Bioniche details plans for Urocidin

In a letter to shareholders, Bioniche’s (ASX:BNC) CEO has laid out some plans for the future of bladder cancer treatment Urocidin following its split with former commercialisation partner Endo Pharmaceuticals.

Bioniche (ASX:BNC) has revealed more details of its plans for bladder cancer treatment candidate Urocidin following the dissolution of its partnership with Endo Pharmaceuticals.

Bioniche last month surprised shareholders by revealing plans to regain control of Urocidin’s clinical development after mutually agreeing to end its contract with Endo. The partnership was ended after Endo called off a phase III trial due to slow recruitment.

In a letter to shareholders filed with the ASX today, Bioniche President and CEO Graeme McRae said Endo’s choice of the chemotherapy mitomycin C as a comparative was likely a major reason for the slow recruitment rate for the trial.

Mitomycin C is not approved for use in non-muscle-invasive bladder cancer, although some practitioners do use it, McRae said. As a result, a number of patients and urologists were uncomfortable participating in a trial involving this treatment.

BioDiem had initially planned to conduct the phase III trial in newly diagnosed non-muscle-invasive bladder cancer, using the vaccine BCG as a comparative, but Endo chose to change the plan and instead trial Urocidin in BCG-refractory bladder cancer.

McRae said, depending on discussions with health regulators, future studies in Canada and elsewhere may revert to Bioniche’s original trial design.

Bioniche is planning to pursue approval for Urocidin in Canada ahead of other international markets.

The company is considering applying for approval under the nation’s Notice of Compliance with Conditions policy - a fast-track for treatments for serious and underserved conditions.

If regulator Health Canada concurs that Urocidin is a candidate for the policy, BioDiem hopes to file a New Drug Submission by the end of 2013, and have the product available for commercial sale in Canada by as early as 2014.

McRae said following the dissolution of its partnership with Endo, it is now in discussions with other potential development partners for markets beyond Canada.

Such a deal could lead to up-front and milestone payments, and support for development costs, which would offset any required investment in additional clinical trial work.

McRae added that the company’s animal health business is performing well “in spite of the challenging global economy”, with year-to-date revenues up 14% compared to the same period in FY12.

Bioniche’s first canine cancer product Immunocidin has been well received since its North American launch, and its second - Oncocidin - will enter clinical trials later this year.

McRae also said that while the group’s financial performance has been on par with the company’s plans and anticipated results, “we continue to have a corporate burn rate of over C$1 million ($965,000) per month - largely due to the carrying costs of our manufacturing facilities.

“[This] means that we need to identify additional sources of financing in the coming months to ensure we maintain adequate cash reserves on an ongoing basis to complete our commercialisation plans over the next few years.”

Bioniche (ASX:BNC) shares were trading unchanged at 25c as of around 11:30 am on Monday.