BRIDGEWATER, N.J., Feb. 20, 2018 (GLOBE NEWSWIRE) -- 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 9,895,385 concerning methods for treating nontuberculous mycobacterial (NTM)
lung infections, including NTM lung infections caused by Mycobacterium avium complex (MAC), with the Company’s amikacin
liposome inhalation suspension (ALIS). The claims of the patent relate to methods for treating MAC lung infections via
administration of ALIS to non-cystic fibrosis patients by nebulization once daily for a defined treatment period. The patent
extends previously existing patent coverage for ALIS by sixteen months, from January 2034 into May 2035. Insmed is currently on
track to file its New Drug Application (NDA) for accelerated approval of ALIS with the U.S. Food and Drug Administration (FDA)
before the end of March.
“The term of this new patent could run almost five years beyond our regulatory designations in the United
States, and is therefore a key addition to our growing patent estate for ALIS, which now includes nine issued US patents,” said
Will Lewis, President and Chief Executive Officer of Insmed. “Insmed places an emphasis on strategies for protecting ALIS and its
other key assets in line with potential market opportunities and will continue to pursue additional patents in major markets
worldwide to further enhance the value potential of ALIS.”
About Insmed
Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare
diseases. The Company’s lead product candidate is ALIS for adult patients with treatment refractory NTM lung disease caused by MAC,
which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. Insmed's
earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1 with therapeutic
potential in non-cystic fibrosis bronchiectasis and other inflammatory diseases and INS1009, an inhaled nanoparticle formulation of
a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial
hypertension. For more information, visit www.insmed.com.
Forward-looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties.
"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 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.
The forward-looking statements in this press release are based upon the Company’s current expectations and
beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company’s 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 risks, uncertainties and other
factors include, among others, the following: risks that the full six-month data from the CONVERT study or subsequent data from the
remainder of the study’s treatment and off-treatment phases will not be consistent with the top-line six-month results of the
study; uncertainties in the research and development of the Company’s existing product candidates, including due to delays in data
readouts, such as the full data from the CONVERT study, patient enrollment and retention or failure of the Company’s preclinical
studies or clinical trials to satisfy pre-established endpoints, including secondary endpoints in the CONVERT study and endpoints
in the CONVERT extension study (the 312 study); risks that subsequent data from the 312 study will not be consistent with the
interim results; failure to obtain, or delays in obtaining, regulatory approval from the U.S. Food and Drug Administration, Japan’s
Ministry of Health, Labour and Welfare, Japan’s Pharmaceuticals and Medical Devices Agency, the European Medicines Agency, and
other regulatory authorities for the Company’s product candidates or their delivery devices, such as the eFlow Nebulizer System,
including due to insufficient clinical data, selection of endpoints that are not satisfactory to regulators, complexity in the
review process for combination products or inadequate or delayed data from a human factors study required for U.S. regulatory
approval; failure to maintain regulatory approval for the Company’s product candidates, if received, due to a failure to satisfy
post-approval regulatory requirements, such as the submission of sufficient data from confirmatory clinical studies; safety and
efficacy concerns related to the Company’s product candidates; lack of experience in conducting and managing preclinical
development activities and clinical trials necessary for regulatory approval, including the regulatory filing and review process;
failure to comply with extensive post-approval regulatory requirements or imposition of significant post-approval restrictions on
the Company’s product candidates by regulators; uncertainties in the rate and degree of market acceptance of product candidates, if
approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer
such an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates
of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment
population for the Company’s product candidates; failure of third parties on which the Company is dependent to conduct the
Company’s clinical trials, to manufacture sufficient quantities of the Company’s product candidates for clinical or commercial
needs, including the Company’s raw materials suppliers, or to comply with the Company’s agreements or laws and regulations that
impact the Company’s business; inaccurate estimates regarding the Company’s future capital requirements, including those necessary
to fund the Company’s ongoing clinical development, regulatory and commercialization efforts as well as milestone payments or
royalties owed to third parties; failure to develop, or to license for development, additional product candidates, including a
failure to attract experienced third-party collaborators; uncertainties in the timing, scope and rate of reimbursement for the
Company’s product candidates; changes in laws and regulations applicable to the Company’s business and failure to comply with such
laws and regulations; inability to repay the Company’s existing indebtedness or to obtain additional capital when needed on
desirable terms or at all; failure to obtain, protect and enforce the Company’s patents and other intellectual property and costs
associated with litigation or other proceedings related to such matters; restrictions imposed on the Company by license agreements
that are critical for the Company’s product development, including the Company’s license agreements with PARI Pharma GmbH and
AstraZeneca AB, and failure to comply with the Company’s obligations under such agreements; competitive developments affecting the
Company’s product candidates and potential exclusivity related thereto; the cost and potential reputational damage resulting from
litigation to which the Company is a party, including, without limitation, the class action lawsuit pending against the Company;
loss of key personnel; lack of experience operating internationally; and risks that the net proceeds from our offerings of our
securities are not spent as currently intended or in ways that enhance the value of your investment.
We may not actually achieve the results, plans, intentions or expectations indicated by our forward-looking
statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and
depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that
may affect the Company’s business, please see the factors discussed in Item 1A, "Risk Factors," in the Company’s Quarterly Report
on Form 10-Q for the three months ended September 30, 2017 and any subsequent filings with the Securities and Exchange
Commission.
The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak
only as of the date of this press release. The Company 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. You should read this press release with the
understanding that our actual future results may be materially different from those expressed in forward-looking statements.
Contact:
Blaine Davis
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com