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GSK, Theravance COPD Treatment Approved

Approval triggers $30 million payment from Theravance, with another $30 mil. due to GSK at launch

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GlaxoSmithKline and Theravance have received approval from the FDA to market Anoro Ellipta as a combination anticholinergic/long-acting beta2-adrenergic agonist (LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

Anoro Ellipta (umeclidinium and vilanterol inhalation powder) is the first once-daily product approved in the U.S. that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD. The FDA-approved strength is umeclidinium/vilanterol 62.5 mcg/25 mcg.

The product is expected to launch in 1Q14. Under the terms of their 2002 LABA collaboration agreement, Theravance must make a milestone payment of $30 million to GSK following FDA approval of Anoro Ellipta. Another $30 million payment to GSK is due following theU.S. of the treatment.

The Phase III program for Anoro Ellipta included seven trials with nearly 6,000 patients with COPD.

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