Japan’s Eisai says that US regulators have granted a priority review for a new application of the firm’s proton pump inhibitor Aciphex.

The US Food and Drug Administration will look at Aciphex (rabeprazole) as a short-term treatment (of up to eight weeks) for gastroesophageal reflux disease in patients ages 12-16 and the priority review is in accordance with the Best Pharmaceuticals for Children Act, said Eisai. This means that the agency will likely decide within the next six months whether to give the green light to the treatment, rather than the usual 10-month review period.

Aciphex, which is sold as Pariet in Japan, is a major earner for Eisai, second only to its Alzheimer’s drug Aricept (donepezil). The PPI market is pretty crowded but approval in this new indication for adolescents would provide a boost for the treatment which is co-marketed in the USA by Johnson & Johnson’s PriCara division.

Nippon Shinyaku and Actelion team up for PAH drug
Staying with Japanese firms and Nippon Shinyaku has linked up with Switzerland’s Actelion in a deal which will see the two companies develop the Kyoto-based group's novel prostaglandin I2 (PGI-2) receptor agonist NS-304 as a potential treatment for pulmonary arterial hypertension.

Under the terms of the agreement, for which no financial details were disclosed, Actelion will be responsible for global development and commercialisation of NS-304 outside Japan, whereas the two companies will co-develop and co-market in Japan. Nippon Shinyaku has recently completed Phase I evaluation in the UK with NS-304 and a Phase II programme was initiated in Europe at the end of last year.

Actelion specialises in PAH and its dual endothelin receptor antagonist Tracleer (bosentan) brought in revenues of 1.18 billion Swiss francs last year, a rise of 31%.