Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical
company focused on the unmet needs of patients with rare diseases,
today announced a licensing agreement with AstraZeneca (NYSE:AZN)
for global exclusive rights to AZD7986, a novel oral inhibitor of
dipeptidyl peptidase I (DPP1, also known as cathepsin C). DPP1 is
an enzyme that catalyzes the activation of neutrophil serine
proteases (NSPs), which play a key role in pulmonary diseases such
as non-cystic fibrosis bronchiectasis (non-CF
bronchiectasis).
Insmed has renamed the compound INS1007 and will pursue an
initial indication of non-CF bronchiectasis, a rare, progressive,
neutrophil-driven pulmonary disorder in which the bronchi become
permanently dilated due to chronic inflammation and infection.
Symptoms include chronic cough, excessive sputum production,
shortness of breath, and repeated respiratory infections, which can
worsen the underlying condition. The estimated global prevalence of
non-CF bronchiectasis exceeds 2 million, of which at least 110,000
cases are in the United States. There is currently no cure for
non-CF bronchiectasis.
Bronchiectasis increases susceptibility to nontuberculous
mycobacterial (NTM) lung disease, and up to 50 percent of patients
with bronchiectasis may also have an active NTM infection. NTM lung
disease is a rare and often chronic infection that is capable of
causing irreversible lung damage and can be fatal. Insmed is
currently advancing a global phase 3 clinical study of ARIKAYCE
(liposomal amikacin for inhalation) in NTM lung disease. Insmed has
also completed a phase 2 study of ARIKAYCE for the treatment of
chronic Pseudomonas aeruginosa infection in non-CF
bronchiectasis.
“With this transaction we have added a highly complementary
therapy that aligns perfectly with our established expertise in
rare pulmonary diseases,” said Will Lewis, president and chief
executive officer of Insmed. “Because NTM lung disease and
bronchiectasis often co-exist, we can readily leverage our existing
relationships with physician experts around the world who are
eagerly awaiting new treatment options. We continue to expect
patient enrollment in our phase 3 study of ARIKAYCE to conclude
later this year and to report top line data in 2017. We expect that
when approved, ARIKAYCE and INS1007 will allow us to provide great
value to the patients who are living with NTM lung disease and
bronchiectasis, as well as the physicians who treat them.”
“We are pleased to be working with Insmed on this program from
our early stage respiratory portfolio, which represents a novel
approach to treating bronchiectasis,” said Maarten Kraan, head of
the Respiratory and Inflammation Innovative Medicines Unit at
AstraZeneca. “Insmed has the expertise and experience required to
take AZD7986 forward in this important indication and bring about
results that we hope will benefit patients in the future.”
In a phase 1 study of healthy volunteers AZD7986 was well
tolerated and demonstrated inhibition of the activity of the NSP
neutrophil elastase in a dose and concentration dependent manner.
In preclinical studies, AZD7986 was shown to effectively and
reversibly inhibit DPP1 and the activation of NSPs within maturing
neutrophils. Insmed is completing its plans for a phase 2 study in
non-CF bronchiectasis. The study is expected to begin in 2017.
Under the terms of the agreement, Insmed will pay AstraZeneca an
upfront payment of $30 million. AstraZeneca will be eligible to
receive future payments totaling $120 million in future clinical,
regulatory, and sales-related milestones. AstraZeneca would also be
entitled to receive tiered royalties ranging from a high
single-digit to mid-teen. In addition, the agreement provides
AstraZeneca with the option to negotiate a future agreement with
Insmed for commercialization of AZD7986/INS1007 in chronic
obstructive pulmonary disease or asthma.
Insmed recently closed a $55 million debt agreement with
Hercules Capital, Inc., which refinanced the company’s existing
debt and will add $30 million of new debt to fund the upfront
payment. The company confirms its cash operating expense guidance
for the second half of 2016 of $62 to $72 million. Going forward
the company remains committed to maintaining a disciplined use of
capital that ensures key corporate activities pertaining to its
priority ARIKAYCE and INS1007 programs are fully resourced.
About INS1007
INS1007 is a small molecule, reversible inhibitor of dipeptidyl
peptidase I (DPP1), an enzyme responsible for activating neutrophil
serine proteases (NSPs) in neutrophils when they are formed in the
bone marrow. Neutrophils are the most common type of white blood
cell and play an essential role in pathogen destruction and
inflammatory mediation. Neutrophils contain three NSPs (neutrophil
elastase, proteinase 3, and cathepsin G) that have been implicated
in a variety of inflammatory diseases. In chronic
inflammatory lung diseases, neutrophils accumulate in the airways
and result in excessive active NSPs that cause lung destruction and
inflammation. INS1007 may decrease the damaging effects of
inflammatory diseases, such as non-cystic fibrosis bronchiectasis,
by inhibiting DPP1 and its activation of NSPs.
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) in nontuberculous mycobacteria
(NTM) lung disease, a rare and often chronic infection that is
capable of causing irreversible lung damage and can be fatal. There
are currently no products indicated for the treatment of NTM lung
disease in the United States or European Union. The company’s
earlier-stage clinical pipeline includes INS1009, a nebulized
prodrug formulation of treprostinil that the company believes may
offer a differentiated product profile with therapeutic potential
in rare pulmonary disorders such as pulmonary arterial hypertension
(PAH), idiopathic pulmonary fibrosis (IPF), sarcoidosis, and severe
refractory asthma. To complement its internal research, Insmed
actively seeks in-licensing opportunities for a broad range of rare
diseases. 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.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas – Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.
For more information please visit: www.astrazeneca.com
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)
identify forward-looking statements.
Forward-looking statements are based upon the company’s current
expectations and beliefs, and involve known and unknown risks,
uncertainties and other factors, which may cause 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, the
factors discussed in Item 1A “Risk Factors” in the company’s Annual
Report on Form 10-K for the year ended December 31, 2015 and
subsequent quarterly reports on Form 10-Q, and the following: the
ability to successfully develop INS1007 (formerly known as AZD7986)
for the treatment of non-CF bronchiectasis; the ability to complete
development of, receive, and maintain regulatory approval for, and
successfully commercialize ARIKAYCE, INS1007 (formerly known as
AZD7986), and INS1009; the number of patients enrolled and the
timing of patient enrollment in the company’s global phase 3
clinical study of ARIKAYCE; estimates of expenses and future
revenues and profitability; status, timing, and the results of
preclinical studies and clinical trials and preclinical and
clinical data described herein; the sufficiency of preclinical and
clinical data in obtaining regulatory approval for the company’s
product candidates; the timing of responses to information and data
requests from the US Food and Drug Administration, the European
Medicines Agency, and other regulatory authorities; expectation as
to the timing of regulatory review and approval; estimates
regarding capital requirements and the needs for additional
financing, including for payment milestones and royalty obligations
under the license agreement; estimates of the size of the potential
markets for product candidates; selection and licensing of product
candidates; ability to attract third parties with acceptable
development, regulatory and commercialization expertise; the
benefits to be derived from corporate license agreements and other
third party efforts, including those relating to the development
and commercialization of product candidates; the degree of
protection afforded to the company by its intellectual property
portfolio; the safety and efficacy of product candidates; sources
of revenues and anticipated revenues, including contributions from
license agreements and other third party efforts for the
development and commercialization of products; ability to create an
effective direct sales and marketing infrastructure for products
the company elects to market and sell directly; the rate and degree
of market acceptance of product candidates; the impact of any
litigation the company is a party to, including, without
limitation, the class action lawsuit recently filed against the
company; the timing, scope and rate of reimbursement for product
candidates; the success of other competing therapies that may
become available; and the availability of adequate supply and
manufacturing capacity and quality for product candidates.
The company cautions readers not to place undue reliance on any
such forward-looking statements, which speak only as of the date
they are made. Insmed 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.
Insmed Incorporated:
Susan Mesco
Head of Investor Relations
908-947-4326
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