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Reports Corner

THERAPEUTIC CLASS OVERVIEW: NEWER ORAL ANTI ANDROGENS – EXPANDING ROLE IN
THE TREATMENT PARADIGM OF PROSTATE CANCER

RC
Description
Description
XTANDI (Enzalutamide) – Does it have potential to compete
against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) –
Ongoing Combination trials creates potential beyond Patent
Expiry In recent past approval and launch of various newer
treatment options like Xtandi (Enzalutamide, Astellas/Medivation),
Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), &
Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the
treatment paradigm of treating late stage prostate cancer.

www.reportscorner.com

Reports Corner
Brief Summary
Brief Summary
XTANDI (Enzalutamide) – Does it have potential to compete
against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) –
Ongoing Combination trials creates potential beyond Patent
Expiry In recent past approval and launch of various newer
treatment options like Xtandi (Enzalutamide, Astellas/Medivation),
Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), &
Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the
treatment paradigm of treating late stage prostate cancer. In
coming years, we expect this to repeat in early stage prostate
cancer treatment (nmCRPC, before Prostectomy) due to launch of
newer antiandrogens in this setting. Longer duration of therapy
and high prevalence makes this earlier setting market more
lucrative and bigger for newer options than late stage if they
succeed.

www.reportscorner.com

Reports Corner
Brief Summary
Brief Summary
In coming years, we expect second generation antiandrogens
(Androgen synthesis inhibitors/Androgen receptor inhibitors,
Xtandi, ARN-509, ODM-021, Zytiga, TAK-700, TOK-001) to replace
them and expand their use beyond current levels in nmCRPC (non
metastatic Castrate resistance Prostate cancer) patients and also
in pre-prostectomy (Chart 3). This newer agents will expand these
markets atleast by $10b ($6b in pre prostectomy, $4b nmCRPC) if
get success. TAK-700 (Takeda), ARN-509 (JNJ) and Xtandi are
strong candidates to get success in early stage prostate cancer
and in next two years PhIII clinical data from EL-04, PROSPER and
SPARTAN study, will decide who will lead this market. While TAK700 has a first launch advantage it is important to see how ARN509, compete to Xtandi in earlier setting and in terms of safety for
penetrating in early prostate cancer market. Other than these PhIII
studies, Xtandi PhII data from neoadjuvant PC and ARN-509 data
in preprostectomy patients will decide their use in earlier setting.
www.reportscorner.com

Reports Corner
Brief Summary
Brief Summary
We estimate $2.8b peak sales for Xtandi in mCRPC setting, while
in earlier setting it has potential to generate atleast ~$2b if it gets
success in PROSPER , STRIVE, TERRAIN and neoadjuvant study.

www.reportscorner.com

Reports Corner
Table of Contents
Table of Contents
Future role of Oral Antiandrogens in treatment of Prostate Cancer
o Current Role of Oral antiandrogen therapy and its limitations
o What changes are expected for oral antiandrogen therapy role in treatment of prostate
cancer based on ongoing clinical trials
 Oral Anti-androgens use in earlier setting
o WW Targeted Patient population and expected Market size expansion of Anti androgens
in each stage
o Ongoing early stage clinical trials of Antiandrogens and our view on its outcome
 Xtandi in neoadjuvant setting
 TAK-700 in early stage PC- Is TAK-700 would be the rst drug to be launched as rst line
therapy in combination with ADT in nmCRPC hormone naïve patients????
 Zytiga + Xtandi
 ARN-509- One stop solution for earlier setting?
 Zytiga + ARN-509- Tablet vs. Capsule formulation- how it will go further in clinical
development???
www.reportscorner.com

Reports Corner
Table of Contents
Table of Contents
o Prostate Cancer Stage wise Key upcoming Milestones of Antiandrogens
Xtandi: -How big it could be???
 Xtandi current prescription trend and its uptake
o Next important milestone- Xtandi approval in Pre chemo setting based on PREVAIL data
Our expectation
o Xtandi in Japan
o Xtandi in early stage prostate Cancer
o Xtandi ongoing clinical trials in Prostate Cancer and our view on each
 PROSPER Study – Do ARN-509 stands ahead in terms of clinical development in this
setting?
o Xtandi Competition , upcoming milestone and Market potential in each stage of prostate
cancer patients
Xtandi vs. Zytiga- Do Zytiga patent expiry is a Major threat for Xtandi???
 Zytiga Patent expiry – When to expect and Implications on Xtandi
 Ongoing clinical trials of Zytiga with Xtandi
www.reportscorner.com

Reports Corner
Table of Contents
Table of Contents
 New formulation under development for Zytiga/Xtandi
 Combination studies of Zytiga with other targeted therapy vs. combination study of
Xtandi with other targeted therapies, Ongoing Clinical trialsTable Of Contents: Therapeutic Class
Overview: Anti Androgens
TOC:
Anti Androgens
MP
Advisors
Therapeutic Class Overview: Table Of Contents: Anti Androgens/ 02
Pipeline Antiandrogens:
Androgen Receptor inhibitors: Who could be the major threat to Xtandi?
 ARN-509- A better Xtandi is in making
o Ongoing Clinical trials of ARN-509 and our expectations
o ARN-509- Clinical data comparison vs. Xtandi and other pipeline candidates
 ODM-201- Does its safety differentiate it against ARN-509/Xtandi?
www.reportscorner.com

Reports Corner
Table of Contents
Table of Contents
 Other pipeline Antiandrogens and our view –
o EPI-001
o AZD3514
o HE3232 (Apoptone)
o BMS-641988
Androgen Synthesis inhibitors: Do the pipeline candidates have potential to replace Zytiga?
 TAK-700- How it is different from Zytiga?
 TOK-001
Indirect near term key competitors to Zytiga/Xtandi in Post chemo setting:
 OGX-011

www.reportscorner.com

Reports Corner
For more information
For more information
For more information please visit our website
https://www.reportscorner.com/reports/37926/THERAPEUTIC-CLASS-OVERVIEW:NEWER-ORAL-ANTI-ANDROGENS-%E2%80%93-EXPANDING-ROLE-IN-THETREATMENT-PARADIGM-OF-PROSTATE-CANCER/

www.reportscorner.com

Reports Corner
RC

Thank You
Thank You

Contact us: contact@reportscorner.com
www.reportscorner.com

Reports Corner

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Therapeutic class overview newer oral anti androgens – expanding role in the treatment paradigm of prostate cancer - ReportsCorner

  • 1. Reports Corner THERAPEUTIC CLASS OVERVIEW: NEWER ORAL ANTI ANDROGENS – EXPANDING ROLE IN THE TREATMENT PARADIGM OF PROSTATE CANCER RC
  • 2. Description Description XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. www.reportscorner.com Reports Corner
  • 3. Brief Summary Brief Summary XTANDI (Enzalutamide) – Does it have potential to compete against ARN-509 in earlier setting?Zytiga (Abiraterone Acetate) – Ongoing Combination trials creates potential beyond Patent Expiry In recent past approval and launch of various newer treatment options like Xtandi (Enzalutamide, Astellas/Medivation), Zytiga (Abiraterone acetate, JNJ), Jevtana (Cabazitaxel, Sanofi), & Xofigo (radium Ra 223, Boehringer Ingelheim) has evolved the treatment paradigm of treating late stage prostate cancer. In coming years, we expect this to repeat in early stage prostate cancer treatment (nmCRPC, before Prostectomy) due to launch of newer antiandrogens in this setting. Longer duration of therapy and high prevalence makes this earlier setting market more lucrative and bigger for newer options than late stage if they succeed. www.reportscorner.com Reports Corner
  • 4. Brief Summary Brief Summary In coming years, we expect second generation antiandrogens (Androgen synthesis inhibitors/Androgen receptor inhibitors, Xtandi, ARN-509, ODM-021, Zytiga, TAK-700, TOK-001) to replace them and expand their use beyond current levels in nmCRPC (non metastatic Castrate resistance Prostate cancer) patients and also in pre-prostectomy (Chart 3). This newer agents will expand these markets atleast by $10b ($6b in pre prostectomy, $4b nmCRPC) if get success. TAK-700 (Takeda), ARN-509 (JNJ) and Xtandi are strong candidates to get success in early stage prostate cancer and in next two years PhIII clinical data from EL-04, PROSPER and SPARTAN study, will decide who will lead this market. While TAK700 has a first launch advantage it is important to see how ARN509, compete to Xtandi in earlier setting and in terms of safety for penetrating in early prostate cancer market. Other than these PhIII studies, Xtandi PhII data from neoadjuvant PC and ARN-509 data in preprostectomy patients will decide their use in earlier setting. www.reportscorner.com Reports Corner
  • 5. Brief Summary Brief Summary We estimate $2.8b peak sales for Xtandi in mCRPC setting, while in earlier setting it has potential to generate atleast ~$2b if it gets success in PROSPER , STRIVE, TERRAIN and neoadjuvant study. www.reportscorner.com Reports Corner
  • 6. Table of Contents Table of Contents Future role of Oral Antiandrogens in treatment of Prostate Cancer o Current Role of Oral antiandrogen therapy and its limitations o What changes are expected for oral antiandrogen therapy role in treatment of prostate cancer based on ongoing clinical trials  Oral Anti-androgens use in earlier setting o WW Targeted Patient population and expected Market size expansion of Anti androgens in each stage o Ongoing early stage clinical trials of Antiandrogens and our view on its outcome  Xtandi in neoadjuvant setting  TAK-700 in early stage PC- Is TAK-700 would be the rst drug to be launched as rst line therapy in combination with ADT in nmCRPC hormone naïve patients????  Zytiga + Xtandi  ARN-509- One stop solution for earlier setting?  Zytiga + ARN-509- Tablet vs. Capsule formulation- how it will go further in clinical development??? www.reportscorner.com Reports Corner
  • 7. Table of Contents Table of Contents o Prostate Cancer Stage wise Key upcoming Milestones of Antiandrogens Xtandi: -How big it could be???  Xtandi current prescription trend and its uptake o Next important milestone- Xtandi approval in Pre chemo setting based on PREVAIL data Our expectation o Xtandi in Japan o Xtandi in early stage prostate Cancer o Xtandi ongoing clinical trials in Prostate Cancer and our view on each  PROSPER Study – Do ARN-509 stands ahead in terms of clinical development in this setting? o Xtandi Competition , upcoming milestone and Market potential in each stage of prostate cancer patients Xtandi vs. Zytiga- Do Zytiga patent expiry is a Major threat for Xtandi???  Zytiga Patent expiry – When to expect and Implications on Xtandi  Ongoing clinical trials of Zytiga with Xtandi www.reportscorner.com Reports Corner
  • 8. Table of Contents Table of Contents  New formulation under development for Zytiga/Xtandi  Combination studies of Zytiga with other targeted therapy vs. combination study of Xtandi with other targeted therapies, Ongoing Clinical trialsTable Of Contents: Therapeutic Class Overview: Anti Androgens TOC: Anti Androgens MP Advisors Therapeutic Class Overview: Table Of Contents: Anti Androgens/ 02 Pipeline Antiandrogens: Androgen Receptor inhibitors: Who could be the major threat to Xtandi?  ARN-509- A better Xtandi is in making o Ongoing Clinical trials of ARN-509 and our expectations o ARN-509- Clinical data comparison vs. Xtandi and other pipeline candidates  ODM-201- Does its safety differentiate it against ARN-509/Xtandi? www.reportscorner.com Reports Corner
  • 9. Table of Contents Table of Contents  Other pipeline Antiandrogens and our view – o EPI-001 o AZD3514 o HE3232 (Apoptone) o BMS-641988 Androgen Synthesis inhibitors: Do the pipeline candidates have potential to replace Zytiga?  TAK-700- How it is different from Zytiga?  TOK-001 Indirect near term key competitors to Zytiga/Xtandi in Post chemo setting:  OGX-011 www.reportscorner.com Reports Corner
  • 10. For more information For more information For more information please visit our website https://www.reportscorner.com/reports/37926/THERAPEUTIC-CLASS-OVERVIEW:NEWER-ORAL-ANTI-ANDROGENS-%E2%80%93-EXPANDING-ROLE-IN-THETREATMENT-PARADIGM-OF-PROSTATE-CANCER/ www.reportscorner.com Reports Corner
  • 11. RC Thank You Thank You Contact us: contact@reportscorner.com www.reportscorner.com Reports Corner