Disease Analysis: Parkinson’s Disease
Author: Dan Digaudio
Publisher: Datamonitor Healthcare
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Latest key takeaways
- Datamonitor Healthcare estimates that in 2018, there were 9.4 million prevalent cases of Parkinson’s disease (PD) in adults aged 40 years and older worldwide, and forecasts that number to increase to 12.4 million prevalent cases by 2027.
- In the last year there have been an array of impactful events that have occurred in the PD space. Data from Ongentys’ pivotal trials confirmed the drug’s superiority in increasing “on” time over placebo and a robust safety profile, thus supporting US approval in April 2020. More recently, Roche released Phase II data for its novel alpha-synuclein monoclonal antibody prasinezumab, which exhibited modest efficacy, while Anavex also released data readouts from a Phase II trial investigating its novel PD dementia drug, ANAVEX 2-73, on the associated cognitive deficits experienced by patients, with the results providing evidence of improvements over placebo across numerous endpoints.
- Duopa is among the most lucrative drugs currently available in the PD market. A contributing factor to the drug’s successful market penetration is the clinical efficacy data achieved in trials, where Duopa treatment significantly reduced “off” periods in PD patients compared to the standard of care, Sinemet (carbidopa/levodopa). Duopa, also a carbidopa/levodopa combination, is delivered directly and continuously into the intestines by a pump for up to 16 hours per day, thus reducing or even eliminating fluctuations and “off” periods. The procedure, however, is one of the most invasive in this market and comes with the usual risks of surgical complications. Duopa also has one of the highest price tags in the PD market, but since payers view its cost-effectiveness ratio positively, AbbVie looks set to maintain fruitful returns on the drug.
- Acadia’s Nuplazid, the first and only US-approved drug for Parkinson’s disease psychosis (PDP), scores well commercially in Datamonitor Healthcare’s drug assessment model. In pivotal trials, Nuplazid demonstrated significant efficacy in reducing the hallucinations and delusions associated with PDP, and through its non-dopaminergic mechanism it has shown no negative impacts on motor function. Furthermore, most other atypical antipsychotics are contraindicated for PDP, with none approved by the FDA for this specific condition. Acadia reported $441.8m in sales for Nuplazid in 2020, and this is expected to increase substantially over the coming decade given the lack of competition in this segment and the drug’s ongoing clinical development in other indications.
- Neupro has performed well commercially since its US approval in 2007, but a looming patent cliff jeopardizes the brand’s future revenues in the PD market. Several factors have contributed to the drug’s performance, including a transdermal, continuous delivery system, its targeting of both early- and late-stage PD patients, monotherapy use, and its availability across the US, EU, and Japan. In trials, the drug showed slightly lower efficacy compared to Mirapex, though despite this has established itself firmly in the PD treatment algorithm. UCB has fended off generic rivals thus far, but the end of market exclusivity is looming with the expiration of the ‘434 patent on 30 March 2021. Actavis Laboratories has received a tentative ANDA approval for its rotigotine generic, and as soon as this and any other rival generics can be launched, Neupro sales will undoubtedly see a dramatic decrease over the coming years.
- Despite levodopa’s status as the drug of choice in PD, long-term use frequently results in diminished efficacy and the development of motor fluctuations and dyskinesia. Advanced PD, therefore, has the greatest opportunities for drug developers. Competition in the rescue therapy space has begun to heat up, with Inbrija and Kynmobi both approved over the past couple of years, and this segment will continue to grow as developers look to target the rapid treatment of “off” periods. Continuous infusions have also emerged to tackle this issue, mimicking the continuous release of dopamine in non-pathological conditions. These therapies have been the most efficacious in reducing “off” time and increasing quality “on” time. Developers have also incorporated complex devices/formulations to extend market exclusivity and combat generic imitations.
- Prothena has partnered with Roche to potentially bring the first disease-modifying therapy (DMT) to the PD market. The drug, known as prasinezumab, is a monoclonal antibody targeting the pathological hallmark of PD, Lewy bodies, which comprise of alpha-synuclein aggregates. In early trials thus far, prasinezumab has signaled strong proof of concept by inducing a mean reduction of free serum alpha-synuclein levels of 96% in healthy volunteers. Recent results from a Phase II randomized, controlled trial in early PD patients displayed statistical superiority in improvements on the Movement Disorder Society Unified PD Rating Scale (MDS-UPDRS) versus placebo, though these improvements were modest at best. This could be explained by the early PD cohort utilized in this study, presumably selected due to the lower likelihood of patients exhibiting severe and irreversible dopaminergic neuronal loss; however, the size of effect would understandably be reduced in this less severe population. An imminent start to the Phase IIb trial of prasinezumab in early PD patients is expected.
- As has been the case for many years, and despite new drug entrants, one of the greatest unmet pharmacological needs in the treatment of PD is for neuroprotective therapies to prevent disease progression. In addition to this, more tolerable drugs and regimens are needed, as well as more effective drugs for non-motor symptoms, and improved control of motor fluctuations/“off” periods.
- The majority of high-impact upcoming catalysts in the PD space comprise later-stage trial readouts for pipeline PD drugs. In later-stage trials, results from Amneal’s IPX203 Phase III trial in advanced PD patients experiencing motor fluctuations are expected in the latter half of 2021. Likewise, AbbVie foresees Phase III trial data in H2 2021 for its subcutaneous carbidopa/levodopa formulation, ABBV-951.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
9 Symptoms
10 Risk factors
11 Diagnosis
12 TREATMENT
12 Non-pharmacological treatment approaches
12 Pharmacological therapy
13 Key pharmacological treatment guideline recommendations
16 EPIDEMIOLOGY
16 Prevalence methodology
19 MARKETED DRUGS
26 PIPELINE DRUGS
39 KEY REGULATORY EVENTS
39 Stada Launches Lecigon In Germany And Austria
40 PROBABILITY OF SUCCESS
41 LICENSING AND ASSET ACQUISITION DEALS
41 Macrogen, Lifex Ink Co-Research Pact For Parkinson’s Therapy
41 Lilly Broadens Its CNS Reach With Rigel RIPK1 Deal
41 Neurocrine Biosciences Terminates Parkinson’s Disease Portion Of Partnership With Voyager Therapeutics
41 Eli Lilly To Acquire Prevail For $880m
42 Adamas Concludes Gocovri Patent Dispute, Obtains Osmolex ER
42 AffaMed Licenses Parkinson’s Candidate From Kissei
42 Stada Progresses In Parkinson’s With Lobsor Purchase
43 Biogen Builds Out Parkinson’s Pipeline With Denali Deal
44 CLINICAL TRIAL LANDSCAPE
45 Sponsors by status
46 Sponsors by phase
47 Recent events
49 DRUG ASSESSMENT MODEL
49 Marketed antiparkinsonian drugs
50 Pipeline antiparkinsonian drugs
52 MARKET DYNAMICS
53 FUTURE TRENDS
53 Older, genericized core therapies will continue to dominate market share
53 Targeting niche segments with the greatest unmet needs will be highly rewarded
55 CONSENSUS FORECASTS
59 RECENT EVENTS AND ANALYST OPINION
59 ANAVEX 2-73 for Parkinson’s Disease (November 6, 2020)
60 Prasinezumab for Parkinson’s Disease (September 11, 2020)
62 THN102 for Parkinson’s Disease (March 31, 2020)
64 Foliglurax for Parkinson’s Disease (March 27, 2020)
65 Tavapadon for Parkinson’s Disease (September 23, 2019)
68 KEY UPCOMING EVENTS
69 UNMET NEEDS
69 Neuroprotective treatments that slow down or halt disease progression
69 Treatment of non-motor symptoms
69 Improved control of motor fluctuations/“wearing off” periods
69 New effective drug treatments with improved side-effect profiles
71 BIBLIOGRAPHY
72 Prescription information
74 APPENDIX
LIST OF FIGURES
10 Figure 1: Parkinson’s disease symptoms and symptom domains
18 Figure 2: Trends in prevalent cases of Parkinson’s disease, 2018–27
26 Figure 3: Overview of pipeline drugs for Parkinson’s disease in the US
27 Figure 4: Pipeline drugs for Parkinson’s disease, by company
27 Figure 5: Pipeline drugs for Parkinson’s disease, by drug type
28 Figure 6: Pipeline drugs for Parkinson’s disease, by classification
40 Figure 7: Probability of success in the Parkinson’s disease pipeline
44 Figure 8: Clinical trials in Parkinson’s disease
44 Figure 9: Top 10 drugs for clinical trials in Parkinson’s disease
45 Figure 10: Top 10 companies for clinical trials in Parkinson’s disease
45 Figure 11: Trial locations in Parkinson’s disease
46 Figure 12: Parkinson’s disease trials status
47 Figure 13: Parkinson’s disease trials sponsors, by phase
49 Figure 14: Datamonitor Healthcare’s drug assessment summary for Parkinson’s disease
52 Figure 15: Market dynamics in Parkinson’s disease
53 Figure 16: Future trends in Parkinson’s disease
60 Figure 17: ANAVEX 2-73 for Parkinson’s Disease (November 6, 2020): Phase II – PD Dementia (PDD)
62 Figure 18: Prasinezumab for Parkinson’s Disease (September 11, 2020): Phase II – PASADENA
64 Figure 19: THN102 for Parkinson’s Disease (March 31, 2020): Phase II – THN102-202
65 Figure 20: Foliglurax for Parkinson’s Disease (March 27, 2020): Phase II – AMBLED (Europe)
67 Figure 21: Tavapadon for Parkinson’s Disease (September 23, 2019): Phase II – Early Stage PD
68 Figure 22: Key upcoming events in Parkinson’s disease
LIST OF TABLES
13 Table 1: Major approved treatments for Parkinson’s disease
17 Table 2: Prevalent cases of Parkinson’s disease, 2018–27
20 Table 3: Marketed drugs for Parkinson’s disease
29 Table 4: Pipeline drugs for Parkinson’s disease in the US
56 Table 5: Historical global sales, by drug ($m), 2015–19
58 Table 6: Forecasted global sales, by drug ($m), 2021–25
59 Table 7: ANAVEX 2-73 for Parkinson’s Disease (November 6, 2020)
61 Table 8: Prasinezumab for Parkinson’s Disease (September 11, 2020)
63 Table 9: THN102 for Parkinson’s Disease (March 31, 2020)
64 Table 10: Foliglurax for Parkinson’s Disease (March 27, 2020)
66 Table 11: Tavapadon for Parkinson’s Disease (September 23, 2019)
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