Teva sees obstacles to copying GSK's Advair drug before 2018

Reuters

LONDON, Oct 8 (Reuters) - Teva Pharmaceuticals does not expect to see the launch of generic copies ofGlaxoSmithKline's best-selling lung drug Advair thatcould be sold as a true substitute to U.S. patients before 2018.

The cautious comments by the world's biggest maker ofgeneric medicines during an investor presentation on Tuesday isgood news for GSK shareholders, who had feared cheaper forms ofthe $8 billion-a-year seller might come around two years sooner.

Deutsche Bank analysts said that pushing back genericcompetition to Advair by 18-24 months would boost GSK's mid- tolong-term earnings outlook and give GSK more time to promote twonewer respiratory drugs, Breo and Anoro.

Speculation about an earlier launch of generic Advair wasfuelled last month by a draft guidance document from the Foodand Drug Administration setting out relatively lenientrequirements for generic versions of the inhaled drug.

Teva, however, said that producing a substitutable, orso-called AB-rated, version of Advair would still be challengingand slides posted on its website stated it did not expect to seesuch a product on the all-important U.S. market before 2018.

Advair, which is marketed as Seretide outside the UnitedStates, is used to treat both asthma and chronic lung diseasecaused by smoking.

Although patents on the active ingredients used in themedicine have expired, it remains protected by U.S. patents onthe Diskus inhaler device that run until 2016 - and, even then,generics companies face hurdles in making high-quality copies.

GSK has always said it would be difficult for generics firmsto make an effective substitute for its popular product.

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