FDA Decision & PIII Data in 3Q 2010..Excellent Opportunity

Discussion in 'Data Sets and Feeds' started by Biotechmaster, Aug 6, 2010.

  1. FDA approval for Econiche (E.coli Vaccine) & Urocidin (Bladder Cancer) Phase 3 results in 3Q 2010 !! Bioniche has tremendous upside Potential .Please do your own Homework.

    Bioniche Has The Potential To Become The Next 10-Bagger .Good Luck to All !!!!!!

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

    Market Cap: 74,6 Mio $
    Cash: 22 Mio $
    Price: 1,03 $

    Dundee Sec with Buy-Rating (June 2010)....

    Bioniche has three businesses with diversified risk/reward profiles:Animal Health, which is expected to generate around $28 million in salesin fiscal 2010; Human Health, with Phase 3 results expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety, with Canadian approval and a conditional license pending in theU.S. of a vaccine for reducing E. coli 0157 in cattle feces, and apipeline of other vaccines.

    Mr. Martin points out that Urocidin provides the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first of two planned Phase 3 trials has a moderate level ofrisk, as the refractory patients enrolled in the trial are a“tougher-to-treat” population than was enrolled in the Phase 2 trial, hesays.

    Mitigating the risk somewhat is the 20% “complete response” hurdlerequired 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 thatwas mainly relapsed but also included a few patients being treated forthe first time.

    A second planned Phase 3 trial will test Urocidin head-to-head againstthe current standard of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based on prior data, and superior safety and tolerability,” hepredicts.

    In 2009, Bioniche licensed Urocidin’s U.S. commercial rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global market opportunity for Urocidin in therefractory population could be $800 million. If the second Phase 3 trialexpands the Urocidin label to first-line treatment, the marketopportunity could grow to an estimated $2 billion.

    “Twenty-five percent penetration of this market would represent $500million in annual sales and an estimated $112.5 million in gross profitfor Bioniche,” Mr. Martin says .


    Bioniche to Get up to $130M in Urology Deal with Endo

    Crystal Research 18.02.2010

    Urocidin Potential New Treatment for Bladder Cancer

    Some Positive Signs ..

    UPDATE 1-Bioniche gets $6 mln milestone payment from Endo Pharma

    Bioniche obtains two additional milestones under licensing agreement with Endo

    All DMC (Data Monitoring Committee) are Positive !!!!

    Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green Light By DMC

    Only 105 patients in current PIII !!!!

    In November 2008,
    during a meeting of urologists in Santigo Chile, the biopharmaceutical research company presented positive clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years old) during the clinical studies noted excellent safety results .

    Upcoming Milestones 2010

    2009/2010 Conditional license for E. coli cattle vaccine in the U.S.

    2009/2010 Achievement of pre-commercialization milestone payments for

    2010 First U.S. sales of E. coli cattle vaccine

    2010 Results of refractory Phase III bladder cancer trial

    2011 Belleville, ON vaccine manufacturing centre operational


    Positive Phase3 results coming in september =Next Dendreon . Market cap of 84 mil$ is ridiculous .Bioniche (BNC.TO) will be a Billion-Dollar-Company within a Year .GLTA

    Trading FDA, Clinical Trial Binary Events:

    Bioniche Life Sciences (BNC.TO) (BNHLF.PK) announced plans with partner Endo Pharma (ENDP) to begin an additional Phase 3 study by year-end 2010 for UROCIDIN (a intravesical formulation of Mycobacterial Cell Wall-DNA Complex or MCC) and ENDP is expected to complete analysis by the end of September for 12-month data for a Phase 3 study conducted in patients with non-muscle-invasive bladder cancer refractory to current therapy.