Introduction:Last Updated 28 October 2013
Parkinson’s disease (PD) is one of the most common chronic neurodegenerative diseases in the elderly, and its prevalence is expected to grow as the general population ages. The PD therapy market features a high rate of polypharmacy that is unique among neurological disorders, driven by the need to manage simultaneously the primary motor symptoms and nonmotor symptoms of the disease, as well as the common complications associated with chronic treatment with levodopa (multiple brand, generics), the long-standing foundation of PD treatment. High drug-treatment rates, the high rate of polypharmacy, and several key areas of unmet need combine to make the PD market one with many potential growth opportunities.
Questions Answered in This Report:
Sales-leading PD brands, most recently entacapone (Novartis/Orion Pharma’s Comtan/Comtess/Stalevo, generics), are beginning to face generics competition. How will progressive genericization of this and other key brands affect the overall PD market, in which generics have long held a strong influence? How will the presence of generics impact the uptake of emerging branded agents?
Among key dopamine agonists used in the treatment of PD, only extended-release (ER) pramipexole (Mirapex ER/Mirapexin ER, Sifrol Retard/Mirapex LA) and rotigotine (UCB/Otsuka Pharmaceutical’s Neupro/Neupro Patch/Leganto) remain branded in the United States and Europe. How does the use of prolonged-release versus immediate-release (IR) formulations differ among the major markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan)? How has the availability of generic ropinirole extended-release affected the uptake of ropinirole IR, pramipexole IR, and pramipexole extended release? Which dopamine agonist will become the market leader during the 2012-2022 forecast period?
The results of the Phase III ADAGIO study, which suggested a disease-modifying effect for the monoamine oxidase B (MAO-B) inhibitor rasagiline (Teva/Lundbeck’s Azilect), the 2012 market leader in PD, continue to affect treatment algorithms in early PD. What do experts interviewed say about the drug’s putative disease-modifying capabilities? How will uptake of rasagiline change over the forecast period?
Impax Laboratories’ long-acting levodopa reformulation IPX-066 (Rytary) has shown efficacy in reducing levodopa complications; the product received a complete response letter from the FDA in early 2013 but is still expected to launch during the 2012-2022 forecast period. What advantages and disadvantages does IPX-066 have that will impact its market performance? How do experts interviewed anticipate incorporating IPX-066 into the PD treatment algorithm?
Acadia Pharmaceuticals’ pimavanserin, a first-in-class inverse agonist of 5-HT2A
receptors, showed positive results in its most recent trial in PD psychosis. We expect the agent to launch during our forecast period, making it the first-ever agent approved specifically to treat psychotic symptoms in PD patients. What level of uptake will pimavanserin enjoy in the PD market? How will the drug’s availability impact the treatment algorithm in in PD patients experiencing psychotic symptoms, which are currently managed by off-label use of mostly generic atypical antipsychotics?
We expect that Newron Pharmaceuticals/Zambon Pharma/Meiji Seika Pharma’s MAO-B inhibitor safinamide will launch for PD during the forecast period. How do experts interviewed expect to incorporate safinamide into the PD treatment algorithm? What level of uptake will safinamide experience in the face of strong competition from rasagiline, for which generics will become available beginning in 2017?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 36 country-specific interviews with movement disorder specialists and neurologists.
Epidemiology: Prevalence of PD by country, diagnosed prevalence by disease stage, diagnosed prevalence of dementia, psychosis, “wearing off,” and dyskinesia.
Emerging therapies: Phase II: 23 drugs; Phase III/PR: 5 drugs. Coverage of 37 select preclinical and Phase I products.
Market forecast features: Using market research, primary research with key opinion leaders, and our proprietary forecasting model, we forecast population sizes and sales of PD therapies through 2022.
Alternative market scenarios: U.S. and European launches of Novartis’s metabotropic glutamate receptor 5 antagonist mavoglurant AFQ-056) as levodopa-adjunctive therapy for advanced PD.