Glaxo/Innoviva's Closed Triple Combination Tops Phase III

GlaxoSmithKline plc (NYSE:GSK) , with its partner Innoviva, Inc. (NASDAQ:INVA) , announced positive top-line data from the phase III FULFIL study on the closed triple combination therapy (fluticasone furoate, FF/umeclidinium, UMEC/vilanterol, VI) for chronic obstructive pulmonary disease (COPD).

The randomized, double-blind, double-dummy, parallel-group study evaluated the once-daily FF/UMEC/VI (100mcg/62.5mcg/25mcg) inhalation powder, in comparison to twice-daily Symbicort Turbohaler (budesonide/formoterol 400mcg/12mcg) administered through the Turbohaler dry powder inhaler.

The study revealed superiority of the closed triple combination over Symbicort Turbohaler in improving lung function and health-related quality of life in COPD patients. Data also demonstrated statistically significant improvements compared to Symbicort Turbohaler, thereby meeting the two co-primary endpoints. In addition, the safety profile of the combination at 24 weeks as well as 52-week extension was consistent with the known profile of the individual medicines and their combinations.

Full results from the FULFIL study, including data on the secondary endpoints and the 52-week extension study will be presented at a future scientific congress.

Glaxo intends to submit regulatory applications for the combination therapy in both the U.S. and the EU by the end of 2016.

We remind investors that earlier this month, following discussions with the FDA, Glaxo announced that it has accelerated the timeline of a New Drug Application (NDA) filling in the U.S. to the end of 2016 from the first half of 2018.

We note that a successful development and commercialization of the combination would allow Theravance Biopharma, Inc. (NASDAQ:TBPH) to receive an 85% economic interest in the royalties paid by Glaxo on worldwide net sales, pursuant to its agreement with Innoviva for certain drug development programs. The royalties are upward tiering from 6.5% to 10%.

Apart from the FULFIL study, the closed triple combination therapy is also being evaluated in the phase III IMPACT study to evaluate the safety and effectiveness of the combination in comparison to existing COPD therapies. Data from the study are expected in 2017.

Glaxo currently carries a Zacks Rank #2 (Buy), while Innoviva is a Zacks Rank #3 (Hold) stock. Bristol-Myers Squibb Company (NYSE:BMY) is another favorably placed stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).

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