BRIDGEWATER, N.J., April 2, 2020 /PRNewswire/ -- Insmed Incorporated
(Nasdaq:INSM), a global biopharmaceutical company on a mission to
transform the lives of patients with serious and rare diseases,
today announced the appointment of Carol A.
Schafer to its Board of Directors. Ms. Schafer has more than
25 years of experience in investment banking and equity capital
markets, and currently serves as a Managing Partner at Hyphen
Advisors, LLC.
"We are thrilled to welcome Carol to our Board of Directors,"
said Will Lewis, Chairman and CEO of
Insmed. "In addition to her strong financial acumen, Carol brings
meaningful knowledge of business development and marketing, a deep
commitment to mentorship and community development, and notable
board experience in the biopharmaceutical industry, all of which
will be a great asset to our organization."
"I am honored to join the Insmed Board and use my experience to
further support the Company's growth as it prepares for potential
commercialization in Europe and
Japan and seeks to advance an
exciting pipeline of potentially novel therapies," said Ms.
Schafer. "I look forward to working with fellow Board members and
the Insmed management team to champion the rare disease community
and bring much-needed therapies to patients."
Prior to Hyphen Advisors, Ms. Schafer worked at Wells Fargo
Securities, most recently serving as Vice Chair, Equity Capital
Markets. She also previously served as the Vice President of
Finance and Business Development at Lexicon Pharmaceuticals, a
publicly traded biotechnology company, and as a Managing Director
at J.P. Morgan. Ms. Schafer earned an MBA from New York University's Stern School of Business and
a Bachelor of Arts from Boston College.
She currently serves on the Board of Directors for the publicly
traded companies Idera Pharmaceuticals, Inc. and Five Prime
Therapeutics, Inc., as well as the private company Repare
Therapeutics Inc.
About Insmed
Insmed Incorporated is a global biopharmaceutical company on a
mission to transform the lives of patients with serious and rare
diseases. Insmed's first commercial product,
ARIKAYCE® (amikacin liposome inhalation
suspension), is the first and only therapy approved in the
United States for the treatment of
refractory Mycobacterium avium complex (MAC) lung
disease as part of a combination antibacterial drug regimen for
adult patients with limited or no alternative treatment options.
MAC lung disease is a chronic, debilitating condition that can
cause severe and permanent lung damage. 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 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: business or economic disruptions due to catastrophes or
other events, including natural disasters or public health crises,
such as the coronavirus; the risk that the full data set from
WILLOW or data generated in further clinical trials of INS1007 will
not be consistent with the top-line results of WILLOW; failure to
successfully commercialize or maintain U.S. approval for ARIKAYCE,
the Company's only approved product; uncertainties in the degree of
market acceptance of ARIKAYCE by physicians, patients, third-party
payors and others in the healthcare community; the Company's
inability to obtain full approval of ARIKAYCE from the FDA,
including the risk that the Company will not timely and
successfully complete the study to validate a PRO tool and complete
the confirmatory post-marketing study required for full approval of
ARIKAYCE; inability of the Company, PARI or the Company's other
third party manufacturers to comply with regulatory requirements
related to ARIKAYCE or the Lamira® Nebulizer
System; the Company's inability to obtain adequate reimbursement
from government or third-party payors for ARIKAYCE or acceptable
prices for ARIKAYCE; development of unexpected safety or efficacy
concerns related to ARIKAYCE or INS1007; inaccuracies in the
Company's estimates of the size of the potential markets for
ARIKAYCE or INS1007 or in data the Company has used to identify
physicians; expected rates of patient uptake, duration of expected
treatment, or expected patient adherence or discontinuation rates;
the Company's inability to create an effective direct sales and
marketing infrastructure or to partner with third parties that
offer such an infrastructure for distribution of ARIKAYCE; failure
to obtain regulatory approval to expand ARIKAYCE's indication to a
broader patient population; failure to successfully conduct future
clinical trials for ARIKAYCE, INS1007 and the Company's other
product candidates, including due to the Company's limited
experience in conducting preclinical development activities and
clinical trials necessary for regulatory approval and the Company's
inability to enroll or retain sufficient patients to conduct and
complete the trials or generate data necessary for regulatory
approval; risks that the Company's clinical studies will be delayed
or that serious side effects will be identified during drug
development; failure to obtain, or delays in obtaining, regulatory
approvals for ARIKAYCE outside the U.S. or for the Company's
product candidates in the U.S., Europe, Japan or
other markets, including the United Kingdom as a result
of its recent exit from the European Union; failure of third
parties on which the Company is dependent to manufacture sufficient
quantities of ARIKAYCE or the Company's product candidates for
commercial or clinical needs, to conduct the Company's clinical
trials, or to comply with laws and regulations that impact the
Company's business or agreements with the Company; the Company's
inability to attract and retain key personnel or to effectively
manage the Company's growth; the Company's inability to adapt to
its highly competitive and changing environment; the Company's
inability to adequately protect its intellectual property rights or
prevent disclosure of its trade secrets and other proprietary
information and costs associated with litigation or other
proceedings related to such matters; restrictions or other
obligations imposed on the Company by its agreements related to
ARIKAYCE or the Company's product candidates, including its license
agreements with PARI and AstraZeneca AB, and failure of the Company
to comply with its obligations under such agreements; the cost and
potential reputational damage resulting from litigation to which
the Company is or may become a party, including product liability
claims; the Company's limited experience operating internationally;
changes in laws and regulations applicable to the Company's
business, including any pricing reform, and failure to comply with
such laws and regulations; inability to repay the Company's
existing indebtedness and uncertainties with respect to the
Company's ability to access future capital; and delays in the
execution of plans to build out an additional FDA-approved
third-party manufacturing facility and unexpected expenses
associated with those plans.
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, 2019 and any subsequent Company
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:
Investors:
Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902
Insmed@argotpartners.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated