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Therapeutic Class Overview: Treating Refractory Hematological Malignancies

February 2014 | 43 pages | ID: T5911376873EN
MP Advisors

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Targeting unmet needs in the treatment of cancer/ hematological malignancies through innovative drug development strategies have witnessed favorable outcomes. Over the past decade, Proteasome inhibitor, Velcade (bortezomib) and the immunomodulatory drugs – Thalomid (thalidomide) and Revlimid (lenalidomide) have become the cornerstone of treatment for patients with Multiple Myeloma (MM) resulting in improved survival. However, eventually all patients relapse and new treatment options for Relapsed/ Refractory Multiple Myeloma (RRMM) are required to further improve survival and quality of life of this group of pts. Two new drugs have successfully fulfilled this need – POMALYST/ IMNOVID (pomalidomide – POM) and Kyprolis (carfilzomib-CFZ) but is there room for more?We expect a similar scenario to unfold in the treatment of Recurrent/ Refractory MDS (RR-MDS, High-Risk MDS), and Relapsed/ Refractory AML (R/R AML). Innovative approach to treating unmet need has been handsomely rewarded in the past through in-licensing or outright acquisition of the mature/nascent product/innovator company at a premium. The report provides an overview of the approved therapies for RRMM, NDMM, AML, MDS, unmet need and limitations of the current SOC for relapsed and refractory pts. The report highlights the competition and commercial opportunity in pursuing these therapy areas – Comprehensive list of the early and late stage drugs in the clinic, their MoA and the companies developing them.
1. EXECUTIVE SUMMARY

2. DISEASE OVERVIEW

3. CURRENT STANDARD OF CARE

1. Relapsed and/or Refractory Multiple Myeloma
2. Newly Diagnosed Multiple Myeloma

4. APPROVED PRODUCTS

1. Revlimid (lenalidomide)
2. Kyprolis (carlzomib)
3. POMALYST / IMNOVID (pomalidomide)

5. PIPELINE – SMALL MOLECULES

1. MLN9708
2. Panobinostat
3. Obatoclax
4. SNS01-T
5. Oprozomib
6. Rocilinostat
7. Afuresertib
8. KW-2478

6. MONOCLONAL ANTIBODIES

1. Elotuzumab
2. Siltuximab
3. Daratumumab
4. MOR202
5. IPH2101

7. KEY MILESTONES

1. MP Advisors’ View on the Late-Stage Pipeline
1. Launch Timeline and Market Potential
2. Drivers of M&A / Licensing Deals in MM

LIST OF TABLES

1 Competitive Landscape – RRMM 6-7
2 Data Comparison – Relapsed / Refractory Multiple Myeloma (RRMM)
3 Competitive Landscape – NDMM
4 Data Comparison – Newly Diagnosed Multiple Myeloma (NDMM)
5 Data Comparison – Relapsed And Refractory Multiple Myeloma (RRMM)
6 MM-003: POM+LoDEX vs. HiDEX in RRMM – Depth of Response
7 Patent Expiries of Market Products
8 Launch Timeline and Market Potential
9 Select M&A and Licensing Deals in Last 6 Years – 2007 to 2013
10 Select In-Licensing Opportunities: Small Molecules & mAbs

LIST OF FIGURES

1 Criteria For Progressive MM and Clinical Relapse
2 Targets for novel targets incl. mAb in Multiple Myeloma
3 SNS01-T: Reduction in Tumor Volume in RPMI 8226 Model

1. EXECUTIVE SUMMARY

2. DISEASE OVERVIEW: MDS

2.1. Unmet Need: MDS

3. CURRENT STANDARD OF CARE

3.1. Supportive Care: Hematopoietic Cytokine
3.2. Low-Intensity Therapy
3.3. High-Intensity Therapy
3.4. Recurrent / Refractory or relapsed MDS

4. DISEASE OVERVIEW: AML

5. CURRENT STANDARD OF CARE

5.1. AML pts Younger than 60 years
5.2. AML pts Older than 60 years

6. UNMET NEED: AML

6.1. Relapsed/ refractory AML

7. LATE-STAGE PIPELINE TARGETING HIGH-RISK OR R/R MDS AND R/R AML

7.1. Estybon
7.2. Vosaroxin
7.3. Quizartinib
7.4. ADI-PEG
7.5. BL-8040

8. LATE-STAGE PIPELINE TARGETING 1ST-LINE LOWER RISK MDS

8.1. Volasertib
8.2. CPX-351
8.3. Sapacitabine
8.4. Oral Rigosrtib

9. KEY MILESTONES OF DRUGS FOR RRMDS/RRAML IN 2014-15

10. LAUNCH TIMELINE AND COMMERCIAL OPPORTUNITY OF LATE-STAGE PIPELINE (RR MDS AND RR AML)

11. DRIVERS OF M&A/LICENSING DEALS IN MDS/AML

LIST OF TABLES

1 Revised International Prognosis Scoring System (IPSS-R)
2 Competitive Landscape: RR/ High-Risk MDS and RR AML
3 Competitive Landscape: Untreated/ Newly Diagnosed MDS and AML
4 CPX-351: PhIIb Data for Patients with 2 Or 3 Risk Factors
5 Launch Timeline and Market Potential
6 Select M&A and Licensing Deals in Last 5 Years – 2007to 2012
7 Select M&A and Licensing Deals Opportunities

LIST OF FIGURES

1 Unmet Need For AML
2 ITT Analysis: Survival Data for Refractory MDS Pts
3 Best Bone Marrow (BM) Responses After Rig. IV
4 Vosaroxin – Overall Survival Kaplan-Meier Curves
5 Phase 3 VALOR Study Design – Vosaroxin in RR AML
6 Overall Survival For AML Pts Less Than 60 Year Old with Flt3ITD Mutation
7 Polo-Like Kinase 1 (PLK1): Key Regulator of Mitosis


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