Advair/Seretide for respiratory diseases such as chronic
obstructive pulmonary disorder (COPD) and asthma is one of the
highest revenue grossers at
). 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
) 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
Glaxo, a large cap pharma company, carries a Zacks Rank #2 (Buy).
Other large-cap pharma stocks such as
Johnson and Johnson
) also look attractive carrying a Zacks Rank #2.
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