Japan approves lung drugs from GSK/Theravance and SkyePharma

LONDON, Sept 20 Fri Sep 20, 2013 3:42am EDT

LONDON, Sept 20 (Reuters) - GlaxoSmithKline and Theravance's new inhaled lung drug Relvar has been approved in Japan, a day after winning a positive recommendation in Europe.

The Japanese Ministry of Health, Labour and Welfare also approved Skyepharma's Flutiform lung treatment, which will be sold by Kyorin Pharmaceutical.

Under the terms of a 2002 agreement, Theravance is obliged to make a milestone payment of $10 million to GSK following the Japanese approval, GSK said on Friday.

SkyePharma, meanwhile, said it would receive a milestone of "several million U.S. dollars" from Kyorin.

The Japanese authorisation for Relvar covers use of the drug, which is inhaled through a palm-sized device called Ellipta, for the treatment of asthma but not chronic obstructive pulmonary disease (COPD).

The medicine was approved in the United States in May for treating COPD but not asthma, while in Europe the recommendation from the European Medicines Agency is that it be used for both conditions.

Relvar consists of a corticosteroid to reduce inflammation and a novel long-acting beta-agonist (LABA), which is designed to open the airways. It is one of two new medicines that GSK is relying on to reinvigorate its respiratory business as the company's $8 billion-a-year blockbuster Advair faces the threat of generic competition in the years ahead.

The other key new lung drug is Anoro, which combines a LABA therapy with a long-acting muscarinic receptor antagonist (LAMA). Anoro is still awaiting approval.

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