Insmed Provides Update on Supply of IPLEX(TM)
27 Juillet 2009 - 2:00PM
PR Newswire (US)
Company to Provide Remaining Supply of IPLEX(TM) to Ensure
Continued Access RICHMOND, Va., July 27 /PRNewswire-FirstCall/ --
Insmed Inc. (NASDAQ: INSM), a biopharmaceutical company, today
announced that, effective immediately, the Company will cease the
supply of IPLEX(TM) to any new patients. In addition, the Company
will not initiate further clinical trials with IPLEX(TM) at this
time. The Company has determined that its limited inventory on hand
must be conserved for the treatment of existing patients. Following
the previously announced sale of Insmed's Boulder, Colorado
manufacturing facility to Merck & Co., Inc. in March 2009,
Insmed no longer has the capability to manufacture IPLEX(TM), an
extremely complicated drug to produce. Moreover, any agreement with
a third party to undertake the manufacture of IPLEX(TM), if it was
economically feasible and could be arranged, would not result in
production of additional quantities of IPLEX(TM) for at least 12 to
18 months. There are approximately 70 patients who currently
receive IPLEX(TM), 12 in the U.S. and the remainder around the rest
of the world. Most of the patients receive IPLEX(TM) pursuant to a
court-ordered Extended Access Program (EAP) for Amyotrophic Lateral
Sclerosis (ALS) in Italy. The 12 U.S. patients are being treated
for ALS under single patient Investigational New Drug applications
approved by the U.S. Food and Drug Administration. The Company
believes that it has sufficient IPLEX(TM) inventory to supply these
patients for no more than 24 months. The Company intends to analyze
the on-going data collected for various indications, including
myotonic muscular dystrophy and ALS, and assess the overall
IPLEX(TM) development program, including possible IPLEX(TM)
manufacturing options with third parties and possible future
clinical trials. Initiation of the Phase II clinical trial for ALS
patients in the U.S. that had been discussed with FDA earlier this
year has been postponed while the Company performs this assessment.
Dr. Melvin Sharoky, Insmed's Chairman, said, "We believe that it is
in the best interests of patients who are currently receiving
IPLEX(TM) to ensure that our current limited inventory is conserved
in order to maintain their drug supply as long as possible, while
allowing the Company time to consider its development options."
About Insmed Insmed Inc. is a biopharmaceutical company with unique
protein development 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 the existing
supply of IPLEX(TM) and possible production of additional
quantities of IPLEX(TM) by third party manufacturers, 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, the available supply of
IPLEX(TM) may be used more quickly than expected; we may decide not
to pursue a third party manufacturing arrangement for IPLEX(TM); if
we decide to pursue such a manufacturing arrangement, we may not be
able to find a third party manufacturer willing to produce
IPLEX(TM) or be able to negotiate acceptable terms; it may take any
third party manufacturer more time than expected to successfully
begin producing new supplies of IPLEX(TM) 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, 2008. 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 Relations Contact:
Irma Gomez-Dib - FD 212-850-5761 DATASOURCE: Insmed Inc. CONTACT:
Investor Relations, Brian Ritchie of FD, +1-212-850-5683, ; or
Media Relations, Irma Gomez-Dib of FD, +1-212-850-5761, Web Site:
http://www.insmed.com/
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