SkyePharma regains EU painkiller rights to aid divestment
SkyePharma, a drug redevloper headquartered in London, has re-obtained the rights for the marketing and distribution of DepoBupivacaine in Europe and other international markets, excluding the US, Canada and Japan. It will also obtain rights to the clinical data from the Phase II trials of DepoBupivacaine.
SkyePharma, a drug redevloper headquartered in London, has re-obtained the rights for the marketing and distribution of DepoBupivacaine in Europe and other international markets, excluding the US, Canada and Japan. It 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. The injectables unit is a stand-alone operation with its own management team and r&d and manufacture in San Diego. SkyePharma's board has concluded that the unit requires significant investment and the divestment will allow management to focus on its core oral/inhalation business.
SkyePharma's ceo 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 $10m to date from Mundipharma, primarily to fund the Phase II clinical trials for DepoBupivacaine. SkyePharma will now pay $5m 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 Co for Japan. Maruho is funding the development of the product for approval by the Japanese regulatory agency.
SkyePharma developed DepoBupivacaine for the prolonged control of pain after surgery. The extended-release injectable formulation of the widely-used local anaesthetic bupivacaine 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.