VEC10 Jun 2010 17:11
LONDON, June 10 (Reuters) - Generic companies hoping to market a cheap copy of GlaxoSmithKline's best-selling inhaled lung drug Advair might have wait until 2012 before winning a green light from regulators in Europe.
That, at least, is the view of analysts at Glaxo's broker Royal Bank of Scotland (RBS), following recent changes in filings by generic companies in Finland, the only country in Europe to publish the details of such applications.
Advair, which made up 18 percent of Glaxo group sales in 2009, with worldwide revenue of 5 billion pounds ($7.3 billion), is vital to the drugmaker's growth in the next few years, but its future is clouded by uncertainty over generics.
In Finland, both Teva Pharmaceuticals and Sandoz, the generics unit of Novartis, filed for approval of a metered dose inhaler (MDI) form of the drug at the end of 2008.
But the latest information on the country's National Agency for Medicines website (www.nam.fi) no longer shows either of the applications, while Sandoz submitted a fresh file in April 2010.
RBS said in a note that the original MDI filings of 2008 appeared to have been withdrawn, and Sandoz had decided to go in preference for a dry powder inhaler (DPI) device.
No details on the DPI filing were given on the website, but industry experts said it could well be the generic product VR315 that Vectura is developing with Sandoz.
Concerns about generic Advair, which is also known as Seretide and Viani, were heightened last month when a German court ruled a key patent on the medicine was not valid, sparking speculation that generics might arrive in some European countries as early as the end of 2010.
But RBS said the fact Sandoz had only just filed for a new device in Finland suggested that generics were unlikely to appear before 2012, since it can take up to two years for a respiratory drug to be approved.
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