Insmed CEO Geoffrey Allan Testifies at Energy and Commerce Committee Hearing
02 Mai 2007 - 3:00PM
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. About Insmed 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. Forward-Looking Statements 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.
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