RICHMOND, Va., Jan 22, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that a leading management consulting firm has completed a market assessment of the potential market for therapeutic treatments related to Myotonic Muscular Dystrophy (MMD), also known as dystrophia myotonica or Steinert's disease. The research was conducted on behalf of Insmed, which is currently conducting a Phase III enabling trial for its MMD product candidate, IPLEX(TM). Based on responses from neurologists interviewed, patients afflicted with MMD could number between 28,300 and 37,000 by 2010, and the total market for MMD treatments could be as high as between $800 million and $1.4 billion.
MMD is an inherited disease characterized by prolonged muscle tensing (myotonia) where certain muscles are not able to relax after use. Muscular Dystrophy is diagnosed at the rate of 50,000 to 250,000 persons annually in the U.S., and MMD is the most common form of the disease. DM1, which occurs in approximately 98% of MMD cases, is caused by an excessive number of cytosine, thymine and guanine (CTG) repeats on Chromosome 19. Symptoms of MMD include muscle wasting, weakness, pain, endurance loss, cognitive impairment and gastro-intestinal dysfunction.
There is currently no cure for the disease, and no specific treatment has been discovered to satisfactorily reverse or ameliorate the common symptoms associated with MMD. Current treatments for MMD are directed toward managing the clinical manifestations of the disease, such as drugs aimed at treating multiple symptoms with the intent of addressing the delayed muscle relaxation.
"The results of this study highlight that the MMD patient population is under-served," said Steve Glover, President, Insmed Therapeutic Proteins. "We intend to continue executing on our regulatory strategy for IPLEX in MMD, which was recently granted Orphan Drug Designation by the FDA in an attempt to better serve this patient category. Our recently secured grant of approximately $2.1 million from the Muscular Dystrophy Association is expected to cover a substantial portion of the external costs associated with our 24-week Phase III enabling trial in MMD patients, and we are hopeful of making this important product candidate available to patients as quickly as possible."
These interviews, seeking information about the current treatment of MMD, emerging treatments and trends and therapies via a blinded product profile, were conducted in physician settings ranging from individual practices to large multi-specialist group practices in rural, urban and academic environments in different locations in the U.S.
IPLEX(TM) 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(TM) (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.
Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit www.insmed.com.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the Nasdaq Global Market and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.