Urocidin (Blasenkrebs) Phase III-Ergebnisse in ca 4 Wochen ..Falls Positiv sind schnell Kurse über 5$ drin .
Bioniche Life Science (BNC.TO)
Marktkap: 72 Mio $
Cash: 22 Mio $
Kurs: 0,97 $
Dundee Sec Juni 2010
Bioniche has three businesses with diversified risk/reward profiles: Animal Health, which is expected to generate around $28 million in sales in fiscal 2010; Human Health, with Phase 3 results expected in mid-2010 from lead product, Urocidin, testing for bladder cancer; and Food Safety, with Canadian approval and a conditional license pending in the U.S. of a vaccine for reducing E. coli 0157 in cattle feces, and a pipeline of other vaccines.
Mr. Martin points out that Urocidin provides the “biggest upside potential” for Bioniche investors. His initial diligence suggests that Urocidin has a “relatively high overall probability of approval,” even though the first of two planned Phase 3 trials has a moderate level of risk, as the refractory patients enrolled in the trial are a “tougher-to-treat” population than was enrolled in the Phase 2 trial, he says.
Mitigating the risk somewhat is the 20% “complete response” hurdle required for Phase 3. That compares with the company’s Phase 2 results, where patients achieved a 46.4% CR rate at 26 weeks in a population that was mainly relapsed but also included a few patients being treated for the first time.
A second planned Phase 3 trial will test Urocidin head-to-head against the current standard of care, baccilus Calmette-Guerin (BCG) in first-line treatment, “where we expect Urocidin to demonstrate better efficacy, based on prior data, and superior safety and tolerability,” he predicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to Endo Pharmaceuticals. Based on incidence of bladder cancer and possible pricing, he figures the global market opportunity for Urocidin in the refractory population could be $800 million. If the second Phase 3 trial expands the Urocidin label to first-line treatment, the market opportunity could grow to an estimated $2 billion.
“Twenty-five percent penetration of this market would represent $500 million in annual sales and an estimated $112.5 million in gross profit for Bioniche,” Mr. Martin says