SkyePharma PLC announced that it has completed negotiations with Mundipharma International Holdings Limited and it will reacquire the rights for the marketing and distribution of DepoBupivacaine in Europe and other international markets excluding the USA, Canada and Japan.
SkyePharma will also obtain rights to the clinical data from the phase II trials of DepoBupivacaine. This is expected to simplify the ongoing divestment process of SkyePharma's injectables unit.
SkyePharma's chief executive Frank Condella said: 'DepoBupivacaine is the most important near-term product in the injectables pipeline and therefore a key component of the value of this business unit. During our negotiations to divest this unit we have identified the desirability of clarifying the commercial rights to this key product and we are gratified that we are now in a position to offer unrestricted global rights to DepoBupivacaine (outside Japan) to parties interested in acquiring the injectables unit. Mundipharma remains our valued marketing partner for DepoCyte in Europe.'
Under an agreement announced in April 2005, SkyePharma has received $10 million to date from Mundipharma, primarily to fund the Phase II clinical trials for DepoBupivacaine. SkyePharma will now pay $5 million for the marketing and distribution rights and for data generated during the Phase II clinical programme.
In November 2005 SkyePharma announced that it had entered into an exclusive marketing and distribution agreement with Maruho Company Limited for Japan. Maruho is funding the development of the product for approval by the Japanese regulatory agency.
DepoBupivacaine is an extended-release injectable formulation of the widely-used local anaesthetic bupivacaine. Local anaesthetics temporarily block the transmission of pain signals along nerve fibres. DepoBupivacaine employs SkyePharma's proprietary DepoFoam technology to release bupivacaine over a period of several days and is supplied as a ready-to-use injectable suspension. DepoBupivacaine is designed for administration by local infiltration at wound sites, as a peripheral nerve block or by the lumbar epidural route. It is not suitable for intrathecal, subarachnoid or intravenous administration.
DepoBupivacaine is designed for the prolonged control of pain after surgery. SkyePharma expects that its main use will be in control of post-operative pain in patients who have undergone ambulatory surgical procedures under local or regional anaesthesia. However DepoBupivacaine will also be suitable for use during surgery on hospital in-patients.
DepoBupivacaine has completed phase II trials and is expected to commence its phase III trial programme later this year.
DepoFoam is SkyePharma's proprietary sustained-release injectable delivery technology. This is fully commercialised and approved by regulatory agencies in both the USA and Europe. DepoFoam consists of lipid-based particles containing discrete water-filled chambers disperse through the lipid matrix. The particles are 10-30 microns in diameter and are suspended in saline. The suspension resembles skimmed milk and can be injected through a fine needle. The water-filled chambers containing active drug account for most of the weight of the particles. The lipids are naturally occurring substances (or close analogues) such as phospholipids and triglycerides. The small amount of lipid is cleared rapidly in the body as the particles deliver their drug payload over a period that can be modified from 1 to 30 days. For example in DepoCyt/DepoCyte the circulating half-life of the drug cytarabine is increased from 3.4 hours to 141 hours.