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SkyePharma Announces First European Approval of DepoDur(TM) |
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28 Apr 2006 |
LONDON, UK | Apr 28, 2006 | SkyePharma PLC (LSE: SKP, Nasdaq: SKYE)) announces today that the UK Medicines and Healthcare products Regulatory Agency ('MHRA') has approved SkyePharma's DepoDur(TM) for the treatment of pain following major surgery. Previously referred to as DepoMorphine(TM), DepoDur(TM) is a novel single dose sustained-release injectable formulation of morphine.
Frank Condella, Chief Executive of SkyePharma, said: 'We are delighted with the approval of DepoDur in the UK and are confident that this will lead to additional approvals in other European markets under the Mutual Recognition Process DepoDur(TM) represents another successful outcome resulting from the major commitment SkyePharma has made to product development, including funding the product through Phase III trials and building and on-going funding of a purpose-built manufacturing plant in San Diego, USA. Our clinical trial programme for DepoDur(TM) involved over 1000 patients in four different pain models and demonstrated the great potential of the product to improve the control of post-operative pain.
'DepoDur(TM) was developed and is manufactured by SkyePharma Inc. the San Diego based injectable business, which SkyePharma has announced is in the process of being divested, 'This approval, along with the availability of EU rights for DepoDur(TM), provides further value to our injectable business.'
DepoDur(TM) was licensed to Zeneus for distribution in the EU. Recently, SkyePharma bought back the rights to the product.
DepoDur(TM) is licensed to Endo Pharmaceuticals (Nasdaq: ENDP) for sale in the USA.
SOURCE: SkyePharma PLC |
