Skyepharma skips on Pacira's Exparel agreement with FDA

15th Dec 2015 10:39

(ShareCast News) - Skyepharma has been boosted by news that the US drug regulator has amicably resolved a dispute over Pacira Pharmaceuticals' Exparel drug, from which it receives a percentage of sales.Pacira, which pays Skyepharma 3% of net sales and is expected to also pay a sales milestones of $8m (£5.3m) next year when annual net sales of Exparel reach $250m, confirmed it has achieved an amicable resolution with the United States Food and Drug Administration (FDA) over a lawsuit filed in September.As a result, the FDA has agreed to formally withdraw its 2014 warning letter and concede that the drug remained "broadly indicated for administration into the surgical site to provide postsurgical analgesia".Among other concessions, the FDA has also agreed that Exparel can be used in a "variety of surgeries" and that the drug's packaging will no longer need to specify any limits to the use, efficacy and safety between different surgeries.Now that approval is confirmed, Pacira said it planned to launch Exparel for use for postsurgical analgesia in oral surgery late next year.Skyepharma is due to receive a $32m milestone when annual net sales of Exparel, on a cash received basis, reach $500m."We are pleased that Pacira has been able to reach this amicable resolution with the FDA, and we look forward to seeing the resumption of the growth trajectory for EXPAREL sales, which has significant cash-generating potential for Skyepharma," said chief executive Peter Grant.Barclays recently chose Pacira as its top pharmaceuticals pick on the basis that Exparel should "prove particularly valuable in the new reimbursement environment given its ability to drive cost savings in large institutions".Shares in Skyepharma climbed 3.8% to 341.75p just before the close on Tuesday.