FORM 6-K
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
April, 2005
SkyePharma PLC
(Translation of registrant's name into English)
SkyePharma PLC, 105 Piccadilly, London W1J 7NJ England
(Address of principal executive office)
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
19 April, 2005
SkyePharma PLC
$80 million European Development and Marketing Agreement
for Novel Pain Control Agent DepoBupivacaine™
LONDON, ENGLAND, 19 April, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)
announces that it has entered into a strategic development and marketing
arrangement with Mundipharma International Holdings Limited ("Mundipharma") for
the marketing and distribution of DepoBupivacaine™ in Europe and other
international markets excluding the USA, Canada and Japan. Mundipharma is
already SkyePharma's European marketing partner for the cancer treatment
DepoCyte®
Under the agreement with Mundipharma, SkyePharma will receive $10 million on
signature, most of which will be deferred and recognised to income to cover the
cost of the Phase II clinical trials. SkyePharma will also receive further
contributions of up to US$20 million towards the cost of the Phase III clinical
trials required to gain approvals, and additional milestone payments on
attainment of development milestones, marketing approvals and sales targets. If
all targets are met total payments will amount to over US$80 million. SkyePharma
will be responsible for clinical development. SkyePharma will also receive a 35%
share of Mundipharma's sales of DepoBupivacaine™ in Europe (30% in other
territories), out of which SkyePharma will bear the cost of manufacture.
SkyePharma's Chief Executive Michael Ashton said: "DepoBupivacaine™ is one of
the most important products in our pipeline. With the possibility of providing
extended localised pain relief for up to 4 days, DepoBupivacaine™ should
become the analgesic of choice for the increasing number of day surgeries. This
type of surgery has already overtaken hospital inpatient operations to become
the most common surgical procedure and is the fastest growing part of the
market. We are delighted to extend our relationship with Mundipharma, which is
currently successfully marketing another of our products, DepoCyte®, in
Europe.
This deal structure not only continues our recent trend towards a larger royalty
share but also relieves our income statement of the considerable cost of
Research and Development."
DepoBupivacaine™ is SkyePharma's novel sustained-release injectable
formulation of the local anaesthetic bupivacaine, currently widely used as a
local or regional anaesthetic during surgery, either in a hospital in-patient
setting or in ambulatory (or "day") surgery in which the patient is discharged
from the hospital or clinic shortly after surgery and recovers at home.
DepoBupivacaine™ employs SkyePharma's proprietary DepoFoam™ technology and
has been shown in Phase 1 studies to provide local relief of pain for up to 96
hours after a single injection instead of 8-12 hours for conventional
immediate-release bupivacaine. Superior control of pain after discharge is
expected to reduce the need for other analgesics and to improve patient recovery
and rehabilitation. DepoBupivacaine™ is currently in Phase II clinical
development. Endo Pharmaceuticals Inc., SkyePharma's North American marketing
partner for DepoDur™, SkyePharma's other product for relief of post-operative
pain, has the right of first negotiation for rights to DepoBupivacaine™ in
North America, exercisable once SkyePharma has requested an end of Phase II
trial meeting with the US Food & Drug Administration.
For further information please contact:
SkyePharma PLC
+44 207 491 1777
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications
+44 207 491 5124
Sandra Haughton, US Investor Relations
+1 212 753 5780
Mundipharma
Rob Cohen, European Communications Director
+44 1223 424211
+44 7734 159122
Buchanan Communications
+44 207 466 5000
Tim Anderson / Mark Court
Notes to Editors
About SkyePharma
SkyePharma PLC uses its world-leading drug delivery technology to develop
easier-to-use and more effective formulations of drugs. The majority of
challenges faced in the formulation and delivery of drugs can be addressed by
one of the Company's proprietary technologies in the areas of oral, injectable,
inhaled and topical delivery, supported by advanced solubilisation capabilities.
For more information, visit www.skyepharma.com.
About Mundipharma
Mundipharma is one of the Purdue/Mundipharma/Napp independent associated
companies, privately owned companies and joint ventures that cover the world's
pharmaceutical markets. The companies have particular expertise in bringing to
patients the benefits of novel drug delivery systems such as those used to
enhance medicines for the relief of severe pain. For further information, visit
www.mundipharma.co.uk.
About DepoBupivacaine™
DepoBupivacaine™ is an extended-release injectable formulation of the 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 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
in surgery on hospital in-patients.
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.
About post-operative pain after ambulatory surgery
Ambulatory surgery (also known as "day" surgery) is normally performed in
hospital out-patient facilities, free-standing ambulatory surgery centres or in
physicians' offices. In contrast with a major surgical operation on a hospital
in-patient, which routinely involves general anaesthesia followed by several
days of recovery in the hospital, ambulatory surgery is normally conducted under
a local or regional anaesthetic, and a few hours after the procedure the patient
is discharged to recover at home. The development of less invasive surgical
procedures and the drive to reduce the high costs of hospitalisation has led to
a rapid growth in ambulatory surgery, which now accounts for about 65% of
elective surgical procedures in the USA (against 16% in 1980). Today more than
30 million patients undergo surgical procedures on an ambulatory basis each year
in the United States. Typical ambulatory procedures include tonsillectomies,
hernia repairs, gall bladder removals, colonoscopies, some cosmetic surgeries,
and cataract surgeries.
Currently oral analgesics are the principal approach to control of pain after
the anaesthetic used in ambulatory surgery wears off. Patients discharged from
hospital after ambulatory surgery to recover at home are not under full-time
medical supervision, which restricts both the type and quantity of analgesics
that can be used. For example, the highly effective opioid analgesics are
largely precluded in the home setting because of the accompanying risks of
nausea and vomiting and respiratory depression. Patients are therefore often
subject to inadequate pain relief during the immediate post-surgical period,
which not only is undesirable but also can delay recovery. Recent surveys
indicate that after ambulatory surgery up to 40% of outpatients suffered from
moderate to severe pain during the first 24-48 hours after discharge. More
invasive, and therefore more painful, surgical procedures (such as knee
reconstruction) are increasingly being performed on an ambulatory basis,
reinforcing the need for more effective ways of controlling post-operative pain.
Except for the historical information herein, the matters discussed in this news
release include forward-looking statements that may involve a number of risks
and uncertainties. Actual results may vary significantly based upon a number of
factors, which are described in SkyePharma's 20-F and other documents on file
with the SEC. These include without limitation risks in obtaining and
maintaining regulatory approval for existing, new or expanded indications for
its products, other regulatory risks, risks relating to SkyePharma's ability to
manufacture pharmaceutical products on a large scale, risks that customer
inventory will be greater than previously thought, risks concerning SkyePharma's
ability to manage growth, SkyePharma's marketing partners' ability to market a
pharmaceutical product on a large scale and manage their sales and marketing
organisation and maintain or expand sales and market share for its products,
risks relating to the ability to ensure regulatory compliance, risks related to
the research, development and regulatory approval of new pharmaceutical
products, risks related to research and development costs and capabilities,
market acceptance of and continuing demand for SkyePharma's products and the
impact of increased competition, risks associated with anticipated top and
bottom line growth and the possibility that upside potential will not be
achieved, competitive products and pricing, and risks associated with the
ownership and use of intellectual property rights. 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: April 19, 2005