) 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.
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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
). Both companies hold a Zacks Rank #2 (Buy).