MediGene has entered into an exclusive worldwide license and development agreement with SynCore Biotechnology, a member of the Sinphar Pharmaceutical, for triple-negative breast cancer drug candidate EndoTAG-1.
The agreement, which is an extension to a July 2012 agreement that covered Asia, Australia and New Zealand, funds a global Phase III trial of EndoTAG-1.
Medigene chief executive officer Dr Frank Mathias said the trial will expedite the clinical development of EndoTAG-1.
"Patients suffering from TNBC tend to have a poor prognosis, and there are only very limited treatment options available," Mathias said.
"Previous clinical trials and the most recent data published on the occasion of the ASCO meeting support the potential of our drug candidate and our shared aim of establishing a new treatment option for this severe illness."
The planned Phase III trial of EndoTAG-1 will be funded by SynCore, which in exchange will gain global marketing rights to the product.
Following the receipt of market approval for EndoTAG-1, SynCore will make direct payments to Medigene in the event of certain development and approval milestones, in addition to royalties.
Commenting on the partnership, SynCore chairman Tim Lee said the expansion of the existing license agreement also opens up marketing opportunities beyond Asia, strengthens the company’s international strategy and marks its first step into Europe.
"EndoTAG-1 pursues an innovative approach and excellently supplements with our current oncologic product portfolio," Lee said.
The Phase III trial is scheduled to begin in the second half of 2014.
Image: Mammograms showing a normal breast (left) and a cancerous breast (right).