MONMOUTH JUNCTION, N.J.,
May 7, 2012 /PRNewswire/ -- Insmed
Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA) has
lifted the clinical hold previously placed on ARIKACE® (liposomal
amikacin for inhalation) in Cystic Fibrosis (CF) patients with
Pseudomonas lung infections.
Insmed has reached agreement with FDA on a revised CF clinical
trial population consisting of adult patients who have chronic
Pseudomonas lung infections and FEV-1 % predicted between
25% and 75%. The Company is continuing discussions with the
Agency in an effort to finalize additional details of the phase 3
study protocol for the potential clinical trial. At the same
time, the Company is evaluating possible next steps for the ARIKACE
U.S. CF clinical program given the current progress and anticipated
resource requirements of the ongoing ARIKACE CF (CLEAR-108) and
U.S. non-tuberculous mycobacteria (NTM) clinical programs.
"We are pleased that FDA has lifted the clinical hold on the
ARIKACE studies in both CF and, as previously disclosed, in
patients with NTM lung disease," said Timothy Whitten, President and CEO of
Insmed. "We believe that ARIKACE has the potential to be an
important treatment option for CF patients who have
Pseudomonas lung infections, and patients who have lung
infections due to NTM."
As recently announced, Insmed has begun dosing patients
in CLEAR-108, a European and Canadian registrational
phase 3 clinical study of ARIKACE in CF patients, and is proceeding
with CLEAR-110, a follow-on multi-cycle open-label study intended
primarily to measure safety and tolerability for patients who
complete CLEAR-108. The Company also previously announced it
is initiating a U.S. phase 2 clinical trial of ARIKACE in
NTM.
About Insmed
Insmed Incorporated is a biopharmaceutical company focused on
the development of innovative inhaled pharmaceuticals for the
site-specific treatment of serious lung diseases. Insmed's
primary focus is on the development of inhaled antibiotic therapy
delivered via proprietary advanced liposomal pulmonary technology
in areas of high unmet need. 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 our financial position,
results of operations, the status and the results of pre-clinical
studies and clinical trials and preclinical and clinical data
described herein, the timing of and costs associated with
pre-clinical studies and clinical trials, the development of our
products, and the business strategies, plans and objectives of
management, 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. Our results may be affected by such factors as
the receipt and timing of FDA and other regulatory reviews and
approvals, if at all, competitive developments affecting our
product development, delays in product development or clinical
trials, and patent disputes involving currently developing
products. The risks and uncertainties include, without
limitation, we may experience unexpected regulatory actions, delays
or requests, our future clinical trials may not be successful, we
may be unsuccessful in developing our product candidates or
receiving necessary regulatory approvals, we may experience delays
in our product development or clinical trials, our product
candidates may not prove to be commercially successful, our
expenses may be higher than anticipated 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,
2011. Investors 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 – FTI
Consulting
212-850-5683
brian.ritchie@fticonsulting.com
Media Contact:
Irma Gomez-Dib – FTI Consulting
212-850-5761
irma.gomez-dib@fticonsulting.com
SOURCE Insmed Incorporated