RICHMOND, Va., April 25, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Incorporated (Nasdaq: INSM) was honored by the National Organization for Rare Disorders (NORD) last night at its annual Tribute Banquet for the development of 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. IPLEX was approved by the United States Food and Drug Administration in December 2005 as an orphan drug.
"For many years we've recognized the need for treatment for Primary IGF-1 deficiency, but few companies were willing to commercially develop insulin- like growth factor until now. IPLEX(TM) is a significant medical advancement worthy of recognition and we thank Insmed for this important contribution," said Abbey S. Meyers, President of NORD.
"We applaud NORD's longstanding tradition of recognizing those that dedicate their life's work to finding treatments for rare diseases, and we are delighted to be included in this celebration," said Ronald D. Gunn, M.B.A., Executive Vice President and Chief Operating Officer of Insmed. "IPLEX(TM) is the culmination of over 20 years of dedicated research and development, and represents a breakthrough in IGF-1 replacement therapy, with potential benefits in several additional rare diseases with unmet medical needs."
About IPLEX
IPLEX, a complex of rhIGF-1 and rhIGFBP-3, is the only once-daily IGF-1 replacement therapy and the only therapy that provides both IGF-1 and IGFBP-3 that is approved by the FDA to treat children with severe Primary IGFD. The drug, expected to launch during the second quarter of calendar year 2006, is also being studied for various other indications with unmet medical needs including extreme insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS).
About the Condition
Severe Primary IGFD is a genetic condition in which patients do not generate sufficient quantities of insulin-like growth factor-I (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3), two key proteins involved in mediating the effects of growth hormone. Patients with severe Primary IGFD present with extreme short stature (height standard deviation score, SDS
About Insmed Incorporated
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 http://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 in this press release include, but are not limited to, statements regarding planned clinical trial design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. 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 or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, 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. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.
