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GlaxoSmithKline and Theravance have announced positive results from the Phase IIb study of their novel long-acting beta2-agonist (LABA) 642444 ('444) in patients with moderate to severe asthma. The study, which was designed to evaluate the efficacy of five doses of '444 administered once-daily for four weeks, showed dose dependent improvements in lung function.
GSK currently markets blockbuster Advair/Seretide (fluticasone/salmeterol), a twice-daily ICS/LABA combination product on the market for the treatment of both asthma and chronic obstructive pulmonary disease (COPD). Advair reached sales of $5.8 billion in the seven major markets (US, Japan, France, Germany, Italy, Spain and the UK) in 2007 and has dominated the asthma/COPD market ever since its launch.
As Advair/Seretide's patent is due to expire in May 2010 in the US and September 2013 in Europe, GSK has put considerable effort into developing a next-generation once-daily combination product through the Horizon Program in collaboration with Theravance, which has been informally branded as 'Beyond Advair'.
The companies have three once-daily LABAs in development with this aim, although '444 seems to be most likely to become the bronchodilator component of the follow-on product. The inhaled corticosteroid (ICS) component is expected to be fluticasone furoate (685698), although GSK also has a novel ICS (870086) in development. Fluticasone furoate is the main ingredient of GSK's allergic rhinitis drug Veramyst/Avamys, which, besides being once-daily, does not considerably improve on the currently available fluticasone propionate.
While the positive Phase IIb results for its LABA component is a step in the right direction, Datamonitor believes that GSK will not be able to launch Beyond Advair before generic fluticasone/salmeterol products enter the market, and the company will therefore miss the opportunity to switch patients from one product to the other.
Furthermore, Beyond Advair will have direct competition from Novartis/Schering-Plough's once-daily mometasone/indacaterol combination (QMF149), which is expected to be filed in 2010. Other twice-daily ICS/LABA combinations in development, including SkyePharma's Flutiform (fluticasone/formoterol), Novartis/Schering-Plough's MFF258 (mometasone/formoterol) and Nycomed's Alvesco Combo (ciclesonide/formoterol), are also expected to make it more difficult to enter the ICS/LABA market in the future.
Significantly, unless GSK and Theravance are able to speed up their development drastically, the launch of Beyond Advair will be too late to protect GSK's lucrative Advair/Seretide franchise.
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