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Metastatic Melanoma: Pipeline Assessment and Market Potential Through 2017

  • ID: 1928586
  • Report
  • October 2011
  • Region: Global
  • 65 Pages
  • MP Advisors

FEATURED COMPANIES

  • Abbott
  • Astrazeneca
  • Celgene
  • Eli Lilly
  • Novartis
  • Roche
Metastatic Melanoma therapy will witness a complete paradigm shift in the way the disease is treated as newer therapies with different mechanisms reach the market. The recent approval of BMY’s Yervoy (Ipilimumab) and Zelboraf (Vemurafenib) has come as good news for the metastatic melanoma patients and is just the beginning. The pipeline in metastatic melanoma is much crowded and there are many more exciting compounds on the anvil. Nab-paclitaxel, Avastin, Oncovex, Allovectin, BRAF and MEK inhibitors, C-Kit inhibitors, and several vaccines are being explored. These newer drugs have shown promising data and offer promise for an improved treatment options for the metastatic melanoma patients of the future.

Broadly there are five new classes of therapies that are expected to improve outcomes in patients with metastatic melanoma.

- Targeted Chemotherapy
- Anti-angiogenesis Therapy
- Targeted Immunotherapy
- Targeted MAP Kinase Therapy
- Vaccines

As the newer therapies have their own pros and cons to maximize the benefit for patients, clinical trials are also ongoing which are exploring the benefits of combination of these newer therapies when administered either concomitantly or sequentially. The future treatment paradigm in melanoma is going to be a real art of sequencing and combinations. On one hand you have a drug like Yeryoy, which does not have a great response rate, but promises durability of response for those who respond well, while on the other hand are BRAF inhibitors, which offer a dramatic response rate but lacks durability.

All in all, we will witness a flurry of newer therapies in the market over the next few years and physicians are likely to tailor the use of these newer therapies to suit the needs of an individual. The melanoma market which is currently worth about $500m will expand to become a $4b market by 2015.

This report analyses the merits and demerits of individual pipeline molecules in greater details along with sales estimate through 2017 for the important molecules across the world.
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Abbott
  • Astrazeneca
  • Celgene
  • Eli Lilly
  • Novartis
  • Roche
1. EXECUTIVE SUMMARY

2. Metastatic Melanoma- Unmet need exist in which stage of Metastatic Melanoma patients? Post YERVOY and ZELOBRAF Launch where it stands?
- Prevalence, market size in different countries
- Disease overview and current available treatment options
-- Etiology and survival of Melanoma Patients
-- Stages of Melanoma
-- Survival rate
-- Treatment option overview
-- Target product profile vs current level of attainment
- Current Market and Potential

3. Melanoma Pipeline by Mechanism of Action and our view on each late stage pipeline candidate

Various approach to treat metastatic melanoma
-- Targeted chemotherapy
-- Targeted Immunotherapy
-- Targeted MAP kinase pathway
-- Vaccines
-- Anti-angiogenesis therapy

Detailed discussions and our view on late stage pipeline compounds
- B-RAF inhibitors Pipeline - Clinical data, Ongoing Clinical trials and Milestones
-- Specificity to B-Raf is the key for efficacy
-- Pipeline B-RAF inhibitors
--- GSK 426
--- ARQ 736
--- RAF 265
--- XL-281/BMS-9086628

MEK inhibitors Pipeline - Clinical data, Ongoing Clinical trials and Milestones
- GSK 212
- AZD 6244
- MEK 162
- GDC 0973
- PD0325901
- TAK 733
- BAY86-9766
- RO5126766

C- KIT inhibitors Pipeline - Clinical data, Ongoing Clinical trials and Milestones
- Tasigna (Nilotinib)
- Masitinib

Immunotherapy Pipeline - Clinical data, Ongoing Clinical trials and Milestones
- CTLA4 inhibitors
- PD1 blocking agents
- CD 40 activation

Chemotherapy or Chemo+ Targeted therapy - Clinical data, Ongoing Clinical trials and Milestones
- Decitabine + Temozolamide
- Nab- Paclitaxel (Abraxane), Abraxane + Avastin
- Avastin + Dacarbazine

Vaccine Pipeline - Clinical data, Ongoing Clinical trials and Milestones
- Allovectin-7 (velimogene aliplasmid)
- Oncovex GM-CSF
- MAGE-A3 ASCI (astuprotimut-r)

Others - Clinical data, Ongoing Clinical trials and Milestones
- Genasense (Oblimersan Sodium)
- PV-10 (Rose Bengal)

4. Detailed Clinical profile, Physician’s view and Sales potential of recently launched drugs

Yervoy (Ipilimumab)
- Drug Profile
- Clinical data
- Approval and pricing
- Predictive biomarker
- Physician/Patients experience
- Ongoing Ipilimumab clinical studies

Zelboraf (Vemurafanib -RG7204)
- Drug Profile
- Clinical trial data
- Approval and pricing
- Ongoing clinical trials

B-Raf resistance –How to Overcome?

Combination / Sequential Therapies to reduce B-Raf resistance
- With MEK inhibitors
- With PI3K/AKT/mTOR inhibitors
- With Immunotherapy
- Early research for reducing B- RAF resistance

5. Trial design and Clinical data comparison of Launched and pipeline candidates in First line, second line setting of metastatic melanoma

6. Upcoming milestones and Launch Timelines of late stage candidates

7. Market Model for Melanoma Therapy Class
- Forecasting Market Model through 2017: US
- Forecasting Market Model through 2017: Ex US

APPENDIX

FDA’s regulatory requirement for the approval of the drug in each stage of metastatic melanoma and what is the requirement of clinical trial design?

List of Tables and Charts
1. Global Incidence and Mortality of Melanoma
2. Melanoma Survival Rate (5y and 10y)
3. Key Pathways And Biomarkers For Metastatic Melanoma
4. Importance of specificity for BRAF inhibitor
5. Competitive Landscape: B-Raf/Ras/Pan-Raf Inhibitor
6. Efficacy Of AZD-6244 In Combinations With Chemotherapy In Advanced Melanoma
7. Pipeline- C-Kit Inhibitor for Metastatic Melanoma
8. Combined Pipeline Milestone in Metastatic Melanoma
9. Ongoing Ipilimumab Clinical Trials in Metastatic Melanoma
10. Clinical Trial Design Comparison of Major Pipeline Molecules
11. Clinical Trial Data Comparison – First-line Setting
12. Clinical Trial Data Comparison – Second-line Setting
13. Clinical Trial Data Comparison - Unresectable Stage IV & Adjuvant Setting
14. Expected Launch Timeline for Late Stage Pipeline Candidates
15. Key Milestones in Metastatic Melanoma Therapy Class
16. Forecasting Market Model through 2017: US
17. Forecasting Market Model through 2017: Ex US
Note: Product cover images may vary from those shown
- Abbott
- Amgen
- Astrazeneca
- Bristol Myers Squibb
- Celgene
- Eisai
- Eli Lilly
- GlaxoSmithKline
- Novartis
- Provectus
- Roche
- Vical
Note: Product cover images may vary from those shown
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