15th Dec 2015 15:47
LONDON (Alliance News) - Skyepharma PLC on Tuesday said that Pacira Pharmaceuticals Inc reached an "amicable resolution" with the US Food and Drug Administration of its lawsuit filed in September.
The resolution confirms that EXPAREL - bupivacaine liposome injectable suspension - is "broadly indicated for administration into the surgical site to provide postsurgical analgesia". That has been the case since since 2011, Skyepharma added.
Skyepharma, an oral and inhalation drug delivery company, receives 3.0% of net sales on a cash received basis of EXPAREL. In addition, Skyepharma is eligible to receive sales milestones.
The company said it expects the next sales milestone of USD8.0 million, which is due when annual net sales on a cash received basis reach USD250.0 million, to be achieved in 2016.
A USD32.0 million milestone is due in the event that annual net sales on the same basis reach USD500.0 million.
"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," Chief Executive Peter Grant said in a statement.
Now that approval has been confirmed, Pacira is planning to launch EXPAREL for use for postsurgical analgesia in oral surgery in the fourth quarter of 2016, Skyepharma said.
Shares in Skyepharma were up 3.0% at 339.25 pence on Tuesday afternoon.
By Samuel Agini; [email protected]; @samuelagini
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