- Improving levodopa is a key development goal: As the gold standard of PD treatment, levodopa captured nearly 70 percent patient share among recently treated PD patients in Q4 2014, according to U.S. claims data. A diverse range of late-stage levodopa reformulations from Intec Pharma, Neuroderm, and others aim to exploit the clinical shortcomings of levodopa and tap into a large potential patient pool. In February 2015, Impax Laboratories launched Rytary—a combined immediate and controlled release formulation of levodopa—in the United States. With three-times-daily dosing and benefits in reducing "off" time, we expect Rytary will see notable uptake in our 10-year major-market forecast, largely in intermediate to advanced PD.
- Rescue alternatives are needed: Today, patients requiring immediate relief from "off" episodes have one option: injectable apomorphine (US WorldMeds' Apokyn). However, less than 1 percent of recently treated patients used the costly drug in Q4 2014. Interviewed experts are enthusiastic that Acorda's CVT-301 and Cynapsus's APL-130277 will present effective, patient-friendly alternatives that could meaningfully increase the number of patients who seek and receive a rescue option, and DRG forecasts strong sales potential in this arena.
- PD psychosis is prevalent and underserved: A safe and effective treatment for PD psychosis remains an unmet need for roughly one-third of PD patients, according to DRG epidemiological estimates. Approximately 10 percent of recently treated patients received off-label treatment with an atypical antipsychotic in Q4 2014, but current options have modest efficacy, a limited evidence base, and bear safety risks. Acadia's Nuplazid could become the first therapy approved specifically for PD psychosis, and following projected U.S. and European launches in 2016, we forecast the drug will start to unlock this market opportunity, garnering peak-year sales above $500 million in PD.
- "Until recently, the PD pipeline was stagnant, but new drugs have the potential to bring real therapeutic advances in key areas of opportunity. The result, according to our latest PD forecast, is a greater than $1 billion increase in the PD drug market in the G7 by 2024."
- "With an abundance of effective, generic options, a major challenge for novel entrants in the PD drug market will be successfully navigating the market access landscape—particularly in Europe. Recent DRG research with EU5 payers makes clear that a high bar is set for new PD brands; demonstrating clinically meaningful improvements over appropriate comparators—in efficacy, above all—will be the surest path to positive HTA outcomes."
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dresources@shiftcomm.com
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