INSM Approval and Orphan
Took a very small position in INSM this afternoon....
FDA APPROVES INSMED'S ORPHAN DRUG, IPLEX, FOR THE TREATMENT OF SEVERE PRIMARY IGF-1 DEFICIENCY
The First Once-Daily Therapy for the Treatment of Severe Primary IFG-1 Deficiency
RICHMOND, VA - (December 12, 2005) - Insmed Incorporated (NASDAQ-NMS: INSM) (Nasdaq: INSM) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate [rDNA origin] injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, IPLEX is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.
"We are very pleased IPLEX was approved, making IPLEX the only approved once-daily IGF-1 replacement therapy available to treat children with severe short stature," stated Geoffrey Allan, Ph.D., President and Chief Executive Officer of Insmed. "Today marks the beginning of a new treatment paradigm for treating children with Primary IGFD. I am grateful to all who have made this drug approval possible. This is also an exciting transition for Insmed as we now begin to focus on the commercialization of IPLEX, which we expect to launch during the second quarter of calendar year 2006."
Andreas Sommer, Ph.D., Chief Scientific Officer of Insmed added, "This event marks the end of a long road and two decades of hard work by hundreds of dedicated people. I'm thrilled that our visionary efforts have now culminated in making available a novel therapeutic composition for the treatment of children who suffer from Primary IGFD."
"It is gratifying to see that a Company who cares for the needs of patients has developed a needed therapy that allows physicians to treat children with Primary IGFD. From my experience in treating these types of patients, IPLEX therapy has produced improvements in growth rates while providing an excellent safety profile" said Louis Underwood, M.D., Professor of Pediatrics, University of North Carolina, Chapel Hill, and a Principal Investigator and a member of Insmed's Pivotal Trial Steering Committee. Dr. Underwood is a world renowned Pediatric Endocrinologist who pioneered the early use of GH and IGF-1.
Conference Call at 8:00am
Insmed management will host a conference call to discuss FDA approval of IPLEX and provide a corporate update at 8:00am ET December 13, 2005. To participate in the conference call, dial 800-289-0529 (domestic) or 913-981-5523 (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: 9626439. A web replay of the call will be available through the corporate website beginning at 10:00 a.m.
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