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news.Mayne Pharma has acquired exclusive rights to market Bioenvision's anticancer drug Evoltra for certain haematological malignancies in Australia and New Zealand.
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Bioenvision will receive milestone payments and a percentage of Mayne's net sales revenue. Mayne Pharma is responsible for securing regulatory approval and government reimbursement in Australia and New Zealand.
Evoltra has been approved in the US for the treatment of acute lymphoblastic leukaemia in paediatric patients who have relapsed or are refractory to other chemotherapies.
In Europe, the EMEA's Committee for Medicinal Products for Human Use has adopted a positive opinion for the use of the drug in the treatment of acute lymphoblastic leukemia in pediatric patients who have relapsed or are refractory to at least two prior regimens and where there is no other treatment option anticipated to result in a durable response.
Bioenvision is also developing Evoltra for the treatment of other haematological malignancies, including for use as first-line therapy of adult acute myeloid leukaemia (AML).
“Evoltra is an exciting addition to our growing branded oncology portfolio. We are very pleased to enter into a partnership with Bioenvision to bring an important new oncology product into the Australian and New Zealand market. We look forward to filing the regulatory dossier with the Australian and New Zealand agencies in the second half of 2006,” said Michael Kotsanis, president of the Asia Pacific region for Mayne Pharma.