Glaxo/Innoviva Expedite Closed Triple Combination NDA Filing

GlaxoSmithKline plc (NYSE:GSK) with partner, Innoviva, Inc. (NASDAQ:INVA) , announced that it has accelerated the timeline for filing a New Drug Application (NDA) for the once-daily closed triple combination therapy (FF/UMEC/VI) for the treatment of patients with chronic obstructive pulmonary disease (COPD).

The closed triple therapy is a combination of an inhaled corticosteroid (fluticasone furoate/FF), a long-acting muscarinic antagonist (umeclidinium/UMEC) and a long-acting beta agonist (vilanterol/VI).

Following discussions with the FDA, the companies brought the regulatory filing forward to the end of 2016 from the first half of 2018. However, the EU regulatory submission is still expected to be made by the end of 2016.

The companies stated that the NDA would consist of data currently in hand from the closed triple combination therapy development program and results from studies on FF, UMEC and VI either alone or in combination.

We note that the closed triple combination therapy is currently being evaluated in two phase III studies – FULFIL and IMPACT – designed to assess the safety and the effectiveness of the combination, in comparison with existing COPD treatments. Data from the FULFIL study are expected later in 2016, while results from the IMPACT study are anticipated in 2017.

Glaxo’s acceleration of the NDA filing is a big positive for Theravance Biopharma, Inc. (NASDAQ:TBPH) , as the latter has an economic interest in future payments, pursuant to its agreement with Innoviva for certain drug development programs.

Per the agreement, Theravance Biopharma is entitled to receive 85% economic interest in royalties paid by Glaxo in worldwide net sales. The royalties are upward-tiering from 6.5% to 10%.

Meanwhile, Innoviva retains a 15% economic interest in future payments made by Glaxo.

Currently, both Glaxo and Innoviva carry a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company (NYSE:BMY) is a better-ranked stock in the health care sector with a Zacks Rank #1 (Strong Buy).

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