Glaxo (GSK), Theravance (THRX) Receive EC Marketing Approval for RELVAR ELLIPTA

November 18, 2013 8:25 AM EST
GlaxoSmithKline plc (NYSE: GSK) and Theravance, Inc. (Nasdaq: THRX) announced that the European Commission has granted marketing authorisation for RELVAR ELLIPTA, which is now licensed across 31 European countries for the following uses:

Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:

* patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists

COPD: the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1 < 70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2-agonist (LABA), vilanterol "VI" (FF/VI). Two strengths of FF/VI have been licensed for the treatment of asthma (92/22 mcg and 184/22 mcg) and one strength has been licensed for the treatment of COPD (92/22 mcg). Both strengths will be administered once-daily using Ellipta, a new dry powder inhaler (DPI).

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "For many years GSK has been focused on developing a portfolio of new treatments for patients across the world with asthma and COPD. We are delighted that Relvar Ellipta is now licensed, which means that healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler."

"This is yet another important achievement and is testament to our successful partnership with GSK in respiratory disease," said Rick E Winningham, Chief Executive Officer of Theravance. "We are delighted that another significant regulatory body has granted marketing authorisation for Relvar Ellipta for the treatment of asthma and COPD and look forward to seeing the benefits of this effective once-daily treatment option in these patient populations."

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 million (USD) following marketing authorisation for Relvar Ellipta from the European Commission. A further $15 million (USD) payment to GSK will follow the launch of Relvar Ellipta in Europe.

As part of its assessment, the European Medicines Agency reviewed results of 10 clinical studies in 7,783 patients with COPD and 16 studies in 9,326 patients with asthma.

For the EU Summary of Product Characteristics for Relvar Ellipta, please visit http://ec.europa.eu/health/documents/community-register/index_en.htm. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the "GSK Enquiries" section at the end of this document.

In Europe, the FF/VI strengths of 92/22 mcg and 184/22 mcg are specified as the delivered doses (emitted from the inhaler). The lower strength is equivalent to the 100/25 mcg pre-dispensed dose (contained inside the inhaler) and the higher strength is equivalent to the 200/25 mcg pre-dispensed dose.


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