Insmed Fortifies Global Patent Portfolio
11 Septembre 2013 - 1:30PM
Marketwired
Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company
focused on developing and commercializing an inhaled anti-infective
to treat patients battling serious lung diseases in orphan
indications that are often life-threatening, announces two
important patent allowances in the U.S. and Europe that strengthen
the Company's global patent portfolio. Insmed is focused on the
development and commercialization of ARIKACE® (liposomal amikacin
for inhalation) for at least two identified orphan patient
populations: cystic fibrosis (CF) patients with Pseudomonas
aeruginosa lung infections and patients with non-tuberculous
mycobacteria (NTM) lung infections.
The U.S. Patent and Technology Office (USPTO) intends to grant
U.S. Patent Application No. 13/666,420 for ARIKACE in a patent
titled, "Lipid-based compositions of anti-infectives for treating
pulmonary infections and methods of use thereof." Once granted, it
will provide exclusivity at least through December 5, 2026. The new
U.S. patent will cover an aerosolized composition of Insmed's
novel, once-daily inhalation formulation comprising amikacin and
liposomal delivery technology for the treatment of pulmonary
infections, including Pseudomonas aeruginosa and mycobacterial
infections, among others.
In May 2010 and July 2012, the USPTO issued
composition-of-matter patents covering the Company's liposomal
amikacin for inhalation, with exclusivity extending until at least
June 2025 and August 2028, respectively.
The European Patent Office intends to grant EU Patent
Application No. 03816990 for ARIKACE in a patent titled, "Sustained
release of anti-infectives." Once granted, it will provide
exclusivity at least through October 29, 2023 in any European
Patent Office member state where Insmed chooses to validate the
patent. This patent will provide protection for the use of
ARIKACE's formulation comprising amikacin and liposomal delivery
technology for the treatment of pulmonary infections in CF
patients. Specifically, the allowed patent application includes
claims relating to the use of the aforementioned formulation for
treating Pseudomonas aeruginosa pulmonary infections, as well as
certain mycobacterial infections among others.
This patent allowance is in addition to the recent European
Patent Office's issuance of EU patent No. 1909759 for ARIKACE that
will provide exclusivity through at least July 19, 2026.
"These patent allowances provide a firm foundation for our
ARIKACE intellectual property estate, which now includes four
granted and allowed U.S. patents and 27 granted and allowed patents
in Europe and other countries including Japan, Australia, China and
Korea," commented Walter Perkins, Ph.D., Chief Technology Officer
of Insmed.
Will Lewis, President and Chief Executive Officer of Insmed,
commented, "These new patent allowances are a credit to our
technology development team and demonstrate the inventiveness and
utility of our approach to treating serious and oftentimes
life-threatening lung diseases. As we move toward potential
marketing approval and commercialization of ARIKACE to treat
Pseudomonas aeruginosa in CF patients in Europe and Canada, and
continue the clinical development of our liposomal amikacin for
inhalation to treat NTM in the U.S., these new patent allowances
provide additional protection for this valuable asset. We are
pursuing a broad intellectual property strategy that provides the
foundation to achieve our global clinical and commercial objectives
and protects shareholder value."
About Insmed Insmed Incorporated is a
biopharmaceutical company dedicated to improving the lives of
patients battling serious lung diseases. Insmed is focused on the
development and commercialization of ARIKACE®, or liposomal
amikacin for inhalation, for at least two identified orphan patient
populations: cystic fibrosis (CF) patients with Pseudomonas
aeruginosa lung infections and patients with non-tuberculous
mycobacteria (NTM) lung infections. 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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