RICHMOND, Va., Sep 19, 2005 (BUSINESS WIRE) -- Insmed Incorporated (NASDAQ: INSM) today announced that data from the Company's New Drug Application for Somatokine (rhIGF-I/rhIGFBP-3) (mecasermin rinfibate) for the treatment of Growth Hormone Insensitivity Syndrome (GHIS), will be featured in a podium presentation on Friday, September 23 at the European Society Pediatric Endocrinology/ Lawson Wilkins Pediatric Endocrine Society 7th Joint Meeting, a global meeting of pediatric endocrinologists occurring every four years.
During the Conference Symposium titled, "Update on Growth and Anabolic Therapies", Cecelia Camacho-Hubner, M.D., of St. Bartholemew's Hospital, London, United Kingdom will give the lecture featuring long-term safety and efficacy of the once-daily IGF-I replacement therapy, SomatoKine, in children with GHIS.
About GHIS
GHIS encompasses a variety of genetic and acquired conditions in which the action of growth hormone (GH) is absent or severely attenuated, resulting in low serum levels of IGF-I. Because IGF-I is the primary mediator of the growth-promoting actions of GH, SomatoKine replacement therapy in children with GHIS is intended to bypass the blocked actions of GH by replacing the deficient IGF-I, resulting in improved growth.
More on SomatoKine
Insmed's SomatoKine is a proprietary drug product for the delivery of recombinant insulin-like growth factor I (IGF-I). It is administered as a preformed complex with a recombinant form of its natural binding protein, insulin-like growth factor binding protein 3 (rhIGFBP-3). The novel compound is administered as a once-daily subcutaneous injection, which can restore and maintain IGF-I levels to physiologically relevant levels. The binding protein (rhIGFBP-3) extends the residence time of IGF-I in the blood, conferring a superior pharmacokinetic profile as compared with rhIGF-I alone. In the bound state, the IGF-I is inactive, and remains so until delivered to target tissues in the body where it is released and becomes biologically active. This reduces the risk of short- and long-term safety concerns that have been associated with unrestrained levels of free IGF-I.
SomatoKine has been investigated in a number of other indications in addition to growth disorders. In patients with Type 1 and Type 2 diabetes, administration of SomatoKine demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. In children and adults suffering severe burn injury, administration of SomatoKine demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In elderly individuals recovering from hip fractures, administration of SomatoKine demonstrated a significant improvement in functional recovery and bone mineral density. In addition to the GHIS program, SomatoKine is currently being studied in a Phase II clinical trial at the University of California, San Francisco in patients with HIV-Associated Lipodystrophy, and in a Phase II clinical trial at the University of Cambridge, U.K. in patients with Extreme Insulin Resistance.
About Insmed
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders. For more information, please visit 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.
