Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today announced the appointment of Leo Lee to its Board of
Directors. Mr. Lee has more than 21 years of experience in the
pharmaceutical industry in Japan; most recently at Merck KGaA, a
global pharmaceutical company, where he served as President, Japan.
“We are delighted to welcome Leo to the Insmed
Board, where his deep global commercial expertise will be
invaluable to Insmed as we prepare for the potential launch of ALIS
(Amikacin Liposome Inhalation Suspension) in the United States,”
said Will Lewis, President and Chief Executive Officer of Insmed.
“Concurrently we are expanding our global footprint, beginning with
Japan, where we are building our infrastructure to support a
potential future launch in this geography where the prevalence of
NTM lung disease is high. We look forward to Leo’s guidance based
on the depth of his experience in commercial leadership roles in
Japan and the Asia Pacific region.”
“I am honored to be joining the Insmed Board at
such an exciting time for the company. The potential for a product
launch in the US in 2018 combined with the rapid geographic
expansion plans for Japan make this a perfect fit for my
background,” said Lee. “I look forward to working with the other
members of the Insmed Board and the management team to maximize
Insmed’s potential.”
Prior to his role at Merk KGaA, Mr. Lee served
as President, Japan of Allergan plc, a global pharmaceutical
company, from 2011 to 2015. Before that he served as Vice President
of Sales at Merck & Co. from 2008 to 2011. From 2003 to 2008,
he held various commercial positions at IQVIA (Cegedim Dendrite), a
life sciences services company. Mr. Lee also served in various
roles at Accelrys, Inc., a software company serving pharmaceutical
and biotech companies, from 1997 to 2003. Currently, Mr. Lee serves
on the Board of Directors of Regeneus Ltd, a global pharmaceutical
company based in Australia. Mr. Lee received a B.S. in Molecular
Genetics and Microbiology from the University of California, Los
Angeles.
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,
which is in late-state development 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 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)
may 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 data
from the remainder of the treatment and off-treatment phases of
INS-212 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 INS-212 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 INS-212 study and
endpoints in the INS-212 extension study (the INS-312 study); risks
that subsequent data from the INS-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 or may be a party, loss of key personnel; and
lack of experience operating internationally.
The Company may not actually achieve the
results, plans, intentions or expectations indicated by the
Company’s 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 Annual Report on Form 10-K for the year ended December
31, 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.
Contact:Blaine Davis Insmed Incorporated (908)
947-2841 blaine.davis@insmed.com
Insmed (NASDAQ:INSM)
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