Corporate Overview
Insmed is a research-driven biopharmaceutical company with broad expertise in and innovative approaches to the development of protein-based therapeutics, and efficiently moving product candidates through the regulatory approval process.
We are pursuing a dual path strategy involving entry into the follow on biologics arena (also known as biosimilars, biogenerics and biologics) and advancing our proprietary protein platform into niche markets with unmet needs. In the follow on biologics field Insmed is developing a robust pipeline of products targeted for markets in anemia, neutropenia and autoimmune diseases. In addition, on the proprietary protein front Insmed's lead product, the FDA-approved IPLEX™, is being studied as a treatment for several serious medical conditions such as Myotonic Muscular Dystrophy, HIV-associated Adipose Redistribution Syndrome and Retinopathy of Prematurity.
Focusing on Markets with Unmet Needs
Some of the biggest advances in science over the last century have occurred in the development of pharmaceuticals. Diseases which once terrified millions upon millions of people in the world have been held in check or in some cases completely eradicated because of the great work of some of the world's pharmaceutical corporations.
But at Insmed Incorporated (NASDAQ: INSM), we asked a couple of simple questions: Is there a way that medicines can be introduced into the marketplace more efficiently and at less cost? Of course.
And meanwhile, what about those diseases that don't affect "millions upon millions" of people? What about those people who may be one of 200,000 patients who suffer from a relatively rare condition? Is their suffering less meaningful because their conditions are more rare? Is their need for safe and effective medicines any less real? Of course not.
This is why at Insmed our unique vision emphasizes a dual strategy: a) expediting the process for bringing lower cost follow on biologic drugs to market and b) developing safe and effective medicines for those conditions in which needs are currently unmet.
Insmed Therapeutic Proteins - World Class Capabilities TODAY!
The process of testing, developing, and manufacturing medicines often takes several years. How many more patients' lives would be enhanced if this process could be shortened in such a way that companies' costs are reduced but the medicines are just as safe. Our FDA approved facility in Boulder CO, coupled with our protein development expertise represents a significant asset and offers a unique combination of specialized manufacturing skills and drug approval capability which is currently scarce elsewhere in the industry. To design, build and gain FDA approval for a similar facility would require a sizeable capital investment and take several years to complete. At Insmed we have the asset available now along with the skill set in house to develop and manufacture a portfolio of follow on biologics and take them through the FDA approval process.
Insmed develops medicines to address the uncommon needs
We applaud our industry colleagues who are attempting to tackle more common diseases; these conditions certainly require many brilliant minds working on their solutions. However, at Insmed our strategic focus is on the areas where patients needs are presently unmet, as our science and protein manufacturing capabilities enable us to efficiently and effectively target smaller patient populations. A testament to our focus is our success in gaining orphan status for our lead product, IPLEX™. Orphan status is granted by the FDA for drugs which serve patient populations of under 200,000 in the US. At present we have been successful in gaining this unique designation for three specific indications for IPLEX™ in Growth Hormone Insensitivity Syndrome, Severe Insulin Resistance and Severe Burn Injury.
Our key assets which allow us to rapidly pursue these needs are our FDA approved protein manufacturing facility in Boulder CO. and the combined efforts of our experienced team with proven ability to develop recombinant protein products. Our team has more than 500 years of experience working with industry leaders such as Amgen, Roche, Chiron, Cetus, J&J, Lilly, and Baxter and brings the experience of working with over 50 therapeutic protein drug products.
FDA approves IPLEX™ in December, 2005
Each year, the Food & Drug Administration (FDA) reviews hundreds of drugs to consider them for approval. Insmed's lead product, IPLEX™, was approved in December 2005 for the treatment of growth failure in children with severe primary IGF-I deficiency (Primary IGFD) or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH., one of only 22 medicines approved by the FDA that year. Now IPLEX -- a composition of recombinant human IGF-1 and IGF binding protein 3 - is being studied as a treatment for several serious medical conditions, including two neuromuscular disorders, Myotonic Muscular Dystrophy (MMD) and ALS (Lou Gehrig's Disease); HIV- Associated Adipose Redistribution Syndrome (HARS); and retinopathy of prematurity (ROP). The chart shown in the Products and Pipeline section reflects IPLEX's progress through the FDA's rigorous testing phases. If you'd like further information about IPLEX or its testing protocols feel free to contact us.
Insmed keeps pushing forward
But Insmed isn't content to rest on its achievement laurels. Insmed has other products in the pipeline, specifically developing novel products for the treatment of cancer. rhIGFBP-3 and INSM-18 are promising potential novel treatments for a variety of cancer types. Preclinical models demonstrate that both treatments interact with the IGF system to reduce tumor growth.
Please revisit us here at this site for future updates on our progress with these products.
