Thursday, December 20, 2007

Insmed and Colorado Manufacturing

Another question for today…What do Amgen (NASDAQ: AMGN) and Roche (VTX: ROG.VX) have in common with Richmond, VA-based Insmed (NASDAQ: INSM) and Columbia, MD-based Martek Biosciences (NASDAQ: MATK)? Answer…they too have their state-of-the-art FDA-approved biologic commercial manufacturing facilities in Boulder. I find it interesting how Colorado is emerging as an unambiguous center of excellence in the manufacture of small molecules and biologics. Please leave some comments below as to why you think this trend is emerging.

Insmed specializes in the development of drugs to treat metabolic diseases, endocrine disorders, and oncology. Its lead product candidate IPLEX™, a recombinant protein product candidate, is in Phase II clinical trials for the treatment of myotonic muscular dystrophy, the common form of adult-onset muscular dystrophy. It is also conducting a Phase II clinical study for investigating IPLEX™ as a treatment for HIV associated adipose redistribution syndrome; a Phase I clinical study investigating IPLEX™™ as a treatment for retinopathy of prematurity, a disease where the small blood vessels in the back of the eye and the retina grow abnormally; and an expanded access program in Italy to provide IPLEX™ to physicians for patients with amyotrophic lateral sclerosis, a neurodegenerative disease that affects nerve cells in the brain and the spinal cord. In addition, Insmed is developing INSM-18, a small molecule tyrosine kinase inhibitor that is under Phase I/II clinical trials for the treatment of breast, lung, pancreatic, and prostate tumors; and rhIGFBP-3, a Phase I clinical product candidate for the treatment of breast, prostate, liver, ovarian, and colon cancers. The company has license and collaborative agreements with Fujisawa Pharmaceutical Co., Ltd. to use IGF-I therapy for the treatment of extreme or severe insulin resistant diabetes; and a license to Pharmacia AB's portfolio of regulatory filings pertaining to rhIGF.

Just this week Insmed was granted Orphan Drug Designation for IPLEX™ for the treatment of Myotonic Muscular Dystrophy (MMD). Insmed is currently conducting a 24-week Phase III enabling trial for IPLEX™ in MMD, and recently was awarded a grant of approximately $2.1M from the Muscular Dystrophy Association which will be allocated to trial costs.

More on Martek coming soon...

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