NU-100 (Multiple Sclerosis) – Forecast and Market Analysis to 2022

Pages: 46 Published: March 01, 2013 Report Code: GDHC1131DFR

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GlobalData has released its new PharmaPoint Drug Evaluation report, “NU-100 (Multiple Sclerosis) – Forecast and Market Analysis to 2022”. Multiple sclerosis (MS) is a chronic, inflammatory neurological disorder characterized pathologically by demyelination, axonal transection and neurodegeneration within the central nervous system. With curative therapy still elusive, current disease management is dependent on life-long pharmacotherapy with disease-modifying therapies (DMT). The dominance of first-line injectable DMTs, including the interferon beta (IFNß) agents: Bayer’s Betaseron/Betaferon (IFNß-1b), Biogen’s Avonex (IFNß-1a) and Merck’s Rebif (IFNß-1a), and Teva’s Copaxone (glatiramer acetate), has been a salient feature of the MS therapeutics market. However, the competitive landscape is undergoing significant change with the emergence of oral therapies, several pipeline products with notable efficacies, and looming generics/biosimilars following the patent expiries of key branded products during the forecast period. In addition, the entry of new companies such as Sanofi/Genzyme and F. Hoffmann-La-Roche/Genentech will challenge the position of the established players in the MS marketplace. Nuron Biotech’s NU-100 is a next-generation proprietary recombinant human interferon beta-1b produced using the company’s proprietary refolding process technology. It is being developed as a monotherapy for the treatment of RRMS, and as a new molecular entity, based on positive opinions from the FDA and EMA. NU-100 is currently in the Phase III stage of clinical development, with an expected launch in 2016 in the US and 2017 in Europe. NU-100, formerly known as BaroFeron, was exclusively licensed to Nuron Biotech from BaroFold in 2010.

Scope

Overview of Multiple Sclerosis, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on NU-100 including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for NU-100 for the top ten countries from 2012 to 2022.

Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India

Reasons to Buy

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Make more informed business decisions from insightful and in-depth analysis of NU-100 performance

Obtain sales forecast for NU-100 from 2012-2022 in top ten countries (the US, France, Germany, Italy, Spain, the UK, Japan, Canada, China and India)

Table of Contents

1Table of Contents1

1.1List of Tables3

1.2List of Figures3

2Executive Summary4

2.1Sales for NU-100 in the Multiple Sclerosis Market5

2.2What Do the Physicians Think?5

3Introduction7

3.1Catalyst7

3.2Related Reports7

3.3Upcoming Related Reports8

4Disease Overview9

4.1Etiology and Pathophysiology9

4.1.1Etiology9

4.1.2Pathophysiology9

4.1.3Classification of Multiple Sclerosis10

4.2Symptoms12

4.2.1Prognosis13

4.2.2Quality of Life13

5Disease Management14

5.1Diagnosis14

5.2Treatment Overview17

5.2.1Management of Acute Relapse18

5.2.2Treatment with Disease-Modifying Therapies18

5.2.3Symptomatic Therapies20

6Competitive Assessment21

6.1Overview21

6.2Strategic Competitor Assessment21

7Opportunity and Unmet Need23

7.1Overview23

7.2Unmet Needs24

7.2.1Currently Available MS Drugs Only Provide Partial Benefits24

7.2.2The High Cost of MS Drugs Could Continue to Price out Patients25

7.2.3Safety and Tolerability of Therapy is Undermined by Side Effects26

7.2.4Effective Treatments for Progressive MS Are Still Elusive27

7.2.5Inconvenient Route of Administration and Frequent Dosing Limits Compliance28

7.2.6The Lack of Predictive Biomarkers Delays MS Diagnosis29

7.3Unmet Needs Gap Analysis30

7.4Opportunities31

7.4.1Treatments for Progressive MS31

7.4.2Targeting Patients with Clinically Isolated Syndrome31

8Pipeline Assessment32

8.1Overview32

8.2Promising Drugs in Clinical Development33

9NU-100 (interferon beta-1b)35

9.1Overview35

9.2Efficacy36

9.3Safety36

9.4Dosing and Formulation36

9.5Potential Clinical Positioning36

9.6Potential Commercial Positioning36

9.7Pricing and Reimbursement36

9.8SWOT Analysis37

9.9Forecast38

10Appendix39

10.1Bibliography39

10.2Abbreviations41

10.3Methodology42

10.4Forecasting Methodology43

10.4.1Diagnosed MS patients43

10.4.2Percent Drug-Treated Patients43

10.4.3General Pricing Assumptions43

10.4.4Generic Erosion44

10.4.5Pricing of Pipeline agents44

10.5Physicians and Specialists Included in This Report44

10.6Primary Research – Prescriber Survey45

10.7About the Authors45

10.7.1Analysts45

10.7.2Global Head of Healthcare46

10.8About GlobalData46

10.9Contact Us46

10.10Disclaimer46

List of Tables

Table 1: NU-100 (interferon beta-1b): Key Metrics in the Multiple Sclerosis Pharmaceutical Markets4

Table 2: Common Presenting Symptoms of Multiple Sclerosis12

Table 3: Factors That Can Affect Prognosis in Multiple Sclerosis13

Table 4: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis15

Table 5: Treatment Guidelines for Multiple Sclerosis17

Table 6: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market18

Table 7: Pharmacotherapy for Common Multiple Sclerosis Symptoms20

Table 8: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 201222

Table 9: Overall Unmet Needs – Current Level of Attainment23

Table 10: Clinical Unmet Needs – Gap Analysis, 201230

Table 11: Multiple Sclerosis – Phase Pipeline, 201233

Table 12: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 201234

Table 13: Product Profile – NU-10035

Table 14: NU-100 SWOT Analysis, 201237

Table 15: Global Sales Forecasts ($m) for NU-100, 2012–202238

Table 16: Physicians Surveyed, By Country45

List of Figures

Figure 1: Global Sales for NU-100 (interferon beta-1b) by Region, 20224

Figure 2: Accrual of Disability in the Four Subtypes of Multiple Sclerosis11

Figure 3: Expanded Disability Status Scale (EDSS)16

Figure 4: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies19

Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 2012–202233

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