Insmed Reports First-Quarter 2024 Financial Results and Provides Business Update
— ARIKAYCE® (amikacin liposome inhalation suspension) Total Revenue of
—Company Reports Positive Topline Safety and Tolerability Data from the Phase 2 PH-ILD Study of TPIP with 79.3% of Patients Reaching the Maximum Dose of 640 µg by Week 5, with an Unexpectedly Positive and Robust Signal on the Exploratory Endpoint of Clinical Worsening—
—Encouraging Blinded Data from First 40 Patients in Phase 2 PAH Study of TPIP, with Combined Active Treatment and Placebo Arms Showing Mean PVR Reduction of 19.9% and 6-Minute Walk Distance Improvement of 43 Meters—
—Topline Data from the Phase 3 ASPEN Trial of Brensocatib in Patients with Bronchiectasis Remains on Track to
—Company Reiterates
2024 Global ARIKAYCE Revenue Guidance in the Range of
"Today,
Recent Pillar Highlights
Pillar 1: ARIKAYCE
- ARIKAYCE global revenue grew 16% in the first quarter of 2024 compared to the first quarter of 2023, reflecting double-digit year-over-year growth in the
U.S. ,Japan , andEurope . - The Company received notification that the
National Agency for the Safety of Medicines and Health inFrance plans to proceed with a program to allow for the compassionate prescribing of ARIKAYCE for the treatment of adult patients with mycobacterium abscessus lung infection. - The Company is scheduled to meet with the U.S. Food and Drug Administration (FDA) in late June to gain additional insights and guidance on the patient-reported outcome tool to be used in the Phase 3 ENCORE study, after which it will finalize its statistical plan for ENCORE.
- The Data Safety Monitoring Committee for the ongoing ENCORE trial held its fourth safety review meeting in April of 2024 and recommended that the study progress unchanged.
- The Company continues to expect topline data from ENCORE in 2025.
Pillar 2: Brensocatib
-
Insmed continues to expect topline data from the Phase 3 ASPEN study of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFBE) in the latter part of the second quarter of 2024. - As of the end of the first quarter of 2024, all adult patients in
ASPEN had completed their 52-week visit, the point in the trial at which the primary and secondary efficacy endpoints are measured. - If
ASPEN is successful and regulatory approval is obtained, the Company anticipates a launch in theU.S. in mid-2025, followed by launches inEurope andJapan in the first half of 2026.Insmed continues to advance its launch readiness activities in preparation for these potential launches. - In the first quarter of 2024, Insmed received notification from the Medicines and Healthcare products Regulatory Agency in the
United Kingdom regarding a positive outcome for the Company'sInnovative Licensing and Access Pathway (ILAP) passport application, granting Innovation Passport designation for brensocatib in the treatment of NCFBE in patients aged 12 years and older. The ILAP and the Innovation Passport are intended to accelerate time to market, facilitating patient access for important new medicines in theUnited Kingdom . - The Company continues to enroll patients in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and anticipates providing topline data from the study in 2025.
- The Company expects to initiate a Phase 2 study of brensocatib in patients with hidradenitis suppurativa (HS) in the second half of 2024, pending positive results from the
ASPEN study.
Pillar 3: TPIP
PH-ILD
- Today, Insmed reported topline safety and tolerability data as well as certain exploratory efficacy endpoints from the Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).
- In the TPIP arm, 79.3% of patients were successfully able to reach the maximum 640 microgram (µg) dose by Week 5, compared to 100.0% of patients in the placebo arm.
- Treatment-emergent adverse events which led to treatment discontinuation occurred in 13.8% of patients in the active treatment arm and 30.0% of patients in the placebo arm.
- Adverse events of any kind were observed in 93.1% of patients in the TPIP arm and 90.0% of patients in the placebo arm. Adverse events related to study drug occurred in 55.2% of TPIP patients and 40.0% of placebo patients.
- Study drug-related cough was observed in 37.9% of patients in the TPIP arm and 0.0% of patients in the placebo group.
- All events of cough were mild, and none led to treatment discontinuation.
- Serious adverse events occurred in 20.7% of TPIP-treated patients and 40.0% of placebo-treated patients.
- Deaths occurred in 6.9% of patients taking TPIP and 20.0% of patients taking placebo.
- All deaths were attributed to disease progression or comorbid causes, none of which were deemed related to study drug.
- There were no meaningful changes in oxygenation levels compared to baseline for TPIP-treated patients at rest or at the lowest point during or after exercise. There was also no change in the use of supplemental oxygen for patients taking TPIP.
- There was a small decrease in oxygenation levels observed after exercise for patients on TPIP, compared to a slight increase for patients taking placebo. However, there was variability in the timing of when this endpoint was measured in the study, which could make the results less interpretable than the measurements taken at rest or at the lowest point during or after exercise.
- On the exploratory endpoint of change from baseline in 6-minute walk distance, TPIP-treated patients demonstrated a 30-meter improvement compared to patients treated with placebo. However, this result was associated with a wide confidence interval.
- There was a directional improvement observed in NT-proBNP levels from baseline for patients taking TPIP and a directional worsening observed in patients on placebo, although no meaningful separation was observed between groups.
- Events of clinical worsening occurred in 10.3% of patients taking TPIP, compared to 50.0% of patients taking placebo. This difference was nominally significant (p=0.0164).
- Due to the small size of the study, the Company interprets these results with appropriate caution.
-
Insmed looks forward to the opportunity to present pharmacokinetic results and additional safety and exploratory endpoints from this trial at an upcoming medical conference later this year. - Based on these Phase 2 results in PH-ILD, the Company is advancing toward discussions with global regulatory authorities on the design of a Phase 3 study in PH-ILD, which the Company anticipates initiating in 2025.
PAH
- Today, the Company also shared updated blinded and blended data from the first 40 patients who completed the full 16 weeks of treatment in the ongoing Phase 2 study of TPIP in pulmonary arterial hypertension (PAH).
- Of those 40 patients, including those on placebo, the average reduction in pulmonary vascular resistance (PVR) at Week 16 compared to baseline levels was 19.9%.
- Among the 40 patients across the treatment and placebo arms, the average improvement in 6-minute walk distance from baseline was 43 meters.
- Among the first 43 patients to complete the Week 5 visit, 79.1% were able to reach the maximum dose of 640 µg or matching placebo.
-
Insmed has received the necessary regulatory approvals in 10 of 17 countries where the study is taking place to amend the protocol to allow for an increase in the maximum dose of TPIP from 640 µg to up to 1,280 µg, once a day, in the open label extension study for certain PAH patients based on investigator decision. - Enrollment remains ongoing in the Phase 2 PAH study, with more than half of the target enrollment currently complete.
- In March of 2024, the second meeting of the Data Monitoring Committee took place for the Phase 2 trial in PAH, resulting in the committee's recommendation to continue the trial without changes.
- Topline results from the Phase 2 PAH study continue to be expected in 2025.
Pillar 4:
-
Insmed's early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies. - The Company continues to anticipate the totality of its early-stage research programs will comprise less than 20% of overall spend.
Corporate Updates
-
Insmed plans to present nine abstracts from across its respiratory portfolio (ARIKAYCE, brensocatib, and TPIP) at theAmerican Thoracic Society (ATS) 2024International Conference , taking placeMay 17-22, 2024 . - The Company served as the founding sponsor of the COPD Foundation's new Care Center Network for patients with bronchiectasis and nontuberculous mycobacterial lung disease. Through this initiative, the
COPD Foundation aims to create 150 multi-disciplinary centers of excellence across theU.S. to establish consistent standards of care coming from expert-led academic centers and share them with the broader community in an effort to bring more comprehensive care to patients as they strive to meet treatment goals. -
Insmed's Chief Medical Officer,Martina Flammer , M.D., M.B.A., has been appointed Chair of theNew Jersey Rare Disease Advisory Council (RDAC) by GovernorPhil Murphy . In an effort established by theNational Organization for Rare Disorders (NORD), RDACs bring together a unified, multidisciplinary network of state-wide experts focused on raising awareness of rare diseases and funding much-needed new research. Martina was nominated by BioNJ, the life sciences trade association forNew Jersey , to represent the biopharma industry inNew Jersey's RDAC.
First-Quarter 2024 Financial Results
- Total revenue for the first quarter ended
March 31, 2024 was$75.5 million , reflecting 16% growth compared to total revenue of$65.2 million for the first quarter of 2023. - Total revenue for first-quarter 2024 was comprised of ARIKAYCE net sales of
$56.3 million in theU.S. ,$14.9 million inJapan , and$4.3 million inEurope and rest of world. First-quarter 2024 sales demonstrated year-over-year growth of 15% in theU.S. , 13% inJapan , and 42% inEurope and rest of world, reflecting continued growth trends for ARIKAYCE in these regions. - Cost of product revenues (excluding amortization of intangibles) was
$17.5 million for the first quarter of 2024, compared to$13.8 million for the first quarter of 2023, primarily reflecting increased sales volumes of ARIKAYCE. - Research and development (R&D) expenses were
$121.1 million for the first quarter of 2024, compared to$127.9 million for the first quarter of 2023, a decrease that reflects a non-cash charge of$10.3 million related to the acquisition ofVertuis Bio, Inc. in the first quarter of 2023. - Selling, general and administrative (SG&A) expenses for the first quarter of 2024 were
$93.1 million , compared to$79.9 million for the first quarter of 2023. The year-over-year increase in SG&A expenses resulted primarily from increases in compensation and benefit-related expenses. - For the first-quarter 2024, Insmed reported a net loss of
$157.1 million , or$1.06 per share, compared to a net loss of$159.8 million , or$1.17 per share, for the first-quarter 2023.
Balance Sheet, Financial Guidance, and Planned Investments
- As of
March 31, 2024 ,Insmed had cash and cash equivalents totaling$595.7 million . -
Insmed is reiterating its sales guidance for full-year 2024 global ARIKAYCE revenues in the range of$340 million to$360 million , representing 15% year-over-year growth at the midpoint compared to 2023. -
Insmed continues to anticipate that over 80% of total expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company's historical approach to spending. - The Company plans to continue to invest in the following key activities in 2024:
(i) commercialization and expansion of ARIKAYCE globally;
(ii) advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, commercial launch readiness activities, the ongoing Phase 2 trial in patients with CRSsNP, and the Phase 2 program in HS to be initiated in the second half of the year if the
(iii) advancement of the clinical trial program for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;
(iv) advancement of its clinical development programs for TPIP; and
(v) development of its early-stage research programs.
Conference Call
Insmed will host a conference call beginning today at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (
A replay of the conference call will be accessible approximately 1 hour after its completion through
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Consolidated Statements of Net Loss |
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(in thousands, except per share data) |
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(unaudited) |
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|
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|
|
|
Three Months Ended |
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||
|
|
2024 |
|
2023 |
|
|
|
|
|
||
|
Product revenues, net |
$ 75,500 |
|
$ 65,214 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Cost of product revenues (excluding amortization of intangible assets) |
17,457 |
|
13,830 |
|
|
Research and development |
121,083 |
|
127,865 |
|
|
Selling, general and administrative |
93,102 |
|
79,914 |
|
|
Amortization of intangible assets |
1,263 |
|
1,263 |
|
|
Change in fair value of deferred and contingent consideration |
(11,900) |
|
(9,500) |
|
|
Total operating expenses |
221,005 |
|
213,372 |
|
|
|
|
|
|
|
|
Operating loss |
(145,505) |
|
(148,158) |
|
|
|
|
|
|
|
|
Investment income |
8,783 |
|
10,524 |
|
|
Interest expense |
(21,042) |
|
(20,003) |
|
|
Change in fair value of interest rate swap |
2,362 |
|
(1,533) |
|
|
Other expense, net |
(1,100) |
|
(111) |
|
|
Loss before income taxes |
(156,502) |
|
(159,281) |
|
|
|
|
|
|
|
|
Provision for income taxes |
589 |
|
483 |
|
|
|
|
|
|
|
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Net loss |
$ (157,091) |
|
$ (159,764) |
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|
|
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Basic and diluted net loss per share |
$ (1.06) |
|
$ (1.17) |
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|
|
|
|
|
|
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Weighted average basic and diluted common shares outstanding |
148,456 |
|
136,355 |
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Consolidated Balance Sheets |
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(in thousands, except par value and share data) |
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As of |
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As of |
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(unaudited) |
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Assets |
|
|
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Current assets: |
|
|
|
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Cash and cash equivalents |
|
$ 595,729 |
|
$ 482,374 |
Marketable securities |
|
- |
|
298,073 |
Accounts receivable |
|
37,162 |
|
41,189 |
Inventory |
|
82,957 |
|
83,248 |
Prepaid expenses and other current assets |
|
42,874 |
|
24,179 |
Total current assets |
|
758,722 |
|
929,063 |
|
|
|
|
|
Fixed assets, net |
|
68,660 |
|
65,384 |
Finance lease right-of-use assets |
|
20,307 |
|
20,985 |
Operating lease right-of-use assets |
|
17,157 |
|
18,017 |
Intangibles, net |
|
62,441 |
|
63,704 |
|
|
136,110 |
|
136,110 |
Other assets |
|
95,698 |
|
96,574 |
Total assets |
|
$ 1,159,095 |
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$ 1,329,837 |
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|
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Liabilities and shareholders' equity |
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|
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Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ 189,362 |
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$ 214,987 |
Current portion of long-term debt |
|
224,194 |
|
- |
Finance lease liabilities |
|
2,695 |
|
2,610 |
Operating lease liabilities |
|
4,609 |
|
8,032 |
Total current liabilities |
|
420,860 |
|
225,629 |
|
|
|
|
|
Debt, long-term |
|
939,081 |
|
1,155,313 |
Royalty financing agreement |
|
156,967 |
|
155,034 |
Contingent consideration |
|
63,700 |
|
84,600 |
Finance lease liabilities, long-term |
|
26,320 |
|
27,026 |
Operating lease liabilities, long-term |
|
13,809 |
|
11,013 |
Other long-term liabilities |
|
3,166 |
|
3,145 |
Total liabilities |
|
1,623,903 |
|
1,661,760 |
|
|
|
|
|
Shareholders' equity: |
|
|
|
|
Common stock, |
|
|
|
|
shares, 148,560,882 and 147,977,960 issued and outstanding |
|
1,486 |
|
1,480 |
Additional paid-in capital |
|
3,138,578 |
|
3,113,487 |
Accumulated deficit |
|
(3,603,236) |
|
(3,446,145) |
Accumulated other comprehensive loss |
|
(1,636) |
|
(745) |
Total shareholders' deficit |
|
(464,808) |
|
(331,923) |
Total liabilities and shareholders' deficit |
|
$ 1,159,095 |
|
$ 1,329,837 |
About ARIKAYCE
ARIKAYCE is approved in the United States as ARIKAYCE® (amikacin liposome inhalation suspension), in
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
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
IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE
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
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-
Please see Full Prescribing Information .
About Insmed
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,
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
With respect to the blended and blinded data observed from the ongoing TPIP study in PAH noted above, the dose titration and efficacy analyses were based on data available as of
Contact:
Investors:
Executive Director, Investor Relations
(646) 812-4030
bryan.dunn@insmed.com
Eleanor Barisser
Associate Director, Investor Relations
(718) 594-5332
eleanor.barisser@insmed.com
Media:
Executive Director, Corporate Communications
(732) 718-3621
amanda.fahey@insmed.com
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