—Retrospective Cohort Study Shows Significant
Reductions in All-Cause and Respiratory Disease-Related
Hospitalizations in the 12 Months Following ARIKAYCE®
(amikacin liposome inhalation suspension) Initiation in Real-World
Settings—
—Post-Hoc Analysis of Phase 2 WILLOW Study in
Adult Patients with Non-Cystic Fibrosis Bronchiectasis Supports
Favorable Benefit-Risk Profile of Brensocatib—
BRIDGEWATER, N.J., May 17, 2022
/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
seven presentations across three of its pillars—ARIKAYCE,
brensocatib, and treprostinil palmitil inhalation powder (TPIP)—at
the American Thoracic Society (ATS) 2022 International
Conference.
"We were pleased to present a broad range of data at ATS from
across our portfolio of programs, demonstrating our continued
progress in addressing the needs of patients living with serious
and rare diseases," said Martina
Flammer, M.D., M.B.A, Chief Medical Officer of Insmed. "In
particular, we were excited to share the first real-world data for
ARIKAYCE, which showed significant reductions in hospitalizations
in the 12 months after ARIKAYCE was initiated. These findings
provide important information to better understand the impact of
ARIKAYCE in the treatment paradigm for refractory MAC lung
disease."
Summaries of these presentations are as follows:
ARIKAYCE
Poster: "Reduction in Hospitalizations Following Initiation
of Amikacin Liposome Inhalation Suspension: A Retrospective Cohort
Study of Patients in Real-world Settings"
Data were presented from a noninterventional retrospective
cohort study to assess changes in hospitalizations among patients
initiating ARIKAYCE in the real-world setting. The study used the
All-Payer Claims Database – including health insurance claims data
from more than 300 million unique U.S. patients – to identify
patients receiving ARIKAYCE from October
2018 to April 2020. An
analysis of 331 patients who were treated with ARIKAYCE in the
real-world setting showed the following key findings:
- A significant reduction in the proportion of patients with
all-cause hospitalizations was observed after 6 months of ARIKAYCE
treatment, from 35.9% in the 6 months immediately before ARIKAYCE
initiation to 26.6% (P=0.0033) in the first 6 months after ARIKAYCE
initiation.
- These significant reductions in all-cause hospitalization
continued during the follow-up period of 7 to 12 months after
ARIKAYCE initiation, from 35.9% in the 6 months before ARIKAYCE
initiation to 23.0% (P<0.0001) in the 7 to 12 months after
ARIKAYCE initiation.
- The mean number of all-cause hospitalizations per person per 6
months decreased significantly from 1.2 ± 1.8 in the 6 months
before ARIKAYCE initiation to 0.7 ± 1.2 (P=0.0002) and 0.7 ± 1.4
(P<0.0001) in the 0 to 6 months and 7 to 12 months after
ARIKAYCE initiation, respectively.
- A significant reduction was observed in the proportion of
patients with respiratory disease-related hospitalizations, from
26.9% in the 6 months immediately before ARIKAYCE initiation to
19.3% (P=0.0061) in the first 6 months after ARIKAYCE initiation
and 15.4% (P<0.0001) in the 7 to 12 months after ARIKAYCE
initiation.
- The mean number of respiratory disease-related hospitalizations
per person per 6 months decreased significantly from 1.0 ± 1.6 in
the 6 months before ARIKAYCE initiation to 0.6 ± 1.0 (P=0.0002) and
0.6 ± 1.2 (P=0.0001) in the 0 to 6 months after ARIKAYCE initiation
and in the 7 to 12 months after ARIKAYCE initiation,
respectively.
Investigators concluded that both all-cause and respiratory
disease-related hospitalizations were significantly reduced in the
12 months following ARIKAYCE initiation.
Poster: "The Hospitalization Burden Among Potentially
Treatment-Refractory Nontuberculous Mycobacterial Lung Disease
Patients in Japan"
Investigators presented data from a retrospective cohort study
that used claims data to assess treatment patterns and healthcare
resource utilization among patients with potentially
treatment-refractory nontuberculous mycobacterial (NTM) lung
disease in Japan. The study showed
that most patients who were identified as having potentially
refractory disease had a high hospitalization burden that
consistently remained high over the 30-month study period, despite
treatment of ≥18 months in contrast to patients who were identified
as having potentially nonrefractory disease. Investigators
concluded that refractory NTM lung disease has a substantial burden
on patients in Japan.
Brensocatib
Mini Symposium: "Brensocatib for the Treatment of Non-Cystic
Fibrosis Bronchiectasis (NCFBE): Number Needed to Treat (NNT) and
Number Needed to Harm (NNH)"
Findings were presented from post-hoc analyses of clinical trial
data to assess the NNT and NNH for brensocatib to provide further
context for its risk-benefit profile. The analyses used data from
the WILLOW study, a phase 2, randomized, double-blind,
placebo-controlled study that assessed the efficacy, safety and
tolerability, and pharmacokinetics of brensocatib in patients with
non-cystic fibrosis bronchiectasis (NCFBE). As previously reported,
the WILLOW study showed that brensocatib significantly prolonged
time to first pulmonary exacerbation, the primary endpoint, over
the 24-week treatment period versus placebo. Treatment with
brensocatib also reduced the rate of pulmonary exacerbations, a key
secondary endpoint.
The post-hoc analyses showed the following:
- The NNT for exacerbation prevention – which represents the
average number of patients who would need to be treated to prevent
one patient from having an exacerbation – was low, ranging from 6
to 7.
- When exacerbations were included, the NNH – which represents
the number of patients who would need to be treated with
brensocatib for one additional patient to experience one serious
treatment-emergent adverse event (TEAE) vs. placebo – was negative,
ranging from -9 to -11. A negative NNH suggests a lower risk of
serious TEAEs for patients treated with brensocatib compared with
placebo.
- When exacerbations were excluded, the NNH ranged from -25 to
-55. Thus, the lower risk of serious TEAEs for patients receiving
brensocatib compared with placebo was maintained when exacerbations
were excluded from the analysis. Exacerbations that were captured
as serious TEAEs were excluded from this analysis to provide a true
measure of harm avoidance, since exacerbation incidence was the key
outcome for the NNT analysis.
Investigators concluded that the low NNT and negative NNH
suggest a potential favorable benefit-risk profile for brensocatib
in patients with NCFBE.
Poster: "Pulmonary Exacerbations (PEx) and Hospitalizations
in Commercially Insured Patients with Non-Cystic Fibrosis
Bronchiectasis (NCFBE) Over 1- and 2-Year Follow-Up
Periods"
Data were presented from a longitudinal retrospective insurance
claims database study evaluating pulmonary exacerbation frequency
and all-cause hospitalization frequency in patients with NCFBE over
1 and 2 years of follow-up. The study showed that most insured
patients with NCFBE experience frequent exacerbations and increased
hospitalization rates over 2 years of follow-up, and that the
number of both exacerbations and hospitalizations increased from
year 1 to year 2. Specifically, 67.4% of patients experienced at
least one exacerbation during year 1 and 76.6% experienced at least
one exacerbation in year 2 of follow-up. In addition, 41.04% of
patients were hospitalized at least once during year 1, and 51.05%
were hospitalized at least once during year 2. Notably, an
occurrence of 2 or more exacerbations increased the likelihood of
multiple subsequent exacerbations within 1 and 2 years of
follow-up. Investigators concluded that in patients with NCFBE,
pulmonary exacerbations result in an increased disease burden over
time.
TPIP
Posters: "Treprostinil Exerts Anti-Fibrotic Effects via the
Prostanoid Receptor Subtype EP2 in Human Lung
Fibroblast"; "Administration of Treprostinil to the Basolateral
Surface, but Not the Apical Surface of Human Bronchial Air-Liquid
Interface Epithelial Cells Induces Release of Prostaglandin
E2"; and "Binding Affinity of Treprostinil to Rat
Recombinant Prostanoid Receptors IP and
EP2"
Three treprostinil posters were presented at ATS showcasing
preclinical data. The first showed that treprostinil exerts an
anti-fibrotic effect by acting via prostanoid receptor subtype
EP2. The anti-fibrotic effects of treprostinil may also
be enhanced by its ability to inhibit profibrotic cytokine
secretion. The second study showed that treprostinil does not alter
the integrity of the bronchial epithelium or induce an inflammatory
response, and that prostaglandin E2 release is
caused by administering treprostinil on the basolateral but not the
apical surface, suggesting a polarized distribution of the
prostanoid receptors on the bronchial epithelium. Therefore, the
scale and duration of treprostinil-induced vasodilation may be
controlled by regulating the epithelial penetration of inhaled
treprostinil. Lastly, the third study showed that the binding
affinity of treprostinil to the rat prostanoid receptors was
similar for the prostaglandin I2 (IP)
receptor compared with that in humans and about 7-fold higher
for the EP2 receptor compared with that in humans.
Researchers concluded that these data may be useful in interpreting
results from rat studies of treprostinil palmitil to inform dosage
selection for studies in patients with pulmonary arterial
hypertension (PAH).
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 differentiated prostanoid being evaluated for the
treatment of patients with PAH, pulmonary hypertension associated
with interstitial lung disease (PH-ILD), 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 footprint
across Europe and in Japan. For more information,
visit https://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 timings discussed, projected,
anticipated or indicated in any forward-looking statements. Such
risks, uncertainties and other factors include, among others, the
following: 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,
including regulatory approval for the Lamira® Nebulizer System
and the drug delivery device for TPIP in each market and for each
usage; 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, and 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 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
successfully or in a timely manner complete the study to validate a
patient reported outcome tool and the confirmatory post-marketing
clinical trial 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 the
Company's product candidates; inaccuracies in the Company's
estimates of the size of the potential markets for ARIKAYCE,
brensocatib, TPIP or the Company's other 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; risk that the Company's competitors may obtain orphan
drug exclusivity for a product that is essentially the same as a
product the Company is developing for a particular indication;
failure to successfully predict the time and cost of development,
regulatory approval and commercialization for novel gene therapy
products; 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 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
successfully integrate its recent acquisitions and appropriately
manage the amount of management's time and attention devoted to
integration activities; risks that the Company's acquired
technologies, products and product candidates are not commercially
successful; the Company's inability to adapt to its highly
competitive and changing environment; risk that the Company is
unable to maintain its significant customers; risk that government
healthcare reform materially increases the Company's costs and
damages its financial condition; 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 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; risk
that the Company's operations are subject to a material disruption
in the event of a cybersecurity attack or issue; business
disruptions or expenses related to the upgrade to the Company's
enterprise resource planning system; 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; the Company's history of operating losses, and the
possibility that the Company may never achieve or maintain
profitability; goodwill impairment charges affecting the Company's
results of operations and financial condition; 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, 2021 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
Executive Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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