* Approvals for inhaled drugs from GSK, Novartis, SkyePharma
* SkyePharma shares up more than 15 percent
(Adds detail on Novartis drug, SkyePharma share price jump)
LONDON, Sept 20 Japan has approved three new
lung drugs from Western companies, underscoring how the world's
second-biggest medicines market is opening up as an important
growth driver for international pharmaceuticals groups.
GlaxoSmithKline and Theravance said on
Friday that their inhaled lung drug Relvar Ellipta had been
approved by the Japanese Ministry of Health, Labour and Welfare,
a day after it won a positive recommendation in Europe.
Tokyo also approved Skyepharma's Flutiform
treatment, which will be sold by Kyorin Pharmaceutical
, and Novartis's Ultibro Breezhaler
inhalation capsules. Vectura said the Ultibro approval
triggered a payment to it of $2.5 million.
The clutch of approvals was particularly good news for
Britain's SkyePharma, which will receive a milestone payment of
"several million U.S. dollars" from Kyorin and is also entitled
to royalties of up to 6 million pounds ($9.6 million) a year
following the green light for Relvar.
Its shares were up 15.5 percent at 98 pence by 1019 GMT.
Under the terms of a 2002 agreement, Theravance is also
obliged to make a milestone payment of $10 million to GSK
following the Japanese approval.
The Japanese authorisation for Relvar covers use of the drug
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.
Novartis's Ultibro, also known as QVA149, is just such a
LABA/LAMA combination and was recommended for approval in Europe
Ultibro was approved in Japan for COPD and SkyePharma's
Flutiform for asthma.
($1=0.6226 British pounds)
(Reporting by Ben Hirschler; Editing by David Holmes, Greg