One more month for SKYE to find a partner for DepoMorph.
SkyePharma Announces Positive Phase II Results for DepoMorphine and DepoCyt Approval in Canada
- Seven New Injectable Feasibility Contracts Signed -
LONDON, Feb. 22 /PRNewswire/ -- SkyePharma PLC (Nasdaq: SKYE) (LSE:SKP) today announced positive Phase II results for DepoMorphine, its sustained release morphine formulation utilising SkyePharma's proprietary DepoFoam injection technology. The company intends to take DepoMorphine into Phase III trials later this year.
Dr. John Longenecker, President of SkyePharma Inc. in San Diego commented, "DepoMorphine given to patients as a single pre-operative epidural injection using hip replacement surgery as the pain model, showed a significant decrease in the requirement for additional pain medication. The trials showed a significant and dose dependant drop in fentanyl demand by patients who received DepoMorphine over 48 hours post-surgery. At a 30 milligram dose over 70% of patients rated the pain control of DepoMorphine as either 'very good' or 'excellent'."
SkyePharma also announced that in the area of sustained release injectable technology, 7 new feasibility contracts have been signed since the acquisition of the DepoFoam technology. These include contracts in the biopharmaceutical area where the candidate molecules SkyePharma is working on have multi-billion dollar current sales.
Separately, SkyePharma announced that DepoCyt, its sustained release DepoFoam injection of cytarabine has received regulatory approval in Canada. DepoCyt received approval from the U.S. Food and Drug Administration in 1999.
Michael Ashton, Chief Executive Officer of SkyePharma said: "The results for DepoMorphine are extremely exciting. We are delighted with the new approval of DepoCyt which importantly is for multiple indications including solid tumour, and lymphomatous meningitis. We are also very pleased with the increasing interest from multi-national companies in this delivery technology as evidenced by the number of new feasibility contracts signed."
SkyePharma PLC, one of the world's leading drug delivery companies, develops and manufactures advanced drug delivery solutions. Its technologies include oral controlled release, injectable, inhalation and topical systems. For company information, visit SkyePharma on the World Wide Web at skyepharma.com.
This press release may contain forward-looking statements regarding SkyePharma PLC. Actual results may differ materially from those described in the press release as a result of a number of factors, including but not limited to the following: There can be no assurance that any product in the SkyePharma product pipeline will be successfully developed or manufactured, or that final results of human clinical trials will result in the regulatory approvals required to market products, or that final regulatory approval will be received in a timely manner, if at all, or that patient and physician acceptance of these products will be achieved. The Company undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.
SOURCE: SkyePharma PLC
CONTACT: Michael Ashton , Chief Executive Officer, or Tim Ryan, Corporate Communications, both of SkyePharma PLC, 0171-491-1777; US Investor Relations - Lisa Carlton for SkyePharma, 212-753-5780; or Tim Anderson of Buchanan Communications, 0171-466-5000, for SkyePharma |
