BRIDGEWATER, N.J., May 19, 2021 /PRNewswire/ -- Insmed Incorporated
(Nasdaq:INSM), a global biopharmaceutical company on a mission to
transform the lives of patients with serious and rare diseases,
today reported data from a total of nine posters and oral
presentations across its three programs—ARIKAYCE, brensocatib, and
treprostinil palmitil inhalation powder (TPIP)—at the virtual
American Thoracic Society (ATS) 2021 International Conference.
"We are pleased to have the opportunity to showcase the
significant potential of our clinical development portfolio at
ATS," said Martina Flammer, M.D.,
MBA, Chief Medical Officer of Insmed. "The breadth of data
presented across our three programs demonstrates our significant
progress as we advance through clinical development with the goal
of delivering transformative therapies to patients living with
diseases that have previously been overlooked and underserved."
Summaries of these presentations are as follows:
ARIKAYCE
Oral Title: "Incremental Mortality Associated with
Nontuberculous Mycobacterial Lung Disease Among US Medicare
Beneficiaries with Chronic Obstructive Pulmonary Disease"
Data were presented from a retrospective cohort study that used
the US Medicare claims database to assess the incremental burden of
mortality associated with nontuberculous mycobacterial (NTM) lung
disease in patients with underlying chronic obstructive pulmonary
disease (COPD). A total of 4,926 cases (COPD patients with NTM lung
disease) were matched to 14,778 controls (COPD patients without NTM
lung disease). Mean follow-up was 2.6 years for cases and 3.1 years
for controls. The study showed the following key findings:
- A higher proportion of patients with both COPD and NTM lung
disease died during follow-up than patients with COPD without NTM
lung disease (41.5% vs. 26.7%; p<0.0001).
- Annual mortality rates were higher among patients with both
COPD and NTM lung disease than patients with COPD without NTM lung
disease (158.5 vs. 86 deaths per 1000 person-years;
p<0.0001).
- Time to death was shorter among patients with both COPD and NTM
lung disease than among patients with COPD without NTM lung
disease; further, time to death was shorter among male patients
with COPD and NTM lung disease than female patients with COPD and
NTM lung disease (p<0.0001).
- Even after controlling for age, gender, comorbidities and
severity of COPD, patients with both COPD and NTM lung disease had
an increased risk of death compared to patients with COPD without
NTM lung disease (hazard ratio [95% confidence interval]: 1.45
[1.36-1.54]; p<0.0001).
Investigators concluded that the statistically significantly
increased mortality associated with NTM lung disease in patients
with COPD highlights the acute need for appropriate management of
NTM lung disease.
Oral Title: "ALIS (Amikacin Liposome Inhalation Suspension)
for the Treatment of Patients with Refractory Mycobacterium
avium Complex Lung Disease (MACLD): The Number Needed to Treat
(NNT) and Number Needed to Harm (NNH)"
Findings were presented from a post-hoc analysis of clinical
trial data to assess the NNT and NNH for ARIKAYCE. The NNT analysis
used data from the CONVERT study, a Phase 3, randomized,
multicenter trial comparing ARIKAYCE plus guideline-based therapy
(GBT) (N=224) with GBT alone (N=112) in adults with refractory MAC
lung disease, and found that the NNT – which represents the average
number of patients who would need to be treated to obtain a benefit
– for culture conversion by month 6 with ARIKAYCE plus GBT was low
(5). The NNH analysis, which used data from the CONVERT study as
well as a Phase 3b open-label safety
extension of CONVERT (INS-312) and a Phase 2b study with an open-label extension (TR02-112),
showed high NNH values, meaning relatively large numbers of
patients would need to be treated with ARIKAYCE plus GBT for a
patient to experience an adverse event of interest (including
ototoxicity, nephrotoxicity, neuromuscular events, or allergic
alveolitis). These results support the favorable clinical benefit
and safety profile of ARIKAYCE in patients with
treatment-refractory MAC lung disease. As previously reported, the
CONVERT study demonstrated that the addition of ARIKAYCE to GBT
resulted in culture conversion (which we defined as three
consecutive negative monthly sputum cultures) by Month 6 in 29.0%
of patients, compared to 8.9% of patients on GBT alone
(p<0.0001).
Poster Title: "Identifying Potentially Undiagnosed
Nontuberculous Mycobacterial Lung Disease Among Patients with
Chronic Obstructive Pulmonary Disease: Development of a Predictive
Algorithm Using Claims Data"
Investigators presented data from a retrospective study using
the Medicare claims database that evaluated patients with NTM lung
disease with preexisting COPD compared to patients with COPD
without NTM lung disease. The database was then used to develop a
predictive model to identify patients at risk of NTM lung disease.
The results found that by analyzing patterns of healthcare use,
respiratory symptoms, and comorbidities, a predictive algorithm may
be used to identify COPD patients at risk of NTM lung disease.
Further validation of this algorithm is required; however, it may
offer the potential to identify NTM lung disease among patients
with COPD earlier by raising clinical suspicion.
Poster Title: "Concurrent Randomized, Double-Blind,
Placebo-Controlled Trials to Validate Patient-Reported Outcome
(PRO) Instruments and Assess Clinical Benefit of Treatment in
Adults with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung
Infection Caused by Mycobacterium Avium Complex
(MAC)"
Authors described the study designs for the post-approval
confirmatory frontline clinical trial program of ARIKAYCE in
patients with NTM lung disease caused by MAC. This program includes
ARISE, an interventional study designed to validate a
patient-reported outcome (PRO) tool in MAC lung disease, and
ENCORE, a pivotal trial designed to establish, using the PRO tool
validated in the ARISE trial, the clinical benefits and safety of
ARIKAYCE in patients with newly diagnosed MAC lung disease. This
clinical trial program was initiated in December of 2020.
Brensocatib
Poster Title: "Effects of Food Intake on the
Pharmacokinetics, Safety, and Tolerability of a Single Dose of the
Dipeptidyl Peptidase 1 (DPP1) Inhibitor Brensocatib in Healthy
Japanese and White Adults"
Results from this Phase 1 study showed that brensocatib was well
tolerated in the study population and the safety profile was
similar whether participants fasted or took brensocatib with food.
Data also showed that when brensocatib is administered with food,
oral absorption may be slightly delayed, but overall exposure is
likely unchanged. Authors concluded that brensocatib may be
administered with or without food.
Poster Title: "Safety, Tolerability, and Pharmacokinetic
Evaluation of Single and Multiple Doses of the Dipeptidyl Peptidase
1 (DPP1) Inhibitor Brensocatib in Healthy Japanese and White
Adults"
Results from this Phase 1 study showed that brensocatib doses of
10 mg, 25 mg, and 40 mg were well tolerated in Japanese and White
participants following once-daily administration for 28 days. Data
also showed that brensocatib exposure was generally comparable
between Japanese and White participants, with predictable
pharmacokinetic characteristics observed.
Poster Title: "Population Pharmacokinetic Evaluation of the
Dipeptidyl Peptidase 1 (DPP1) Inhibitor Brensocatib in Healthy
Participants and Patients with Bronchiectasis"
Researchers completed a pooled analysis from two studies – a
Phase 1 study of once-daily oral brensocatib in 10 mg, 25 mg, and
40 mg doses in healthy Japanese and White participants, and the
Phase 2 WILLOW study of brensocatib in patients with non-cystic
fibrosis bronchiectasis – to develop a population pharmacokinetic
(PPK) model to aid in the selection of brensocatib doses for future
clinical studies. A PPK model was successfully developed, and the
analysis supports a once-daily dosing regimen with no dose
adjustments needed based on age of the studied population or on
mild to moderate renal impairment.
TPIP
Poster Titles: "Pulmonary Vasodilator Activity of Inhaled
Treprostinil Palmitil, Inhaled Treprostinil, Intravenous
Treprostinil and Oral Selexipag in Hypoxia-Challenged Rats" and
"Beneficial Effects of Treprostinil Palmitil in a Sugen/Hypoxia Rat
Model of Pulmonary Arterial Hypertension; a Comparison with Inhaled
and Intravenous Treprostinil and Oral Selexipag"
In two poster presentations, preclinical data were presented
that compared the effects of TPIP to three other drugs – inhaled
treprostinil, intravenous (IV) treprostinil, and oral selexipag –
targeting the prostacyclin pathway in a Sugen/hypoxia rat model of
pulmonary arterial hypertension (PAH). In the first study,
researchers established the doses of each of the drugs to be
assessed in the subsequent study. In the second study, after
subcutaneous injection of Sugen (a vascular growth factor receptor
inhibitor), rats were exposed for 3 weeks to inhaled hypoxic gas to
damage the pulmonary arteries. Researchers then administered each
of the drugs for 5 weeks to evaluate their effect on hemodynamics
(pulmonary arterial pressure and cardiac output), right ventricular
hypertrophy (Fulton index), and remodeling in the pulmonary
arteries (wall thickness, obliteration, and muscularization).
Results demonstrated that at delivered doses of 59 μg/kg and 117
μg/kg, TPIP exerted therapeutic benefits, with the high dose of
TPIP showing superior effects overall versus the comparators and
representing a potentially clinically relevant dose level.
About ARIKAYCE
ARIKAYCE is approved in the United
States as ARIKAYCE® (amikacin liposome inhalation
suspension), in Europe as
ARIKAYCE® Liposomal 590 mg Nebuliser Dispersion, and in
Japan as ARIKAYCE®
inhalation 590 mg (amikacin sulfate inhalation drug product).
Current international treatment guidelines recommend the use of
ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled,
once-daily formulation of amikacin, an established antibiotic that
was historically administered intravenously and associated with
severe toxicity to hearing, balance, and kidney function. Insmed's
proprietary PULMOVANCE™ liposomal technology enables the delivery
of amikacin directly to the lungs, where liposomal amikacin is
taken up by lung macrophages where the infection resides, while
limiting systemic exposure. ARIKAYCE is administered once daily
using the Lamira® Nebulizer System manufactured by PARI
Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer
System
ARIKAYCE is delivered by a novel inhalation device, the
Lamira® Nebulizer System, developed by PARI.
Lamira® is a quiet, portable nebulizer that enables
efficient aerosolization of ARIKAYCE via a vibrating, perforated
membrane. Based on PARI's 100-year history working with aerosols,
PARI is dedicated to advancing inhalation therapies by developing
innovative delivery platforms to improve patient care.
About Brensocatib
Brensocatib is a small molecule, oral, reversible inhibitor of
dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the
treatment of patients with bronchiectasis and other
neutrophil-mediated diseases. DPP1 is an enzyme responsible for
activating neutrophil serine proteases (NSPs), such as neutrophil
elastase, 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. In chronic inflammatory lung diseases, neutrophils
accumulate in the airways and result in excessive active NSPs that
cause lung destruction and inflammation. Brensocatib may decrease
the damaging effects of inflammatory diseases such as
bronchiectasis by inhibiting DPP1 and its activation of NSPs.
Brensocatib is an investigational drug product that has not been
approved for any indication in any jurisdiction.
About TPIP
Treprostinil palmitil inhalation powder (TPIP) is a dry powder
formulation of treprostinil palmitil, a treprostinil prodrug
consisting of treprostinil linked by an ester bond to a 16-carbon
chain. Developed entirely in Insmed's laboratories, TPIP is a
potentially highly differentiated prostanoid being evaluated for
the treatment of patients with PAH and other rare and serious
pulmonary disorders. TPIP is administered in a capsule-based
inhalation device. TPIP is an investigational drug product that has
not been approved for any indication in any jurisdiction.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S.
WARNING: RISK OF INCREASED RESPIRATORY ADVERSE
REACTIONS
ARIKAYCE has been associated with an increased risk of
respiratory adverse reactions, including hypersensitivity
pneumonitis, hemoptysis, bronchospasm, and exacerbation of
underlying pulmonary disease that have led to hospitalizations in
some cases.
Hypersensitivity Pneumonitis has been reported with
the use of ARIKAYCE in the clinical trials. Hypersensitivity
pneumonitis (reported as allergic alveolitis, pneumonitis,
interstitial lung disease, allergic reaction to ARIKAYCE) was
reported at a higher frequency in patients treated with ARIKAYCE
plus background regimen (3.1%) compared to patients treated with a
background regimen alone (0%). Most patients with hypersensitivity
pneumonitis discontinued treatment with ARIKAYCE and received
treatment with corticosteroids. If hypersensitivity pneumonitis
occurs, discontinue ARIKAYCE and manage patients as medically
appropriate.
Hemoptysis has been reported with the use of
ARIKAYCE in the clinical trials. Hemoptysis was reported at a
higher frequency in patients treated with ARIKAYCE plus background
regimen (17.9%) compared to patients treated with a background
regimen alone (12.5%). If hemoptysis occurs, manage patients as
medically appropriate.
Bronchospasm has been reported with the use of
ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma,
bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea
exertional, prolonged expiration, throat tightness, wheezing) was
reported at a higher frequency in patients treated with ARIKAYCE
plus background regimen (28.7%) compared to patients treated with a
background regimen alone (10.7%). If bronchospasm occurs during the
use of ARIKAYCE, treat patients as medically appropriate.
Exacerbations of underlying pulmonary disease has
been reported with the use of ARIKAYCE in the clinical trials.
Exacerbations of underlying pulmonary disease (reported as chronic
obstructive pulmonary disease (COPD), infective exacerbation of
COPD, infective exacerbation of bronchiectasis) have been reported
at a higher frequency in patients treated with ARIKAYCE plus
background regimen (14.8%) compared to patients treated with
background regimen alone (9.8%). If exacerbations of underlying
pulmonary disease occur during the use of ARIKAYCE, treat patients
as medically appropriate.
Anaphylaxis and Hypersensitivity Reactions: Serious
and potentially life-threatening hypersensitivity reactions,
including anaphylaxis, have been reported in patients taking
ARIKAYCE. Signs and symptoms include acute onset of skin and
mucosal tissue hypersensitivity reactions (hives, itching,
flushing, swollen lips/tongue/uvula), respiratory difficulty
(shortness of breath, wheezing, stridor, cough), gastrointestinal
symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and
cardiovascular signs and symptoms of anaphylaxis (tachycardia, low
blood pressure, syncope, incontinence, dizziness). Before therapy
with ARIKAYCE is instituted, evaluate for previous hypersensitivity
reactions to aminoglycosides. If anaphylaxis or a hypersensitivity
reaction occurs, discontinue ARIKAYCE and institute appropriate
supportive measures.
Ototoxicity has been reported with the use of
ARIKAYCE in the clinical trials. Ototoxicity (including deafness,
dizziness, presyncope, tinnitus, and vertigo) were reported with a
higher frequency in patients treated with ARIKAYCE plus background
regimen (17%) compared to patients treated with background regimen
alone (9.8%). This was primarily driven by tinnitus (7.6% in
ARIKAYCE plus background regimen vs 0.9% in the background regimen
alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen
vs 2.7% in the background regimen alone arm). Closely monitor
patients with known or suspected auditory or vestibular dysfunction
during treatment with ARIKAYCE. If ototoxicity occurs, manage
patients as medically appropriate, including potentially
discontinuing ARIKAYCE.
Nephrotoxicity was observed during the clinical trials of
ARIKAYCE in patients with MAC lung disease but not at a higher
frequency than background regimen alone. Nephrotoxicity has been
associated with the aminoglycosides. Close monitoring of patients
with known or suspected renal dysfunction may be needed when
prescribing ARIKAYCE.
Neuromuscular Blockade: Patients with neuromuscular
disorders were not enrolled in ARIKAYCE clinical trials. Patients
with known or suspected neuromuscular disorders, such as myasthenia
gravis, should be closely monitored since aminoglycosides may
aggravate muscle weakness by blocking the release of acetylcholine
at neuromuscular junctions.
Embryo-Fetal Toxicity: Aminoglycosides can cause
fetal harm when administered to a pregnant woman. Aminoglycosides,
including ARIKAYCE, may be associated with total, irreversible,
bilateral congenital deafness in pediatric patients exposed in
utero. Patients who use ARIKAYCE during pregnancy, or become
pregnant while taking ARIKAYCE should be apprised of the potential
hazard to the fetus.
Contraindications: ARIKAYCE is contraindicated in
patients with known hypersensitivity to any aminoglycoside.
Most Common Adverse Reactions: The most common
adverse reactions in Trial 1 at an incidence ≥5% for patients using
ARIKAYCE plus background regimen compared to patients treated with
background regimen alone were dysphonia (47% vs 1%), cough (39% vs
17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%),
ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%),
musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs
10%), exacerbation of underlying pulmonary disease (15% vs 10%),
diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%),
headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash
(6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs
1%), and chest discomfort (5% vs 3%).
Drug Interactions: Avoid concomitant use of ARIKAYCE
with medications associated with neurotoxicity, nephrotoxicity, and
ototoxicity. Some diuretics can enhance aminoglycoside toxicity by
altering aminoglycoside concentrations in serum and tissue. Avoid
concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea,
or intravenous mannitol.
Overdosage: Adverse reactions specifically
associated with overdose of ARIKAYCE have not been identified.
Acute toxicity should be treated with immediate withdrawal of
ARIKAYCE, and baseline tests of renal function should be
undertaken. Hemodialysis may be helpful in removing amikacin from
the body. In all cases of suspected overdosage, physicians should
contact the Regional Poison Control Center for information about
effective treatment.
U.S. INDICATION
LIMITED POPULATION: ARIKAYCE is indicated in adults, who have
limited or no alternative treatment options, for the treatment of
Mycobacterium avium complex (MAC) lung disease as part of a
combination antibacterial drug regimen in patients who do not
achieve negative sputum cultures after a minimum of 6 consecutive
months of a multidrug background regimen therapy. As only limited
clinical safety and effectiveness data for ARIKAYCE are currently
available, reserve ARIKAYCE for use in adults who have limited or
no alternative treatment options. This drug is indicated for use in
a limited and specific population of patients.
This indication is approved under accelerated approval based
on achieving sputum culture conversion (defined as 3 consecutive
negative monthly sputum cultures) by Month 6. Clinical benefit has
not yet been established. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in confirmatory trials.
Limitation of Use: ARIKAYCE has only been studied in
patients with refractory MAC lung disease defined as patients who
did not achieve negative sputum cultures after a minimum of 6
consecutive months of a multidrug background regimen therapy. The
use of ARIKAYCE is not recommended for patients with non-refractory
MAC lung disease.
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1–800–FDA–1088. You can also call the Company at
1-844-4-INSMED.
Please see Full Prescribing Information.
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 is a first-in-disease
therapy approved in the United
States, Europe, and
Japan to treat a chronic,
debilitating lung disease. The Company is also progressing a robust
pipeline of investigational therapies targeting areas of serious
unmet need, including neutrophil-mediated inflammatory diseases and
rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a growing
footprint across Europe and in
Japan. 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: failure to successfully conduct future clinical trials
for ARIKAYCE, brensocatib, TPIP and the Company's other product
candidates due to the Company's limited experience in conducting
preclinical development activities and clinical trials necessary
for regulatory approval and its potential inability to enroll or
retain sufficient patients to conduct and complete the trials or
generate data necessary for regulatory approval, among other
things; 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., Europe or Japan, or for the Company's product candidates
in the U.S., Europe, Japan or other markets; failure to
successfully commercialize ARIKAYCE, the Company's only approved
product, in the U.S., Europe or
Japan (amikacin liposome
inhalation suspension, Liposomal 590 mg Nebuliser Dispersion or
amikacin sulfate inhalation drug product, respectively), or to
maintain U.S., European or Japanese approval for ARIKAYCE; business
or economic disruptions due to catastrophes or other events,
including natural disasters or public health crises; impact of the
novel coronavirus (COVID-19) pandemic and efforts to reduce its
spread on the Company's business, employees, including key
personnel, patients, partners and suppliers; risk that brensocatib
does not prove effective or safe for patients in ongoing and future
clinical studies, including the ASPEN study; risk that TPIP does not prove to
be effective or safe for patients in ongoing and future clinical
studies; 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 U.S. Food and Drug Administration,
including the risk that the Company will not timely and
successfully complete the study to validate a PRO tool and the
confirmatory post-marketing study required for full approval of
ARIKAYCE; inability of the Company, PARI Pharma GmbH (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 the Company's product
candidates; inaccuracies in the Company's estimates of the size of
the potential markets for ARIKAYCE or its product candidates 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 or any of the Company's product candidates
that are approved in the future; failure to obtain regulatory
approval to expand ARIKAYCE's indication to a broader patient
population; 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 the
Company's agreements or 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 third-party
manufacturing facility approved by the appropriate regulatory
authorities 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, 2020 and any subsequent
Company filings with the Securities and Exchange Commission
(SEC).
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 SEC, 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:
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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