ARIKACE Receives Orphan Drug Designation for Treating Infections Caused by Non-Tuberculous Mycobacteria
28 Mars 2013 - 1:00PM
Marketwired
Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company
focused on developing and commercializing inhaled therapies for
patients battling serious lung diseases in orphan indications that
are often life-threatening, today announced that ARIKACE®, the
Company's Iiposomal amikacin for inhalation, has received orphan
drug designation from the U.S. Food and Drug Administration (FDA)
Office of Orphan Products Development for the treatment of
infections caused by non-tuberculous mycobacteria (NTM).
Orphan drug designation provides certain exclusivity benefits,
tax credits for certain research and a waiver of the New Drug
Application user fee. According to a recent company-sponsored
patient chart study conducted by Clarity Pharma Research,
approximately 50,000 cases of NTM lung disease were treated by
physicians in the U.S. during 2011. There is no current
FDA-approved treatment for NTM lung infection.
"The FDA's timely approval of our request for orphan drug
designation for ARIKACE to treat non-tuberculous mycobacteria is a
key milestone that supports our broader strategy for this
potentially life-saving therapy," stated Will Lewis, President and
Chief Executive Officer of Insmed. "NTM is a chronic, debilitating
disease, and currently available treatments have shown limited
efficacy and tolerability. We continue to enroll patients in our
phase 2 clinical trial of ARIKACE to treat NTM patients in the U.S.
and Canada and look forward to having top-line data by the end of
this year."
About Insmed
Insmed Incorporated is a biopharmaceutical company dedicated to
improving the lives of patients battling serious lung diseases
through the development and commercialization of inhalation
therapies in orphan patient populations with critical unmet needs.
Insmed's lead candidate, ARIKACE® or liposomal amikacin for
inhalation, 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 aeruginosa lung infections and patients
with non-tuberculous mycobacteria lung infections (NTM). Insmed's
phase 3 registrational study of ARIKACE in Europe and Canada
completed enrollment and the Company expects top-line clinical
results in mid-2013. Insmed's phase 2 clinical trial in patients
with NTM is well under way in the U.S. and Canada with clinical
results expected in late 2013. For more information, please visit
http://www.insmed.com.
Forward-Looking Statements
This release contains forward-looking statements that 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 preclinical studies and clinical trials and
preclinical and clinical data and the anticipated benefits of
Insmed's products, constitute forward-looking statements that
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 candidates, delays in product development or clinical
trials or other studies, patent disputes and other intellectual
property developments relating to our product candidates,
unexpected regulatory actions, delays or requests, the failure of
clinical trials or other studies or results of clinical trials or
other studies that do not meet expectations, 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, 2012. Investors are
cautioned not to place undue reliance on any forward-looking
statements that speak only as of the date of this news release. We
undertake no obligation to update these forward-looking statements
to reflect events or circumstances or changes in our
expectations.
Investor Relations Contact: LHA Anne Marie Fields Senior
Vice President 212-838-3777 afields@lhai.com Bruce Voss Managing
Director 310-691-7100 bvoss@lhai.com
Insmed (NASDAQ:INSM)
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