MONMOUTH JUNCTION, N.J.,
Oct. 14, 2011 /PRNewswire/ -- Insmed
Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today
announced that the Company has been notified by the U.S. Food and
Drug Administration (FDA) that it is continuing the clinical hold
previously placed on Insmed's phase 3 clinical trial for ARIKACE®
(liposomal amikacin for inhalation) in patients with
non-tuberculous mycobacterial (NTM) lung disease.
As announced on August 1, 2011,
the clinical holds placed on ARIKACE in NTM and Cystic Fibrosis
(CF) patients with Pseudomonas lung infections were based on
an initial review by FDA of the interim results of a long-term rat
inhalation carcinogenicity study reported to the Agency by Insmed
with ARIKACE. At that time, FDA requested additional
information on ARIKACE and data from the rat study. Insmed
submitted its complete response to this request before the end of
August.
Insmed has been informed by FDA that, based on its review of the
information provided to date, including the rat inhalation
carcinogenicity study results, the Agency has insufficient
information to assess the risks of ARIKACE in NTM patients in the
planned phase 3 clinical trial. FDA is requiring that Insmed
conduct a phase 2 clinical trial in adult NTM patients intended to
provide proof-of-concept efficacy and safety data for ARIKACE in
NTM before the Company can proceed with a phase 3 clinical trial.
In addition, Insmed will also need to further revise the
assessment of the rat carcinogenicity study findings in the
investigator brochure.
"Now that we have responses from FDA with respect to both
clinical holds, we are seeking further input from the Agency in
order to gain a better understanding of their requests regarding CF
and NTM," said Timothy Whitten,
President and CEO of Insmed. "Once we have received
clarifications from FDA on their requests, and have sufficient
opportunity to evaluate potential next steps, we will provide a
further update to the market."
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 June 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