Thread: Phase III Data in July = Next Dendreon !!!

Urocidin (Bladder Cancer) Phase III Results within 4 Weeks .Lots will want this goldmine in the future. Please do your own Homework .

Bioniche Life Science (BNC.TO) or (BNHLF.PK) Canadian Stock !!!

Market Cap: 75 Mio $
Cash: 22 Mio $
Price: 1,03 $


Buy rating by Dundee Sec (June 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 *****, 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 (ENDP 22.13 ?1.10%) (NASDAQ:ENDP). 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.