Disease Analysis: Multiple Sclerosis
Author: Jeff Stevens
Publisher: Datamonitor Healthcare
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Definition
Multiple sclerosis (MS) is widely recognized as the most common neurological and inflammatory disorder of the central nervous system (CNS) in the adult population. It is a chronic, recurrent, progressive autoimmune disorder characterized by repeated episodes of inflammation of the white matter nervous tissue of the CNS. The location of the inflammation varies from person to person and from episode to episode, and as such, results in a variety of clinical symptoms. The periventricular regions, optic nerves, brainstem, cerebellum, and spinal cord are common locations for inflammation in MS. The average age for disease onset is 30 years, with women being twice as likely to develop MS compared to men.
Latest key takeaways
- Datamonitor Healthcare estimates that in 2018, there were 2.1 million prevalent cases of multiple sclerosis (MS) worldwide, and forecasts that number to increase to 2.2 million prevalent cases by 2027.
- A large selection of disease-modifying therapies (DMTs) are currently available in the MS market with a sizable range of attributes, potencies, and safety profiles. Consequently, this set of DMTs typically can yield some relief from this chronic condition.
- Utilization of first-generation DMTs such as Avonex, Betaseron, Copaxone, and Rebif is declining due to their comparatively poor safety, efficacy, and administration profiles versus newer DMTs. Most are genericized, but still see some use in the first-line treatment setting, particularly for less severe cases of MS and especially where payer pressure is involved.
- Since Ocrevus’s launch in 2017, the drug has quickly risen to realize its gold-standard potential in the wider MS field. Its efficacy is unparalleled, and coupled with its six-monthly dosing regimen, the drug is popular with patients and physicians alike. As the only approved therapy for primary progressive MS (PPMS), it has little competition in this patient segment. Furthermore, Ocrevus is increasingly being prescribed at the first and second lines of treatment in other MS subtypes, and particularly in more rapidly progressing and severe cases.
- Long-awaited decisions have come from the key patent litigation trials of former blockbuster DMTs. In 2020 it was ruled that Biogen’s ‘514 patent, protecting Tecfidera until 2028, was invalid. This paved the way for Mylan to gain FDA approval for its dimethyl fumarate generic and launch the drug in rapid succession.
- Novartis fared better in litigation trials, as a US district court upheld the validity of the Gilenya dosing regimen patent, which is set to expire in December 2027 (inclusive of the pediatric exclusivity extension). However, Novartis has previously settled agreements with some generic drug companies, and generic fingolimod will likely enter the market before the expiration of the Gilenya patent. Nevertheless, at least for the next few years, Novartis will enjoy exclusivity for its blockbuster oral MS therapy.
- Bristol Myers Squibb’s Zeposia, a sphingosine-1-phosphate (S1P) receptor modulator, was approved in 2020 for relapsing forms of multiple sclerosis (RMS), and will provide stiff competition for rival S1P drugs Gilenya and Mayzent. Meanwhile, market penetration may be difficult for Johnson & Johnson’s Ponvory, which was approved in March 2021. As another S1P receptor modulator, the drug lacks a clearly distinguished profile from its rivals.
- Another recent event in the MS space was Novartis’s anti-CD20 targeting drug Kesimpta receiving FDA approval for the treatment of RMS in adults. This positions the drug as a direct market competitor of Roche’s dominant Ocrevus, though Roche has the underserved PPMS segment contained in the Ocrevus label. Kesimpta, however, has the advantage of a more appealing subcutaneous administration route.
- High-impact upcoming events for drugs in the MS space that are expected by the end of 2021 include an EU approval decision for Vumerity.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
8 DISEASE BACKGROUND
8 Definition
8 Patient segmentation
9 Symptoms
10 Risk factors
10 Diagnosis
11 TREATMENT
15 Summary of key treatment guideline recommendations
18 EPIDEMIOLOGY
18 Prevalence methodology
21 MARKETED DRUGS
27 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 FDA Accepts ANI’s Refiled Cortophin Gel
35 Two Dimethyl Fumarate Drugs Among New EU Filings
35 Viatris Sues Teva In US Over ‘Illegal Copaxone Scheme’
35 Viatris Eyes Gilenya Generic Following ‘Unreliable’ Study Data
36 CRL For Aubagio In Pediatric MS
36 Janssen’s Ponvory Will Face Stiff Competition In Europe’s MS Market
36 Zeposia Turned Down By NICE For MS
37 Tysabri Stays IV, For Now
37 NICE Funding Wins For Enhertu & Kesimpta Are Firsts For England
37 Breakthrough Device That Improves Gait In People With MS Authorized By FDA
37 CHMP Recommends EU-Wide Approval Of Ponvory
38 Janssen’s Newly Approved Ponvory Joins Crowded MS Space
38 Teva Under Investigation For Creating ‘False Perceptions’ Of Generics
38 FDA Approves Intramuscular Formulation For Plegridy
38 Novartis Wins EU Thumbs Up For MS Treatment
39 Diroximel Fumarate Among New EU Filings
39 NICE OKs Sarclisa & Mayzent For Funding In England, But Rejects Vindaqel
40 PROBABILITY OF SUCCESS
41 LICENSING AND ASSET ACQUISITION DEALS
41 FSD Pharma To Acquire Lucid Psycheceuticals
41 Biogen Partners With InnoCare To Keep Up With BTK Inhibitor Leaders in MS
41 Yale Unveils Research Pact With Repertoire Immune Medicines
41 Sorrento Acquires Abivertinib Partner ACEA
42 Lilly Broadens Its CNS Reach With Rigel RIPK1 Deal
42 Jazz Wades Into Cannabinoid Weeds With $7.2bn GW Buy
42 Clene Nanomedicine Goes Public In SPAC Buyout
43 MyMD Goes Public Through Reverse Merger With Akers
43 Cytocom Goes Public Via Merger With Cleveland BioLabs
44 CLINICAL TRIAL LANDSCAPE
45 Sponsors by status
46 Sponsors by phase
47 Recent events
49 DRUG ASSESSMENT MODEL
49 Genericized DMTs
49 Anti-CD20 drugs
50 S1P receptor modulator drugs
50 Pipeline drugs
52 MARKET DYNAMICS
53 FUTURE TRENDS
53 Widespread genericization will deplete key brands’ market share
53 Drugs utilizing novel mechanisms for MS are in development
53 Key brands will face competition from pipeline “me-too” drugs, though uptake may be slow if distinguishing factors cannot be established
54 More DMTs will become available for underserved MS patient populations
55 CONSENSUS FORECASTS
60 RECENT EVENTS AND ANALYST OPINION
60 Ontinua ER for Multiple Sclerosis (December 29, 2020)
60 Ublituximab for Multiple Sclerosis (December 10, 2020)
61 Analyst Opinion
62 Opicinumab for Multiple Sclerosis (October 21, 2020)
64 IMU-838 for Multiple Sclerosis (August 2, 2020)
66 SAR442168 for Multiple Sclerosis (April 23, 2020)
68 Qizenday for Multiple Sclerosis (March 10, 2020)
70 KEY UPCOMING EVENTS
71 KEY OPINION LEADER INSIGHTS
71 Quotes regarding specific drug use
71 Quote regarding unmet needs
71 Quote regarding pricing
73 UNMET NEEDS
73 More effective therapies for PPMS/SPMS
73 Development of neuroprotective/remyelinating therapies
74 BIBLIOGRAPHY
75 APPENDIX
LIST OF FIGURES
20 Figure 1: Trends in prevalent cases of multiple sclerosis, 2018–27
27 Figure 2: Overview of pipeline drugs for multiple sclerosis in the US
27 Figure 3: Pipeline drugs for multiple sclerosis, by company
28 Figure 4: Pipeline drugs for multiple sclerosis, by drug type
28 Figure 5: Pipeline drugs for multiple sclerosis, by classification
40 Figure 6: Probability of success in the multiple sclerosis pipeline
44 Figure 7: Clinical trials in multiple sclerosis
44 Figure 8: Top 10 drugs for clinical trials in multiple sclerosis
45 Figure 9: Top 10 companies for clinical trials in multiple sclerosis
45 Figure 10: Trial locations in multiple sclerosis
46 Figure 11: Multiple sclerosis trials status
47 Figure 12: Multiple sclerosis trials sponsors, by phase
49 Figure 13: Datamonitor Healthcare’s drug assessment summary for multiple sclerosis
52 Figure 14: Market dynamics in multiple sclerosis
53 Figure 15: Future trends in multiple sclerosis
62 Figure 16: Ublituximab for Multiple Sclerosis (December 10, 2020): Phase III – ULTIMATE I, Phase III – ULTIMATE II
64 Figure 17: Opicinumab for Multiple Sclerosis (October 21, 2020): Phase IIb – AFFINITY
66 Figure 18: IMU-838 for Multiple Sclerosis (August 2, 2020): Phase II – EMPhASIS
68 Figure 19: SAR442168 for Multiple Sclerosis (April 23, 2020): Phase IIb – Dose Finding
69 Figure 20: Qizenday for Multiple Sclerosis (March 10, 2020): Phase III – MS-SPI2
70 Figure 21: Key upcoming events in multiple sclerosis
LIST OF TABLES
9 Table 1: Clinical subtypes of multiple sclerosis
12 Table 2: Leading disease-modifying therapies for multiple sclerosis
16 Table 3: Available DMTs and the strength of the evidence base supporting their efficacy in preventing MS relapses
19 Table 4: Prevalent cases of multiple sclerosis, 2018–27
22 Table 5: Marketed drugs for multiple sclerosis
29 Table 6: Pipeline drugs for multiple sclerosis in the US
56 Table 7: Historical global sales, by drug ($m), 2016–20
58 Table 8: Forecasted global sales, by drug ($m), 2021–25
60 Table 9: Ontinua ER for Multiple Sclerosis (December 29, 2020)
61 Table 10: Ublituximab for Multiple Sclerosis (December 10, 2020)
63 Table 11: Opicinumab for Multiple Sclerosis (October 21, 2020)
65 Table 12: IMU-838 for Multiple Sclerosis (August 2, 2020)
67 Table 13: SAR442168 for Multiple Sclerosis (April 23, 2020)
68 Table 14: Qizenday for Multiple Sclerosis (March 10, 2020)
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