FDA Oks GSK-Theravance's Anoro Ellipta To Treat COPD

(RTTNews) - Skyepharma Plc. (SKP.L) announced Wednesday that the U.S. Food and Drug Administration or FDA has approved the New Drug Application or NDA submitted by GlaxoSmithKline (GSK, GSK.L) for Anoro Ellipta(umeclidinium / vilanterol) as a combination anticholinergic/long-acting beta2-adrenergic agonist indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease or 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 is a combination of two bronchodilator molecules: umeclidinium bromide and vilanterol, administered using the Ellipta inhaler.

Skyepharma stated that Anoro Ellipta incorporates one of its dry powder inhalation formulation technologies licensed to GSK.

Skyepharma noted that The technology has also been incorporated in Breo Ellipta, which was approved in the U.S. in May for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD and launched at the end of October. This product has been approved under the brand name Relvar Ellipta in Japan for the treatment of asthma and in Europe for the treatment of both asthma and COPD.

Skyepharma said it is entitled to a low single digit royalty on net sales of products using the licensed technology, capped at a maximum amount of 3 million pounds per annum for each chemical entity for the life of the relevant patents. The two GSK combination products involve three chemical entities, with a total potential income to Skyepharma of up to 9 million pounds a year.

GSK has stated that it anticipates that launch activities in the U.S. will commence during the first quarter of 2014 for ANORO ELLIPTA. The product has also been filed in Europe and Japan for the treatment of COPD.

On Wednesday, GlaxoSmithKline and Theravance Inc. (THRX) announced that the US Food and Drug Administration has approved Anoro Ellipta as a combination anticholinergic/long-acting beta2-adrenergic agonist or LABA indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease or 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 US 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.

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million to GSK following FDA approval of Anoro Ellipta. A further $30 million payment to GSK will follow the launch of Anoro Ellipta in the US.