Maruho and SkyePharma form marketing partnership

DepoBupivacaine is SkyePharma’s novel sustained-release injectable formulation of the local anaesthetic bupivacaine and is designed to provide localized pain relief for more than 48 hours after a surgical operation.

Maruho is to pay to SkyePharma up to $18 million including upfront and milestone payments in consideration of this agreement. Maruho will conduct at its own cost the clinical development of DepoBupivacaine required for regulatory approval in Japan. Additionally, SkyePharma will receive a share of Maruho’s sales of this product in Japan, out of which SkyePharma will bear the cost of manufacture.

DepoBupivacaine employs SkyePharma’s proprietary DepoFoam technology and has been shown in phase I studies to provide local relief of pain for more than 48 hours after a single injection instead of 8-12 hours for conventional immediate-release bupivacaine. Superior control of pain after discharge is expected to reduce the need for other analgesics and to improve patient recovery and rehabilitation.

The anesthetic is currently in phase II clinical development outside Japan, with results expected to be available by the end of 2005.

Maruho’s president Koichi Takagi said: “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.”