Glaxo Asthma Drug Stumbles in Ambitious Heart Patient Study

  • Summit study fails to show statistical difference in mortality
  • Shares of Glaxo decline; partner Theravance slid 15 percent

GlaxoSmithKline Plc’s Breo Ellipta medicine didn’t extend lives in an ambitious study that sought to show the drug could help patients suffering from both lung and heart troubles.

Patients taking the inhaled asthma drug Breo were 12 percent less likely to die than those who didn’t, a difference too small to be statistically significant, Glaxo and partner Theravance Inc. said in a statement on Tuesday. Shares of South San Francisco, California-based Theravance fell 15 percent in New York trading, while Glaxo slumped in London today.

Breo is crucial to Glaxo because it’s intended to help replace Advair, the asthma treatment that ranks as the London-based company’s biggest seller and may soon face generic competition in the U.S. The drug treats chronic obstructive pulmonary disease as well as asthma. The Summit study was unusual in its breadth: it examined Breo’s impact on 16,485 patients from 43 countries who had a history of cardiovascular disease (or were deemed at risk) on top of limited airflow to their lungs.

“Unfortunately, Summit did not deliver the goods,” Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, wrote in a note to clients. “Even if results had been positive, it was never clear how impactful they would be because physicians largely view Breo and Advair as interchangeable.”

Shares Drop

Glaxo shares fell 1 percent to 1,316 pence at 10:05 a.m. in London trading. The stock dropped 4.3 percent so far this year, making it one of the four worst performers in the Bloomberg index that tracks European drugmakers.

The study’s disappointment may affect rival products in the same class, such as AstraZeneca Plc’s Symbicort, and drive a switch to a category of medicines that work by preventing bronchial constriction rather than promoting dilation, according to Bloomberg Intelligence. They include Glaxo’s Anoro, AstraZeneca’s Duaklir and Boehringer Ingelheim GmbH’s Spiriva.

Chief Executive Officer Andrew Witty had cited the difficulty of copying the inhaler that delivers Advair as a hurdle for generic challengers. Mylan NV plans to file its generic version to U.S. regulators by the end of the year. Advair copies are already available in Europe.

“With the failure of Summit, GSK’s Breo looks entirely exposed to generic Advair competition,” Andrew Baum, an analyst at Citigroup Inc., wrote in a note to clients. He estimated that Breo would have sales of 1 billion pounds ($1.54 billion) in 2022, and Advair sales of 1.1 billion pounds.

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