Study by Leading Economist Identifies Potential for $378 Billion of Savings From Follow On Biologics
11 Février 2008 - 3:25PM
PR Newswire (US)
RICHMOND, Va., Feb. 11 /PRNewswire-FirstCall/ -- A report released
today, commissioned by Insmed Inc. (NASDAQ:INSM), identifies
potential cost savings of approximately $378 billion over the next
20 years from making follow on biologics (FOBs) available in the
U.S. The econometric study by economist Dr. Robert J. Shapiro,
former Under Secretary of Commerce in the Clinton Administration,
found that "...generic versions of the top 12 categories of
biologic treatments with patent protections that have expired or
that are due to expire in the near future could save Americans $67
billion to $108 billion over 10 years and $236 billion to $378
billion over 20 years." According to other published reports, an
estimated $10 billion worth of biologic drugs are expected to come
off patent by 2010, with an additional $10 billion by 2015. FOBs
would provide safe and effective therapies at a reduced cost
following the expiration of the original product's patent. Dr.
Shapiro's report, entitled The Potential American Market for
Generic Biological Treatments and the Associated Cost Savings, also
finds that "...the economic and medical benefits from generic
biologics should be as great or perhaps even greater as those from
generic forms of traditional pharmaceuticals... Moreover, the
potential savings from the discounted prices that generics provide
will be larger with biogenerics, because original biologics are so
much more expensive than other brand pharmaceuticals..." The
scientific, regulatory and legal framework for the approval of
small- molecule generic drugs is well developed, and a regulatory
system for approving FOBs was established in Europe in 2006.
However, no regulatory pathway currently exists for FOBs, which are
also commonly referred to as biosimilars or biogenerics, in the
U.S. "Dr. Shapiro's comprehensive analysis presents a compelling
case for the need for Congress to adopt legislation so patients can
receive affordable access to life-saving biotech drugs in a timely
manner," said Geoffrey Allan, CEO of Insmed, a developer of
follow-on biologics and biopharmaceuticals. "The cost savings to
the health care system have the potential to be enormous, while the
environment for new market participants could introduce competition
to these monopolistic markets, similar to that seen in the
traditional pharmaceutical generics industry." The release of Dr.
Shapiro's report is part of Insmed's broad education campaign on
the importance of establishing a regulatory pathway in the U.S. for
large molecule protein-based drugs, known as follow-on biologics
(FOBs), which are also commonly referred to as biosimilars or
biogenerics. Insmed is currently developing a portfolio of FOBs and
intends to initiate clinical trials for its first two FOBs in 2008.
Members of Insmed's skilled biologics team have worked on over 50
therapeutic proteins. Their focused protein-based drug development
backgrounds, coupled with the Company's FDA- approved protein
manufacturing facility, and clinical and regulatory expertise,
positions Insmed, upon the establishment of a regulatory pathway,
to be an initial entrant into the U.S. FOBs market with a broad
range of medicines following the expiration of patents covering the
innovator products. Dr. Shapiro is the chairman of Sonecon, LLC, a
private firm that advises U.S. and foreign businesses, governments
and non-profit organization. His full report is available on
Insmed's website at: http://www.insmed.com/. Journalists may
contact Dr. Shapiro by calling 202-213-7233 or e-mailing . Insmed
is currently developing a portfolio of FOBs and intends to initiate
clinical trials for its first two FOBs in 2008, both of whose brand
sales represent over $3 billion in current sales world wide.
Members of Insmed's skilled biologics team have worked on over 50
therapeutic proteins. Their focused protein-based drug development
backgrounds, coupled with the Company's FDA-approved protein
manufacturing facility, and clinical and regulatory expertise,
positions Insmed, upon the establishment of a regulatory pathway,
to be an initial entrant into the U.S. FOBs market with a broad
range of medicines following the expiration of patents covering the
innovator products. About Insmed 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. Insmed has a state-of-the- art,
FDA-approved biologic commercial manufacturing facility in Boulder,
Colorado and a Corporate office in Richmond, Virginia. For more
information, please visit http://www.insmed.com/. About Robert J.
Shapiro Robert J. Shapiro is the chairman of Sonecon, LLC, a
private firm that advises U.S. and foreign businesses, governments
and non-profit organizations. Dr. Shapiro has advised, among
others, U.S. President Bill Clinton and British Prime Minister Tony
Blair; private firms including Amgen, AT&T, Gilead Sciences,
Google, MCI, Inc., SLM Corporation, Nordstjernan of Sweden, and
Fujitsu of Japan; and non-profit organizations including the
American Public Transportation Association, the Education Finance
Council, BIO, and the U.S. Chamber of Commerce. He is also chairman
of the Globalization Initiative of NDN, co-chair of the American
Task Force Argentina, Policy Fellow of the Georgetown University
School of Business, Senior Fellow of the Progressive Policy
Institute (PPI), and a director of the Ax:son-Johnson Foundation in
Sweden. From 1997 to 2001, Dr. Shapiro was Under Secretary of
Commerce for Economic Affairs. Prior to that, he was co-founder and
Vice President of PPI. Dr. Shapiro also served as the principal
economic advisor to Bill Clinton in his presidential campaign,
senior economic advisor to Albert Gore, Jr. in 2000, Legislative
Director for Senator Daniel P. Moynihan, and Associate Editor of
U.S. News & World Report. He has been a Fellow of Harvard
University, the Brookings Institution and the National Bureau of
Economic Research. He holds a Ph.D. from Harvard, an A.B. from the
University of Chicago and a M.Sc. from the London School of
Economics and Political Science. He is the author of numerous
articles for scholarly and popular journals, and his forthcoming
book is Futurecast: How Superpowers, Globalization and Populations
Will Change the Way You Live and Work, to be published by St.
Martins Press in April 2008. Forward-Looking Statements 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.
Investor Relations Contact: Brian Ritchie - FD 212-850-5683
Corporate Communications Contact: John Procter - Gibraltar
Associates 202-879-5808 DATASOURCE: Insmed Inc. CONTACT: Investor
Relations, Brian Ritchie of FD, +1-212-850-5683, ; or Corporate
Communications, John Procter of Gibraltar Associates,
+1-202-879-5808, , both for Insmed Inc. Web site:
http://www.insmed.com/
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