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