September 20, 2013 / 7:46 AM / 4 years ago

Japan approves three new lung drugs from Western firms

LONDON (Reuters) - 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 authorization 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 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.

Novartis’s Ultibro, also known as QVA149, is just such a LABA/LAMA combination and was recommended for approval in Europe in July.

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 Mahlich

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