—Patients Treated with ARIKAYCE Plus
Macrolide-Based Background Regimen Had Meaningfully Greater
Improvements in Respiratory Symptoms vs. Macrolide-Based Background
Regimen Alone, As Measured By the QOL-B Respiratory Domain
Instrument—
—QOL-B Respiratory Domain Scores for
ARIKAYCE Patients Showed Improvement Through Month 6 and Continued
to Improve Through Month 7 (1 Month Off Treatment), While
Improvements in the Comparator Arm Plateaued After Month 3 and
Worsened After Month 6—
—Microbiologic Data Presented Showed Patients
in the ARIKAYCE-treated Arm Had Numerically Greater Rates of
Culture Conversion By Month 6, and Nominally Statistically
Significantly Higher Rates By Month 7, With Earlier Time to First
Culture Conversion vs. Comparator Arm—
—No Study Patients Developed MAC with
Resistance to ARIKAYCE or Macrolides—
BRIDGEWATER, N.J., May 20, 2024
/PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global
biopharmaceutical company on a mission to transform the lives of
patients with serious and rare diseases, today announced that
late-breaking data from the ARISE study of ARIKAYCE®
(amikacin liposome inhalation suspension) were presented at the
American Thoracic Society (ATS) 2024 International Conference in
San Diego. Data from ARISE
evaluating patients with newly diagnosed or recurrent
nontuberculous mycobacterial (NTM) lung infection caused by
Mycobacterium avium complex (MAC) who had not received
antibiotics for their current infection were presented in an oral
session and during the ATS Breaking News session "Clinical Trial
Results in Pulmonary Medicine."
"The inclusion of late-breaking ARISE data in both a plenary and
in two oral sessions at ATS highlights the importance of these
study results for the NTM community and the exciting potential for
ARIKAYCE to reach a broader population of people living with MAC
lung disease," said Martina Flammer,
M.D., M.B.A., Chief Medical Officer of Insmed. "Additionally, the
ATS congress is an important opportunity for us to share our
continued efforts to bring new therapies to patients with serious
pulmonary diseases. We are pleased to be presenting seven
additional abstracts during the congress, including data on our
investigational medicine brensocatib, as well as studies that
deepen our understanding of bronchiectasis and pulmonary
hypertension."
As previously announced, data from ARISE demonstrated that the
Quality of Life-Bronchiectasis (QOL-B) respiratory domain may be an
effective patient-reported outcome (PRO) tool in patients with MAC
lung disease. The ARISE study was designed to help support the
validation of a PRO tool to be used in ENCORE, the ongoing Phase
3b registrational study
evaluating the efficacy and safety of an ARIKAYCE-based regimen in
patients with newly diagnosed or recurrent MAC lung disease who
have not received antibiotics for their current infection.
In ARISE, ARIKAYCE-treated patients performed better than those
in the comparator arm (a macrolide-based multi-drug regimen) as
measured by the QOL-B instrument, with 43.8% of patients achieving
an improvement in QOL-B respiratory score above or equal to the
estimated meaningful within-subject score difference of 14.8,
compared with 33.3% of patients in the comparator arm. While the
study was not powered to show a statistically significant
difference between treatment arms, a strong trend toward
significance was observed for improvement from baseline at Month 7
(least-squares mean change from baseline 12.24 vs. 7.76,
p=0.1073).
New data presented showed that patients in the ARIKAYCE
treatment arm experienced continued improvement in QOL-B scores to
Month 7, which included one month off treatment (observed mean
QOL-B score change from baseline: 14.1). In contrast, in patients
randomized to the comparator arm, QOL-B scores plateaued between
Month 3 and Month 6 and worsened after stopping treatment at Month
6 through Month 7 (observed mean QOL-B score change from baseline:
6.9).
In a separate abstract presented, microbiologic evaluation of
sputum samples showed that a greater proportion of patients treated
with the ARIKAYCE plus macrolide-based background regimen achieved
culture conversion by Month 6 versus patients in the comparator arm
(80.6% vs. 63.9%, p=0.0712). Patients in the ARIKAYCE arm
also achieved nominally statistically significantly higher culture
conversion rates at Month 7 versus patients in the comparator arm
(78.8% vs. 47.1%, p=0.0010) with culture conversion more
likely to persist by Month 7.
Of those patients who achieved culture conversion by Month 6,
more patients in the ARIKAYCE arm achieved culture conversion by
Month 1 versus the comparator arm (74.3% vs. 46.7%, respectively)
and median time to first culture conversion event was 1.0 month in
the ARIKAYCE arm and 2.0 months in the comparator arm. Notably, no
patients in this study developed a MAC isolate with resistance to
ARIKAYCE and/or macrolide.
"These findings are very important given that NTM lung disease
is a challenging and complex disease to treat with limited
therapeutic options. Based on the positive results from ARISE, I
look forward to seeing the results from the ongoing Phase 3
registrational study ENCORE and the impact they may have on the NTM
patient community," said lead study investigator Charles Daley, M.D., Chief of the Division of
Mycobacterial and Respiratory Infections at National Jewish
Health.
The discontinuation rate of ARIKAYCE or the placebo used in the
comparator arm was 22.9% in the ARIKAYCE arm and 7.8% in the
comparator arm. Study completion rates were 91.7% in the ARIKAYCE
arm and 94.1% in the comparator arm. No new safety signals were
observed in the ARIKAYCE arm, and the safety profile in general was
as expected in both treatment arms. Treatment-emergent adverse
events (TEAEs) were reported by 91.7% of patients in the ARIKAYCE
arm and 80.4% of patients in the comparator arm. The most common
TEAEs were dysphonia (41.7% for the ARIKAYCE arm vs. 3.9% for the
comparator arm), cough (27.1% vs. 7.8%), diarrhea (27.1% vs.
25.5%), and COVID-19 (12.5% vs. 9.8%). Of the treatment-emergent
serious adverse events observed in the trial, none were determined
to be related to ARIKAYCE and none were deemed related to
COVID-19.
In addition to the ARISE results, the following Insmed abstracts
are being presented at ATS from across the Company's respiratory
portfolio, expanding the understanding of serious and rare
pulmonary diseases:
- Incremental Burden of Pulmonary Hypertension Among Patients
With Connective Tissue Disease-related Interstitial Lung Disease in
the Real-world Setting
- Incremental Burden of Pulmonary Hypertension Among Patients
With Non-Connective Tissue Disease-related Interstitial Lung
Disease in the Real-world Setting
- Treprostinil Palmitil Conversion Sites in the Lung
- Incidence and Prevalence of Non-Cystic
Fibrosis Bronchiectasis in Japan
- A Phase 1 Study of Brensocatib Following a Single Oral
Administration in Subjects With or Without Renal Impairment
- Association Between Exacerbation Burden and Comorbidities
Among Patients With Non-Cystic Fibrosis Bronchiectasis Over 1
Year
- Novel Anti-Inflammatory and Immunomodulatory Effects of
the Dipeptidyl Peptidase-1 Inhibitor Brensocatib: A Post-Hoc
Analysis of the WILLOW Trial
About the ARISE & ENCORE Clinical Trial Program
ARIKAYCE was granted accelerated approval by the FDA in September
of 2018 for the treatment of MAC lung disease as part of a
combination antibacterial drug regimen for adult patients who have
limited or no alternative treatment options. It is the first and
only therapy approved in the U.S. for the treatment of MAC lung
disease. The ARISE and ENCORE clinical trial program is intended to
fulfill the FDA's post-marketing requirement to allow for full
approval of ARIKAYCE in the U.S. and to support a supplemental new
drug application for the use of ARIKAYCE as a treatment for
patients with a MAC lung infection.
ARISE was a global, randomized, double-blind,
placebo-controlled, Phase 3b study in
adult patients with newly diagnosed or recurrent MAC lung disease
who had not received antibiotics for their current infection that
aimed to generate evidence demonstrating the domain specification,
reliability, validity, and responsiveness of PRO-based scores.
Patients were randomized 1:1 to receive ARIKAYCE plus background
regimen or placebo plus background regimen once daily for six
months. Patients then discontinued all study treatments and
remained in the trial for one month for the continued assessment of
PRO endpoints. The study enrolled 99 patients.
The ongoing ENCORE trial is a randomized, double-blind,
placebo-controlled, Phase 3b study to
evaluate the efficacy and safety of an ARIKAYCE-based regimen in
patients with newly diagnosed or recurrent MAC lung disease who
have not started antibiotics. Patients are randomized 1:1 to
receive ARIKAYCE plus background regimen or placebo plus background
regimen once daily for 12 months. Patients will then discontinue
all study treatments and remain in the trial for three months for
the assessment of durability of culture conversion. The primary
endpoint is change from Baseline to Month 13 in respiratory symptom
score. The key secondary endpoint is the proportion of patients
achieving durable culture conversion at Month 15.
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, CRSsNP, 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.
IMPORTANT SAFETY INFORMATION AND BOXED WARNING 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 progressing a robust pipeline of
investigational therapies targeting areas of serious unmet need,
including neutrophil-mediated inflammatory diseases and rare
pulmonary disorders. Insmed is also advancing an early-stage
research engine encompassing a wide range of technologies and
modalities, including artificial intelligence-driven protein
engineering, gene therapy, and protein manufacturing. Insmed is
headquartered in Bridgewater, New
Jersey, with additional offices and research locations
throughout the United States,
Europe, and Japan. Visit www.insmed.com to learn
more.
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 continue to successfully commercialize
ARIKAYCE, our only approved product, in the US, Europe or Japan (amikacin liposome inhalation
suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin
sulfate inhalation drug product, respectively), or to maintain US,
European or Japanese approval for ARIKAYCE; uncertainties or
changes in the degree of market acceptance of ARIKAYCE by
physicians, patients, third-party payors and others in the
healthcare community; our inability to obtain full approval of
ARIKAYCE from the FDA, including the risk that we will not
successfully or in a timely manner validate a patient reported
outcome (PRO) tool and complete the confirmatory post-marketing
clinical trial required for full approval of ARIKAYCE; inability of
us, PARI or our other third-party manufacturers to comply with
regulatory requirements related to ARIKAYCE or Lamira®;
our inability to obtain and maintain 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 our other product
candidates; inaccuracies in our estimates of the size of the
potential markets for ARIKAYCE, brensocatib, TPIP or our other
product candidates or in data we have 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,
our secured senior loan with certain funds managed by Pharmakon and
our 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 impact of the restrictions on our
operations under these agreements; our inability to create or
maintain 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 our 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 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; risk
that our competitors may obtain orphan drug exclusivity for a
product that is essentially the same as a product we are 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 our other product candidates and our
potential inability to enroll or retain sufficient patients to
conduct and complete the trials or generate data necessary for
regulatory approval of our product candidates or to permit the use
of ARIKAYCE in the broader population of patients with MAC lung
disease, among other things; risks that our clinical studies will
be delayed, that serious side effects will be identified during
drug development, or that any protocol amendments submitted will be
rejected; risks that interim or partial data sets are not
representative of a complete or larger data set or that blinded
data will not be predictive of unblinded data; failure to obtain,
or delays in obtaining, regulatory approvals for ARIKAYCE outside
the US, Europe or Japan, or for our product candidates in the
US, Europe, Japan or other markets, including separate
regulatory approval for Lamira® in each market and for
each usage; failure of third parties on which we are dependent to
manufacture sufficient quantities of ARIKAYCE or our product
candidates for commercial or clinical needs, to conduct our
clinical trials, or to comply with our agreements or laws and
regulations that impact our business or agreements with us; our
inability to attract and retain key personnel or to effectively
manage our growth; our inability to successfully integrate our
recent acquisitions and appropriately manage the amount of
management's time and attention devoted to integration activities;
risks that our acquired technologies, products and product
candidates are not commercially successful; inability to adapt to
our highly competitive and changing environment; inability to
access, upgrade or expand our technology systems or difficulties in
updating our existing technology or developing or implementing new
technology; risk that we are unable to maintain our significant
customers; risk that government healthcare reform materially
increases our costs and damages our financial condition; business
or economic disruptions due to catastrophes or other events,
including natural disasters or public health crises; risk that our
current and potential future use of artificial intelligence and
machine learning may not be successful; deterioration in general
economic conditions in the US, Europe, Japan
and globally, including the effect of prolonged periods of
inflation, affecting us, our suppliers, third-party service
providers and potential partners; inability to adequately protect
our intellectual property rights or prevent disclosure of our trade
secrets and other proprietary information and costs associated with
litigation or other proceedings related to such matters;
restrictions or other obligations imposed on us by agreements
related to ARIKAYCE or our product candidates, including our
license agreements with PARI and AstraZeneca AB, and failure to
comply with our obligations under such agreements; the cost and
potential reputational damage resulting from litigation to which we
are or may become a party, including product liability claims; risk
that our operations are subject to a material disruption in the
event of a cybersecurity attack or issue; our limited experience
operating internationally; changes in laws and regulations
applicable to our business, including any pricing reform and laws
that impact our ability to utilize certain third parties in the
research, development or manufacture of our product candidates, and
failure to comply with such laws and regulations; our history of
operating losses, and the possibility that we never achieve or
maintain profitability; goodwill impairment charges affecting our
results of operations and financial condition; inability to repay
our existing indebtedness and uncertainties with respect to our
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, 2023 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-positive-patient-reported-outcomes-and-microbiologic-data-from-phase-3-arise-study-of-arikayce-amikacin-liposome-inhalation-suspension-in-patients-with-ntm-lung-disease-caused-by-mac-at-american-thoracic-society-302150522.html
SOURCE Insmed Incorporated