Bioniche Life Sciences said today it plans to revive development of its Phase III bladder cancer drug Urocidin™ now that sponsorship has been returned to the company by former global licensing partner Endo Pharmaceuticals. The shift follows Endo’s halting a Phase III trial in November due to slower-than-expected recruiting of patients.
"We will endeavor to schedule meetings with North American regulatory agencies," Graeme McRae, Bioniche’s president and CEO, said in a statement. “With Health Canada, we will discuss the potential for approval of a regulatory submission under its Notice of Compliance with Conditions policy. With the U.S. Food and Drug Administration (FDA), we will propose a revised clinical development plan to achieve U.S. registration."
If Bioniche can enter the Canadian market under a Notice of Compliance with Conditions (NOC/c), a new drug submission could be made to Health Canada before the end of 2013. Approximately one year of review would follow and, if Health Canada is satisfied with the submission, an approval under NOC/c could follow before the end of 2014, the company said.
Bioniche is seeking an early registration in Canada in order to generate revenues from commercial sales that would offset the cost of additional clinical trial work the company said may be required for the U.S. and other jurisdictions.
Another potential funding source for Bioniche, the company said, is its new wholly owned private human health subsidiary, Bioniche Therapeutics Corp. The stand-alone subsidiary could carry out direct external investment to support research and development activities, commercialization activities, and acquisition opportunities, which according to Bioniche may result in accretive value to the parent company. The company is searching for a CEO for the new subsidiary.
Bioniche also said it is actively in discussions with potential new development partners interested in obtaining rights to Urocidin in certain jurisdictions. Any partnerships that result are expected to generate up-front payments, milestones, development support, and licensing revenues, the company said.
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition designed to act through both immune stimulation and direct anticancer activity. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) contributed to the development of Bioniche's mycobacterial cell wall technology through a C$9.6 million (about $9.5 million) loan to be repaid by Bioniche from sales.
Endo teamed up with Bioniche in 2009, with Endo obtaining from Bioniche exclusive rights to develop and market Urocidin in the U.S. with an option for global rights. In return, Endo agreed to pay Bioniche a $20 million up-front cash payment, as well as up to $110 million in payments tied to achievement of future clinical, regulatory, and commercial milestones. Bioniche agreed to manufacture the product, in return for receiving a transfer price for supply.
At the time, Endo was looking to strengthen its bladder cancer franchise after launching Valstar™ for the BCG-refractory form of the disease.
In 2011, the companies announced preliminary results of a 129-patient Phase III trial of Urocidin, showing a 25% overall disease-free survival rate after 12 months. The preliminary results also showed that the product was well-tolerated by patients, with most adverse events considered "mild to moderate."
However, a second Phase III trial failed to recruit patients at the expected rate. Endo pulled the plug on the trial following talks with FDA, with both companies announcing December 21 that Endo would return its Urocidin rights to Bioniche.