Insmed Inc (INSM)

[Christiaan F]

This is what he wrote 2 years ago; he knwos what INSM & IPLEX is about! Also mentioning off label usage!

Insmed Incorporated
Ticker: INSM
Description: Insmed develops medicines for the treatment of metabolic diseases and endocrine disorders. Insmed’s most advanced drug, a proprietary complex of rhIGF-I, is currently in Phase III for GHIS, a severe growth disorder. Insmed expects to file for marketing approval for GHIS in 2004. Insmed’s anti-cancer medicine, rhIGFBP-3, is expected to enter clinical trials in 2004.
Website: http://www.insmed.com

The information below is based on the most recent information we have received from analysts and the companies participating in The REIT Report. We encourage you to visit the company's web site for updates. “On November 17, 2003, we initiated coverage of INSM shares with a Market Outperform rating and 12-month price target of $8 (30x our 2007 EPS estimate of $0.68 discounted annually at 35%). Insmed Incorporated (Nasdaq: INSM) is a biopharmaceutical company developing recombinant human insulin-like growth factor-I (rhIGF-I) in combination with recombinant human IGF-I binding protein –3 (rhIGFBP-3) for the treatment of various endocrine disorders. The equimolar complex of rhIGF-I and rhIGFBP-3 is designated as rhIGF-I/rhIGFBP-3 or SomatoKine and is in a Phase III pivotal trial in children with growth hormone insensitive syndrome (GHIS). SomatoKine is also in Phase II trials for severe burn injury, hip fracture in osteoporotic patients, and severe insulin resistant Type 1 and Type 2 diabetes mellitus. Pharmacia’s free IGF-I went through all phases of clinical development and was shown to be efficacious for the treatment of growth retardation in children with GHIS. The drug was approved in Europe. However, Pharmacia never marketed the product. No other IGF-I drug is currently approved and marketed and GHIS remains an unmet medical need. We believe INSM’s pivotal Phase III trial of SomatoKine in children with GHIS has a high probability of success because (a) free IGF-1 is effective and (b)apharmacokinetic study has established that once daily subcutaneous administration of SomatoKine is equally effective as a twice-daily subcutaneous injection free IGF-I in elevating serum IGF-I level in patients which in turn restores IGF-I functions in vivo. We expect SomatoKine to be approved and launched in 2005 and project sales of $7.8 million in 2005, $44.7 million in 2006 and $140.4 million in 2007. Physicians thought leaders find SomatoKine to be promising and once approved, to find significant off-label use in the general GHIS population, in late-stage diabetic patients with severe insulin resistance, in patients with severe burn injury, and in osteoporotic patients suffering from hip facture. INSM's pipeline also consists of rhIGFBP-3 in early clinical development as an anti-cancer therapeutic agent for a variety of tumor types. We consider INSM shares, at a technology value of around $80 million, to be significantly undervalued compared to its peers. We reiterate our Outperform rating for INSM shares. Our 12-month target price remains unchanged at $8.00.” (February 11, 2004)
-NAVDEEP S. JAIKARIA, RODMAN & RENSHAW

http://www.thereitreport.com/pub/co/526

CF