Wednesday, 18 December 2013

GlaxoSmithKline FDA approval

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GlaxoSmithKline a global healthcare company that develops, manufactures and markets pharmaceutical products, including vaccines, over-the-counter (OTC) medicines and health-related consumer products.  I have a holding in my income portfolio (epic code: GSK). 



GSK announced today that the US FDA has approved ANORO/ELLIPTA to be used as a once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. 
 
They stated that Anoro/Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
 
Theravance (NASDAQ: THRX) who jointly developed this medication with GSK is obliged to make a milestone payment of $30m to GSK following FDA approval. A further $30m payment to GSK will follow the launch of Anoro/Ellipta in the US, expected in the first quarter 2014.
 
I make this 5 FDA approvals this year:
 
May 2013 - Trametinib (Mekinist)
 
May 2013 - Dabrafenib (Tafinlar)
 
May 2013 - Breo/Ellipta
 
August 2013 - Tivicay
 
December 2013 - Anora/Ellipta
 
I understand that there have been 34 approvals this year, so GSK appears to have a good share, this compares to 43 approvals last year.  Although lower in number, a few analysts have said that the expected sales by their fifth year for 2013 approvals, will be up to 14% higher than last year

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