Phase 3 Daten und mögliche Zulassung in 3Q 2010 !!!

[Biotechmaster]

In den nächsten 4-6 Wochen sind mit den Urocidin (Blasenkrebs) PIII-Daten zurechnen was einer Kursexplosion zufolge haben könnte .

Schon 9 mal haben die Experten ( The Data Safety Monitoring Committee (DSMC) )in dieser ersten PIII Studie das OK für Urocidin gegeben was für mich ein gutes Zeichen ist .

Urocidin hat natürlich Blockbuster Potential und bei positiven Daten haben wir hier einen Multibagger .



Bioniche Life Science (BNC.TO)

Marktkap: 74,6 Mio $
Cash: 22 Mio $
Kurs: 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 .

[Biotechmaster]

Die Rally bis zu den ergebnissen hat gerade angefangen...
http://ih.advfn.com/p.php?pid=webchart&symbol=TSE:BNC&period=0&size=19&volume=1


Gute Nachrichten ..
http://finance.yahoo.com/news/Additional-Phase-III-clinical-cnw-2336203888.html?x=0&.v=1


Phase 3 daten kommen gegen ende September ..Was aber wichtig ist : Endo plant eine grössere und teure Phase 3 -Studie das würden die aber niemals tun wenn die aktuelle P3 Studie schlecht wäre .

Also ein super gutes Zeichen ...