Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, Monday, 2 December 1996.
Serono Laboratories markets Serostim, human growth hormone (rDNA origin) indicated for the treatment of AIDS wasting or cachexia, a leading cause of death among people with AIDS. AIDS wasting causes the body to inappropriately burn vital lean body mass (muscle and organ tissue) for energy instead of fat.
Serostim is indicated for the treatment of AIDS wasting or cachexia. This indication is based on analyses of surrogate endpoints (lean body mass and weight) in studies of up to 12 weeks in duration. Concomitant anti-viral therapy is necessary. The continued use of Serostim treatment should be reevaluated in patients who continue to lose weight in the first two weeks of treatment.
SEROSTIM TREATMENT CONTINUATION PROGRAM
In a groundbreaking effort to respond to the needs of the AIDS community, Serono has committed to a cost containment program, the Serostim Treatment Continuation Program(TM), that limits the cost of Serostim to $36,000 for each patient per calendar year for those who qualify.
This program is sponsored in full by Serono Laboratories, Inc., and is solely managed by the National Organization for Rare Diseases (NORD), a not- for-profit organization dedicated to the identification, treatment and cure of rare "orphan diseases."
"Serono has responded to community needs by implementing unique educational programs and cost containment measures to ensure greater access to its drugs. I was personally gratified to make the important decision to limit the cost of Serostim," said Hisham Samra, M.D., president, Serono Laboratories, Inc. "Serono has truly benefited from our long-standing dialogue with AIDS activists. It was through this spirit of communication and exchange that we were able to agree with the community on the Serostim Treatment Continuation Program."
SPECIALTY PHARMACY DISTRIBUTORS
Serostim is available nationwide through a number of specialty mail order distributors which have extensive experience in AIDS treatment and are committed to providing educational services, advocacy, support and convenient access to therapies for people with AIDS.
The Serostim network of specialty pharmacy distributors will initially include: American Preferred Pharmacy, Community Prescription Services, Coram Healthcare, Nations Chartwell Scripts, Priority, Stadtlanders, and Statscript Pharmacy.
SEROSTIM PATIENT ASSISTANCE PROGRAM
The Serostim Patient Assistance Program is a potential source of Serostim coverage for people with AIDS wasting with limited financial resources. In order to provide Serostim therapy to as many people as possible, Serono allocates certain quantities of drug to be supplied to program beneficiaries. The Serostim Patient Assistance Program is sponsored in full by Serono Laboratories, Inc., and is solely managed by the National Organization of Rare Diseases (NORD).
EDUCATIONAL SUPPORT
As the leader in the treatment of AIDS wasting, Serono will continue its efforts to gain greater awareness and improved treatment options for AIDS wasting through ongoing research, and through educational programs for healthcare providers and patients.
"We believe in a comprehensive approach to the treatment of AIDS wasting, including Serostim therapy, proper nutritional intake and appropriate exercise," said Ellen Frank, Ph.D., executive vice president, Serono Laboratories. "Our objective is to provide medical professionals with the information and clinical data they need, and patients with a better understanding of AIDS wasting, so that, together, they can pursue the most effective treatment options."
Serostim is the only recombinant human growth hormone authorized by the FDA for the treatment of people with AIDS wasting. As an anticatabolic (protein sparing) and anabolic (protein building) agent, Serostim therapy addresses the metabolic derangement of AIDS wasting, resulting in a significant increase in lean body mass and weight. While depletion of body weight and lean body mass has been associated with increased morbidity and mortality, the clinical significance of treatment-induced weight gain and LBM accrual have yet to be established. During the course of Phase III trials, it was learned that preventing the continued loss, as well as promoting the accrual, of lean body mass, are the keys to improving physical function.
For additional information on the SeroCare Program, the Serostim Treatment Continuation Program, the national network of Serostim specialty pharmacy distributors, the Serostim Patient Assistance Program or any of the educational programs being offered by Serono Laboratories, please contact the Serostim Access Line at 800-714-2437 (Monday through Friday, 8:30 a.m. to 5:00 p.m., EST).
Serono Laboratories, Inc., Norwell, MA, is the United States member of The Ares-Serono Group of companies, the world's foremost developer and manufacturer of pharmaceuticals for the treatment of infertility. Ares-Serono, headquartered in Geneva, Switzerland, also specializes in the fields of growth, metabolism and immunology/oncology. Products of The Ares-Serono Group are sold under the trademark Serono in over 90 countries. Shares of Ares-Serono S.A., the parent company of Ares-Serono, are traded on the Swiss stock exchanges.
CONTACT: Gina M. Cella of Serono Laboratories, 617-982-9000
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PR961205
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