The firm has signed over marketing rights to its DepoBupivacaine product in Europe and other international markets - but excluding the US, Canada and Japan - to UK-based Mundipharma in return for up to $80m (€61m). The latter is already SkyePharma's European marketing partner for its cancer treatment DepoCyt (cytarabine liposome injection).
DepoBupivacaine is based on SkyePharma's DepoFoam technology, which consists of microscopic, spherical particles composed of hundreds of non-concentric aqueous chambers encapsulating the drug to be delivered. The result is that the duration of local anesthesia with bupivacaine can be extended for up to four days from around 8-12 hours with the current formulations of the drug.
This improved duration of action will, claims SkyePharma, make DepoBupivacaine the drug of choice for a number of day surgeries, which have already overtaken hospital inpatient operations to become the most common surgical procedure and the fastest growing part of the surgery market. Superior control of pain after discharge could also reduce the need for other analgesics and improve patient recovery and rehabilitation, according to the firm.
SkyePharma will receive $10 million on signature, most of which will be deferred and recognised to income to cover the cost of the Phase II clinical trials. The drug delivery company said it will also receive further contributions of up to $20 million towards the cost of the Phase III clinical trials required to gain approvals, and additional milestone payments on attainment of development milestones, marketing approvals and sales targets.
SkyePharma will be responsible for clinical development. SkyePharma will also receive a 35 per cent share of Mundipharma's sales of DepoBupivacaine in Europe and a 30 per cent share in other territories, but will bear the cost of manufacture.
DepoBupivacaine is currently in Phase II clinical development. Endo Pharmaceuticals, SkyePharma's North American marketing partner for DepoDur (morphine sulfate), SkyePharma's other product for relief of post-operative pain, has the right of first negotiation for rights to DepoBupivacaine in North America.