MONMOUTH JUNCTION, N.J.,
Feb. 10, 2012 /PRNewswire/
-- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical
company, today announced that the Company is proceeding with a
phase 2 clinical trial of ARIKACE® (liposomal amikacin for
inhalation) in patients with non-tuberculous mycobacteria (NTM)
lung disease, as well as the previously planned European
registration phase 3 clinical study of ARIKACE in Cystic Fibrosis
(CF) patients with Pseudomonas aeruginosa (Pa) lung
infections. Simultaneously, Insmed continues its discussions with
the U.S. Food and Drug Administration (FDA) regarding the clinical
hold previously placed on the ARIKACE clinical study in CF patients
with Pa lung infections.
"I am pleased to announce that we are moving forward with the
ARIKACE clinical development program in NTM in the U.S., and with
the European CF program," said Timothy
Whitten, President and CEO of Insmed. "We look forward
to continuing our dialogue with FDA regarding the CF clinical
program in the U.S., and continue to believe that ARIKACE has the
potential to be an important treatment option for CF and NTM
patients."
The phase 2 clinical trial for ARIKACE in NTM patients will
consist of a randomized, placebo-controlled study of approximately
100 adult patients with recalcitrant NTM lung disease.
Patients who are NTM culture positive will continue with their
antibiotic treatment regimen, and receive additionally, either
ARIKACE 560 mg, delivered once daily via an optimized,
investigational eFlow® Nebulizer System (PARI Pharma GmbH), or
placebo once daily. The primary efficacy endpoint will be
change in mycobacterial density from baseline to the end of 84 days
of treatment. At the conclusion of the randomized portion of
the study, eligible patients will receive ARIKACE 560 mg once daily
for an additional 84 days in an open-label design, primarily to
measure longer-term safety and efficacy. The clinical trial
design was previously agreed upon by Insmed and FDA. The
Company expects to begin enrolling patients in the phase 2 clinical
trial in mid-2012.
The European study in CF patients with Pa lung infections
will be a randomized, phase 3 trial comparing ARIKACE 560 mg,
delivered once daily via an optimized, investigational eFlow
Nebulizer System, to TOBI®(1) (inhaled tobramycin solution),
which is a marketed inhaled antibiotic that is delivered twice
daily. The Company anticipates that the study will be conducted in
approximately 300 patients. The primary endpoint will be
change in pulmonary function (FEV-1) measured after three 28 day
on-treatment and three 28 day off-treatment cycles (about six
months). A key secondary endpoint will be time to
pulmonary exacerbation. The study design was previously
agreed upon by Insmed and the European Medicines Agency.
Eligible patients will have the option to participate in a
longer term open-label safety study. The Company expects to
begin enrolling patients in the phase 3 European clinical study in
the second quarter of 2012.
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.
About eFlow® Technology and PARI Pharma
ARIKACE is delivered by an investigational eFlow® Nebulizer
System developed by PARI Pharma and optimized specifically for
ARIKACE. The optimized device uses eFlow Technology to enable
highly efficient aerosolization of medication including liposomal
formulations via a vibrating, perforated membrane that includes
thousands of laser drilled holes. Compared to other nebulization
technologies, eFlow Technology produces aerosols with a very high
density of active drug, a precisely defined droplet size, and a
high proportion of respirable droplets delivered in the shortest
possible period of time. eFlow® Technology is not an ultrasonic
nebulizer technology, and it is not a general purpose electronic
aerosol generator nebulizer technology. Combined with its quiet
mode of operation, small size, light weight, and battery use, eFlow
Technology reduces the burden of taking daily, inhaled treatments.
PARI Pharma focuses on the development of aerosol delivery devices
and inhalation drug development to advance aerosol therapies where
drug and device can be optimized together. Online at
www.paripharma.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.
(1) TOBI® is a Registered Trademark of Novartis
Pharmaceuticals Corporation
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