GlaxoSmithKline (NYSE:GSK) plans to submit new drug applications in the United States and Europe this year for Relovair, an inhaled drug candidate developed to treat asthma and chronic obstructive pulmonary disease or COPD.
But in announcing the plans with drug partner Theravance (NASDAQ:THRX), GSK also disclosed that a study comparing Relovair to Advair showed that the drug candidate was not better than the blockbuster drug it is expected to succeed. That could hurt the commercial potential of the respiratory treatment. Advair generates more than $8 billion in annual sales for GSK. But if the Relovair is not better than Advair, its main advantage will be dosing. Relovair would be a once-a-day drug compared to the twice-a-day dosing of Advair.
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London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, said it will submit regulatory applications for COPD in the United States and Europe in mid-2012. An asthma submission will also be filed in Europe in the middle of this year. GSK is continuing discussions with the U.S. Food and Drug Administration on Relovair as an asthma treatment.
Relovair is one of three respiratory drug programs that California drug-developer Theravance is pursuing in partnership with GSK. The companies entered into a drug partnership in 2004 that gives GSK exclusive access to Theravance’s drug-discovery programs before September 2007. The deal calls for GSK to fund development, manufacturing and commercialization of those compounds.
Relovair pairs Advair’s main ingredient fluticasone with another compound, vilanterol. Although the drug candidate was not shown in the studies to be better than Advair, it did achieve statistical significance. In the study results released today, the companies said that the first study showed Relovair reduced exacerbation of COPD compared with vilanterol alone. But in a second study, the drug candidate was not statistically significant at the highest dose. GSK said the companies will ask regulators to look at all of the data.
Image from the Cleveland Clinic
