Recipharm Gets Regulatory Nod to Make and Package Abstral in Japan

22-Sep-2013 - Last updated on 23-Sep-2013 at 12:01 GMT

Recipharm granted Japanese approval to make and package Abstral

Recipharm has received approval to manufacture and package the opioid drug Abstral for Kyowa Hakko Kirin in Japan.

Last week, Japan’s Ministry of Health, Labour and Welfare (MHLW) gave approval to Kyowa Hakko Kirin for the manufacturing and marketing of Abstral with the green light granted to Swedish contract manufacturing organisation (CMO) Recipharm to make and package the tablets.

Abstral (fentanyl citrate) is an opioid used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients and a Recipharm spokesperson told Outsourcing-Pharma.com the CMO also “manufactures [the drug] for EU and other markets, but not US” from its facilities in Sweden.

However, receiving the nod from the Japanese authorities for both the manufacturing and packaging of the drug is an extremely complicated process, Recipharm said.

For one thing, “the packaging process is different for Japan due to their special requirements,” we were told, though further details were not available at time of going to press.

The sublingual tablets will be compressed and formulated at Recipharm’s manufacturing plant in Årsta, whilst packaging will be undertaken at the company’s Jordbro complex, both in Sweden. As for quality control, this will occur in Stockholm.

Earlier this year, Recipharm received approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) at its facility in Fontaine, France, allowing products made at that site to enter the Japanese market.

Abstral’s Approval

Another Swedish firm, Orexo, sold Abstral’s marketing rights in the EU and rest of the world to ProStrakan - a Scottish subsidiary of Kyowa Hakko Kirin acquired in February 2011 for $475m (€346m) - for £55m ($88m) in 2012, whilst in the US the rights are held by Galena Biopharma.

The news of approval in Japan will trigger a milestone payment to Orexo, from Kyowa Hakko Kirin who will jointly distribute the drug in the region with Hisamitsu Pharmaceutical.

“With this approval, Abstral has now successfully been developed in the three major pharmaceutical markets in the world,” Orexo CEO Nikolaj Sørensen said. “The approval in Japan is an exciting opportunity for Abstral and for Orexo and we are convinced that Kyowa Hakko Kirin is well positioned to successfully launch Abstral in Japan.”