Product Profiles: Prostate Cancer - Recent Approvals Create Competitive Environment for New Market Entrants
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Androgen deprivation therapies (ADTs) are the main treatment type for hormone-sensitive prostate cancer. As the disease is hormonally fuelled, chemical castration provides adequate disease control for a number of years. The greatest level of unmet need exists for castrate-resistant patients. There are currently nine drugs in development for this disease stage. In-depth analysis of the prostate cancer pipeline – drug profiles, product positioning and clinical and commercial attractiveness of pipeline drugs. Overview of key events leading to Taxotere (docetaxel; Sanofi) becoming the standard of care for metastatic castrate-resistant prostate cancer. Discussion of key marketed drugs for prostate cancer and attributes differentiating them. Review of current therapies and their ability to fulfill unmet needs compared to the current standard of care, Taxotere (docetaxel; Sanofi).Developers will face strong competition from recently approved therapies. These newly approved therapies must now be sequenced in order for patients to receive the most appropriate treatment. Toxicity is a major consideration for older patients with advanced stages of disease. Choice of therapy must consider toxicity rates in addition to other patient specifics. The older age of the prostate cancer population (with an average diagnosis age of 68) limits the number of treatments prostate cancer patients are able to tolerate. Any potential new therapies for metastatic castrate-resistant prostate cancer must show clinical benefits equal to or superior than the three recently approved therapies and the current standard of care, Taxotere (docetaxel; Sanofi) to maximize commercial success and penetrate the prostate cancer market. Understand how the dynamics of prostate cancer treatment are changing as a result of emerging therapies. Analyze targets for pipeline drugs in development, assessing how these may be achieved through well designed clinical trialing. Compare and contextualize pipeline drugs through reviewing clinical data and comparing to drugs already on the market.
OVERVIEW
•Catalyst
•Summary
EXECUTIVE SUMMARY
•Strategic scoping and focus
•Datamonitor key findings
•Related reports
PRODUCT OVERVIEW
•Product overview
MARKETED PRODUCT PROFILES: ANDROGEN BIOSYNTHESIS INHIBITORS
•Zytiga (abiraterone acetate; Johnson & Johnson)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
MARKETED PRODUCT PROFILES: IMMUNOTHERAPIES
•Provenge (Sipuleucel-T; Dendreon/Kyowa Hakko Kirin/Immune Response)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
MARKETED PRODUCT PROFILES: CYTOTOXICS
•Jevtana (cabazitaxel; Sanofi)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
•Taxotere (docetaxel; Sanofi)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
MARKETED PRODUCT PROFILES: GNRH ANALOGS
•Lupron (leuprolide acetate; Takeda/Abbott)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
MARKETED PRODUCT PROFILES: ANTI-ANDROGENS
•Casodex (bicalutamide; AstraZeneca)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
•Nilandron (nilutamide; Sanofi/Astellas)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
•Eulexin (flutamide; Merck & Co. /Nippon Kayaku)
- Drug profile
- Development overview
- SWOT analysis
- Product positioning
- Clinical and commercial attractiveness
PIPELINE PRODUCT PROFILES
•Avastin (bevacizumab; Genentech/Roche/Chugai)
- Drug profile
- Development overview
- Clinical and commercial attractiveness
•DCVax-prostate (Northwest Biotherapeutics)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•MDV3100 (Medivation/Astellas)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
- Datamonitor drug assessment summary for MDV3100
•Orteronel (TAK-700; Takeda)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•Revlimid (lenalidomide; Celgene)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•Sprycel (dasatinib; Bristol-Myers Squibb/Otsuka)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•TASQ (tasquinimod; Active Biotech/Ipsen)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•Yervoy (ipilimumab; Medarex/Bristol-Myers Squibb)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•Zaltrap (aflibercept/VEGF-Trap; Regeneron/Sanofi)
- Drug Profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
•Zibotentan (ZD-4054; AstraZeneca)
- Drug profile
- Development overview
- SWOT analysis
- Satisfaction of unmet needs
- Clinical and commercial attractiveness
BIBLIOGRAPHY
•Journal papers
•Websites
•Datamonitor reports
•Other
APPENDIX
•Market definition
•PharmaVitae Explorer database
•Contributing experts
•Conferences attended
•Report methodology
TABLES
•Table: Key marketed products for prostate cancer, 2011
•Table: Key pipeline products for prostate cancer, 2011
•Table: Zytiga – drug profile , 2011
•Table: Pivotal clinical trial summary for Zytiga in prostate cancer, 2011
•Table: Datamonitor's drug assessment summary of Zytiga for prostate cancer, 2011
•Table: Provenge – drug profile, 2011
•Table: Overview of pivotal trial data for Provenge in prostate cancer
•Table: Datamonitor's drug assessment summary of Provenge (sipuleucel-T; Dendreon/Kyowa Hakko Kirin/Immune Response) for prostate cancer, 2011
•Table: Jevtana – drug profile, 2011
•Table: Overview of TROPIC trial data for Jevtana in prostate cancer, 2011
•Table: Datamonitor's drug assessment summary of Jevtana (cabazitaxel; Sanofi) for prostate cancer, 2011
•Table: Taxotere – drug profile, 2011
•Table: Overview of SWOG 9916 and TAX 327 trials of Taxotere in CRPC
•Table: Datamonitor's drug assessment summary of Taxotere (docetaxel; Sanofi) for prostate cancer, 2011
•Table: Lupron – drug profile, 2010
•Table: Overview of pivotal trial data for Lupron depot 3 month 40mg
•Table: Datamonitor's drug assessment summary of Lupron (leuprolide acetate; Takeda/Astellas) for prostate cancer, 2011
•Table: Casodex – drug profile, 2011
•Table: Overview of pivotal trial data for Casodex in prostate cancer
•Table: Datamonitor's drug assessment summary of Casodex (bicalutamide; AstraZeneca) for prostate cancer, 2011
•Table: Main factors impacting on Casodex revenue
•Table: Nilandron – drug profile, 2011
•Table: Overview of pivotal trial data for Nilandron in prostate cancer
•Table: Datamonitor's drug assessment summary of Nilandron (nilutamide; Sanofi/Astellas) for prostate cancer, 2011
•Table: Eulexin – drug profile, 2011
•Table: Overview of pivotal trial data for Eulexin in prostate cancer
•Table: Datamonitor's drug assessment summary of Nilandron (flutamide; Merck & Co./Nippon Kayaku) for prostate cancer, 2011
•Table: Avastin – drug profile , 2011
•Table: Clinical trial summary for Avastin in prostate cancer, 2011
•Table: CALGB 90401 trial design for Avastin in metastatic, castrate-resistant prostate cancer patients
•Table: CALGB 90401 trial results for Avastin in metastatic, castrate-resistant prostate cancer patients
•Table: Docetaxel versus docetaxel plus Avastin in progressive castrate-resistant prostate cancer following first-line docetaxel
•Table: DCVax-prostate – drug profile , 2011
•Table: Clinical trial summary for DCVax-prostate in prostate cancer, 2011
•Table: DCVax-prostate versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: MDV3100 – drug profile, 2011
•Table: Clinical trial summary for MDV3100 in prostate cancer, 2011
•Table: Pivotal Phase III PREVAIL and AFFIRM trials for MDV3100 in prostate cancer
•Table: Long-term follow up results for MDV3100 in advanced prostate cancer
•Table: MDV3100 versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of MDV3100 (Medivation/Astellas) for prostate cancer, 2011
•Table: Orteronel – drug profile, 2011
•Table: Clinical trial summary for Orteronel in prostate cancer, 2011
•Table: Orteronel versus second-line comparator therapy carboplatin for the treatment of metastatic castrate-resistant prostate cancer after docetaxel failure
•Table: Datamonitor drug assessment summary of Orteronel (TAK-700; Takeda) for prostate cancer, 2011
•Table: Revlimid – drug profile, 2010
•Table: Clinical trial summary for Revlimid in prostate cancer, 2011
•Table: Revlimid versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of Revlimid (lenalidomide; Celgene) for prostate cancer, 2011
•Table: Sprycel – drug profile , 2011
•Table: Clinical trial summary for Sprycel (dasatinib) in prostate cancer, 2011
•Table: Sprycel versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of Sprycel (dasatinib; Bristol-Myers Squibb) for prostate cancer, 2011
•Table: TASQ– drug profile, 2011
•Table: Clinical trial summary for TASQ in prostate cancer, 2011
•Table: TASQ versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of TASQ (tasquinimod; Active Biotech/Ipsen) for prostate cancer, 2011
•Table: Yervoy – drug profile, 2011
•Table: Clinical trial summary for Yervoy in prostate cancer, 2011
•Table: Yervoy versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of Yervoy (ipilimumab; Medarex/Bristol-Myers Squibb) for prostate cancer, 2011
•Table: Zaltrap – drug profile, 2011
•Table: VENICE trial to evaluate Zaltrap in prostate cancer, 2011
•Table: Zaltrap versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Datamonitor drug assessment summary of Zaltrap (aflibercept/VEGF Trap; BTG/Johnson & Johnson) for prostate cancer, 2011
•Table: Zibotentan – drug profile, 2009
•Table: Clinical trial summary for Zibotentan in prostate cancer, 2011
•Table: Zibotentan versus first-line comparator therapy docetaxel (plus prednisone) for the treatment of metastatic castrate-resistant prostate cancer
•Table: Summary of therapeutic classes in prostate cancer by ATC code, 2011
FIGURES
•Figure: Zytiga – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Zytiga for prostate cancer, 2011
•Figure: Provenge – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Provenge (sipuleucel-T; Dendreon/Kyowa Hakko Kirin/Immune Response) for prostate cancer, 2011
•Figure: Jevtana – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Jevtana (cabazitaxel; Sanofi) for prostate cancer, 2011
•Figure: Taxotere – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Taxotere (docetaxel; Sanofi) for prostate cancer, 2011
•Figure: Lupron – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Lupron (leuprolide acetate; Takeda/Astellas) for prostate cancer, 2011
•Figure: Casodex – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Casodex (bicalutamide; AstraZeneca) for prostate cancer, 2011
•Figure: Nilandron – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Nilandron (nilutamide; Sanofi/Astellas) for prostate cancer, 2011
•Figure: Eulexin – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor's drug assessment summary of Eulexin (flutamide; Merck & Co./Nippon Kayaku) for prostate cancer, 2011
•Figure: Phase II results investigating neoadjuvant docetaxel and Avastin in high-risk localized prostate cancer
•Figure: DCVax-prostate – SWOT analysis in prostate cancer, 2011
•Figure: Phase I/II study of MDV3100 in castrate-resistant prostate cancer
•Figure: MDV3100 – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of MDV3100 (Medivation/Astellas) for prostate cancer, 2011
•Figure: Orteronel – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of Orteronel (TAK-700; Takeda) for prostate cancer, 2011
•Figure: Results of a Phase II double-blind, randomized study of Revlimid in non-metastatic castrate- resistant prostate cancer
•Figure: Revlimid – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of Revlimid (lenalidomide; Celgene) for prostate cancer, 2011
•Figure: Phase II results for patients with metastatic CRPC with rising PSA levels
•Figure: Phase I/II results investigating first-/second-line Sprycel and docetaxel in metastatic castrate-resistant prostate cancer
•Figure: Sprycel – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of Sprycel (dasatinib; Bristol-Myers Squibb/Otsuka) for prostate cancer, 2011
•Figure: TASQ – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of TASQ (tasquinimod; Active Biotech/Ipsen) for prostate cancer, 2011
•Figure: Phase I/II study investigating first/second-line Yervoy alone and in combination with radiotherapy in metastatic castrate-resistant prostate cancer
•Figure: Phase II study investigating Yervoy either as a monotherapy or in combination with docetaxel for castrate-resistant prostate cancer
•Figure: Yervoy – SWOT analysis in prostate cancer, 2011
•Figure: Datamonitor drug assessment summary of Yervoy (ipilimumab; Medarex/Bristol-Myers Squibb) for prostate cancer, 2011
•Figure: Zaltrap – SWOT analysis in prostate cancer, 2009
•Figure: Datamonitor drug assessment summary for Zaltrap (aflibercept/VEGF-Trap; Regeneron/Sanofi) in prostate cancer, 2011
•Figure: Phase II study investigating first-line Zibotentan in castrate-resistant prostate cancer with bone metastases
•Figure: The PharmaVitae Explorer
Companies Mentioned
Abbott Laboratories, Aviva Plc, Celgene Corporation, Fiskars Corporation, GlaxoSmithKline Plc, Hutchison 3G UK Limited, Informa plc, Ipsen S.A., Johnson & Johnson, Kewill plc, Schindler Holding Ltd.
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