Insmed Announces FDA Issues Statement Regarding Position on Allowing Patients With ALS Access to IPLEX(TM) Under an IND
10 Mars 2009 - 6:39PM
PR Newswire (US)
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
http://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 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 continuing efforts to grow the business and develop IPLEX(TM)
may be unsuccessful, the actual market for MMD may not actually
match up with our external assessment, our common stock could be
delisted from the Nasdaq Capital Market and other risks and
challenges detailed in our filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K for
the year ended December 31, 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 Media Contact: Irma
Gomez-Dib - FD 212-850-5761 DATASOURCE: Insmed Incorporated
CONTACT: Investor Relations, Brian Ritchie, +1-212-850-5683, , or
Media, Irma Gomez-Dib, +1-212-850-5761, , both of FD for Insmed Web
Site: http://www.insmed.com/
Copyright