Recently, Theravance Inc. (THRX) and partner GlaxoSmithKline Plc (GSK) presented encouraging data from a mid-stage study (n=60) on their combination therapy Relovair for treating patients suffering from chronic obstructive pulmonary disorder (COPD). The data from the double-blind, parallel-group, placebo-controlled study was presented at the European Respiratory Society congress in Spain.
The 28- day study evaluated the safety and efficacy of Relovair (FF 400mcg in conjunction with VI 25mcg) compared to placebo. The therapy was administered once daily to COPD patients.The results revealed that Relovair was a safe and effective treatment for COPD patients. The drug’s impact on heart rate was comparable to placebo.
Moreover, there was significant improvement in the functioning of the lungs after 28 days of treatment. Patients treated with Relovair demonstrated greater improvements in lung function as opposed to those treated with placebo. However, 68% patients in the Relovair arm reported adverse events as against 50% in the placebo arm. The late-stage studies for Relovair in COPD and asthma began in October 2009 and March 2010 respectively.
We remind investors that the collaboration, known as the Relovair program, was entered into in 2002. The program, which aims to replace one of Glaxo’s best selling drugs Advair- a lung treatment has the biggest potential in Theravance’s pipeline in our view. Advair is slated to lose patent exclusivity in 2010 in the US and in 2013 in Europe.
Development of the pipeline is quite crucial for Theravance as it has only one marketed product, Vibativ for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including resistant pathogens such as methicillin-resistant staphylococcus aureus (MRSA).
Currently, we are Neutral on Theravance in the long-run which is supported by our Zacks#3 Rank (short-term ‘Hold’ recommendation) on the stock. We have similar short-term as well as long-term views on Glaxo.
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