GSK and Theravance post COPD pill data

pharmafile | July 2, 2012 | News story | Research and Development, Sales and Marketing |  COPD, GSK, LABA, LAMA, Theravance 

GSK and partner Theravance have released new data for its combination COPD drug.

Results from four late-stage trials suggest that GlaxoSmithKline and Theravance’s new once-daily chronic obstructive pulmonary disease maintenance treatment helps patients breathe more easily.

The new Phase III data showed the combination drug produced statistically significant improvements when compared with its individual components alone and compared to placebo.

Two further studies also compared LAMA/LABA against Boehringer/Pfizer’s established drug Spiriva, which found statistically significant positive results for GSK and Theravance’s pill.

The companies say the investigational product, UMEC/VI, a combination of a long-acting muscarinic antagonist and long-acting beta agonist (LAMA/LABA), should be filed from the end of this year.

GSK hopes that this will become a next-generation medicine to succeed its $5 billion lung drug Advair/Seretide.

But its hopes are not only resting on the novel LAMA/LABA combination drug. GSK also has high hopes for Relovair which is being developed with Theravance, combining a LABA and an inhaled corticosteroid.

GSK partly owns Theravance, and recently bought more of the firm, topping up its total to over a quarter.

Both firms will be particularly pleased that the headline results showed their combination had at least some success when pit against Boehringer and Pfizer’s drug.

“These studies, together with our earlier dose-ranging work, give us confidence that this is a once-daily medicine with the potential to benefit many patients with COPD,” said Darrell Baker, GSK’s respiratory portfolio optimisation leader.

“Subject to successful completion of the ongoing studies, we plan to commence global regulatory filings from the end of this year,” he added.

The World Health Organization estimates that more than 21 million people are currently living with the disease: treatments already on the market include Merck’s once-daily pill Daxas (roflumilast) and GSK’s older, top-selling Seretide/Advair. 

In May Boehringer said its own investigational once-daily LABA olodaterol had improved lung function versus placebo in a Phase II trial. 

Adam Hill