LONDON, Sept 20 (Reuters) - GlaxoSmithKline andTheravance's new inhaled lung drug Relvar has beenapproved in Japan, a day after winning a positive recommendationin Europe.
The Japanese Ministry of Health, Labour and Welfare alsoapproved Skyepharma's Flutiform lung treatment, whichwill be sold by Kyorin Pharmaceutical.
Under the terms of a 2002 agreement, Theravance is obligedto make a milestone payment of $10 million to GSK following theJapanese 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 thedrug, which is inhaled through a palm-sized device calledEllipta, for the treatment of asthma but not chronic obstructivepulmonary disease (COPD).
The medicine was approved in the United States in May fortreating COPD but not asthma, while in Europe the recommendationfrom the European Medicines Agency is that it be used for bothconditions.
Relvar consists of a corticosteroid to reduce inflammationand a novel long-acting beta-agonist (LABA), which is designedto open the airways. It is one of two new medicines that GSK isrelying on to reinvigorate its respiratory business as thecompany's $8 billion-a-year blockbuster Advair faces the threatof generic competition in the years ahead.
The other key new lung drug is Anoro, which combines a LABAtherapy with a long-acting muscarinic receptor antagonist(LAMA). Anoro is still awaiting approval.