—Brensocatib Reduced Risk of Exacerbations Irrespective of
Disease Severity in Patients with Non-Cystic Fibrosis
Bronchiectasis (NCFBE) in Phase 2 WILLOW Subgroup Analysis—
—Real-World Cohort Study Shows Fewer Hospitalizations Among
Patients with Chronic Obstructive Pulmonary Disease (COPD) Who
Received Early Diagnosis of Nontuberculous Mycobacterial (NTM) Lung
Disease vs. Patients in the Late-Diagnosis Group—
—Analysis of WILLOW Data Demonstrates Reduction in
Azurocidin-1 (AZU1) Sputum Levels with Brensocatib
Treatment—
BRIDGEWATER, N.J., May 22, 2023
/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
eight presentations across three of its
pillars—ARIKAYCE® (amikacin liposome inhalation
suspension), brensocatib, and treprostinil palmitil inhalation
powder (TPIP)—at the American Thoracic Society (ATS) 2023
International Conference in Washington,
D.C.
"We were pleased to share Insmed's breadth of new data with
experts at this year's conference, including treatment-specific
data and disease state findings that can help advance the care of
patients with rare and serious diseases," said Martina Flammer, M.D., M.B.A, Chief Medical
Officer of Insmed. "Data were presented on how early diagnosis of
NTM lung disease in patients with COPD may be associated with a
reduction in healthcare resource utilization, particularly
all-cause and respiratory-related hospitalizations. In addition, we
were excited to share the latest subgroup analyses from WILLOW,
which showed a reduction of exacerbations in patients with NCFBE,
regardless of baseline disease severity."
Summaries of these presentations follow:
Poster: "Outcomes of Patients With Bronchiectasis by Disease
Severity: Subgroup Analysis From the Brensocatib WILLOW
Study"
This subgroup analysis of the phase 2 WILLOW study (a
randomized, double-blind, placebo-controlled trial of brensocatib
in adults with NCFBE) compared patient characteristics and
outcomes, as determined by the Bronchiectasis Severity Index (BSI),
in mild (≤4), moderate (5–8), and severe (≥9) bronchiectasis
subgroups.
- At baseline, mean (standard deviation [SD]) BSI score in all
patients was 8.3 (4.4).
- Compared with placebo, brensocatib 10 mg and 25 mg (pooled
data) reduced the risk of exacerbations across BSI subgroups during
the study:
-
- In the mild subgroup: 41.2% of placebo and 13.9% of brensocatib
patients had ≥1 exacerbation.
- In the moderate subgroup: 36.1% of placebo and 28.3% of
brensocatib patients had ≥1 exacerbation.
- In the severe subgroup: 64.7% of placebo and 43.8% of
brensocatib patients had ≥1 exacerbation.
- Across all subgroups, compared with placebo, brensocatib was
also associated with numerical reductions in rate of lung function
decline.
- Both doses of brensocatib were well-tolerated. The most
frequent AEs were headache, cough and sputum increased. No major
differences were seen across BSI subgroups.
- Between-group statistical comparisons were not possible because
this was a post hoc analysis. Effects should be interpreted with
caution because the size of some patient subgroups was small.
Mini Symposium: "Long-term Hospitalization Burden Among
Patients With Chronic Obstructive Pulmonary Disease With Possible
Diagnostic Delays of Nontuberculous Mycobacterial Lung
Disease"
This retrospective cohort study used US Medicare
claims (2006–2017) to assess the association between possible
diagnostic delay of nontuberculous mycobacterial (NTM) lung disease
and hospitalization burden among patients with chronic obstructive
pulmonary disease (COPD) over a five-year period. The study
identified 2,122 patients with COPD who were predicted to have NTM
lung disease and received a subsequent NTM lung disease diagnosis.
These patients were grouped by the possible diagnostic delay (time
from predicted NTM lung disease onset to date of NTM lung disease
diagnosis): <2 years (early diagnosis), 2–3 years (intermediate
diagnosis), and >3 years (late diagnosis).
- Patients who were diagnosed earlier showed a decrease in
hospitalizations over the 5-year follow-up.
- Possible NTM lung disease diagnostic delay was found among a
substantial proportion of patients with COPD, especially among
those with more severe COPD and other respiratory
comorbidities.
- By the 5th year following the predicted NTM lung disease onset,
hospitalization burden was highest in the late-diagnosis group: the
late-diagnosis group was 2.1 times (95% CI, 1.6–2.7) more likely to
experience all cause hospitalizations and 3.1 times (95% CI,
2.3–4.2) more likely to experience respiratory-related
hospitalizations compared with the early-diagnosis group, despite
controlling for confounding factors such as patient
characteristics, comorbidities, and COPD severity.
- Study authors concluded that early NTM lung disease diagnosis
may be associated with reduced longer-term hospitalization
burden.
Poster: "The Dipeptidyl Peptidase-1 Inhibitor Brensocatib
Reduces Airway Azurocidin-1 Levels in Bronchiectasis"
In
this post-hoc analysis from the WILLOW study, researchers sought to
measure the effect of brensocatib on azurocidin-1 (AZU1), an
inflammatory mediator that is structurally related to neutrophil
elastase but lacks protease activity. Sputum samples of patients
enrolled in the trial were assessed at Day 1, Day 29, Day 169, and
Day 197 (29 days following cessation of brensocatib treatment).
Measurements of AZU1 concentration in sputum by ELISA showed:
- At Day 1, median sputum AZU1 levels, μg/mL (95% CI) were
comparable across groups: brensocatib 10 mg, 80.26 (57.59, 182.8);
brensocatib 25 mg, 122.7 (73.89, 198.1); and placebo, 137.5 (74.91,
258.5).
- By Day 29, 51/134 (38%) in the combined brensocatib group
compared with 5/86 (7%) in the placebo group had undetectable AZU1
(P < 0.001).
- This significant effect on AZU1 was maintained over the entire
duration of the treatment period with levels returning to
pre-treatment levels 29 days after brensocatib was stopped.
- These findings suggest a novel effect of brensocatib on the
multifunctional inflammatory mediator AZU1. The role of AZU1 in the
pathophysiology of bronchiectasis warrants further
investigation.
Poster: "Association of Baseline and Subsequent
Bronchiectasis Exacerbations in Patients From the US Bronchiectasis
and NTM Research Registry (BRR)"
This retrospective cohort study utilized data from patients
enrolled in the US Bronchiectasis and Nontuberculous Mycobacteria
(NTM) Research Registry (BRR) to explore the association between
the number of bronchiectasis exacerbations at baseline and
follow-up over 4 years. Analyses of 520 patients were conducted at
3 time points in 2-year intervals: baseline (retrospective period
of 2 years before enrollment), follow-up window 1 (years 1–2 after
enrollment), and follow-up window 2 (years 3–4 after enrollment).
Patients were categorized according to their baseline exacerbation
status: 0 exacerbations or ≥1 exacerbation.
- Compared with patients with no exacerbations at baseline,
patients with prior exacerbations had significantly more
exacerbations in years 1–2 (60% vs. 71%, P < 0.01) and
years 3–4 (53% vs. 75%, P<0.0001).
- Prior bronchiectasis exacerbations at baseline increased the
odds of bronchiectasis exacerbations in the first 2 years by 1.5
times (95% CI, 1.1–2.3) and in the subsequent 4 years by 2.4 times
(95% CI, 1.6–3.5).
- These findings suggest that prevention or improved control of
bronchiectasis exacerbations is a potential unmet need in patients
with bronchiectasis.
Poster: "A Qualitative Interview Study to Explore the Use of
Adverse Event Mitigation Strategies Among Adults Receiving Amikacin
Liposome Inhalation Suspension (ALIS) in Real World
Settings"
This real-world study of adults in the United States with a self-reported,
clinician-confirmed diagnosis of refractory Mycobacterium
avium complex (MAC) lung disease provided insights on patient
perspectives and practices used to mitigate adverse events (AEs)
associated with ARIKAYCE (referred to as ALIS in this poster).
Patients were recruited through Insmed's patient support program if
they had received ARIKAYCE for ≥7 consecutive days; data were
collected through one-on-one patient interviews.
- Patients described more than 40 unique AE mitigation
strategies, which were grouped into three main categories: 1)
prepare for treatment, 2) prevent increased emergence of AEs, and
3) persist on treatment by mitigating AEs.
- The most common mitigation strategies (≥ 50%) included taking
lozenges to manage throat irritation (70%); soothing fluid intake
(e.g., hot tea) (65%); and the use of educational materials to
understand what to expect in advance of starting treatment
(60%).
- The results of this real-world interview study identified a
diverse set of AE mitigation strategies used by patients with MAC
lung disease taking ARIKAYCE.
The following Insmed posters were also presented at ATS 2023:
- Treatment Patterns and Adverse Events (AEs) Among Patients With
Bronchiectasis (BE) Chronically Receiving Macrolides Over a 1-Year
Follow-up Period
- Longitudinal Changes in Forced Expiratory Volume 1 (FEV1)
According to Exacerbation Frequency in Patients From the US
Bronchiectasis and NTM Research Registry (BRR)
- Treprostinil Palmitil Hydrolysis Is Facilitated by Lung
Esterases
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,
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 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 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 separate regulatory approval for the
Lamira® Nebulizer System 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 or TPIP does not prove to
be effective or safe for patients in ongoing and future clinical
studies, including, for brensocatib,
the ASPEN study; 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, brensocatib, TPIP or the Company's other
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 risks and uncertainties associated with,
and the perceived benefits of, the Company's secured senior loan
with certain funds managed by Pharmakon Advisors, LP and the
Company's royalty financing with OrbiMed Royalty & Credit
Opportunities IV, LP, including our ability to maintain compliance
with the covenants in the agreements for the senior secured loan
and royalty financing and the perceived impact of the restrictions
on the Company's operations under these agreements; 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; deterioration in general economic
conditions in the U.S., Europe, Japan and globally,
including the effect of prolonged periods of inflation, affecting
the Company, its suppliers, third-party service providers and
potential partners; 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, 2022 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:
Bryan Dunn
Executive Director, Investor Relations
Insmed
(646) 812-4030
bryan.dunn@insmed.com
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/insmed-presents-range-of-new-study-findings-at-american-thoracic-society-2023-international-conference-301831230.html
SOURCE Insmed Incorporated