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Theravance, Glaxo SUMMIT Study Misses Primary Endpoint

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Theravance, Inc.THRX and GlaxoSmithKline plc GSK announced initial data from the SUMMIT (Study to Understand Mortality and MorbidITy) study on Relvar/Breo Ellipta (100/25mcg) in chronic obstructive pulmonary disease (COPD) patients with moderate airflow limitation and either a history or increased risk of cardiovascular disease (CVD).

Although the risk of dying on Relvar/Breo Ellipta was 12.2% less than placebo, the results were not statistically significant thereby signifying the non-achievement of the primary endpoint. Moreover, Relvar/Breo Ellipta failed to achieve statistical significance in one of the secondary endpoints (risk of experiencing an on-treatment cardiovascular (CV) event (CV death, myocardial infarction, stroke, unstable angina and transient ischemic attack [TIA]) at any time).

Relvar/Breo Ellipta, however, reduced the rate of lung function decline by 8mL per year compared to placebo - this was one of the secondary endpoints.

We note that, Theravance has a collaboration agreement with Glaxo on the development of respiratory treatment products - Relvar/Breo Ellipta and Anoro Ellipta.

Relvar/Breo Ellipta is currently approved in the U.S. for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations. In EU, the drug is approved for the symptomatic treatment of adults with COPD with a FEV1

Meanwhile, both companies continue to evaluate Relvar/Breo Ellipta in Salford Lung study in COPD patients. The study is expected to be completed by the year-end with initial data expected in 2016.

Our Take

The study results are disappointing - a reduction in death from any cause in patients with both COPD and CV would have helped boost Relvar/Breo Ellipta.

Theravance carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Vanda Pharmaceuticals, Inc. VNDA , each sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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