MONMOUTH JUNCTION, N.J.,
April 16, 2012 /PRNewswire/
-- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical
company, today announced the initiation of the Company's
CLinical Evaluation of ARIKACE phase 3 study
(CLEAR-108) of ARIKACE® (liposomal amikacin for inhalation) in
Europe for Cystic Fibrosis (CF)
patients with Pseudomonas aeruginosa (Pa) lung
infections.
"The initiation of this clinical trial represents an important
milestone for Insmed as we advance our ARIKACE program," said
Timothy Whitten, President and CEO
of Insmed. "Even with currently available treatments, chronic
Pa lung infections remain a significant medical issue for CF
patients, and we believe ARIKACE has the potential to be an
important treatment option for these patients. In our
randomized, placebo controlled phase 2 clinical study, ARIKACE
demonstrated statistically significant improvement in lung function
over the course of one complete 28-day on-treatment and 28-day
off-treatment cycle in CF patients with Pa lung infections.
Our goal is to confirm the benefits of ARIKACE in this phase
3 trial."
CLEAR-108 is a randomized, phase 3 trial comparing ARIKACE 560
mg, delivered once daily via an optimized, investigational eFlow®
Nebulizer System (PARI Pharma GmbH), to TOBI®(1) (inhaled
tobramycin solution), which is a commercially available 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, called
CLEAR-110. The study's Principal Investigator is Diana Bilton, M.D., Director of Adult CF Centre
at the Royal Brompton Hospital in London, England.
Top-line data from CLEAR-108 are currently expected to be
available in the second half of 2013.
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.
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 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.
(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