MONMOUTH JUNCTION, N.J.,
June 27, 2012 /PRNewswire/
-- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical
company, today announced that the first patient has been dosed in
the Company's U.S. phase 2 clinical study of ARIKACE® (liposomal
amikacin for inhalation) in patients with non-tuberculous
mycobacterial (NTM) lung disease entitled TARGET-NTM
(Treatment with ARIKACE to Realize
Greater Efficacy Trial).
"The prevalence of this debilitating chronic disease continues
to grow, and the current NTM treatment paradigm lacks acceptable
treatment options," said Mark Rolfe,
M.D. FCCP, President of New Lung Associates P.A., Medical Director
of the Lung Transplant and Adult Cystic Fibrosis Programs at Tampa
General Hospital, where the first patient in the trial was
dosed. "Many of these patients are treated with combinations
of antibiotics which have shown limited efficacy and are poorly
tolerated, especially when given long term. It has been many years
since we had a promising new treatment to study in these patients,
and I believe that if ARIKACE is successful in clinical trials,
such as this one, then it has the potential to become an important
treatment option for patients suffering from NTM lung
infections."
The Principal Investigator of the study is Kenneth N. Olivier, M.D., M.P.H., staff
pulmonologist in the Laboratory of Clinical Infectious Diseases at
the National Institute of Allergy and Infectious Diseases, part of
the National Institutes of Health.
"The dosing of the first patient in this clinical trial is an
important step in the development of ARIKACE," said Timothy Whitten, President and CEO of
Insmed. "Individuals who have NTM lung infections are part of
a substantially underserved patient population, and if ARIKACE is
shown effective in this indication, it could prove to be a
significant advancement in the treatment of this orphan
disease."
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.
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 pre-clinical
studies and clinical trials and pre-clinical and clinical data
described herein, the timing of and costs associated with
pre-clinical studies and clinical trials, the development of our
products, our estimates of the size of the potential markets for
our product candidates, 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 and
our Quarterly Report on Form 10-Q for the quarter ended
March 31, 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 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