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Advair/Seretide for respiratory diseases such as chronic obstructive pulmonary disorder (COPD) and asthma is one of the highest revenue grossers at GlaxoSmithKline (GSK - Analyst Report). 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.

Amidst debate over the timing of entry of Advair generics, Glaxo in collaboration with its partner Theravance, Inc. (THRX - Analyst Report) has launched another COPD drug, Breo Ellipta, in Oct 2013. The news did not come as a surprise as in the third quarter conference call, the company had announced that it has started shipping the drug to wholesalers in the U.S.

Breo Ellipta is a combination of fluticasone furoate (FF) and vilanterol (VI), administered using a dry powder inhaler called Ellipta. We remind investors that in May 2013, the U.S. Food and Drug Administration (FDA) had cleared Breo Ellipta as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD.

Glaxo and Theravance are also looking to get the drug approved in other regions including the EU. A favorable opinion was issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Breo Ellipta’s (proposed trade name: Relvar Ellipta in EU) approval in the EU for the asthma and COPD indications in September. The positive CHMP opinion was based on results from 11 studies in 7,851 COPD patients and 16 studies in 9,326 asthma patients. A final decision from the European Commission is expected by year end.

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

Glaxo, a large cap pharma company, carries a Zacks Rank #2 (Buy). Other large-cap pharma stocks such as Bayer (BAYRY - Analyst Report) and Johnson and Johnson (JNJ - Analyst Report) also look attractive carrying a Zacks Rank #2.

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