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 July, 2003
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 21 July, 2003
SkyePharma PLC
European marketing rights for DepoCyte®
Licensed to Mundipharma International Holdings Limited
LONDON, ENGLAND, July 21, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announced today that in June 2003
it licensed exclusive marketing and distribution rights for DepoCyte®, a treatment for lymphomatous
meningitis, to Mundipharma International Holdings Limited ("Mundipharma") for most European and Eastern
European countries.
Under the terms of the agreement, Mundipharma will pay SkyePharma €4.25 million (US$4.9 million) on
signature plus additional milestone payments that may amount in total to €10.75 million (US$12.3 million).
SkyePharma will manufacture the drug at its San Diego facility and supply to Mundipharma associates at an
agreed transfer price. Mundipharma will also pay SkyePharma an additional royalty on sales.
SkyePharma's chief executive officer, Michael Ashton, said "We are delighted to have found in Mundipharma a
partner which can bring the focused marketing and sales support needed for a specialist product like
DepoCyte®. Mundipharma shares our view that lymphomatous meningitis is both under-diagnosed and
under-treated and that DepoCyte® offers great potential to bring relief of suffering from this devastating
complication of cancer. We look forward to working together."
DepoCyte® (known as DepoCyt® in the USA) is a sustained release injectable formulation of cytarabine and is
approved in both the USA and Europe for the treatment of lymphomatous meningitis, a serious late-stage
complication of lymphoma, a form of cancer affecting the lymphatic system. Lymphomatous meningitis is a
subset of neoplastic meningitis (see explanation below). Cytarabine is known to be an effective treatment
for neoplastic meningitis but is rapidly metabolised and so patients require spinal (intrathecal)
injections every two days. SkyePharma's proprietary DepoFoam™ delivery technology encapsulates cytarabine
in water solution within minute particles of lipid. After injection, these particles gradually degrade,
prolonging the release of the drug and extending the period between injections to two weeks. This brings
quality of life benefits to the patient and also savings in hospital costs. Furthermore, maintenance of
sustained higher levels of cytarabine in the cerebrospinal fluid may also prolong the time to neurological
progression.
Lymphomatous meningitis is a comparatively uncommon condition with approximately 10,000 cases reported
worldwide each year. Consequently DepoCyt® has been granted "Orphan Drug" status in the USA. SkyePharma is
currently conducting a Phase IV study, the data from which will be submitted in applications to the FDA and
EMEA to expand the treatment indication for DepoCyt®/DepoCyte® to neoplastic meningitis associated with
solid tumours. This is a more common condition and would increase the number of patients eligible for
treatment with DepoCyt®/DepoCyte® approximately threefold.
DepoCyt® was approved by the US Food & Drug Administration in April 1999 and is marketed in North America
by Enzon Pharmaceuticals. Rights in Japan were licensed to Nippon-Shinyaku in 2001 although the product is
not yet on the market. DepoCyte® was approved by the European Medicines Evaluation Authority in August
2001. European marketing and distribution rights for DepoCyte® were licensed to Elan Pharmaceuticals
("Elan") in June 2001 but following Elan's decision not to proceed with the planned establishment of an
oncology sales force, SkyePharma has reacquired these European rights for an unspecified amount. This
amount will be written off in full in SkyePharma's accounts for the six months to June 30th, 2003.
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
http://www.skyepharma.com.
About neoplastic meningitis
In many forms of cancer, secondary tumours (metastases) form in the meninges, the membrane that surrounds
the brain and spinal cord. From autopsy data, neoplastic meningitis affects up to 20% of all cancer
patients (Posner, Neurological Complications of Cancer, 1995) but the condition is only diagnosed in 4-7%
of cancer patients. The symptoms are pain and progressive neurological deterioration and few patients
survive more than a few months, either from neurological dysfunction or from the primary tumour. The goal
of therapy for neoplastic meningitis is palliation, not cure. The principal treatments are normally
radiotherapy and chemotherapy to clear the cerebrospinal fluid of malignant cells and to prevent or slow
recurrence. Most cytotoxic drugs do not cross the blood-brain barrier so the main chemotherapy treatments
are methotrexate or cytarabine, injected intrathecally. These drugs reduce pain and slow neurological
degradation but have the disadvantage of rapid clearance from the circulation and so require frequent
injections.
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 tiny
lipid-based particles which contain 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 lecithin 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 Mundipharma
Mundipharma is part of the Purdue/Mundipharma/Napp independent associated companies, a group of privately
owned companies and joint ventures covering 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.
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 DepoCyt®/DepoCyte® and 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,
market a pharmaceutical product on a large scale and integrate and manage an internal sales and marketing
organization and maintain or expand sales and market share for DepoCyt®/DepoCyte®, 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.
For further information please contact: SkyePharma PLC +44 207 491 1777 Michael Ashton, Chief Executive Officer Peter Laing, Director of Corporate Communications Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000 Tim Anderson / Nicola HowEND
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: July 21, 2003