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Zorbtive Launched, First Drug Product for Treatment of Short Bowel Syndrome

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™ [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™ may help to achieve this."

Results from a pivotal clinical trial showed that a four-week regimen of Zorbtive™, 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™ 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™. 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™ treatment. Zorbtive™ 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™ 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™ 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™ 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.

Source: Serono International S.A.

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