The UK’s SkyePharma has entered into a strategic agreement with Maruho Company Ltd, providing the latter with rights to develop, market and distribute its DepoBupivacaine in Japan. The product is SkyePharma’s novel, sustained-release, injectable version of the local anaesthetic bupivacaine, which is designed to provide localised pain relief for more than 48 hours after surgery.
Under the terms of the deal, Maruho will pay SkyePharma up to $18 million, including upfront and milestone payments, as well as fund the clinical development necessary for regulatory approval in Japan. SkyePharma will receive a share of Maruho's sales, out of which the UK firm will bear the cost of manufacture.
Commenting on the deal, Maruho's president Koichi Takagi, said: “Pain is one of Maruho's target strategic care domains. We believe that DepoBupivacaine addresses the disadvantage of short-time efficacy of conventional anaesthetics. By using DepoFoam technology, a single injection at operation sites or affected sites provides long-term efficacy without the need for continuous epidural injection, which is complicated and also whose technique is more difficult, and improves the quality of life of patients who suffer pain.”
Equally enthusiastic over the deal was SkyePharma's chief executive Michael Ashton, who noted that “DepoBupivacaine is a key pipeline product for SkyePharma,” and that “There are approximately 5 million surgical procedures each year in Japan and the number is growing fast because of the ageing population,” signifying the agent’s potential in this market.
DepoBupivacaine, which uses SkyePharma's proprietary DepoFoam technology, is currently in Phase II clinical development outside Japan. Results are expected by the end of the year.