Glaxo-Theravance’s Second Lung Drug Wins U.S. Approval

GlaxoSmithKline Plc and Theravance Inc. won approval for the second lung drug in their partnership aimed at treating the third-leading cause of death in the U.S.

The Food and Drug Administration today cleared Anoro Ellipta for chronic obstructive pulmonary disorder, an umbrella term for emphysema and chronic bronchitis. Anoro is the first in a competition with companies including Novartis AG and Forest Laboratories Inc. to combine two drugs that relax airways.

The once-daily dry powder inhaler may generate $1.2 billion in sales in 2016, according to the average of eight analysts’ estimates compiled by Bloomberg. COPD is a progressive disease, often caused by smoking, that makes it difficult to breath.

“Anoro Ellipta works by helping the muscles around the airways of the lungs stay relaxed to increase airflow in patients with COPD,” Curtis Rosebraugh, director of the FDA Office of Drug Evaluation II, said in the agency’s statement.

The drug carries a boxed warning that one of its main ingredients can increase the risk of asthma-related death. London-based Glaxo and Theravance, based in South San Francisco, California, gained approval in May for Breo Ellipta, which combines one of the medicines in Anoro with a steroid.

Theravance fell less than 1 percent to $35.75 at 4 p.m. in New York. Glaxo lost 1.1 percent to 1,548.50 pence at the close of trading in London.

Royalty Payments

Theravance will earn tiered royalties of 6.5 percent to 10 percent on Anoro sales, Michael Aguiar, the company’s chief financial officer, said in an interview when the drug was considered at a meeting of FDA advisers in September. The advisers overwhelmingly supported Anoro approval.

Anoro is a combination of vilanterol, a long-acting beta agonist or LABA, and umeclidinium, a long-acting muscarinic antagonist or LAMA, used with Glaxo’s Ellipta inhaler. Breo’s active ingredient is vilanterol.

Other long-acting COPD treatments include Pfizer Inc. and Boehringer Ingelheim GmbH’s Spiriva.

Novartis AG is researching a LABA/LAMA combination for COPD called QVA149. Basel, Switzerland-based Novartis said in July that it expects to file for U.S. approval at the end of 2014.

Forest Laboratories and Almirall SA, as well as Boehringer Ingelheim and AstraZeneca Plc also are studying LABA/LAMA combinations.

Theravance said in April it would split into two companies at the end of this year or early 2014. One of the companies will be called Royalty Management Co. and will focus on the Glaxo collaboration. The other, Theravance Biopharma, will focus on developing drugs. Glaxo is the largest shareholder of Theravance with 27 percent of the stock.