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FDA Approves Insmed's Orphan Drug, Iplex (mecasermin rinfabate [rDNA origin] injection), for Treatment of Severe Primary IGF-1 Deficiency

The First Once-Daily Therapy for the Treatment of Severe Primary IFG-1 Deficiency

RICHMOND, VA -- December 13, 2005 -- Insmed Incorporated announced 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, PhD, 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, PhD, 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.

More on Iplex
Iplex, mecasermin rinfabate, is the human recombinant of the naturally occurring protein complex of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). The targeted treatment indication for Iplex is Primary IGFD which encompasses a variety of genetic and acquired conditions in which the action of growth hormone (GH) is absent or attenuated resulting in low serum levels of IGF-I.

Patients with Primary IGFD present with extreme short stature (height standard deviation score, SDS < -3) and an extremely poor prognosis for adult stature. Whereas prepubertal height SDS can range as low as -9, a blunted pubertal growth spurt is usually apparent, resulting in adult height that is typically 5-12 SD's below the normal population (adult height between 100 and 140 cm). The profound short stature in patients is often associated with severe psychosocial problems.


SOURCE: Insmed Incorporated

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