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Glaxo-Innoviva's Triple Combo Inhaler Positive in Phase III

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GlaxoSmithKline plc (GSK - Free Report) and partner Innoviva, Inc. (INVA - Free Report) announced that its once-daily single inhaler triple therapy — Trelegy Ellipta (FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol) — met primary endpoint in a phase III IMPACT study, showing reduction in exacerbations in patients with chronic obstructive pulmonary disease (COPD).

While fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium is a long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2-adrenergic agonist (LABA). This combination medicine will be delivered once daily in the Ellipta dry powder inhaler. Typically, the ICS/LAMA/LABA amalgamation for advanced COPD is delivered via two or more inhalers with a potentially differing dose regime. However, GlaxoSmithKline’s triple therapy combination offers a daily treatment in a single Ellipta inhaler.

Notably, this week, the triple combination therapy was approved in the United States under the brand name, Trelegy Ellipta, as maintenance therapy for treatment of patients with COPD. Last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion, recommending approval of this combination therapy in the EU.

Notably, the closed triple combination therapy is not licensed as a single inhaler triple therapy anywhere outside the United States.

GlaxoSmithKline’s shares are up 4.3% so far this year, comparing unfavorably with the 16.8% rally of the industry during the period.


The IMPACT study was a randomised, double-blind, 3-arm parallel group, multicentre program, conducted on a total of 10,355 patients. The trial evaluated Trelegy Ellipta in comparison to the dual therapies of Anoro Ellipta (UMEC/VI) and Relvar/Breo Ellipta (FF/VI).

Data from the study demonstrated statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations in patients with COPD, which determines the primary endpoint of the study. The study met its secondary endpoints too. Based on the positive data from the IMPACT analysis, the company expects to commence global regulatory filing in the second quarter of 2018 for the given indication.

It is important to note that the combination therapy is also under assessment across countries including Australia and Canada.

Per the company’s press release, COPD is a progressive serious lung disease, commonly found to affect approximately 384 million people worldwide, thus representing a significant need for such therapies.

Zacks Rank & Stocks to Consider

GlaxoSmithKline currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector are Aduro Biotech, Inc. (ADRO - Free Report) and ACADIA Pharmaceuticals Inc. (ACAD - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates reduced from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 for 2018 over the last 60 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

ACADIA’s loss per share estimates narrowed from $2.82 to $2.57 for 2017 and from $2.07 to $1.90 for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 7.97%.

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