RICHMOND, Va., July 5, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Incorporated (Nasdaq: INSM): Insmed today announced the European Medicines Agency (EMEA) has validated its application to market IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection), in the European Union (EU). The validation was granted within the scope of the EU Commission designations of IPLEX as an orphan medicinal product for the Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects (EU/3/06/378); and Treatment of patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH (EU/3/06/377).
"We are pleased to have reached this important milestone in the European drug approval process and particularly at this time as it positions us ahead of schedule in our pursuit of EU approval," said Geoffrey Allan, President and Chief Executive Officer of Insmed. "This is just one more example of Insmed's ability and commitment to execute our development and commercialization plans."
The validation signifies that the EMEA can now begin review of Insmed's marketing authorization application. The review process is being coordinated by the EMEA under the centralized licensing procedure, which, if resulting in approval, provides one marketing authorization for all 25 member states of the EU, as well as Norway and Iceland. With the validation step complete, the application will be assessed on a timetable that could lead to an approval and marketing authorization in 2007. The orphan medicinal product status would assure Insmed Inc. a ten year period to market IPLEX in the EU.
IPLEX is approved in the United States as the only once daily treatment for children with short stature associated with severe primary IGF-I deficiency (Primary IGFD). IPLEX, a complex of recombinant human IGF-I and its binding protein IGFBP-3 (rhIGF-I/rhIGFBP-3), is the only FDA-approved IGF- I replacement therapy that also replaces deficient IGFBP-3 in these patients. The drug, which was launched in the second quarter of 2006, is also being investigated for various other indications with unmet medical needs, including severe insulin resistance, myotonic muscular dystrophy and HIV Associated Adipose Redistribution Syndrome (HARS). For more information about IPLEX please go to www.go-IPLEX.com.
Insmed is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.
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