Japan ushers in big meds from AZ, GSK, Merck

Japanese health regulators spread some happiness yesterday, granting marketing approval to several major Big Pharma products. AstraZeneca, GlaxoSmithKline, and Merck each got the nod for a key drug that's already marketed elsewhere, but still awaiting launch in Japan. In each case, as the world's second largest drug market, Japanese approval could be a boon.

In AstraZeneca's case, in fact, the drug is Nexium, and its Japanese approval will offer a tailwind just as it's nearing the end of its patent life in other markets. Daiichi Sankyo has signed on to co-promote and distribute the stomach drug, while AZ will manufacture the product. It's set for launch during the second half of this year, and it will compete for a share of the $2 billion market for proton pump inhibitors in the country.

Merck won Japan's blessing on its human papillomavirus vaccine Gardasil, which is designed to prevent cervical cancer and genital warts. It hit the market hard in the U.S. at first, but after a big rush of vaccinations in its target age group, went on the wane. The company has gained new indications to help broaden use, which could help U.S. sales, but Gardasil now faces competition from GSK's Cervarix. Japan is a big market that could give Gardasil a boost, but the Merck shot will have to compete with the GSK version here, too.

Which brings us to GlaxoSmithKline, which got the nod for its rotavirus shot Rotarix. The childhood vaccine is the first rotavirus preventive to gain approval in Japan, but GSK's third vaccine in the market. Besides Cervarix, which won the Japanese OK in 2009, GSK has been marketing its Arepanrix vaccine. Rotarix is expected to be launched in Japan by year's end.

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