SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a - 16 OR 15d - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of June, 2006
SkyePharma PLC
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F.
Form 20-F X Form 40-F
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _______
For Immediate Release 30 June 2006
SkyePharma PLC
SkyePharma Reacquires European Rights for DepoBupivacaine™
LONDON, UK, 30 June 2006 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) 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™ 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™. This is expected to simplify the ongoing divestment process
of SkyePharma's injectables unit.
SkyePharma's Chief Executive Frank Condella said: "DepoBupivacaine™ 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™ (outside Japan) to
parties interested in acquiring the injectables unit. Mundipharma remains our
valued marketing partner for DepoCyte® 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™. 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
www.skyepharma.com.
About DepoBupivacaine™
DepoBupivacaine™ 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™ employs
SkyePharma's proprietary DepoFoam™ technology to release bupivacaine over a
period of several days and is supplied as a ready-to-use injectable suspension.
DepoBupivacaine™ 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™ 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™ will also be suitable for use
during surgery on hospital in-patients.
DepoBupivacaine™ has completed Phase II trials and is expected to commence
its Phase III trial programme later this year.
About DepoFoam™
DepoFoam™ 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™ 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®/DepoCyte® 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
SkyePharma PLC
By: /s/ Douglas Parkhill
Name: Douglas Parkhill
Title:
Company Secretary
Date: June 30, 2006