Skyepharma Regulatory News (SKP)

SkyePharma announces receipt of $10 million milestone payment

on U.S. launch of   EXPAREL^®

LONDON, UK, 20 April, 2012 - SkyePharma PLC (LSE: SKP) today announces that the SkyePharma Group has received a milestone payment of U.S.$10 million (£6.2 million) from Pacira Pharmaceuticals, Inc, following the launch of EXPAREL^® in the United States. The New Drug Application ("NDA") for EXPAREL^® (bupivacaine liposome injectable suspension) was approved by the United States Food and Drug Administration on 31 October 2011.

Under the terms of the sale of SkyePharma's former Injectable Business, now called Pacira Pharmaceuticals, Inc, ("Pacira"), the Group is also entitled to receive further contingent milestone payments of up to an aggregate of U.S.$52 million (£32.5 million) and 3% of net sales of EXPAREL^® in the United States, Japan, United Kingdom, France, Germany, Italy and Spain.  

EXPAREL^® (bupivacaine liposome injectable suspension) is indicated for administration into the surgical site to produce postsurgical analgesia.  The product combines bupivacaine with DepoFoam^®, a proven product delivery technology that delivers medication over a desired time period.  EXPAREL^® represents the first and only multivesicular liposome local anaesthetic that can be utilised in the peri- or postsurgical setting in the same fashion as current local anaesthetics.  By utilising the DepoFoam^® platform, a single dose of EXPAREL^® delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours.  Pivotal studies have demonstrated the safety and efficacy of EXPAREL^® in patients undergoing bunionectomy or haemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures.

Peter Grant, Chief Executive Officer, SkyePharma, commented:

"We are pleased that Pacira has launched EXPAREL^® in the US, triggering a milestone payment to SkyePharma of $10 million. Under the agreement with Pacira, SkyePharma could earn substantial additional milestone payments and is entitled to 3% of net sales in the US. Pacira has a large sales force in place aimed at gaining good traction for EXPAREL^® in the US as a new option in the control of pain during and after surgery." 

Note on Accounting Treatment:

Due to the nature of the milestone, as contingent proceeds related to the disposal of the Injectable Business by the Group to Pacira, the U.S.$10 million launch milestone will be treated as exceptional income arising from  discontinued operations in the financial accounts of the Group.  It is currently envisaged that future receipts of the share of net sales will be treated as other income in the revenue line.

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About SkyePharma PLC

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products.  The Group has eleven approved products in the areas of oral and topical delivery as well as important license and revenue-generating arrangements in inhalation and injectable technologies.  The Group's products are marketed throughout the world by leading pharmaceutical companies.  For more information, visit www.skyepharma.com.