GlaxoSmithKline (GSK) and partner Theravance (THRX) announced that their respiratory drug, Anoro Ellipta (once daily), has been cleared by the Japanese Ministry of Health, Labour and Welfare (:MHLW). The approval was gained for the relief of symptoms due to airway obstruction in patients suffering from chronic obstructive pulmonary diseases (:COPD) on the basis of positive data from eight studies (n~6,000).
Anoro Ellipta (an inhaler) is a combination of umeclidinium, a long-acting muscarinic antagonist and vilanterol a long-acting beta2 agonist. The COPD treatment will be launched in Japan by Sep 30, 2014.The Japanese approval triggered a payment of $10 million from Theravance to Glaxo. The collaboration between the two companies was inked in 2002.
Glaxo stated in its press release that Anoro Ellipta is the first COPD treatment from its portfolio to gain a Japanese approval in five years. We note that the COPD cocktail treatment is already approved in the U.S., EU and Canada.
Apart from Anoro Ellipta, the other marketed respiratory product (emanating from the partnership) is Breo Ellipta. The FDA cleared Breo Ellipta in May 2013 as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD. The drug is also available in Canada for the COPD indication. The treatment is also approved in the EU (trade name: Relvar Ellipta) for asthma and COPD. Relvar Ellipta is available in Japan for treating patients suffering from bronchial asthma where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is needed. Apart from this, the candidates under development through this partnership also hold promise.
We remind investors that Theravance had split into two independent, listed companies last month. While Theravance, Inc., a royalty management company, deals with products/candidates under the Glaxo partnership, Theravance Biopharma (TBPH) focuses on the discovery, development and commercialization of small-molecule therapies targeted towards areas of high unmet medical need.
Both Theravance and Glaxo carry a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Regeneron Pharmaceuticals (REGN), sporting a Zacks Rank #1 (Strong Buy).