Marketing Rights for DepoCyte

RNS Number:7497N
Skyepharma PLC
21 July 2003


For Immediate Release                                     21 July, 2003


                                 SkyePharma PLC


                   European marketing rights for DepoCyte(R)  
             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(R), 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 Euro4.25 million
(US$4.9 million) on signature plus additional milestone payments that may amount
in total to Euro10.75 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(R). Mundipharma
shares our view that lymphomatous meningitis is both under-diagnosed and
under-treated and that DepoCyte(R) offers great potential to bring relief of
suffering from this devastating complication of cancer. We look forward to
working together."


DepoCyte(R) (known as DepoCyt(R) 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 DepoFoamTM 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(R) 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(R)/DepoCyte(R) 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(R)/DepoCyte(R) approximately threefold.


DepoCyt(R) 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(R) was approved by the European Medicines Evaluation Authority
in August 2001. European marketing and distribution rights for DepoCyte(R) 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 DepoFoamTM 

DepoFoamTM is SkyePharma's proprietary sustained release injectable delivery
technology. This is fully commercialised and approved by regulatory agencies in
both the USA and Europe. DepoFoamTM 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(R)/
DepoCyte(R) 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(R)/DepoCyte(R) 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(R)/DepoCyte(R), 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                                                  [phone]
Michael Ashton, Chief Executive Officer
Peter Laing, Director of Corporate Communications

Sandra Haughton, US Investor Relations                          [phone]

Buchanan Communications                                         [phone]
Tim Anderson / Nicola How



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