Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Un... ( RICHMOND Va. March 10 /- Insmed Inc. ...)

Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Under an IND

Date:3/10/2009

RICHMOND, Va., March 10 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics (FOB) and biopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has issued a statement on its website in regards to the agency's position on allowing patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease) access to IPLEX(TM) under an Investigational New Drug (IND) application. The statement can be accessed at: http://www.fda.gov/cder/drug/infopage/mecasermin_rinfabate/FDA_statement.htm.

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. For more information, please visit www.insmed.com.

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 closing conditions under our agreement with Merck & Co., Inc. may not be met, product candidates may fail in the clinic or may not be successfully marketed or manufactured, we
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