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