Recently, GlaxoSmithKline (GSK) and US partner Theravance Inc. (THRX) announced data from two late stage trials of its lead pipeline program Relovair, which support continuation of development of the candidate for the treatment of chronic obstructive pulmonary disease (COPD). Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, comprising fluticasone furoate (FF) and vilanterol (VI).
The two pivotal 6-month studies evaluated the efficacy, safety and tolerability of three strengths of Relovair, its individual components (FF and VI) and placebo in approximately 2,200 patients. Both studies showed statistically significant improvements for Relovair and for vilanterol versus placebo for two primary endpoints [0-4 hour weighted mean FEV1 (forced expiratory volume in 1 second) and trough FEV1].
Theravance has an agreement with GlaxoSmithKline for the development and commercialization of Relovair. Theravance and GlaxoSmithKline are currently conducting a phase IIIa program for the candidate for the treatment of asthma and COPD. The phase III program for COPD consists of five studies and involves approximately 6,000 patients.
Regulatory applications for Relovair across the globe will be based on data from the above mentioned studies along with data from two larger 12-month exacerbation studies. These exacerbation studies, which are evaluating over 3,000 patients, will provide a better understanding of the efficacy of Relovair compared with VI and FF on reduction of exacerbations and improvement in lung function. These 12-month studies will also ascertain the appropriate dose of Relovair for patients with COPD.
The Relovair program aims to replace one of GlaxoSmithKline’s best selling asthma and COPD drugs, Advair, which will lose patent protection soon.
This program also holds the biggest potential in Theravance pipeline as the company is entitled to receive royalties on sales of Relovair without any cost obligations. We believe the revenue generated following the approval of Relovair will ultimately lead Theravance to profitability.
Our Recommendation
We currently have a Neutral recommendation on both GlaxoSmithKline and Theravance. Both the stocks currently carry a Zacks #3 Rank (short-term Hold rating).
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