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 November, 2005
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 1 November, 2005
Maruho and SkyePharma Sign Development and Marketing Agreement for Novel Pain
Control Agent DepoBupivacaine™ in Japan
LONDON, ENGLAND, 1 November, 2005 -- Maruho Company Limited ("Maruho") and
SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announce that they have entered into a
strategic agreement for the development, marketing and distribution of
DepoBupivacaine™ in Japan. DepoBupivacaine™ is SkyePharma's novel
sustained-release injectable formulation of the local anaesthetic bupivacaine
and is designed to provide localised pain relief for more than 48 hours after a
surgical operation.
Maruho shall pay to SkyePharma up to 18 million dollars including up-front and
milestone payments in consideration of this agreement. Maruho will conduct at
its own cost the clinical development of DepoBupivacaine™ required for
regulatory approval in Japan. Additionally, SkyePharma will receive a share of
Maruho's sales of this product in Japan, out of which SkyePharma will bear the
cost of manufacture.
Maruho's president Koichi Takagi said: "Pain is one of Maruho's target strategic
care domains. We believe that DepoBupivacaine™ addresses the disadvantage of
short-time efficacy of conventional anaesthetics. By using DepoFoam™
technology, a single injection at operation sites or affected sites provides
long-term efficacy without the need for continuous epidural injection, which is
complicated and also whose technique is more difficult, and improves the quality
of life of patients who suffer pain."
SkyePharma's Chief Executive Michael Ashton said: "DepoBupivacaine™ is a key
pipeline product for SkyePharma. We are delighted to have found in Maruho an
excellent development partner for the important Japanese market. There are
approximately 5 million surgical procedures each year in Japan and the number is
growing fast because of the ageing population. We and Maruho believe that
DepoBupivacaine™ will bring important advantages to patients undergoing
surgery."
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 to recover at home.
DepoBupivacaine™ employs SkyePharma's proprietary DepoFoam™ technology and
has been shown in Phase 1 studies to provide local relief of pain for more than
48 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 outside Japan, the results of which are expected to be available by
the end of 2005.
In April 2005, SkyePharma announced that it had entered into a development and
marketing agreement with Mundipharma Inc. for all territories outside North
America and Japan. Endo Pharmaceuticals Inc., SkyePharma's North American
marketing partner for DepoDur™, SkyePharma's first 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
Maruho +81-6-6371-8438
Strategy & Licensing Department
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
Notes to Editors
About Maruho
Maruho, established in Osaka in 1915, is a research-based pharmaceutical company
with a focus on dermatological and orthopaedic products. In 2004 it employed
over 800 staff and had revenues of Y37 billion (US$345 million). For further
information, visit www.maruho.co.jp.
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 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.
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.
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: November 01, 2005