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RICHMOND, Va., Mar 26, 2007 (BUSINESS WIRE) -- Insmed, Inc. (NASDAQ:INSM) President and Chief Executive Officer, Geoffrey Allan, Ph. D., testified today at a congressional hearing, "Safe and Affordable Biotech Drugs - The Need for a Generic Pathway."
Dr. Allan was a witness before the House of Representatives Oversight and Government Reform Committee Majority Staff hearing. He, along with other industry and regulatory experts, shared his views on the role of biotech companies in the debate on the need for a generic pathway for biologics. Currently, the FDA lacks clear 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, "Insmed has developed significant intellectual capital focused towards protein characterization and purification. We have invested in building the facilities required to manufacture quality proteins...The combination of our proprietary protein platform with a biogeneric protein platform meets our goal to sustain innovation along with the ability to provide safe and affordable drugs to address a growing economic issue."
He added, "The science has reached a level of sophistication to make this endeavour entirely possible, all we need now is the regulatory go ahead."
It is Dr. Allan's belief that once legislation comes into effect, Insmed will be well positioned to be a key player in the generic biologics market, given the Company's expertise.
A full transcript of Dr. Allan's testimony is available on the Insmed web site, www.insmed.com.
About Insmed Incorporated
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 devlopment 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 trial 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.