Insmed Incorporated Receives Orphan Drug Designation for SomatoKine for the Treatment of Growth Hormone
Insensitivity Syndrome -Laron Syndrome- and Inititates Clinical Study
RICHMOND, Va.--(BW HealthWire)--June 17, 2002--Insmed Incorporated (Nasdaq: INSM - News) today announced that the Office of Orphan Products Development of the Food and Drug Administration has approved the Company's application for orphan drug designation in the United States for SomatoKine®, for the treatment of growth hormone insensitivity syndrome (GHIS/LARON SYNDROME).
With this orphan drug designation, Insmed will be granted seven years of market exclusivity upon SomatoKine approval for this indication. There is currently no approved treatment available for growth deficiency due to Laron syndrome.
In addition, Insmed has announced that a Phase II dose-range finding study with SomatoKine in children with GHIS has been initiated at Saint Bartholomew's and the Royal London School of Medicine in London, England. Professor Martin O. Savage, M.D. and Cecelia Camacho-Hubner, M.D., Ph.D. both recognized experts in growth hormone disorders, are serving as Principal Investigators for the study.
"This is a major milestone in the development of a treatment for children afflicted with Laron syndrome. We are delighted to have the opportunity to work with Professor Savage and his colleagues to treat these patients with what we believe to be a safe and powerful growth-promoting therapy," commented Geoffrey Allan, Ph.D., President and CEO of Insmed Incorporated.
Growth Hormone Insensitivity Syndrome (GHIS) is a condition in which patients fail to produce adequate quantities of insulin-like growth factor-I (IGF-I) due to failure to recognize or respond to the growth hormone signal. In GHIS subjects, IGF-I deficiency results in a diminished growth rate and a short stature. Treatment with IGF-I restores growth in this patient population. Since the bioactive component of SomatoKine is IGF-I, treatment of this growth deficiency with SomatoKine serves as hormone replacement therapy.
About SomatoKine®
The company's product candidate, SomatoKine®, is being developed as an insulin sensitizer and growth promoting/anabolic agent. The drug is the recombinant form of human insulin-like growth factor-I (IGF-I) and its regulatory binding protein, IGFBP-3. SomatoKine is currently in clinical development for type 1 and type 2 diabetes, and growth hormone insensitivity syndrome (GHIS).
About Insmed Incorporated
Insmed Incorporated is a biopharmaceutical company focused on the discovery and development of pharmaceutical products for the treatment of metabolic diseases and endocrine disorders. Further information is available at www.insmed.com.
Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding expected financial position, results of operations, cash flows, dividends, financing plans, business strategies, operating efficiencies or synergies, budgets, capital and other expenditures, competitive positions, growth opportunities for existing or proposed products or services, plans and objectives of management, demand for new pharmaceutical products, market trends in the pharmaceutical business, inflation and various economic and business trends. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed, the company may lack financial resources to complete development of product candidates, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release.
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Contact:
Insmed Incorporated, Richmond
Baxter Phillips, III, 804/565-3041, bphillips@insmed.com |
