Insmed Announces CLEAR-108 Phase 3 Clinical Study of ARIKACE® in
Cystic Fibrosis Patients with Pseudomonas Lung Infections Has
Completed Target Enrollment
MONMOUTH JUNCTION, N.J.,
Nov. 13, 2012 /PRNewswire/
-- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical
company focused on developing inhaled therapeutics for serious
diseases of the lung, today announced that the Company's
CLinical Evaluation of ARIKACE (CLEAR-108)
phase 3 European and Canadian registrational study of ARIKACE®
(liposomal amikacin for inhalation) for Cystic Fibrosis (CF)
patients with Pseudomonas aeruginosa (Pa) lung infections
has now enrolled over 300 patients.
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) (tobramycin
solution for inhalation), which is a commercially available inhaled
antibiotic that is delivered twice daily. The study is being
conducted in over 300 patients in Europe and Canada.
"The completion of enrollment in this pivotal phase 3 clinical
trial represents an important milestone for Insmed as we advance
ARIKACE closer to commercialization," said Will Lewis, President and CEO of Insmed.
"We continue to expect top-line data from CLEAR-108 to be available
in mid-2013."
About Insmed
Insmed Incorporated is a biopharmaceutical company dedicated to
improving the lives of patients battling serious orphan lung
diseases through the development and commercialization
of novel, targeted inhalation therapies in orphan patient
populations with critical unmet needs. Insmed's lead
candidate, ARIKACE®, is engineered to deliver a
proven and potent anti-infective directly to the site of serious
lung infections to improve the efficacy, safety and
convenience of treatment for at least two identified patient
populations: cystic fibrosis (CF) patients with Pseudomonas
lung infections and patients with nontuberculous mycobacteria lung
infections (NTM). Following positive phase 2 results in CF
patients, Insmed's phase 3 registrational study of ARIKACE
(CLEAR-108) in Europe and
Canada is well underway, as is the
U.S. Phase 2 trial in NTM (TARGET-NTM). The Company expects to
report clinical results from both the CF Phase 3 and NTM Phase 2
studies in 2013 and currently is preparing for regulatory filings
and for commercialization, if and when regulatory approvals are
obtained. 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. Words, and variations of words, such as "intend",
"expect", "will", "anticipate", "believe", "continue", "propose"
and similar expressions are intended to identify forward-looking
statements. Investors are cautioned that such statements in
this release, including statements relating to the status, results
and timing of results of pre-clinical studies and clinical trials
and pre-clinical and clinical data and the anticipated benefits of
Insmed's products, constitute forward-looking statements which
involve risks and uncertainties that could cause actual results to
differ materially from those in the forward-looking statements.
Such risks and uncertainties include, without limitation, failure
or delay of U.S. Food and Drug Administration and other regulatory
reviews and approvals, competitive developments affecting our
product development, delays in product development or clinical
trials, patent disputes involving currently developing products,
unexpected regulatory actions, delays or requests, the failure of
future clinical trials, inability to successfully develop our
product candidates or receive necessary regulatory approvals,
inability to make product candidates commercially successful,
changes in anticipated expenses, 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 and our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. 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 update these forward-looking statements to reflect
events or circumstances or changes in our expectations.
(1)TOBI® is a Registered Trademark of Novartis Pharmaceuticals
Corporation
Investor Relations Contact:
Brian Ritchie – FTI Consulting
646-576-8117
brian.ritchie@fticonsulting.com
Media Contact:
Irma Gomez-Dib – FTI Consulting
646-576-8112
irma.gomez-dib@fticonsulting.com
SOURCE Insmed Incorporated