GSK share price: Company receives EU marketing authorisation for Anoro

on May 9, 2014
Updated: Apr 9, 2020
Listen, Friday, May 9: British pharma giant GlaxoSmithKline (LON:GSK) has been granted marketing authorisation in Europe for a new inhaled lung drug, Anoro Ellipta, boosting its respiratory franchise.

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Anoro Ellipta, which was co-developed with San Francisco-based Theravance (NASDAQ:THRX), is a once-daily combination treatment, which provides a new alternative for chronic obstructive pulmonary disease (COPD) patients for whom a dual bronchodilator treatment in a single inhaler may be appropriate.
A final green light had been expected for the product following a recommendation from the European Medicines Agency (EMA) in February (GSK share price: COPD drug gets green light in Europe).

Glaxo said in a statement yesterday that under the terms of the collaboration agreement with Theravance for the treatment, the US company is obligated to make a milestone payment to Glaxo of $15 million following marketing authorization by the European Commission. A further $15 million payment to Glaxo will follow the launch of Anoro in Europe, which is expected to take place in the second or third quarter of the year, with additional launches to follow thereafter, GSK remarked.

Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise, said, “We are delighted by today’s marketing authorisation for Anoro Ellipta which provides a new alternative for COPD patients for whom dual bronchodilator treatment in a single inhaler may be appropriate.”

Theravance CEO Rick E Winningham also commented on the development: “A further positive outcome from the collaboration between Theravance and GlaxoSmithKline to bring to market new respiratory medicines that meet patient needs.” He added that the company is very pleased that Anoro Ellipta is now licensed across 31 European countries for the treatment of COPD.

**Sales forecast**
Respiratory drugs are a major business for GSK. Advair or Seretide, its market-leading lung drug, makes up a fifth of its sales, but it is already facing competition from generic versions in Europe.
Industry analysts expect Anoro to generate worldwide annual sales of about $2.65 billion by 2019, according to Thomson Reuters data.
**GSK share price edges lower**


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