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Skyepharma notes Pacira resolution with FDA

15 December 2015 15:45

Skyepharma has noted that Pacira Pharmaceuticals has announced it has achieved an amicable resolution with the US Food and Drug Administration of the lawsuit filed in September.

The resolution confirms that EXPAREL (bupivacaine liposome injectable suspension) is, and has been since 2011, broadly indicated for administration into the surgical site to provide postsurgical analgesia.

The FDA also approved a labelling supplement which amends the EXPAREL package insert to clarify and reinforce that:

- the use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site;

- the proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilised in the pivotal trials provided as examples for the purpose of providing general guidance;

- there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal haemorrhoidectomy study;

- EXPAREL may be admixed with bupivacaine - including co-administered in the same syringe - provided certain medication ratios are observed. - The FDA's September 2014 Warning Letter has been formally withdrawn via a 'rescission letter'. At the request of Pacira, the rescission letter includes FDA guidance related to two key procedures:

- infiltration into the transversus abdominis plane, which is a field block technique covered by the approved indication for EXPAREL;

- infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPAREL®. Now that approval is confirmed, Pacira is planning to launch EXPAREL for use for postsurgical analgesia in oral surgery in Q4, 2016. Skyepharma receives 3% of net sales (on a cash received basis) of EXPAREL. In addition, Skyepharma is eligible to receive certain sales milestones. The Board expects that the next sales milestone of $8.0m, which is due when annual net sales (on a cash received basis) reach $250m, will be achieved in 2016.

A $32.0m milestone is due when annual net sales (on a cash received basis) reach $500m.

At 3:45pm:

(LON:SKP) SkyePharma PLC share price was +11.25p at 340.5p

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