) and partner
) announced that the European Commission (EC) has cleared Relvar
Ellipta. The EC approved the drug for the regular treatment of
asthma in adults and adolescents (aged above 12 years) in cases
where treatment by a combination therapy is appropriate. Approval
was also granted for treating asthma patients whose disease was
not sufficiently controlled with inhaled corticosteroids and
inhaled short acting beta2-agonists.
The EC also approved the drug for the symptomatic treatment of
adults suffering from chronic obstructive pulmonary disease
The Relvar Ellipta EU approval was not surprising considering
that the European Medicines Agency's Committee for Medicinal
Products for Human Use recommended the approval of the drug in
We remind investors that in May 2013, the U.S. Food and Drug
Administration (FDA) approved the drug (trade name: Breo Ellipta)
as a long-term maintenance therapy of airflow obstruction and for
bringing down exacerbations in patients suffering from COPD.
The European approval for Relvar Ellipta triggered a $15 million
payment from Theravance to Glaxo. Glaxo will receive further $15
million upon launch in the Europe. We are positive on Glaxo's
pipeline programs in collaboration with Theravance.
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,
2013 (target date).
Both Glaxo and Theravance carry a Zacks Rank #3 (Hold). Right
Johnson & Johnson
) look attractive. Both carry a Zacks Rank #2 (Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
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THERAVANCE INC (THRX): Free Stock Analysis
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