Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular...( RICHMOND Va. Dec. 18 /- Insmed In...),Health

RICHMOND, Va., Dec. 18 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for IPLEX(TM) for the treatment of Myotonic Muscular Dystrophy (MMD). Insmed is currently conducting a 24-week Phase III enabling trial for IPLEX(TM) in MMD, and recently was awarded a grant of approximately $2.1 million from the Muscular Dystrophy Association (MDA), which is expected to cover a substantial portion of the external costs associated with the trial.

"This Orphan Drug Designation is another milestone for Insmed in our development and commercialization plan for IPLEX(TM) in MMD," said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer. "Orphan status, combined with the recent $2.1 million MDA grant, positions us well to continue advancing this important product candidate through clinical development, and maximize the market opportunities for MMD available to us."

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. This orphan drug designation for IPLEX(TM), grants Insmed seven years of market exclusivity upon approval for the MMD indication. In addition, Insmed is eligible for tax credits relative to its development costs, as well as assistance from the FDA in advancing the drug candidate through the regulatory process.

MMD affects approximately 37,000 Americans, and nearly 60,000 people in the European Union. MMD is a genetic disease characterized by endurance loss, muscle wasting, weakness, pain, cognitive impairment and gastro-intestinal dysfunction. There is currently no cure for the disease, and no specific treatment has been developed to satisfactorily reverse or ameliorate the common symptoms associated with the disease.

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