iPlexTreatment for Primary IGF-1 Deficiency
Insmed Submits New Drug Application -NDA- to Seek Regulatory Approval of SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome
RICHMOND, Va., January 3, 2005 - Insmed Incorporated (Nasdaq: INSM) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of SomatoKine (mecasermin rinfabate) for the treatment of growth hormone insensitivity syndrome (GHIS). The application includes safety and efficacy results from Insmed's prospective, multicenter, Phase III clinical trial with SomatoKine conducted in patients with growth hormone insensitivity syndrome. SomatoKine is Insmed's proprietary insulin-like growth factor I (IGF-I) therapy, composed of recombinant human IGF-I and IGF binding protein 3 (rhIGF-I/rhIGFBP-3 complex).
"The submission of the NDA for SomatoKine represents a great achievement for the Company, highlighting our efforts to bring the first specific treatment for children with this disease. We believe that SomatoKine is a breakthrough therapeutic agent and that it will become the standard of care for treating GHIS," said Geoffrey Allan, Ph.D., President and CEO of Insmed Incorporated.
SomatoKine has already received orphan drug designation for the GHIS indication. Orphan drug designation is conferred upon investigational products by the FDA for indications that affect fewer than 200,000 people in the United States. The GHIS indication 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, replacement therapy in children with GHIS using SomatoKine is intended to bypass the blockade of GH action and improve longitudinal growth.
Insmed will host a conference call on Wednesday, January 5, at 11:00 a.m. Eastern Time (10:00 a.m. Central Time) to provide an update on recent corporate events and planned activities for 2005.
To participate in the conference call, dial 800-479-9001(domestic) or 719-457-2618 (international). The call will be webcast live through Insmed's corporate website: www.insmed.com. A telephonic replay of the call will be available for one week at 888-203-1112 (domestic) or 719-457-0820 (international), passcode: 238426. A web replay of the call will be available through the corporate website beginning at 1:00 p.m. Wednesday.
More on SomatoKine
Insmed's SomatoKine is a proprietary delivery composition of insulin-like growth factor I (IGF-I). The novel compound is administered as a subcutaneous injection, which can restore IGF-I levels to physiologically relevant levels. On July 20, Insmed provided the top-line results from a six-month data analysis of the pivotal Phase III GHIS clinical trial showing a statistically significant increase (p<0.0001) in height velocity in children receiving SomatoKine as a once-daily injection.
In diabetic subjects, administration of SomatoKine demonstrated a significant improvement in blood sugar control and a significant reduction in daily insulin use. Following severe burn injury, in both children and adults, administration of SomatoKine demonstrated a significant improvement in muscle protein synthesis and a significant reduction in the inflammatory response associated with the trauma. In recovery from hip fractures, administration of SomatoKine demonstrated a significant improvement in functional recovery and bone mineral density.
Insmed is a biopharmaceutical company focused on the discovery and development of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs.
For more information, please visit www.insmed.com.
Posted: January 2005
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- FDA Extends PDUFA Date for SomatoKine to October 3, 2005 - June 10, 2005
- FDA Accepts for Review Insmed's NDA for SomatoKine for the Treatment of Growth Hormone Insensitivity Syndrome - March 10, 2005