Key Developments For Insmed Incorporated
Insmed Incorporated (INSM.O) (Consolidated Issue listed on NASDAQ Capital Market)
Insmed Incorporated Results of IPLEX Phase II Trial In Myotonic Muscular Dystrophy
Insmed Incorporated announced the results from its exploratory U.S. Phase II clinical trial evaluating IPLEX (mecasermin rinfabate) in patients with myotonic muscular dystrophy (MMD). The randomized, double blind, placebo-controlled Phase II trial conducted in 13 centers across the U.S. enrolled 69 patients with MMD, for a six-month period. As this was an exploratory trial, a primary endpoint was not pre-defined. The trial explored measures of endurance, using the six-minute walk test, muscle function and strength, cognitive function, gastrointestinal function, pain, quality of life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX. The results of the trial indicated that IPLEX did not exhibit a statistically significant improvement in the functional measure of endurance by the six-minute walk test, muscle function, muscle strength, or quality of life in any of the tests utilized in this study. Based on the limited number of subjects enrolled with significant impairments in cognitive function, gastrointestinal function or pain, Insmed was unable to reach any conclusions regarding the effects of IPLEX on these endpoints. IPLEX did, however, demonstrate improvements in standard measures of insulin sensitivity and reductions in fasting glucose, fasting insulin, cholesterol and triglycerides, which is consistent with the expected metabolic profile of insulin-like growth factor.
Insmed Incorporated CEO Resigns Due To Health Concerns
Insmed Incorporated announced that Geoffrey Allan, Ph.D. has resigned as Insmed's President, Chief Executive Officer and Chairman of the Board of Directors, effective immediately, due to a health condition. Dr. Allan has served as Insmed's President, Chief Executive Officer and Chairman of the Board since its inception in November 1999. Insmed's Board of Directors has chosen Melvin Sharoky, M.D. to assume the role of Chairman of the Board, formerly held by Dr. Allan.
Insmed Incorporated Completes Sale Of Follow-On Biologics Platform To Merck & Co., Inc.
Insmed Incorporated announced that it has successfully closed the sale of all of the Company's assets related to its follow-on biologics business to a subsidiary of Merck & Co., Inc. As a result of this closing, Insmed has now received $130 million, the aggregate purchase price, for the assets. After fees, taxes and other costs related to the transaction, net proceeds are expected to be approximately $123 million. Insmed will continue to carefully evaluate potential uses of the proceeds from the transaction.
US Allows Lou Gehrig's Patients To Try Insmed Incorporated Drug-Reuters
Reuters reported that U.S. regulators will allow experimental use of Insmed Incorporated's drug Iplex for certain patients with Lou Gehrig's disease, the Food and Drug Administration said. The drug is approved for treating a growth hormone deficiency but is not currently marketed because of a court order related to patent infringement. The agency said a number of doctors had requested permission to use the drug for patients with Lou Gehrig's disease, also known as amyotrophic lateral sclerosis or ALS. Similar drugs have been tested for the fatal neurological disease but failed to show benefit. Some trials suggested patients may fare worse with one of the medicines than a placebo, the FDA said.
Merck & Co., Inc. Acquires Biologic Manufacturing Capabilities and Developmental Follow-on Biologics Portfolio From Insmed
Merck & Co., Inc. announced that it has entered into a definitive agreement with Insmed Inc., to purchase Insmed's portfolio of follow-on biologic therapeutic candidates and its commercial manufacturing facilities located in Boulder, Colo. (Boulder facilities). Under the terms of the agreement, Merck, through an affiliate, will pay Insmed $130 million in cash to acquire all rights to the Boulder facilities and Insmed's pipeline of follow-on biologic candidates. The Boulder facilities comprise 50,000 square feet of biologics process development analytical laboratory and manufacturing facilities. Insmed's follow-on biologics portfolio includes INS-19, an investigational recombinant granulocyte-colony stimulating factor (G-CSF) that will be evaluated in Phase III clinical trials for its ability to prevent infections in patients with cancer receiving chemotherapy and INS-20, a pegylated recombinant G-CSF designed to allow for less frequent dosing, that is currently in Phase I clinical trials. The agreement provides for initial payments of up to $10 million for INS-19 and INS-20. Merck will pay Insmed the remaining balance upon closing of the transaction, without any further milestone or royalty obligations.
