MONMOUTH JUNCTION, N.J.,
Jan. 20, 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 patients with
non-tuberculous mycobacteria (NTM) lung disease. Insmed
continues to engage in discussions with FDA regarding the clinical
hold placed on ARIKACE in Cystic Fibrosis (CF) patients with
Pseudomonas lung infections.
The clinical holds placed on the ARIKACE programs in NTM and CF
were based on an initial review by FDA of the results reported by
Insmed of a long-term rat inhalation carcinogenicity study of
ARIKACE.
FDA previously requested that Insmed conduct a phase 2 clinical
trial of ARIKACE in adult patients with NTM to provide
proof-of-concept efficacy and safety data before proceeding with a
phase 3 clinical trial. As part of its on-going assessment of
the appropriate path forward for the ARIKACE program, including the
phase 2 trial of ARIKACE in NTM patients, the Company is continuing
communication with FDA regarding the CF clinical hold.
Insmed also announced that it will move ahead with the 9-month
dog inhalation toxicity study of ARIKACE as previously requested by
FDA to determine if the findings of the rat inhalation
carcinogenicity study are observed in a non-rodent model.
"We are pleased that FDA has lifted the clinical hold on the
ARIKACE development program in NTM," said Timothy Whitten, President and CEO of
Insmed. "Insmed continues to work closely with regulatory
authorities regarding the development program for ARIKACE. We
are initiating the work required to begin the 9-month dog study
during the second quarter and are continuing our dialogue with FDA
regarding the CF clinical program."
Insmed also announced that IPLEX® inventory has now been fully
depleted. At present, about 10 patients remain on drug.
Regarding potential future IPLEX initiatives, the Company is
currently evaluating possible out-licensing opportunities for the
drug.
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, and has a
proprietary protein platform aimed at niche markets with high unmet
medical need. 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 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, 2010 and our Quarterly Report on
Form 10-Q for the quarter ended September
30, 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