Glaxo/Theravance Update on COPD Drugs

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Pipeline updates are highly-awaited events in the pharma/biotech sector as they play an important role in deciding whether to invest in a particular company or not. These updates provide information on drugs and sometimes give an insight on its commercial potential.

Late last week, GlaxoSmithKline (GSK) and partner Theravance, Inc. (THRX) announced encouraging data from three phase III studies (116134, 114930 and 114951) on their chronic obstructive pulmonary disease (:COPD) drug, Anoro Ellipta.

While two studies compared the efficacy and safety of Anoro Ellipta to Advair Diskus (fluticasone propionate/salmeterol - FSC 250/50), the third compared the efficacy and safety of Anoro Ellipta to Seretide Diskus (FSC 500/50).

In all three studies, Anoro Ellipta demonstrated statistically significant improvement in lung function compared to the comparator arms (Advair Diskus and Seretide Diskus).

Anoro is already approved in the U.S. as a long-term maintenance therapy for airflow obstruction in patients suffering from COPD, including chronic bronchitis and/or emphysema.

Meanwhile, Glaxo and Theravance also finished recruiting patients for SUMMIT (Study to Understand Mortality and MorbidITy) which will evaluate another COPD drug, Breo Ellipta (EU trade name: Relvar). The study will assess the impact of Breo Ellipta on all cause mortality in moderate COPD patients who have or are at increased risk of cardiovascular disease.

Our Take

Glaxo has a strong portfolio of respiratory products including Anoro Ellipta and Breo Ellipta. Glaxo and Theravance are preparing to launch Anoro in the U.S. If successfully commercialized, these drugs will compensate for the loss of revenues once Advair – one of Glaxo’s highest revenue grossers – goes generic. The product generated sales of $5.3 billion in 2013, accounting for almost 25% of the company’s Pharmaceuticals and Vaccines segment revenues.

Glaxo carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN) and Alkermes (ALKS). Both carry a Zacks Rank #1 (Strong Buy).

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