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RICHMOND, Va., May 02, 2007 (BUSINESS WIRE) -- Insmed Inc. (Nasdaq:INSM) President and Chief Executive Officer Geoffrey Allan, Ph.D., testified today at a congressional hearing, "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States."
Dr. Allan was a witness before the Energy and Commerce Committee Subcommittee on Health. He, along with other industry and regulatory experts, shared views on the ability of biotech companies to produce safe and affordable versions of currently approved recombinant protein products. This hearing is one of a series of hearings that has been scheduled to discuss legislative alternatives to provide the FDA with the regulatory authority to approve a generic form of a biologic medication.
Biologics comprise one of the fastest growing and most expensive categories of drugs. By 2009, sales are estimated to reach $90 billion. Many biopharmaceutical drugs are already off patent or will come off patent, allowing for a generic pathway to create biologics. According to published reports, an estimated $10 billion worth of biopharmaceutical drugs are expected to come off patent by 2010.
In his testimony, Dr. Allan stated, "I believe the scientific expertise and capability exist for many companies to manufacture safe and affordable generic biological products. There is no reason to believe that a generic biologic would be of a lesser quality and less safe than a brand product. FDA has only a single standard to approve safe and effective products."
He added, "Insmed intends to be a leader in the emerging field of biogenerics It currently has the capability and expertise to produce generic biologicals. What is lacking at this time is legislation that provides the regulatory pathway."
A full transcript of Dr. Allan's testimony is available on the Insmed web site, www.insmed.com.
Insmed is a biopharmaceutical company focused on the development and commercialization of drug candidates for the treatment of metabolic diseases and endocrine disorders with unmet medical needs.
The company's leading product, IPLEX(TM), is currently in clinical trials for Myotonic Muscular Dystrophy, the most common form of adult-onset muscular dystrophy.
It is also in development for HIV-associated Adipose Redistribution Syndrome (HARS). IPLEX was approved as an orphan drug by the United States Food and Drug Administration 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. For more information, please visit www.insmed.com.
Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding planned clinical study design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.