Bioniche resumes control of bladder cancer drug

Bioniche (ASX:BNC) has formally taken back the rights to bladder cancer treatment Urocidin after completing a split with its former global development and marketing partner.

The company yesterday announced that its original licensing agreement with Endo Pharmaceuticals has now been fully wound up and sponsorship of Urocidin has been returned to Bioniche.

Bioniche will now meet with regulators in the US and Canada to discuss the regulatory steps required to secure approval for Urocidin in the two markets. This will include proposing a new clinical development plan to achieve US registration for the product.

If all goes to plan, Bioniche aims to secure Canadian approval before the end of 2014. The company hopes to use revenues from commercial sales in the market to help fund any additional clinical trial work required for applications in the US and other markets.

Meanwhile, Bioniche is in talks with potential new development partners interested in acquiring the rights to Urocidin. But deals are likely to concentrate on various markets, in contrast to the global agreement with Endo.

Bioniche and Endo announced over the new year that they would terminate their commercialisation agreement for Urocidin. Endo had a month earlier called off a planned phase III trial due to poor recruitment.

Under the termination agreement, Endo will be entitled to a 5% royalty on revenues for the first 10 years of sale, or until patents protecting Urocidin expire.

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition. It has been shown to stimulate the immune system and have direct anticancer activity in bladder cancer.

Urocidin has already been through a phase III trial, which commenced recruitment in November 2006. Trial activities concluded in December 2011.

Bioniche recently established a wholly owned human health subsidiary, Bioniche Therapeutics. This will allow the parent to concentrate on its animal health and food safety operations.

Bioniche shares were trading unchanged at $0.23 as of around 10.30 am on Tuesday.