Tuesday, January 08, 2008

Insmed Awarded $2.1 Million by Muscular Dystrophy Association

Insmed Awarded $2.1 Million by Muscular Dystrophy Association

RICHMOND, Va., Dec 12, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), today announced that it has been awarded a grant of $2,087,325 from the Muscular Dystrophy Association (MDA). The grant is expected to cover a substantial portion of the external costs associated with Insmed's 24-week Phase 3 enabling trial in patients with Myotonic Muscular Dystrophy (MMD).

Insmed, a development stage biopharmaceutical company with extensive expertise in biologics and orphan drug development, decided to initiate the Phase 3 enabling trial based on promising results from an ongoing open-label, dose-escalation trial of IPLEX™ in MMD. To date, up to 70% of patients have reported improvements in one or more of several symptoms commonly associated with Myotonic Muscular Dystrophy. Furthermore, patients undergoing a standardized 6 minute walk test, a well accepted FDA endpoint for endurance, have significantly improved their walking distance (p<0.03).

"The Muscular Dystrophy Association is pleased to announce its support for IPLEX™, which shows early stage promise in this debilitating disease, and we look forward to working closely with Insmed to further its clinical testing," said Sharon Hesterlee, MDA, VP of Translational Research for the Muscular Dystrophy Association.

"We are delighted to have a well-respected organization such as the MDA take an active role in the development of IPLEX™ for this important indication," said Geoffrey Allan Ph.D., Insmed's President and Chief Executive Officer. "We believe third party commitments such as this clearly demonstrate the significance of our results to date and the validity of this approach to treat patients with this severely debilitating disease."

About the Muscular Dystrophy Association (MDA)

The Muscular Dystrophy Association www.mda.org is a voluntary health agency working to defeat more than 40 neuromuscular diseases through programs of worldwide research, comprehensive services, and far-reaching professional and public health education.

About Myotonic Muscular Dystrophy

Myotonic Muscular Dystrophy 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, which affects approximately 37,000 individuals in the U.S., and no specific treatment has been discovered to satisfactorily reverse or ameliorate the common symptoms associated with the disease.

About IPLEX™

IPLEX™ was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX™ (rhIGF-I/rhIGFBP-3), is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs.

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