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Glaxo/Theravance Seek to Expand Breo Ellipta's Label

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Theravance, Inc. (THRX) and partner GlaxoSmithKline (GSK) are seeking to expand the label of their respiratory drug, Breo Ellipta, in the U.S.

To that end, the companies announced the submission of a supplemental New Drug Application for the drug (once a day) to the FDA for treating patients (aged above 12 years) suffering from asthma. Approval has been sought for Breo Ellipta as a combination therapy (fixed-dose) across two doses — 100/25mcg and 200/25mcg. The companies are seeking to expand the drug’s label on the basis of encouraging data from a comprehensive clinical development program for the asthma indication.

We remind investors that the FDA cleared Breo Ellipta in May 2013 as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from chronic obstructive pulmonary disease (:COPD). In the event of the drug receiving clearance for the asthma indication, its sales potential would be boosted significantly. The drug is also approved in the EU (trade name: Relvar Ellipta) for asthma and COPD.

Another approved respiratory product under Theravance’s partnership with Glaxo is Anoro Ellipta. The drug is available for the COPD indication. Theravance receives royalties from Glaxo on these two respiratory products. Furthermore, the respiratory candidates developed by the companies hold great promise.

We remind investors that Theravance had split into two independent, listed companies last month. While Theravance, Inc., a royalty management company, deals with products/candidates under the Glaxo partnership, Theravance Biopharma (TBPH) focuses on the discovery, development and commercialization of small-molecule therapies targeted towards areas of high unmet medical need.

Theravance carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Regeneron Pharmaceuticals (REGN), sporting a Zacks Rank #1 (Strong Buy).

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