Hours after getting the backing from regulators in Europe, GlaxoSmithKline and Theravance's Relvar has been approved in Japan.
The Japanese Ministry of Health, Labor and Welfare has given the green light to Relvar, a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, delivered through the Ellipta inhaler, for asthma (but not for chronic obstructive pulmonary disease). The approval triggers a milestone payment of $10 million to Theravance and will lead to royalties for the UK’s Skyepharma as the combo uses one of the group’s dry powder formulation technologies.
Skyepharma is also in line to pocket “several million dollars” in milestone payments from licensing partner Kyorin Pharmaceutical Co which has secured Japanese approval for the asthma drug Flutiform (fluticasone and formoterol).
The MHLW has also approved Novartis’ once-daily Ultibro (glycopyrronium/indacaterol), delivered through the Breezhaler device, for relief of various symptoms due to airway obstruction in COPD. This has triggered a $2.5 millon payment to the UK’s Vectura.
Roche has also got the thumbs-up in Japan for the antibody drug conjugate Kadcyla for patients with HER2-positive, late-stage breast cancer. The drug combines the Swiss major's blockbuster Herceptin (trastuzumab) with partner ImmunoGen's chemotherapy DM1 (emtansine). It is intended for patients who were previously treated with Herceptin and taxanes.
The Japanese regulator has also given the green light to Norgine and Takeda’s Oblean (cetilistat) for the treatment of obesity with complications. The drug is a lipase inhibitor discovered by Alizyme Therapeutics and Norgine acquired all rights to the product from the UK in October 2009. In 2003, Takeda acquired the rights for development and commercialisation for Japan.
Finally, Sweden's Orexo announced the approval of Abstral (fentanyl) sublingual tablets in Japan. The product will be sold by Kyowa Hakko Kirin for the management of episodes of breakthrough pain experienced by cancer patients.