MONMOUTH JUNCTION, N.J.,
Aug. 1, 2011 /PRNewswire/ -- Insmed
Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today
announced that the U.S. Food and Drug Administration (FDA) has
notified the Company that the agency has placed a clinical hold on
Insmed's phase 3 clinical trials for ARIKACE® (liposomal amikacin
for inhalation) in Cystic Fibrosis (CF) patients with
Pseudomonas lung infections and patients with
non-tuberculous mycobacterial (NTM) lung disease. A clinical
hold is a notification issued by FDA to the sponsor to delay a
proposed clinical trial or suspend an ongoing clinical trial.
The Company has been informed by FDA that this decision was
based on an initial review of the interim results of a long-term
rat inhalation carcinogenicity study, recently reported to the
agency by Insmed, with ARIKACE. In this study, rats received
daily doses of ARIKACE by inhalation for up to two years.
FDA has requested additional information on ARIKACE and data
from the rat study. Insmed anticipates being able to supply
the currently requested information and data within the next 30
days.
As a result of the clinical hold, the Company has suspended
initiation of the ARIKACE phase 3 clinical trial programs,
including the recruitment and enrollment of patients. To
date, no patients have been dosed in the pending clinical trials.
The clinical hold will remain in effect at least until FDA
reviews the information and data that is provided by Insmed.
"We will work closely with FDA to provide the agency with all
appropriate information and data required to expedite their review
and evaluation," said Timothy
Whitten, President and CEO of Insmed. "Once FDA has
completed its review, we can better assess the impact this clinical
hold might have on our phase 3 clinical programs for ARIKACE in CF
and 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 pulmonary liposome technology in
areas of high unmet need in lung diseases. 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 preclinical
studies and clinical trials and preclinical and clinical data
described herein, the timing of responses to information and data
requests from FDA, 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 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, 2010.
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 - FD
212-850-5683
brian.ritchie@fd.com
Media Contact:
Irma Gomez-Dib - FD
212-850-5761
irma.gomez-dib@fd.com
SOURCE Insmed Incorporated