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22.05.2019 07:14:46

Press Release: Novartis phase II data for new inhaled combination treatment (QVM149) demonstrates significant improvements over current standard-of-care inha...

Novartis International AG / Novartis phase II data for new inhaled

combination treatment (QVM149) demonstrates significant improvements

over current standard-of-care inhaled treatment. Processed and

transmitted by West Corporation. The issuer is solely responsible for

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the content of this announcement.

-- New inhaled combination for asthma treatment (indacaterol acetate,

glycopyrronium bromide and mometasone furoate - IND/GLY/MF) was superior

to the standard of care (long-acting beta-agonist/inhaled corticosteroid

- LABA/ICS) in terms of lung function in a phase II study

-- In another phase II study, IND/GLY/MF was superior to placebo in lung

function improvement irrespective of administration time of morning or

evening

-- The combination of IND/GLY/MF is in development as a once-daily inhaled

treatment for asthma, delivering the comprehensive bronchodilation of

indacaterol/glycopyrronium and the established efficacy of mometasone via

the dose-confirming Breezhaler(R)

-- IND/GLY/MF demonstrated a favorable safety and tolerability profile in

both phase II studies

Basel, May 22, 2019 - Novartis announced today that new phase II data

for IND/GLY/MF (QVM149), an investigational, once-daily, fixed dose

combination asthma treatment containing indacaterol acetate,

glycopyrronium bromide and mometasone furoate, delivered with the

dose-confirming Breezhaler(R) inhalation device, was presented at the

2019 annual international congress of the American Thoracic Society

(ATS).

In two phase II clinical studies, IND/GLY/MF was superior to the

comparators, salmeterol/fluticasone propionate (a standard-of-care

treatment)[1] and placebo[2], separately by demonstrating improvement in

lung function in patients with asthma. In one study, IND/GLY/MF also

demonstrated improvements versus placebo irrespective of administration

time of morning or evening[2].

In the phase II CQVM149B2208 study (ClinicalTrials.gov Identifier:

NCT03063086), both once-daily doses of IND/GLY/MF (150/50/160 Mu g,

high-dose ICS; 150/50/80 Mu g, medium-dose ICS) met the primary endpoint

with statistically significant improvements of peak FEV(1) (forced

expiratory volume in 1 second) versus twice daily salmeterol/fluticasone

propionate (50/500 Mu g, high-dose ICS) with mean differences of 172 mL

(95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively

(p<0.001)[1].

Additionally, compared with salmeterol/fluticasone propionate 50/500 Mu

g twice a day, both high and medium doses of IND/GLY/MF met the

secondary endpoint with statistically significant improvements (p<0.001)

in FEV(1) AUC (FEV(1) area under the curve) across both time intervals

of FEV(1) AUC(5min-1h) and FEV(1) AUC(5min-23h45min) [1].

"These results demonstrate that this novel combination offering dual

bronchodilation plus an inhaled corticosteroid can provide further lung

function benefits to patients with asthma beyond established therapies,"

said Dr Henrik Watz, Pulmonary Research Institute at LungenClinic

Grosshansdorf, Airway Research Center North, German Center for Lung

Research.

In study CQVM149B2209 (ClinicalTrials.gov Identifier: NCT03108027),

once-daily IND/GLY/MF provided consistent and substantial lung function

benefits over the entire 24-hour dosing interval in adult patients with

asthma, irrespective of dosing time (morning or evening). The study met

the primary endpoint by demonstrating the improved FEV(1) for both

morning and evening administrations of IND/GLY/MF versus placebo over 14

days, with mean differences of 610 mL (90% CI: 538, 681) and 615 mL (90%

CI: 544, 687) respectively[2].

The safety data from both studies suggest that IND/GLY/MF has a

favorable safety and tolerability profile. The adverse events observed

in the IND/GLY/MF groups were comparable to placebo (CQVM149B2209)[2]

and salmeterol/fluticasone propionate (CQVM149B2208) [1], with no

serious adverse events reported in any treatment period in both studies.

While phase III trials are ongoing, Novartis plans to present more data

and analyses at future medical conferences to address the clinical and

regulatory path forward for IND/GLY/MF delivered by Breezhaler(R).

"Despite the availability of numerous asthma treatments, more than

one-third of asthma patients remain uncontrolled and continue to

experience symptoms and/or exacerbations," said Linda Armstrong, MD,

Respiratory Development Unit Head. "These phase II studies' results are

a promising stride forward for this once daily combination. Together

with a dose-confirming Breezhaler(R) inhalation device, which is well

established in COPD, this new combination, if approved, has the

potential to improve lives of those with uncontrolled asthma."

About QVM149 (IND/GLY/MF)

The combination of indacaterol acetate, glycopyrronium bromide and

mometasone furoate (IND/GLY/MF) is currently in development for the

treatment of inadequately controlled asthma. This formulation combines

comprehensive bronchodilation of indacaterol acetate (a LABA

[long-acting beta agonist]) and glycopyrronium bromide (a LAMA

[long-acting muscarinic receptor antagonists]) with mometasone furoate

(high- or medium-dose ICS [inhaled corticosteroid]) in a precise

once-daily formulation, delivered with the dose-confirming Breezhaler(R)

device. Glycopyrronium bromide and certain use and formulation

intellectual property were exclusively licensed to Novartis in April

2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively

licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth,

NJ, USA, for use in QVM149 (Worldwide excluding US).

About CQVM149B2208 study (ClinicalTrials.gov Identifier: NCT03063086)[3]

The CQVM149B2208 study was a phase II, randomized, double-blind,

double-dummy, active comparator-controlled, three-period cross-over

trial with 21 treatment days per treatment period in adults with

moderate-to-severe asthma. Patients were randomized to receive

once-daily high- or medium-dose of indacaterol acetate/glycopyrronium

bromide/mometasone furoate (150/50/160 Mu g in the high-dose ICS

formulation; 150/50/80 Mu g in the medium-dose ICS formulation) or

twice-daily salmeterol/fluticasone propionate (50/500 Mu g, high-dose

ICS).

Of 116 randomized patients, 107 patients completed the study. The median

(range) age of participants was 52.0 (18-76) years and 52.6% were male.

At screening, mean (SD) pre-bronchodilator FEV(1) (% predicted of

normal) was 62.1% (11.5) and the mean (SD) reversibility was 23.9%

(12.61). A majority of patients (90.5%) were receiving stable medium- or

high-dose ICS.

Spirometry was performed at the end of each treatment period. The

primary endpoint was peak FEV(1) during the first 4 hours after the last

dose in each treatment period. Secondary endpoints included FEV(1) area

under the curve (AUC(5min-1h) ; AUC(5min-23h45min) ) and safety

assessments.

About CQVM149B2209 study (ClinicalTrials.gov Identifier: NCT03108027)[4]

The CQVM149B2209 study was a phase II, randomized, double-blind,

placebo-controlled, three-period, crossover study in 37 adult patients

with asthma, investigating the bronchodilator effect of IND/GLY/MF

(150/50/80 Mu g) when administered in the morning or evening versus

placebo over 14 days.

Of 37 randomized patients, 34 completed the three dosing periods. The

median (range) age of participants was 46.0 (18-72) years and 56.8% were

male. At screening, mean (SD) pre-bronchodilator FEV(1) was 75.8% (9.0),

83.3% for patients receiving stable low-dose ICS and 16.2% for mid-dose

ICS. The mean (SD) reversibility was 18.9% (7.83).

Spirometry was performed at the end of each treatment period. The

primary endpoint was weighted FEV(1) area under the curve (AUC(0-24h) )

after the last morning or evening dose of IND/GLY/MF or placebo.

About Asthma

Asthma affects an estimated of 358 million people worldwide and can

cause a significant personal, health, and financial burden when not

adequately controlled[5],[6]. Despite the availability of numerous

asthma treatments, more than one-third of patients remain

uncontrolled[7].

About Novartis in Respiratory

Novartis is a leading respiratory company that drives novel advances to

improve the lives of those living with lung conditions around the world.

Through courageous innovation and close partnership with patients and

medical experts, Novartis is committed to solving the unmet needs in

asthma management and improving better treatment outcomes for chronic

obstructive pulmonary disease (COPD).

Disclaimer

This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

such as "potential," "can," "will," "plan," "expect," "anticipate,"

"look forward," "believe," "committed," "investigational," "pipeline,"

"launch," or similar terms, or by express or implied discussions

regarding potential marketing approvals, new indications or labeling for

the investigational or approved products described in this press release,

or regarding potential future revenues from such products. You should

not place undue reliance on these statements. Such forward-looking

statements are based on our current beliefs and expectations regarding

future events, and are subject to significant known and unknown risks

and uncertainties. Should one or more of these risks or uncertainties

materialize, or should underlying assumptions prove incorrect, actual

results may vary materially from those set forth in the forward-looking

statements. There can be no guarantee that the investigational or

approved products described in this press release will be submitted or

approved for sale or for any additional indications or labeling in any

market, or at any particular time. Nor can there be any guarantee that

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May 22, 2019 01:15 ET (05:15 GMT)