Positive Data on Glaxo/Theravance Drug


GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) announced encouraging data on Breo Ellipta (fluticasone furoate/vilanterol or FF/VI) from a phase III study (n = 990). The 12-week, double-blind, parallel group, multi-center study compared the efficacy and safety of Breo Ellipta  (200/25mcg, FF/VI 100/25mcg) with Veramyst (FF, 100mcg) in patients with moderate-to-severe persistent asthma.

A statistically significant improvement in lung function was observed in patients receiving Breo Ellipta (100/25mcg) as compared to Veramyst. Moreover, an additional improvement was observed in the higher dosage of Breo Ellipta (200/25mcg). These results should support Glaxo/Theravance’s regulatory filing for Breo Ellipta for the asthma indication.  

Last month, both dosages of Breo Ellipta gained EU approval for the regular treatment of asthma in adults and adolescents (aged above 12 years) in cases where treatment with a combination therapy is appropriate. The drug was also approved for the symptomatic treatment of adults suffering from chronic obstructive pulmonary disease (:COPD).

We remind investors that in Oct 2013, Glaxo and Theravance launched Breo Ellipta (100/25mcg) in the U.S. The U.S. Food and Drug Administration (:FDA) cleared Breo Ellipta as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD.

We note that Glaxo and Theravance are also looking to get another COPD candidate approved. In Sep 2013, Glaxo announced that the Pulmonary-Allergy Drugs Advisory Committee of the FDA voted in favor (11-2) of approving their candidate UMEC/VI (proposed trade name: Anoro Ellipta). A final decision from the U.S. regulatory body on UMEC/VI’s marketing application is expected by Dec 18.

The approval and launch of Breo Ellipta and UMEC/VI will help Glaxo make up for the loss of revenues that will arise once Advair, one of its highest revenue grossers, faces generic competition. The product generated sales of $3.9 billion in the first nine months of 2013, accounting for almost 25% of the company’s Pharmaceuticals and Vaccines segment revenues.

While Glaxo shares were up 0.8% on the news, Theravance shares were up 5%. Both Glaxo and Theravance carry a Zacks Rank #3 (Hold). Some better-ranked stocks include Allergan, Inc. (AGN) and Bayer (BAYRY). Both companies hold a Zacks Rank #2 (Buy).

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