Japanese Approval for Theravance/Glaxo Drug
Japan’s Ministry of Health, Labour and Welfare cleared Theravance, Inc. (THRX) and partner GlaxoSmithKline’s (GSK) Relvar Ellipta (fluticasone furoate/vilanterol) in two dosages-100/25 mcg and 200/25 mcg-for treating patients suffering from bronchial asthma. The Japanese approval was gained only when simultaneous use of inhaled corticosteroid and long-acting inhaled beta2 agonist was needed for treating patients.
We note that the approval triggered a $10 million milestone payment from Theravance to GlaxoSmithKline. The Japanese clearance of Relvar Ellipta for the asthma indication comes close on the heels of the favorable opinion issued by the European Medicines Agency's (:EMA) Committee for Medicinal Products for Human Use (CHMP) on Relvar Ellipta’s approval in the EU for the asthma and chronic obstructive pulmonary disease (:COPD) indications. A final decision from the European Commission is expected by year end. The positive opinion was based on results from eleven studies in 7,851 COPD patients and 16 studies in 9,326 asthma patients.
We remind investors that in May 2013, the U.S. Food and Drug Administration (:FDA) approved the candidate (trade name: Breo Ellipta) as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD. The candidate has also gained Canadian approval for COPDS with the same trade name. The candidate is under review in Japan (proposed brand name Relvar Ellipta) for the asthma indication. We are positive on Theravance’s pipeline programs in collaboration with Glaxo.
We note that Glaxo and Theravance are also looking to get another COPD candidate approved. In Feb 2013, the FDA accepted the regulatory application of Glaxo/Theravance’s UMEC/VI (proposed trade name: Anoro Ellipta). The companies are looking to get the candidate approved in the U.S. as a once daily therapy for treating patients suffering from COPD. A decision from the U.S. regulatory body on the candidate’s marketing application is expected by Dec 18, 2013.
Theravance carries a Zacks Rank #3 (Hold). Companies like Gilead Sciences Inc. (GILD) and Biogen Idec Inc. (BIIB) look well placed. Both stocks carry a Zacks Rank #1 (Strong Buy).
Read the Full Research Report on THRXRead the Full Research Report on GILDRead the Full Research Report on GSKRead the Full Research Report on BIIBZacks Investment Research
