GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) recently announced top-line data from phase III studies conducted with their pipeline candidate, Relovair, for chronic obstructive pulmonary disease (:COPD) and asthma. Relovair is a combination of fluticasone furoate and vilanterol. The companies also announced that they have completed the registrational program for Relovair and the full results from these studies will be presented at upcoming scientific meetings.
Glaxo and Theravance reported results from two non-pivotal 12 week phase III COPD studies with approximately 500 patients each. The studies compared once daily Relovair with twice daily Advair. In the first study, Relovair demonstrated superiority over Advair (combination of fluticasone propionate and salmeterol) and met the primary end point. However, in the second study, the improvements were not statistically significant.
The companies also completed the phase III Relovair registrational program for the treatment of persistent asthma in adults and adolescents. Positive results were reported from a study evaluating the efficacy and safety of fluticasone furoate and fluticasone propionate compared to placebo.
Meanwhile, both Glaxo and Theravance are confident about Relovair’s prospects and remain on-track for regulatory filings. Glaxo plans to submit marketing applications to the regulatory bodies in the US and Europe in mid-2012 for the COPD indication.
For the asthma indication, the company plans to seek EU approval in mid-2012. Glaxo remains in talks with the US Food and Drug Administration (:FDA) on requirements for a filing for the asthma indication of Relovair.
Earlier in January 2012, GlaxoSmithKline and Theravance had announced initial outcomes from pivotal phase III studies of Relovair. In the two COPD studies, Relovair reduced the annual rate of moderate-to-severe exacerbations (worsening of severity of disease) compared to vilanterol. However, in the second study, the reductions were not statistically significant at the highest dose. In the asthma studies, Relovair showed an encouraging efficacy profile.
Advair is one of Glaxo’s highest revenue earners, generating sales of more than £5 billion in 2011. Relovair, if approved, will be positioned as a replacement for Advair. In light of the mixed results from the studies, we remain cautious about the chances of Relovair gaining first-round approval.
We currently have Neutral recommendations on both Glaxo and Theravance. Both the stocks carry a Zacks #3 Rank (Hold rating) in the short run.
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