市場調査レポート

治療クラスの概要:新しい経口抗アンドロゲン剤 - 前立腺がんの治療パラダイムにおける役割の拡大

Newer Oral Anti Androgens - Expanding Role in the treatment Paradigm of Prostate Cancer

発行 MP Advisors 商品コード 296614
出版日 ページ情報 英文 44 Pages
納期: 即日から翌営業日
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治療クラスの概要:新しい経口抗アンドロゲン剤 - 前立腺がんの治療パラダイムにおける役割の拡大 Newer Oral Anti Androgens - Expanding Role in the treatment Paradigm of Prostate Cancer
出版日: 2014年02月25日 ページ情報: 英文 44 Pages
概要

Xtandi(エンザルタミド、/Astellas/Medivation)、 Zytiga (酢酸アビラテロン、JNJ)、Jevtana (Cabazitaxel、Sanofi)、およびXofigo(塩化ラジウム(Ra-223)、Boehringer Ingelheim)など、近年の様々な新しい治療薬の認可・発売は、後期段階の前立腺癌を扱う治療パラダイムを発展させています。このことは同様に、新たな抗アンドロゲン剤の発売によって、早期段階の前立腺癌治療においても繰り返されることが期待されています。

当レポートでは、前立腺がん治療に用いられる新しい経口抗アンドロゲン剤について調査し、現在の経口アンドロゲン剤治療の役割と限界、市場規模、現在の治験動向、開発中の製剤、および主な競合薬剤などに関する分析を提供しており、概略下記の構成でお届けいたします。

エグゼクティブサマリー

前立腺がんの治療における経口抗アンドロゲン剤の将来の役割

  • 経口抗アンドロゲン剤治療における現在の役割とその限界
  • 現行の治験に基づいた前立腺癌の治療における経口アンドロゲン剤治療の役割に予測される変化
    • 早い段階での経口アンドロゲン剤の使用
  • 世界のターゲット患者人口および各段階における抗アンドロゲン剤の予測される市場規模
  • 現行の抗アンドロゲン剤の早期段階の治験とその転帰に関する当社の見解
  • 前立腺がん段階別による抗アンドロゲン剤の近い将来の画期的出来事

Xtandi (エンザルタミド):どのくらいの規模か?

  • Xtandiの現在の処方動向とその利用

Xtandi vs. Zytiga(酢酸アビラテロン):Zytigaの特許満了はXtandiにとって大きな脅威か?

  • Zytigaの特許切れ:いつになるか、またXtandiへの影響
  • XtandiとZytigaの現行の治験
  • Zytiga/Xtandi 向けに開発中の新しい処方
  • Zytigaとその他の標的療法の共同研究 vs. Xtandi とその他の標的療法の共同研究、現行の治験

パイプライン抗アンドロゲン剤

アンドロゲン受容体阻害剤:Xtandiの大きな脅威となるのはどれか?

  • ARN-509
  • ODM-201
  • その他のパイプライン抗アンドロゲン剤および当社の見解
    • EPI-001
    • AZD3514
    • HE3232 (Apoptone)
    • BMS-641988

アンドロゲン合成阻害剤:パイプライン候補薬はZytigaに取って代わる可能性があるか?

  • TAK-700:Zytigaとの違いは?
  • TOK-001

ポスト化学療法環境におけるZytiga/Xtandi の間接的・短期的な主要競合薬

  • OGX-011
目次
Product Code: TC14022101

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.

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 TAK-700 has a first launch advantage it is important to see how ARN-509, 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. 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.

Table of Contents

Executive Summary

Future role of Oral Antiandrogens in treatment of Prostate Cancer

  • Current Role of Oral antiandrogen therapy and its limitations
  • 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
  • WW Targeted Patient population and expected Market size expansion of Anti androgens in each stage
  • 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 first drug to be launched as first 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???
  • Prostate Cancer Stage wise Key upcoming Milestones of Antiandrogens

Xtandi: -How big it could be???

  • Xtandi current prescription trend and its uptake
    • Next important milestone- Xtandi approval in Pre chemo setting based on PREVAIL data Our expectation
    • Xtandi in Japan
    • Xtandi in early stage prostate Cancer
    • 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?
    • 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
  • 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 trials

Pipeline Antiandrogens:

Androgen Receptor inhibitors: Who could be the major threat to Xtandi?

  • ARN-509- A better Xtandi is in making
    • Ongoing Clinical trials of ARN-509 and our expectations
    • ARN-509- Clinical data comparison vs. Xtandi and other pipeline candidates
  • ODM-201- Does its safety differentiate it against ARN-509/Xtandi?
  • Other pipeline Antiandrogens and our view -
    • EPI-001
    • AZD3514
    • HE3232 (Apoptone)
    • 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
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