UK drug developer SkyePharma (LSE: SKP) yesterday issued an update on its R&D pipeline and provided an update on key events since the half-year results announcement in August 2011.
The company recalled that the US Food and Drug Administration approved the New Drug Application for Exparel (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia (The Pharma Letter November 2). Under the terms of the sale of the group’s former Injectables Business, now called Pacira Pharmaceuticals, the group is entitled to receive a milestone payment of $10 million on first commercial sale of Exparel in the USA. The group is also entitled to receive 3% of net sales of the drug in the USA, Japan, the UK, France, Germany, Italy and Spain. Longer-term Skyepharma is entitled to receive further contingent milestone payments up to an aggregate of $52 million from Pacira, depending on the following events occurring: (i) $4 million on first commercial sale in a major EU country (UK, France, Germany, Italy or Spain); (ii) $8 million if worldwide annual net sales reach $100 million; (iii) a further $8 million if worldwide annual net sales reach $250 million and (iii) a further $32 million if worldwide annual net sales reach $500 million.
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