Novartis COPD drug gets approvals in EU, Japan

Novartis ($NVS) has picked up approvals in both Europe and Japan for its new chronic obstructive pulmonary disease (COPD) drug, Ultibro Breezhaler. It is launching the expected blockbuster into a rapidly expanding but increasingly competitive market as established players and newcomers vie for their piece of the action.

The Swiss drugmaker said today that the EU approved Ultibro Breezhaler, developed under the name QVA149, as a maintenance bronchodilator treatment for adult COPD patients. Another version of the drug was approved in Japan for relief of various COPD symptoms. A U.S. filing is expected at the end of 2014. Analysts have given this one a wide range in terms of peak earnings, saying it could hit anywhere between $2 billion and $5 billion a year.

The announcement came only days after the EU recommended approval and Japan granted it for a new respiratory drug from GlaxoSmithKline ($GSK) and Theravance ($THRX). Relvar Ellipta, known as Breo Ellipta in the U.S., was recommended by reviewers in the EU for COPD and asthma, while regulators in Japan gave it the OK for asthma. Breo is already approved in the U.S. for two uses in COPD.

Citigroup is estimating that the COPD market is likely to swell to $14 billion in 2018 from $10 billion this year. That is key since a number of drugs will be fighting to gain a share of that market. The new drugs have to take on established treatments like GSK's $8 billion Advair and Boehringer Ingelheim's Spiriva, a $4.7 billion franchise, as well as Symbicort, AstraZeneca's ($AZN) drug, from which it earns about $3.2 billion. Advair's patent has already expired, but GSK had held off generics for some time because its Diskus inhaler has been too complicated to copy. Some changes in the way the FDA will now consider copies are expected to help stimulate the generics market for that superblockbuster product.

The Japanese market is becoming more important to drugmakers as an aging population and a more receptive healthcare market are setting the stage for greater sales. Japan has become increasingly attractive to multinational drugmakers as U.S. sales stagnate and European price cuts actually undermine growth there. Much of the attention will be on generics as an increasingly cost-conscious government works to ratchet up use of cheaper copycats. Novartis pointed out that since 2007, it has received approvals for 15 new treatments and 16 new indications in that country.

- here's the release (PDF)

Special Report: 15 top blockbuster contenders - QVA149

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