LONDON, June 30 /PRNewswire-FirstCall/ -- SkyePharma PLC announces that it has completed negotiations with Mundipharma International Holdings Limited (“Mundipharma”) the result of which is that SkyePharma will reacquire the rights for the marketing and distribution of DepoBupivacaine(TM) in Europe and other international markets excluding the USA, Canada and Japan. SkyePharma will also obtain rights to the clinical data from the Phase II trials of DepoBupivacaine(TM). This is expected to simplify the ongoing divestment process of SkyePharma’s injectables unit.
SkyePharma’s Chief Executive Frank Condella said: “DepoBupivacaine(TM) is the most important near-term product in the injectables pipeline and therefore a key component of the value of this business unit. During our negotiations to divest this unit we have identified the desirability of clarifying the commercial rights to this key product and we are gratified that we are now in a position to offer unrestricted global rights to DepoBupivacaine(TM) (outside Japan) to parties interested in acquiring the injectables unit. Mundipharma remains our valued marketing partner for DepoCyte(R) in Europe.”
Under an agreement announced in April 2005, SkyePharma has received $10 million to date from Mundipharma, primarily to fund the Phase II clinical trials for DepoBupivacaine(TM). SkyePharma will now pay $5 million for the marketing and distribution rights and for data generated during the Phase II clinical programme.
In November 2005 SkyePharma announced that it had entered into an exclusive marketing and distribution agreement with Maruho Company Limited (“Maruho”) for Japan. Maruho is funding the development of the product for approval by the Japanese regulatory agency.
For further information please contact: SkyePharma PLC +44 207 491 1777 Frank Condella, Chief Executive Officer Peter Laing, Director of Corporate Communications 44 207 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000 Tim Anderson / Mark Court / Rebecca Skye Dietrich About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world- leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now twelve approved products incorporating SkyePharma’s technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit http://www.skyepharma.com.
About DepoBupivacaine(TM)
DepoBupivacaine(TM) is an extended-release injectable formulation of the widely-used local anaesthetic bupivacaine. Local anaesthetics temporarily block the transmission of pain signals along nerve fibres. DepoBupivacaine(TM) employs SkyePharma’s proprietary DepoFoam(TM) technology to release bupivacaine over a period of several days and is supplied as a ready-to-use injectable suspension. DepoBupivacaine(TM) is designed for administration by local infiltration at wound sites, as a peripheral nerve block or by the lumbar epidural route. It is not suitable for intrathecal, subarachnoid or intravenous administration.
DepoBupivacaine(TM) is designed for the prolonged control of pain after surgery. SkyePharma expects that its main use will be in control of post- operative pain in patients who have undergone ambulatory surgical procedures under local or regional anaesthesia. However DepoBupivacaine(TM) will also be suitable for use during surgery on hospital in-patients.
DepoBupivacaine(TM) has completed Phase II trials and is expected to commence its Phase III trial programme later this year.
About DepoFoam(TM)
DepoFoam(TM) is SkyePharma’s proprietary sustained-release injectable delivery technology. This is fully commercialised and approved by regulatory agencies in both the USA and Europe. DepoFoam(TM) consists of lipid-based particles containing discrete water-filled chambers dispersed through the lipid matrix. The particles are 10-30 microns in diameter and are suspended in saline. The suspension resembles skimmed milk and can be injected through a fine needle. The water-filled chambers containing active drug account for most of the weight of the particles. The lipids are naturally occurring substances (or close analogues) such as phospholipids and triglycerides. The small amount of lipid is cleared rapidly in the body as the particles deliver their drug payload over a period that can be modified from 1 to 30 days. For example in DepoCyt(R)/DepoCyte(R) the circulating half-life of the drug cytarabine is increased from 3.4 hours to 141 hours.
Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma’s 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma’s ability to manufacture products on a large scale or at all, risks related to SkyePharma’s and its marketing partners’ ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma’s ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.
SkyePharma PLC
CONTACT: SkyePharma PLC, +44-207-491-1777, Frank Condella, Chief ExecutiveOfficer, or Peter Laing, Director of Corporate Communications,+44-207-491-5124, or Sandra Haughton, US Investor Relations+1-212-753-5780; or Tim Anderson, Mark Court, or Rebecca Skye Dietrich, allof Buchanan Communications, +44-207-466-5000
Web site: http://www.skyepharma.com//
