A patently obvious move by Europe's biggest drug maker, GlaxoSmithKline to try and protect its biggest selling combo inhaled asthma drug Seretide (Advair in the US), having global sales of US over $4 billion, was thwarted last year.
The patent granted to GSK, based on combining the two drugs in one inhaler, was challenged by the generic drug makers on grounds of obviousness.
The case was fought in London. The main grounds on which the patent rested was whether an inventive step was involved in combining the two older drugs, Flovent (fluticasone) and Serevent (salmeterol) to make Advair.
The delghtfully named Mr Justice Pumfray of the London High Court ruled that the combination was indeed "entirely obvious" and cancelled the patent. This victory for generic drug makers means that they could launch cheaper versions of the inhaled asthma treatment as early as October 2005.
Insiders' money is on those clever people at IVAX being the first to market! No wonder TEVA bought them for $7.4 billion recently.
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LONDON, Sept 23 (Reuters) - AstraZeneca Plc (AZN.L: Quote, Profile, Research) has filed for approval to sell its Symbicort asthma drug in the United States, meeting a self-imposed deadline for the submission with one week to spare, the company said on Friday.
The inhaled medicine, which competes with GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) Advair, is already a major seller in Europe but is not yet available in the all-important U.S. market.
AstraZeneca had previously said it aimed to have a regulatory file ready for submission to the U.S. Food and Drug Administration by the end of the third quarter.
Winning a final green light from the agency is likely to take time, however, because the regulator needs to assess both the drug and its delivery device.
It typically takes around two years to win U.S. approval for a new asthma inhaler. Chief Executive Tom McKillop told Reuters recently that the group had made "realistic to conservative" assumptions about when Symbicort might reach the market.
Symbicort had worldwide sales of $800 million in 2004, while Advair, which is also sold as Seretide, raked in 2.5 billion pounds ($4.5 billion) for Glaxo.
Both drugs combine bronchodilators for asthma relief with corticosteroids to treat inflammation. AstraZeneca's medicine uses an adjustable dosing regimen, controlled by the patient, while Advair is given at fixed doses.
AstraZeneca is seeking FDA approval for two strengths of Symbicort, 80/4.5 and 160/4.5 micrograms.
Europe's third biggest drug maker said the current worldwide market for fixed-combination asthma products is worth more than $6 billion a year, with approximately half of the potential market in the United States.
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