News Article

Theravance to pay GSK $60M after FDA approval, launch of COPD drug
Date: Dec 19, 2013
Author: Ron Leuty
Source: bizjournals ( click here to go to the source)

Featured firm in this article: Innoviva Inc of Brisbane, CA



Ron Leuty, Reporter- San Francisco Business Times

Theravance Inc. will pay partner GlaxoSmithKline plc $30 million after regulatory approval Wednesday of a once-daily treatment for the lung condition chronic obstructive pulmonary disease.

South San Francisco-based Theravance (NASDAQ: THRX) also will pay GSK (NYSE: GSK) another $30 million following the launch of the drug and inhaler — together called Anoro Ellipta — in first-quarter 2014.

The drug won the blessing of a Food and Drug Administration advisory panel in September.

Anoro Ellipta is a combination of two bronchodilator molecules — vilanterol, which is a long-acting beta2-agonist, or LABA, and GSK-573719 — that are designed to be a long-term, once-daily treatment for obstructed airflow in patients with COPD.

The Ellipta part refers to a new dry powder inhaler.

COPD is a collection of smoking and environmental-related lung diseases, including chronic bronchitis and emphysema. The conditions are diagnosed in about 12 million Americans a year.

"We are very pleased that Anoro Ellipta has become the first once-daily dual bronchodilator approved in the U.S. for the treatment of COPD," Theravance CEO Rick Winningham said in a press release.

The companies won FDA approval in May of a related product, called Breo Ellipta, that is a combination of fluticasone fuorate, which is an inhaled corticosteroid, and vilanterol. Theravance paid GSK $15 million after European regulators approved that drug — called Relvar Ellipta in Europe — for COPD and asthma patients.

GSK owns about 30 percent of Theravance.