Insmed Inc. Extends ARIKAYCE Intellectual Property Protection with Issuance of New U.S. Patent
15 February 2017 - 12:05AM
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today announced that the United States Patent and Trademark Office
(USPTO) issued U.S. Patent Number 9,566,234 for ARIKAYCE, the
Company’s liposomal amikacin for inhalation. The claims of the
patent relate in part to systems and methods for treating pulmonary
infections, including nontuberculous mycobacteria (NTM) infections.
The systems each include a pharmaceutical formulation containing an
aqueous dispersion of liposomal complexed aminoglycoside, which can
be amikacin sulfate, with a nebulizer. The patent, the seventh U.S.
patent to issue to Insmed for ARIKAYCE in NTM, is expected to
provide patent coverage for ARIKAYCE in NTM into January 2034,
thereby extending previously existing patent coverage by five years
and five months. Insmed is currently evaluating ARIKAYCE in a
global Phase 3 trial in patients with NTM lung disease.
“This new patent significantly extends our long-term
intellectual property protection for ARIKAYCE in the U.S., and
provides us with further protection at a time when we will have
potentially reached a mature point in our commercial efforts for
ARIKAYCE in NTM," said Will Lewis, president and chief executive
officer of Insmed. “We will continue to pursue additional patents
in the U.S. and other major markets worldwide to further strengthen
our patent estate and enhance the value potential of ARIKAYCE.”
About Insmed
Insmed Incorporated is a global biopharmaceutical company
focused on the unmet needs of patients with rare diseases. The
company is advancing a global phase 3 clinical study of ARIKAYCE
(liposomal amikacin for inhalation) in nontuberculous mycobacteria
(NTM) lung disease, a rare and often chronic infection that is
capable of causing irreversible lung damage and can be fatal. There
are currently no products indicated for the treatment of NTM lung
disease in the United States or European Union (EU). Insmed's
earlier-stage clinical pipeline includes INS1007, a novel oral
reversible inhibitor of DPP1 with therapeutic potential in non-CF
bronchiectasis, and INS1009, an inhaled nanoparticle formulation of
a treprostinil prodrug that may offer a differentiated product
profile for rare pulmonary disorders. For more information, visit
www.insmed.com.
"Insmed" and "ARIKAYCE" are the company's trademarks. All other
trademarks, trade names or service marks appearing in this press
release are the property of their respective owners.
Forward-looking statements
This press release contains forward looking statements.
"Forward-looking statements," as that term is defined in the
Private Securities Litigation Reform Act of 1995, are statements
that are not historical facts and involve a number of risks and
uncertainties. Words herein such as "may," "will," "should,"
"could," "would," "expects," "plans," "anticipates," "believes,"
"estimates," "projects," "predicts," "intends," "potential,"
"continues," and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances)
identify forward-looking statements.
Forward-looking statements are based upon the company's current
expectations and beliefs, and involve known and unknown risks,
uncertainties and other factors, which may cause actual results,
performance and achievements and the timing of certain events to
differ materially from the results, performance, achievements or
timing discussed, projected, anticipated or indicated in any
forward-looking statements. Such factors include, among others, the
factors discussed in Item 1A "Risk Factors" in the company's Annual
Report on Form 10-K for the year ended December 31, 2016 and
subsequent quarterly reports on Form 10-Q, and the following: the
ability to complete development of, receive, and maintain
regulatory approval for, and successfully commercialize ARIKAYCE,
INS1007, and INS1009; the number of patients enrolled and the
timing of patient enrollment in the company's global phase 3
clinical study of ARIKAYCE; the ability to successfully develop
INS1007 (formerly known as AZD7986) for the treatment of non-CF
bronchiectasis; estimates of expenses and future revenues and
profitability; status, timing, and the results of preclinical
studies and clinical trials and preclinical and clinical data
described herein; the sufficiency of preclinical and clinical data
in obtaining regulatory approval for the company's product
candidates; the timing of responses to information and data
requests from the US Food and Drug Administration, the European
Medicines Agency, and other regulatory authorities; expectation as
to the timing of regulatory review and approval; estimates
regarding capital requirements, including milestone payments and
royalty obligations due to AstraZeneca, and the needs for
additional financing, the ability to repay our existing
indebtedness, estimates of the size of the potential markets for
product candidates; selection and licensing of product candidates;
the ability to attract third parties with acceptable development,
regulatory and commercialization expertise; the benefits to be
derived from corporate license agreements and other third party
efforts, including those relating to the development and
commercialization of product candidates; the degree of protection
afforded to the company by its intellectual property portfolio; the
safety and efficacy of product candidates; sources of revenues and
anticipated revenues, including contributions from license
agreements and other third party efforts for the development and
commercialization of products; the ability to create an effective
direct sales and marketing infrastructure for products the company
elects to market and sell directly; the rate and degree of market
acceptance of product candidates; the impact of any litigation the
company is a party to, including, without limitation, the class
action lawsuit filed against the company; the timing, scope and
rate of reimbursement for product candidates; the success of other
competing therapies that may become available; and the availability
of adequate supply and manufacturing capacity and quality for
product candidates.
The company cautions readers not to place undue reliance on any
such forward-looking statements, which speak only as of the date
they are made. Insmed disclaims any obligation, except as
specifically required by law and the rules of the Securities and
Exchange Commission, to publicly update or revise any such
statements to reflect any change in expectations or in events,
conditions or circumstances on which any such statements may be
based, or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements.
Investor Contact:
Laura Perry
Argot Partners
212.600.1902
laura@argotpartners.com
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