-- Paolo Tombesi named as Chief Financial Officer
---- Paul Streck, M.D., appointed as Chief Medical Officer ----
Eugene Sullivan, M.D., assumes role of Chief Product Strategy
Officer --
Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today announced the appointment of Paolo Tombesi as Chief Financial
Officer, effective June 1, 2017, and Paul Streck, M.D., as Chief
Medical Officer, effective June 5, 2017. Additionally, Eugene
Sullivan, M.D., has been appointed to the newly created role of
Chief Product Strategy Officer.
“These management changes will strengthen our already solid
leadership team and add critical skills to our organization as we
collectively advance the clinical development of our portfolio and
prepare for the potential commercialization of liposomal amikacin
for inhalation,” said Will Lewis, president and chief executive
officer of Insmed.
Mr. Tombesi brings over 20 years of experience in the
biotechnology and pharmaceutical sector, most recently serving as
Vice President and Chief Financial and Administrative Officer of
Novartis Pharmaceuticals Corporation. In addition, Mr. Tombesi was
also a member of Novartis’s Pharma Executive Committee, Commercial
Leadership Team, Corporate Compliance Committee, Global Pharma
Finance Leadership Team and Global Country CFO Team. He joined
Novartis in 2006 as Head of Finance Region Europe, Oncology, and
held several positions of increasing responsibility, including
serving as Managing Director and CFO of Novartis Japan. Prior to
joining Novartis, Mr. Tombesi held various financial positions with
Bristol-Myers Squibb. His career began in consumer goods with
Unilever NV and Johnson & Johnson. He holds a degree in
business and managerial ecomonics from Rome’s La Sapienza
University and a degree in accounting from Duca degli Abruzzi
Roma.
Dr. Streck joins Insmed with over 25 years of clinical
development, management and leadership expertise. He most recently
served as Vice President, Global Medical Specialty Franchise,
Immuno-inflammation at GlaxoSmithKline where he was responsible for
portfolio strategy, including drug launch, life cycle management,
post-registration clinical strategy and health economics.
Previously, he held various positions with functions ranging from
clinical development to medical affairs to commercial with Shire
Pharmaceuticals and AMGEN USA, Inc. Dr. Streck also practiced
in the Jefferson Health System at Thomas Jefferson University. He
received his medical degree from Jefferson Medical College and was
a resident in oral and maxillofacial surgery at Thomas Jefferson
University Hospital. Dr. Streck also holds a doctorate of dental
medicine from Temple University School of Denistry, a Masters of
Business Administration from the Duke University Fuqua School of
Business and board certification in oral and maxillofacial surgery
from the American Board of Oral and Maxillofacial Surgery.
Dr. Sullivan joined Insmed as Chief Medical and Scientific
Officer in 2015, and has more than 20 years of experience with a
focus on pulmonary and orphan diseases. Prior to joining Insmed,
and in addition to other roles within the industry, Dr. Sullivan
held several positions at the U.S. Food and Drug Administration.
Dr. Sullivan’s extensive product strategy development experience
uniquely qualifies him for the newly-created position as he will be
tasked with overseeing the advancement of Insmed’s product
pipeline.
“Paolo’s extensive financial and commercial understanding of the
pharmaceutical industry will assist us in addressing the challenges
faced by rapidly growing, global businesses. Paul brings proven
management and leadership skills that are critical to us as a
multi-product development organization. Paul has played a crucial
role in the clinical development, launch or commercial marketing of
more than 25 medications across a broad range of indications,
including rare and orphan diseases. In his new role, Gene will
continue to rely on his broad clinical and regulatory background
and will focus his directly relevant experience with the FDA and
demonstrated product strategy expertise on the development of our
ongoing portfolio strategy,” added Mr. Lewis.
About Insmed
Insmed Incorporated is a global biopharmaceutical company
focused on the unmet needs of patients with rare diseases. The
company is advancing a global phase 3 clinical study of ARIKAYCE®
(liposomal amikacin for inhalation) for adult patients with
treatment refractorynontuberculous mycobacteria (NTM) lung disease
caused by Mycobacterium avium complex (MAC), which is a rare and
often chronic infection that is capable of causing irreversible
lung damage and can be fatal. There are currently no approved
inhaled products specifically indicated for the treatment of
refractory NTM lung disease caused by MAC in the United States or
the European Union. Insmed's earlier-stage clinical pipeline
includes INS1007, a novel oral reversible inhibitor of DPP1 with
therapeutic potential in non-cystic fibrosis bronchiectasis, 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.
"Insmed" and "ARIKAYCE" are the company's trademarks. All other
trademarks, trade names or service marks appearing in this press
release are the property of their respective owners.
Forward-looking statements
This press release contains forward looking statements.
"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
factors include, among others: uncertainties in the research and
development of our existing product candidates, including due to
delays in patient enrollment or failure of our preclinical studies
or clinical trials to satisfy pre-established endpoints; failure to
develop, or to license for development, additional product
candidates, including a failure to attract experienced third party
collaborators; failure to obtain, or delays in obtaining,
regulatory approval from the United States Food and Drug
Administration, the European Medicines Agency, and other regulatory
authorities for our product candidates or their delivery devices,
including due to insufficient clinical data or selection of
endpoints that are not satisfactory to regulators; failure of third
parties on which we are dependent to conduct our clinical trials
and to manufacture sufficient quantities of our product candidates
for clinical or commercial needs; failure to comply with license
agreements that are critical for our product development, including
our license agreements with PARI Pharma GmbH and AstraZeneca AB;
lack of safety and efficacy of our product candidates; inaccuracies
in our estimate of the size of the potential markets for our
product candidates; failure to maintain regulatory approval for our
product candidates, once received, due to a failure to satisfy
post-approval regulatory requirements, such as the need for
post-clinical trials; uncertainties in the rate and degree of
market acceptance of product candidates, if approved; uncertainties
in the timing, scope and rate of reimbursement for our product
candidates; competitive developments affecting our product
candidates; inaccurate estimates regarding our future capital
requirements, including those necessary to fund milestone payments
or royalties owed to third parties; inability to repay our existing
indebtedness or to obtain additional financing when needed; failure
to obtain, protect and enforce our patents and other intellectual
property; inability to create an effective direct sales and
marketing infrastructure or to partner with a third party that
offers such an infrastructure for distribution of our product
candidates; the cost and potential reputational damage resulting
from litigation to which we are a party, including, without
limitation, the class action lawsuit pending against us; failure to
comply with the laws and regulations that impact our business; loss
of key personnel; and changes in laws and regulations applicable to
our business, including those related to pricing and reimbursement
of our product candidates. For additional information about
the risks and uncertainties that may affect our 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, 2016.
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.
Investor Contact:
Laura Perry or Heather Savelle
Argot Partners
212.600.1902
laura@argotpartners.com
heather@argotpartners.com
Insmed (NASDAQ:INSM)
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