Biotechmaster
09.08.2010, 12:39
In den nächsten (http://www.spekunauten.de/wort/n%C3%A4chsten) 4-6 Wochen (http://www.spekunauten.de/wort/Wochen) sind mit den Urocidin (Blasenkrebs) PIII-Daten zurechnen was einer Kursexplosion zufolge (http://www.spekunauten.de/wort/zufolge) haben könnte .
Die US-Zulassung für das E.coli Vaccine soll auch noch im 3Q statt (http://www.spekunauten.de/wort/statt) finden ein genauer (http://www.spekunauten.de/wort/genauer) termin steht nicht fest .
Letztes jahr hatte Endo zunächst (http://www.spekunauten.de/wort/zun%C3%A4chst) die US-Rechte an Urocidin übernommen (http://www.spekunauten.de/wort/%C3%BCbernommen) mit der option (http://www.spekunauten.de/wort/option) auf Weltweit (http://www.spekunauten.de/wort/Weltweit) zu erweitern (http://www.spekunauten.de/wort/erweitern) (1 Jahr frist) ,halbes jahr vor Ablauf der frist (http://www.spekunauten.de/wort/frist) (gutes Zeichen) hat Endo die option ausgeübt .
Urocidin hat natürlich Blockbuster Potential (http://www.spekunauten.de/wort/Potential) und bei positiven (http://www.spekunauten.de/wort/positiven) Daten (http://www.spekunauten.de/wort/Daten) haben wir hier einen Multibagger .
Bioniche Life Science (BNC.TO)
Marktkap: 79 Mio $
Cash: 22 Mio $
Kurs: 1,09 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three (http://www.spekunauten.de/wort/three) businesses with diversified risk/reward profiles:Animal Health, which (http://www.spekunauten.de/wort/which) is expected to generate around (http://www.spekunauten.de/wort/around) $28 million (http://www.spekunauten.de/wort/million) in salesin fiscal (http://www.spekunauten.de/wort/fiscal) 2010; Human Health, with Phase (http://www.spekunauten.de/wort/Phase) 3 results (http://www.spekunauten.de/wort/results) expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety, with Canadian (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/other) vaccines.
Mr. Martin points out that Urocidin provides (http://www.spekunauten.de/wort/provides) the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first (http://www.spekunauten.de/wort/first) of two planned (http://www.spekunauten.de/wort/planned) Phase 3 trials has a moderate level (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/weeks) in a population thatwas mainly relapsed but also included (http://www.spekunauten.de/wort/included) a few patients being (http://www.spekunauten.de/wort/being) treated forthe first time.
A second (http://www.spekunauten.de/wort/second) planned Phase 3 trial will test Urocidin head-to-head againstthe current (http://www.spekunauten.de/wort/current) standard (http://www.spekunauten.de/wort/standard) of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based (http://www.spekunauten.de/wort/based) on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial (http://www.spekunauten.de/wort/commercial) rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global (http://www.spekunauten.de/wort/global) market (http://www.spekunauten.de/wort/market) opportunity (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/estimated) $2 billion.
“Twenty-five percent (http://www.spekunauten.de/wort/percent) penetration of this market would (http://www.spekunauten.de/wort/would) represent $500million in annual (http://www.spekunauten.de/wort/annual) sales (http://www.spekunauten.de/wort/sales) and an estimated $112.5 million in gross (http://www.spekunauten.de/wort/gross) profitfor Bioniche,” Mr. Martin says .
--------------------------------------
Hier ein paar Zeichen (http://www.spekunauten.de/wort/Zeichen) die für gute Daten sprechen (http://www.spekunauten.de/wort/sprechen) ...
UPDATE 1-Bioniche gets $6 mln milestone payment (http://www.spekunauten.de/wort/payment) from Endo Pharma (http://www.spekunauten.de/wort/Pharma)
http://www.reuters.com/article/idUSBNG43432420091106
---
Bioniche obtains two additional (http://www.spekunauten.de/wort/additional) milestones under (http://www.spekunauten.de/wort/under) licensing agreement (http://www.spekunauten.de/wort/agreement) with Endo
http://www.tradingmarkets.com/news/stock-alert/bnhlf_endp_bioniche-obtains-two-additional-milestones-under-licensing-agreement-with-endo-777521.html
--
Alle DMC (Data Monitoring Committee) meetings waren (http://www.spekunauten.de/wort/waren) Positiv (http://www.spekunauten.de/wort/Positiv) !!!!
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green (http://www.spekunauten.de/wort/Green) Light By DMC
http://www.medicalnewstoday.com/articles/161677.php
In der aktuellen (http://www.spekunauten.de/wort/aktuellen) PIII-Studie befinden (http://www.spekunauten.de/wort/befinden) sich nur 105 Patienten (http://www.spekunauten.de/wort/Patienten) damit sind die Chancen (http://www.spekunauten.de/wort/Chancen) hoch für gute Ergebnisse (http://www.spekunauten.de/wort/Ergebnisse) !!!!
In November (http://www.spekunauten.de/wort/November) 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research (http://www.spekunauten.de/wort/research) company (http://www.spekunauten.de/wort/company) presented positive (http://www.spekunauten.de/wort/positive) clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years (http://www.spekunauten.de/wort/years) old) during the clinical studies noted excellent safety results .
Bioniche to Get up to $130M in Urology Deal with Endo
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70
Die US-Zulassung für das E.coli Vaccine soll auch noch im 3Q statt (http://www.spekunauten.de/wort/statt) finden ein genauer (http://www.spekunauten.de/wort/genauer) termin steht nicht fest .
Letztes jahr hatte Endo zunächst (http://www.spekunauten.de/wort/zun%C3%A4chst) die US-Rechte an Urocidin übernommen (http://www.spekunauten.de/wort/%C3%BCbernommen) mit der option (http://www.spekunauten.de/wort/option) auf Weltweit (http://www.spekunauten.de/wort/Weltweit) zu erweitern (http://www.spekunauten.de/wort/erweitern) (1 Jahr frist) ,halbes jahr vor Ablauf der frist (http://www.spekunauten.de/wort/frist) (gutes Zeichen) hat Endo die option ausgeübt .
Urocidin hat natürlich Blockbuster Potential (http://www.spekunauten.de/wort/Potential) und bei positiven (http://www.spekunauten.de/wort/positiven) Daten (http://www.spekunauten.de/wort/Daten) haben wir hier einen Multibagger .
Bioniche Life Science (BNC.TO)
Marktkap: 79 Mio $
Cash: 22 Mio $
Kurs: 1,09 $
Dundee Sec with Buy-Rating (June 2010)....
Bioniche has three (http://www.spekunauten.de/wort/three) businesses with diversified risk/reward profiles:Animal Health, which (http://www.spekunauten.de/wort/which) is expected to generate around (http://www.spekunauten.de/wort/around) $28 million (http://www.spekunauten.de/wort/million) in salesin fiscal (http://www.spekunauten.de/wort/fiscal) 2010; Human Health, with Phase (http://www.spekunauten.de/wort/Phase) 3 results (http://www.spekunauten.de/wort/results) expected in mid-2010from lead product, Urocidin, testing for bladder cancer; and FoodSafety, with Canadian (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/other) vaccines.
Mr. Martin points out that Urocidin provides (http://www.spekunauten.de/wort/provides) the “biggest upsidepotential” for Bioniche investors. His initial diligence suggests thatUrocidin has a “relatively high overall probability of approval,” eventhough the first (http://www.spekunauten.de/wort/first) of two planned (http://www.spekunauten.de/wort/planned) Phase 3 trials has a moderate level (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/weeks) in a population thatwas mainly relapsed but also included (http://www.spekunauten.de/wort/included) a few patients being (http://www.spekunauten.de/wort/being) treated forthe first time.
A second (http://www.spekunauten.de/wort/second) planned Phase 3 trial will test Urocidin head-to-head againstthe current (http://www.spekunauten.de/wort/current) standard (http://www.spekunauten.de/wort/standard) of care, baccilus Calmette-Guerin (BCG) infirst-line treatment, “where we expect Urocidin to demonstrate betterefficacy, based (http://www.spekunauten.de/wort/based) on prior data, and superior safety and tolerability,” hepredicts.
In 2009, Bioniche licensed Urocidin’s U.S. commercial (http://www.spekunauten.de/wort/commercial) rights to EndoPharmaceuticals. Based on incidence of bladder cancer and possiblepricing, he figures the global (http://www.spekunauten.de/wort/global) market (http://www.spekunauten.de/wort/market) opportunity (http://www.spekunauten.de/wort/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 (http://www.spekunauten.de/wort/estimated) $2 billion.
“Twenty-five percent (http://www.spekunauten.de/wort/percent) penetration of this market would (http://www.spekunauten.de/wort/would) represent $500million in annual (http://www.spekunauten.de/wort/annual) sales (http://www.spekunauten.de/wort/sales) and an estimated $112.5 million in gross (http://www.spekunauten.de/wort/gross) profitfor Bioniche,” Mr. Martin says .
--------------------------------------
Hier ein paar Zeichen (http://www.spekunauten.de/wort/Zeichen) die für gute Daten sprechen (http://www.spekunauten.de/wort/sprechen) ...
UPDATE 1-Bioniche gets $6 mln milestone payment (http://www.spekunauten.de/wort/payment) from Endo Pharma (http://www.spekunauten.de/wort/Pharma)
http://www.reuters.com/article/idUSBNG43432420091106
---
Bioniche obtains two additional (http://www.spekunauten.de/wort/additional) milestones under (http://www.spekunauten.de/wort/under) licensing agreement (http://www.spekunauten.de/wort/agreement) with Endo
http://www.tradingmarkets.com/news/stock-alert/bnhlf_endp_bioniche-obtains-two-additional-milestones-under-licensing-agreement-with-endo-777521.html
--
Alle DMC (Data Monitoring Committee) meetings waren (http://www.spekunauten.de/wort/waren) Positiv (http://www.spekunauten.de/wort/Positiv) !!!!
Bioniche Phase III Clinical Trial With Urocidin(TM) Given Continued Green (http://www.spekunauten.de/wort/Green) Light By DMC
http://www.medicalnewstoday.com/articles/161677.php
In der aktuellen (http://www.spekunauten.de/wort/aktuellen) PIII-Studie befinden (http://www.spekunauten.de/wort/befinden) sich nur 105 Patienten (http://www.spekunauten.de/wort/Patienten) damit sind die Chancen (http://www.spekunauten.de/wort/Chancen) hoch für gute Ergebnisse (http://www.spekunauten.de/wort/Ergebnisse) !!!!
In November (http://www.spekunauten.de/wort/November) 2008,
during a meeting of urologists in Santigo Chile, the biopharmaceutical research (http://www.spekunauten.de/wort/research) company (http://www.spekunauten.de/wort/company) presented positive (http://www.spekunauten.de/wort/positive) clinical studies (one and two) involving 130 bladder cancer patients treated with Urocidin. Elderly patients (average 73 years (http://www.spekunauten.de/wort/years) old) during the clinical studies noted excellent safety results .
Bioniche to Get up to $130M in Urology Deal with Endo
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51437
Crystal Research 18.02.2010
http://www.crystalra.com/pdf/BNC_2QFY10_Update_02-18-10.pdf
Urocidin Potential New Treatment for Bladder Cancer
http://www.associatedcontent.com/article/1939454/urocidin_potential_new_treatment_for_pg3.html?cat=70