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Novartis (NVS) Reports Positive Phase III Data on Asthma Drug

Zacks Equity Research

Novartis AG NVS announced positive results from a late-stage study on QMF 149 for asthma.

QMF149 is an investigational, once-daily, fixed dose combination, containing indacaterol acetate (IND - a long acting beta agonist [LABA]) and mometasone furoate (MF), currently in development for the treatment of patients suffering from inadequately controlled asthma (who remain symptomatic despite current treatment).

Per the results of the multicentre, double-blind phase III QUARTZ study, once-daily, a low dose of QMF149 demonstrated both statistically significant and clinically meaningful improvements in lung function and asthma control compared to inhaled corticosteroid (ICS) monotherapy.

The candidate met the primary and key secondary endpoints, when compared to once-daily MF, in both adult and adolescent patients with asthma. We note that patients included in the QUARTZ study were inadequately controlled on low dose ICS.

Novartis has submitted a regulatory application for this investigational, once-daily inhaled combination treatment, which has recently been accepted for review by the European Medicines Agency (EMA).

QUARTZ is the first completed study of the phase III PLATINUM clinical development program, which is evaluating both QMF149 (indacaterol and mometasone furoate) and QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate).

Novartis aims to improve inhaled asthma care by developing once-daily, fixed-dose combination treatments, delivered with the dose-confirming Breezhaler device, to help asthma patients achieve better control.

The company also recently received FDA approval for Piqray (alpelisib, formerly BYL719) in advanced breast cancer.

In addition, the FDA also approved Zolgensma, the first and only gene therapy for pediatric patients aged less than 2 years with spinal muscular atrophy (SMA), which is a rare genetic disorder. 

Novartis’ share price has been flat so far in the year against the industry's 2.1% decline.

Approval of new drugs will boost sales for the company. Novartis has streamlined its portfolio to focus on legacy drugs business.  The separation of the Alcon business is a step in the right direction, as the business was not performing as per management’s expectations. Novartis will also sell selected portions of its Sandoz U.S. portfolio, specifically the Sandoz U.S. dermatology business and the U.S. oral solids portfolio.

Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank #5 (Strong Sell).

Some better-ranked stocks are Bristol-Myers Squibb Co. BMY, Roche RHHBY and Celgene Corporation CELG. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $4.78 to $5.03 for 2020 in the past 60 days.

Roche’s earnings per share estimates have increased from $2.35 to $2.40 for 2019 in the past 60 days.

Celgene’s earnings estimates have moved up by a cent to $10.74 over the past 30 days.

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