Reuters: Global Markets: GSK shares hit as Advair generics edge closer in U.S.

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GSK shares hit as Advair generics edge closer in U.S. Sep 10th 2013, 08:24 Tweet Share this Email Print Related Topics Hot Stocks » Asian Markets » A no entry sign is pictured outside the GlaxoSmithKline building in Hounslow, west London June 18, 2013. Credit: Reuters/Luke MacGregor LONDON | Tue Sep 10, 2013 4:24am EDT LONDON (Reuters) - The threat of generic copies of GlaxoSmithKline's (GSK.L) best-selling lung drug Advair finally making it to market in the United States hit confidence in the drug maker on Tuesday, sending the stock down more than 3 percent. Fears of cheaper versions of the $8 billion-a-year seller being launched in the world's biggest market were fuelled by a draft guidance document from the Food and Drug Administration setting out the requirements for generic versions of the inhaled drug. Bernstein analyst Tim Anderson said the requirements looked "fairly benign" for generic firms seeking to make copies that could be automatically substituted for Advair when patients have their prescriptions filled. Citigroup said its worst-case scenario for an accelerated U.S. Advair sales decline, following the FDA document, could slice up to 5 percent off GSK's valuation. Advair, which is marketed as Seretide outside the United States, is used to treat both asthma and chronic lung disease caused by smoking. Although patents on the active ingredients used in the medicine have expired, it remains protected by U.S. patents on the Diskus inhaler device that run until 2016, after which copies may reach the market. Up until now, many investors had assumed that fully substitutable generic versions of Advair were unlikely in the United States and instead generics would have to compete as separate brands. The FDA pathway to permitting "true" generics therefore represents a heightened threat. Shares in GSK were down 3.3 percent at 15.85 pounds by 0805 GMT (3:05 EDT). The uncertainty over Advair comes on the same day that a U.S. advisory panel is due to consider a new lung drug called Anoro from GSK and Theravance (THRX.O). (Reporting by Ben Hirschler; Editing by Louise Heavens) Tweet this Link this Share this Digg this Email Reprints We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/ Comments (0) Be the first to comment on reuters.com. Add yours using the box above.

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