TAKEDA , Challenges Ahead for its New European Presiden

Report Code: HC-R-17-158 | Page Numbers: 24

Post Nycomed and Millenium acquisition, the new leadership of non-Japanese CEO/President Mr. Weber will transform Takeda in a truly global Japanese company in the coming years. It is however important to see how he fulfills the Japanese expectation from these acquisitions and fills the gap for Takeda due to the recent failure of its key late stage pipeline candidates (TAK-875, TAK-700 in chemo experienced Prostate Cancer). From its remaining late stage pipeline candidates (Table 2) Vedolizumab, Contrave (Naltoxone + buproprion, obesity) and MLN-9708 (Ph III, Ixazomib, Multiple Myeloma) are important to drive its growth. Of the recent small to mid-sized consolidation activities in 2013 (Table 1), deals done with Natrogen (New-York, Natura alpha, IBD), Resolve therapeutics, and Inviragen demonstrate Takeda?s focused approach for selective therapy areas (GI Speciality, Autoimmune, Vaccines), while its deal with Arbor for out licensing EDARBI US rights reveals its decreasing focus on primary care therapy area for global market.Vortioxetine (Brintellix) - US launch for MDD Likely in Early 2014 - Competitive Enough Against Genericized MDD Market, Edivoxetine failure a moderate Positive- while development of Brexpiprazole looks a close competitor!.........Vedolizumab (MLN0002, UR, U...

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Post Nycomed and Millenium acquisition, the new leadership of non-Japanese CEO/President Mr. Weber will transform Takeda in a truly global Japanese company in the coming years. It is however important to see how he fulfills the Japanese expectation from these acquisitions and fills the gap for Takeda due to the recent failure of its key late stage pipeline candidates (TAK-875, TAK-700 in chemo experienced Prostate Cancer). From its remaining late stage pipeline candidates (Table 2) Vedolizumab, Contrave (Naltoxone + buproprion, obesity) and MLN-9708 (Ph III, Ixazomib, Multiple Myeloma) are important to drive its growth. Of the recent small to mid-sized consolidation activities in 2013 (Table 1), deals done with Natrogen (New-York, Natura alpha, IBD), Resolve therapeutics, and Inviragen demonstrate Takeda?s focused approach for selective therapy areas (GI Speciality, Autoimmune, Vaccines), while its deal with Arbor for out licensing EDARBI US rights reveals its decreasing focus on primary care therapy area for global market.Vortioxetine (Brintellix) - US launch for MDD Likely in Early 2014 - Competitive Enough Against Genericized MDD Market, Edivoxetine failure a moderate Positive- while development of Brexpiprazole looks a close competitor!.........Vedolizumab (MLN0002, UR, US/EU, vedolizumab, ?4?7 integrin inhibitor, Ulcerative colitis / Crohn?s disease) and MLN-9708 (PhIII, Multiple Myeloma) are the most promising late stage two key candidates: Vedolizumab approval in 2014 in UC/CD by mid 2014 is key to watch out for-MLN-9708/Velcade- Our View on Takeda?s Multiple Myeloma franchise-TAK-700 - Unable to demonstrate OS benefit in chemo experienced patients- What to expect in chemo na?ve pool and in earlier setting?- This 30 page detailed report on Takeda pharmaceuticals provide insightful analysis on its recent M & A activities and potential of late stage pipeline candidates based on their global competitive landscape
Takeda - Challenges Ahead for its New European President
Takeda - Key summary
EU New
products launch in near term get modest help from Nycomed presence while in long term
expected launch of vedolizumab and Natura alpha in IBD market will get big boost
Vortioxetine- US launch for MDD likely in Early 2014, Competitive enough against
genericized MDD market
? Edivoxetine failure a moderate positive
? Brexpriprazole clinical development needs a close watch
? Vortioxetine vs. currently available drugs
? Pipeline drugs ready to unfold in 2014 in major depressive disorder market
Vedolizumab approval and our expectation
? Vedolizumab different mechanism of action
? Vedolizumab does not carry the risk of developing PML as Tysabri although follows the
same pathway
? Ef?cacy comparable to currently available second line options
? Safety data looks impressive vs. currently approved drugs
? Competition from pipeline drugs
? Upcoming near term milestones in UC/CD indication
MLN-9708/Velcade- Our view on Takeda?s multiple myeloma franchise
? MLN-9708 in NDMM and RRMM
? Competitive landscape
? PhIII trial design
? Update post EHA and ASCO 2013
? Current treatment options NDMM and RRMM
? Velcade post launch of Kyprolis and Pomalyst
? Expected competition to Velcade in second/third line setting and upcoming milestones
before patent expiry (2017)
? Recent approvals of Kyprolis and Pomalyst in RRMM have set a new bar for ef?cacy
TAK-700 - Unable to demonstrate OS bene?t in chemo experienced patients- What to expect
in chemo na?ve pool and in earlier setting???
? Xtandi - the real bar in earlier setting
? Key Milestones to watch out for TAK-700 in 2014
? TAK-700 vs. Zytiga
Our view on Takeda?s other important growth drivers in 2014
? SYR-322 - Japan and US sales trend
? EDARBI- Outlicensing deal with Arbor pharma - a smart move
? Adcetris
Table 1: Deals done by Takeda in 2013
Table 2: Key late stage pipeline candidates- Expected launch and peak sales estimate
Table 3: Vortioxetine- Major depressive disorder- late stage pipeline
Chart 1: Anti-depressants - WW Competitive landscape
Table 4: Vortioxetine- Major depressive disorder- Early stage pipeline
Table 5: Vortioxetine- MDD - Drugs discontinued in the recent past
Table 6: Vortioxetine- Major Depressive disorder- Competitive landscape
Table 7: Vedolizumab- Pipeline leukocyte Traf?c inhibitor (Integrin inhibitor)
Table 8: Vedolizumab vs. Marketed Mab in Ulcerative colitis
Table 9: Vedolizumab vs. Marketed MAB in Crohn?s disease
Table 10: Vedolizumab Clinical trial Programme
Chart 2: MLN-9708 Trial design
Chart 3: Reported adverse events in clinical trials- MLN9708
Table 11: MLN 9708- Data Comparision- Newly diagnosed Multiple Myeloma
Table 12: MLN 9708- Data Comparision- Relapsed and refractory Multiple Myeloma
Table 13: TAK-700 Comparision of CY17 inhibitors pipeline drugs action on Androgen synthesis
Chart 4: TAK-700- Drugs acting through androgen pathway in Prostate cancer
Table 14: Key candidates of Antiandrogen therapy in Prostate Cancer
Chart 5: Nesina US prescription trend
Table 15: Key events expected in next year and our expectation on it
Post Nycomed and Millenium acquisition, the new leadership of non-Japanese CEO/President Mr. Weber will transform Takeda in a truly global Japanese company in the coming years. It is however important to see how he fulfills the Japanese expectation from these acquisitions and fills the gap for Takeda due to the recent failure of its key late stage pipeline candidates (TAK-875, TAK-700 in chemo experienced Prostate Cancer). From its remaining late stage pipeline candidates (Table 2) Vedolizumab, Contrave (Naltoxone + buproprion, obesity) and MLN-9708 (Ph III, Ixazomib, Multiple Myeloma) are important to drive its growth. Of the recent small to mid-sized consolidation activities in 2013 (Table 1), deals done with Natrogen (New-York, Natura alpha, IBD), Resolve therapeutics, and Inviragen demonstrate Takeda?s focused approach for selective therapy areas (GI Speciality, Autoimmune, Vaccines), while its deal with Arbor for out licensing EDARBI US rights reveals its decreasing focus on primary care therapy area for global market.Vortioxetine (Brintellix) - US launch for MDD Likely in Early 2014 - Competitive Enough Against Genericized MDD Market, Edivoxetine failure a moderate Positive- while development of Brexpiprazole looks a close competitor!.........Vedolizumab (MLN0002, UR, US/EU, vedolizumab, ?4?7 integrin inhibitor, Ulcerative colitis / Crohn?s disease) and MLN-9708 (PhIII, Multiple Myeloma) are the most promising late stage two key candidates: Vedolizumab approval in 2014 in UC/CD by mid 2014 is key to watch out for-MLN-9708/Velcade- Our View on Takeda?s Multiple Myeloma franchise-TAK-700 - Unable to demonstrate OS benefit in chemo experienced patients- What to expect in chemo na?ve pool and in earlier setting?- This 30 page detailed report on Takeda pharmaceuticals provide insightful analysis on its recent M & A activities and potential of late stage pipeline candidates based on their global competitive landscape

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