Glaxo/THRX' Drug Gets FDA Nod

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GlaxoSmithKline (GSK) and partner Theravance, Inc. (THRX) received a boost with the U.S. Food and Drug Administration (:FDA) approving Anoro Ellipta. The FDA cleared Anoro Ellipta (once daily) as a long-term maintenance therapy for airflow obstruction in patients suffering from chronic obstructive pulmonary disease (:COPD) including chronic bronchitis and/or emphysema.

Anoro Ellipta is a combination of a long-acting muscarinic antagonist/LAMA (GSK573719 or umeclidinium bromide/UMEC) and a long-acting beta2 agonist/LABA (vilanterol/VI).

The U.S. approval of Anoro Ellipta was not surprising considering that the Pulmonary-Allergy Drugs Advisory Committee recommended the approval of the drug in Sep 2013. The approval triggers a milestone payment of $30 million from Theravance to Glaxo. Glaxo will receive a further payment of $30 million following the product launch. The launch activities related to Anoro Ellipta are expected to start from the first quarter of 2014.

We remind investors that in Oct 2013 Glaxo and Theravance had launched another COPD drug, Breo Ellipta, in the U.S.

Anoro Ellipta and Breo Ellipta, if successfully commercialized, will compensate for the loss of revenues once Advair – one of Glaxo’s highest revenue grossers – goes generic. 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.

Both Glaxo and Theravance carry a Zacks Rank #3 (Hold). Some better-ranked stocks include Jazz Pharmaceuticals (JAZZ) and Actelion Ltd. (ALIOF). Both companies hold a Zacks Rank #1 (Strong Buy).

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