October 26, 2011 / 1:25 PM / 9 years ago

GSK says threat of Advair generics in EU recedes

* CEO doesn’t expect generic of any scale for “next few years”

* Follows removal of Sandoz product from Finnish agency website

* Advair is GSK’s top seller, with $8 billion in annual sales

By Ben Hirschler

LONDON, Oct 26 (Reuters) - GlaxoSmithKline is increasingly confident its top-selling lung drug Advair will escape serious generic competition in Europe in the near term, following an apparent setback for a rival from Novartis , its chief executive said on Wednesday.

“Our planning assumption is we are not going to see a generic of any materiality in Europe for the next few years,” Andrew Witty told reporters after presenting third-quarter results.

“We are probably in the most optimistic place we’ve been for several years,” he added.

A submission by Sandoz, the generics arm of Novartis, for a copycat version of Advair was removed from the list of ongoing applications on the website of the Finnish regulatory authority FIMEA last month.

The exact fate of the inhaled product, which Sandoz is developing with Vectura , is unclear but many analysts now assume the generic will be delayed. Previously, a number of investors had assumed it might be cleared in Europe in the next few months.

“It’s proven to be very difficult (for generics companies) in Europe — witness the disappearance of these various files,” Witty said.

Until now, the companies involved have declined to comment on the situation in Finland, where the drug regulator is unusual in disclosing pending applications for generic drugs.

Advair — also known as Seretide and Viani — had worldwide sales of 5.14 billion pounds ($8.2 billion) in 2010 and is a pivotal product for GSK.

COMPLEXITY

The British company has been fighting to defend patents on its drug in Europe, with mixed success. A German court last year ruled a key patent protecting the medicine was not valid, following earlier patent defeats in other countries.

But generics companies still face a considerable hurdle in getting their versions approved by European healthcare regulators, given the complex nature of such inhaled drugs and the need to ensure exactly the right dose gets to the lungs.

Greek firm Elpen earlier this year won a green light for a copy of Advair in Sweden, clearing the way for launch in several other European markets. The product has been available under the brand name Rolenium since November 2009 in Greece.

Elpen’s drug, however, comes in a very different kind of device and GSK believes it will not be substitutable. Witty said it was not a major threat.

The product from Sandoz, by contrast, had been viewed by analysts as a more serious competitor.

A spokesman for Novartis told Reuters last month that Sandoz did not comment on details of its development pipeline but it remained confident about respiratory opportunities.

“Overall, we believe that Sandoz is well positioned for leadership in the generic respiratory field, the third pillar of our differentiated products strategy, next to biosimilars and complex injectables,” he said.

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