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US FDA approval of NDA for Exparel

31st Oct 2011 14:41

RNS Number : 1788R
Skyepharma PLC
31 October 2011
 



SKYEPHARMA PLC - EXPAREL™ RECEIVES APPROVAL IN U.S.

EXPAREL™ launch expected Q1 2012 triggering initial

$10 million milestone payment to SkyePharma

 

LONDON, UK, 31 October 2011 - SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration ("FDA") has approved the New Drug Application ("NDA") for EXPAREL™ (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.

 

Under the terms of the sale of the Group's former Injectables Business, now called Pacira Pharmaceuticals, Inc, ("Pacira") in 2007, the Group is entitled to receive a U.S.$10 million (£6.2 million) payment on the first commercial sale of EXPAREL™ in the United States, up to U.S.$52 million (£32.5 million) in other contingent milestone payments and three per cent. of net sales of EXPAREL™ in the United States, Japan, United Kingdom, France, Germany, Italy and Spain. Pacira filed the NDA for EXPAREL™ with the FDA in September 2010.

 

It is anticipated that Pacira will achieve the first commercial sale of EXPAREL™ early in 2012 and the U.S.$10 million milestone payment would be due to the Group at that time.

 

EXPAREL™ is an innovative product which combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. According to Pacira, by utilising the DepoFoam® platform, a single dose of EXPAREL™ delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours. EXPAREL™ represents the first and only multivesicular liposome local anaesthetic which can be utilised in the peri- or postsurgical setting in the same fashion as current local anaesthetics, which provide a relatively short duration of efficacy.

 

"As a non-opioid local analgesic, EXPAREL™ represents an evolution in the management of postsurgical pain by providing analgesia for several days with a single intraoperative infiltration," said Dave Stack, President and CEO of Pacira. "Over the past several months, our entire organization has diligently focused on completing the pre-commercial activities necessary to prepare EXPAREL™ for launch."

 

Axel Müller, Chief Executive Officer, SkyePharma, said: "EXPAREL™ is a highly promising new agent in the management of post-surgical pain and its approval is a significant milestone for Pacira and SkyePharma. EXPAREL™ represents an important new option for surgeons, clinicians and patients and the potential milestones and share of sales from a successful launch and roll out are a major asset for SkyePharma."

 

 

For further information please contact:

 

SkyePharma PLC

+44 207 881 0524

Axel Müller, Chief Executive Officer

Peter Grant, Chief Financial Officer

 

 

 

FTI Consulting

+44 207 831 3113

Jonathan Birt/Susan Quigley

 

 

About SkyePharma PLC

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

 

This information is provided by RNS
The company news service from the London Stock Exchange
 
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