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 September, 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 | 23 September, 2003 | ||
SkyePharma's New Drug Application for DepoMorphine™
Accepted for Filing by US Food & Drug Administration
LONDON, ENGLAND, September 23, 2003 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announced today that on 16 September the US Food &
Drug Administration ("FDA") formally accepted for filing a New Drug Application ("NDA") for DepoMorphine™, SkyePharma's novel
sustained-release injectable formulation of morphine for control of moderate-to-severe post-operative pain. SkyePharma submitted the
NDA on 18 July. DepoMorphine™ was licensed to Endo Pharmaceuticals Inc. ("Endo", Nasdaq: ENDP) for North America at the end of 2002.
Under the terms of this licence agreement, the FDA's acceptance of the DepoMorphine™ submission triggers a US$5 million milestone
payment from Endo to SkyePharma.
SkyePharma's Chief Executive Michael Ashton said, "DepoMorphine™ is currently our most important pipeline product. We now look
forward to its commercialisation, which we anticipate in the second half of 2004. Our clinical trials show that DepoMorphine™ has
the potential to improve the treatment of pain after surgery. There is widespread recognition that pain relief is an under-served
market and current approaches to control of post-operative pain leave much to be desired."
DepoMorphine™ employs SkyePharma's proprietary DepoFoam™ technology and is supplied as a ready-to-use suspension. It is given as a
single epidural injection before or during surgery and provides pain relief for 48 hours following surgery. There is no need for an
indwelling catheter for continuous infusion, which overcomes a major drawback to the epidural route of administration for opioids.
DepoMorphine™ is designed for the control of moderate-to-severe post-operative pain. SkyePharma expects that its main use will be in
control of post-operative pain in hospitalised patients undergoing surgical procedures requiring general or local anaesthesia such
as major abdominal surgery, orthopaedic surgery and caesarean section. Currently there are an estimated 6 million such procedures
every year in the USA and 5 million in Europe.
SkyePharma has completed seven clinical trials of DepoMorphine™. The Phase IIb and Phase III clinical development programme for
DepoMorphine™ involved four separate pain models and included nearly 1000 patients.
SkyePharma plans to file DepoMorphine™ with the European Agency for the Evaluation of Medicinal Products (EMEA) in the autumn.
SkyePharma expects to announce the appointment of licensees for DepoMorphine™ in Europe and other non-US territories later this year.
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 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 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 a major surgical operation, the level of pain is usually very high for the first one to two days but the intensity of pain
gradually subsides and by the end of the second day pain can normally be controlled with oral analgesics. For the immediate
post-operative period, opioid analgesics like morphine (used alone or in combination with other non-opioid analgesics) are likely to
remain the "gold standard" for relief of severe acute pain. However the relatively short duration of pain relief with opioids means
that they require either continuous infusion or patient-controlled analgesia ("PCA") in which a pump delivers a series of doses of a
short-acting opioid analgesic in response to the patient pressing a button (under computer control to prevent over-dosing). Both of
these approaches require the patient to have an in-dwelling epidural or intravenous catheter. Such catheters can fall out or
interfere with patient mobility and are a potential source of infections. Epidural catheters are also contra-indicated with
concomitant use of anticoagulants because of the risk of bleeding in the spinal column that can potentially result in paralysis.
There is a growing trend toward routine use of anticoagulants in patients undergoing orthopaedic surgery in order to prevent blood
clots.
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, 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 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.
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 / Mark Court | |||
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: September 23, 2003