Endo Pharmaceuticals (Endo), a subsidiary of Endo Health Solutions has returned Urocidin global rights to Bioniche Life Sciences Inc. In exchange for this mutually favourable path forward for the product, Endo will receive a royalty on future revenue.

On November 5, it was announced that a second phase III clinical trial with Urocidin in non-muscle-invasive bladder cancer being run by Endo was being discontinued. The trial, a randomized, active-controlled, open-label, multi-center study, was designed to compare Urocidin with mitomycin C in the intravesical treatment of patients with BCG recurrent or refractory non-muscle-invasive bladder cancer. The trial was not recruiting at the expected rate and, after discussions with the US Food and Drug Administration (FDA) regarding the clinical trial design, Endo decided to end the trial before its scheduled completion. As a result of this decision, the two companies came to an agreement that a mutually favourable path forward for the product is to return global rights to Bioniche.

"This is a tremendous opportunity for us," said Graeme McRae, president & CEO of Bioniche Life Sciences Inc. "With control of the development programme in our hands, we can build on the results of our first phase III clinical trial with Urocidin by working with regulators to assess the best path forward, including exploring a Canadian regulatory submission under Health Canada's Notice of Compliance with Conditions policy, which could result in early access to the Canadian market for Urocidin."

The Company also now has the opportunity to seek alternate partnership arrangements, which would be expected to generate income to offset the costs of any additional clinical trial work required.

"We remain committed to the successful commercialisation of Urocidin, which we believe is an important and much-needed therapy for those suffering from non-muscle-invasive bladder cancer," added McRae.

Bladder cancer is the fourth most common cancer in men and the twelveth most common cancer in women in North America. The prevalence of non-muscle-invasive bladder cancer is ten times its incidence and creates a major economic burden on healthcare systems. As measured on the basis of cumulative per patient cost from the time of diagnosis until death, bladder cancer is the most expensive cancer to treat.

Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.

Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.

The Company's first Phase III trial was a 129-patient open label, single-arm trial, meaning there was no comparator therapy used in the trial. The trial was designed to assess the safety and efficacy of Urocidin as a treatment of non-muscle-invasive bladder cancer in patients whose cancer had not responded positively to prior treatment with BCG therapy. This trial enrolled its first patient in November, 2006 and the last patient was enrolled in April, 2009.

Preliminary results, reported at urology association meetings in March, May and June, 2011, showed that, after 12 months, there was a 25% overall disease-free survival rate and the product was well-tolerated by patients with most adverse events considered "mild to moderate".