Insmed Fortifies Global Patent Portfolio

Insmed Fortifies Global Patent Portfolio 
Further Expands Intellectual Property Foundation in U.S. and Europe
as Company Advances Commercial Plans for ARIKACE to Treat Pulmonary
Infections 
MONMOUTH JUNCTION, NJ -- (Marketwired) -- 09/11/13 --  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(R) (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(R), 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 
 
 
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