These milestones triggers a total payment of $8m to Bioniche from Endo. Endo has also elected to exercise its option for exclusive rights to develop and market the product globally. As a result of the decision, Endo will assume all external development expenses for the product.
As per the licensing agreement, Bioniche has the potential to receive a total of $110m in payments associated with the achievement of certain clinical, regulatory and commercial milestones.
The achievement of the first milestone of $6m was announced by the company in November 2009. The company said that it will announce further milestones as they will achieve and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
Graeme McRae, chairman, president and CEO of Bioniche, said: “We are pleased with this decision by Endo. We look forward to ongoing collaboration in addressing the global market opportunity for our bladder cancer product, as well as effectively completing the clinical development program and achieving product registrations in global jurisdictions.”
Bioniche’s patented intravesical formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed for the treatment of non-muscle-invasive bladder cancer (Urocidin), is undergoing a FDA fast tracked phase III registration study for the treatment-refractory indication. Future plans to further develop Urocidin are being defined and will be disclosed by Endo.