Abstract
Treatment of Parkinson’s disease is expected to lead to $3.56 billion in global sales in 2022. Manufacturers are reformulating medications in addition to creating new ones.
Parkinson’s disease (PD) is a chronic, progressive ailment caused by neurodegeneration and a decreased concentration of dopamine in the brain, which ultimately leads to the brain’s inability to control body movements.1 The global prevalence in 2012 was approximately 2.18 million cases worldwide; this resulted in $3.56 billion in global market sales of therapies, including $1.15 billion in the U.S. market.
PD is one of the most common neurological disorders, and the global prevalence is projected to grow to 2.89 million cases worldwide by 2022. Through advances in technology and drug development, the Parkinson’s market in 2022 is expected to yield $5.26 billion in global market sales, with $2.33 billion from the U.S. market.2
Typical PD symptoms include brady-kinesia, tremors, rigidity, and posture problems.3 Patients may also experience non-motor symptoms, such as rapid eye movements, sleep disorders, and depression.4 While medications have proven helpful in treating the symptoms, there is a large unmet need for therapies aimed at preventing or treating underlying causes of PD.2
Future Therapies
| Drug Manufacturer | Status | Regimen Information | Pivotal Studies | Expected Approval | Anticipated Peak Year Sales/Pricing |
|---|---|---|---|---|---|
| Safinamide Newron Pharmaceuticals | Phase 3 | 50–100 mg once daily, taken orally | MOTION SETTLE Study 015 Study 017 |
2015 | Safinamide is expected to be priced at a 10% premium over Azilect due to its dual mechanism of action; U.S. sales are estimated to peak in 2022 at $296.9M |
| Opicapone Bial | Phase 3 | 25 mg or 50 mg once daily | NCT01851850 | 2019 | Opicapone is expected to be priced at a 25% discount to Comtan due to its status as the third-to-market COMT inhibitor; U.S. sales are estimated to peak in 2022 at $40.1M |
| Rytary/IPX066 Impax Laboratories | Phase 3 (preregistration) | Capsule containing beads with active ingredients that dissolve at different rates, releasing carbidopa and levodopa | NCT00974974 | 2014 | Rytary is expected be priced at a 30% premium to IR Sinemet; U.S. sales are projected to peak in 2022 at $157.1M |
| Duodopa AbbVie | Phase 3 (preregistration) | Permanent tube, surgically inserted, delivers 3 daily doses of carbidopa and levodopa into intestine |
NCT00360568 NCT00335153 NCT00660387 NCT00357994 |
2014 | Duodopa is expected to have an annual cost of treatment of $38,563 in the U.S., where sales are projected to peak in 2022 at $275.7M |
| Tozadenant Roche and Biotie Therapies | Phase 2b/ 3 | 60 mg, 120 mg, 180 mg, or 240 mg, taken orally twice daily | NCT01283594 | 2019 | Tozadenant is expected to be priced at 75% of Requip due to its limited efficacy to date; U.S. sales are estimated at $29.9M in 2022 but are expected to peak after 2022 |
| Mavoglurant/AFQ056 Novartis | Phase 2/3 | 20 mg, 50 mg, 100 mg, 150 mg, or 200 mg taken orally once daily | NCT01491932 | After 2022 | Mavoglurant is expected to be priced similarly to other advanced-stage therapies such as Comtan/Stalevo or Neupro |
| CVT-301 Alkermes, Eli Lilly, Civitas Therapeutics | Phase 2b | ARCUS technology delivers inhaled levodopa in 2 doses (low and high) as an adjunct to oral levodopa | NCT01777555 | 2018 | CVT-301 is expected to be priced at a premium of approximately 30% more than Stalevo due to its novel delivery system; U.S. sales are projected to peak in 2022 at $379.7M |
| CD/LD-GR Indec Pharmaceuticals | Phase 2 | 25 mg carbidopa/125 mg levodopa | NCT00947037 | After 2022 | CD/LD-GR will be priced similarly to Rytary, presumably at a premium over IR levodopa |
COMT = catechol O-methyltransferase; IR = immediate release; M = millions
Sources: GlobalData, ClinicalTrials.gov, manufacturers’ websites: Newron Pharmaceuticals, Roche and Biotie Therapies, Alkermes, Eli Lilly, Civitas Therapeutics, Impax Laboratories, Bial, Novartis, Indec Pharmaceuticals, AbbVie
Manufacturers have turned their attention to reformulating popular medications in addition to creating therapies to provide symptom relief and neuroprotection. Although we may see just a few new medications in the near future, physicians are optimistic that prospective therapies will be developed to improve and reverse the course of this disease.5
Current Therapies
| Drug Manufacturer | Approval Date | Indication | Regimen Information | Approximate Cost of Course of Therapy Per Year† |
|---|---|---|---|---|
| Levodopa Combination Therapy | ||||
| Sinemet* (carbidopa/levodopa, 1:4 ratio) Merck & Co. |
IR: May 2, 1975 CR: May 30, 1991 |
PD | IR: 25 mg/100 mg TID CR: 50 mg/200 mg BID |
IR: $1,195 (generic, $319) CR: $1,716 (generic, $511) |
| Catechol O-methyltransferase Inhibitors | ||||
| Comtan* (entacapone) Novartis |
October 19, 1999 | PD | 200 mg BID | $3,545 (generic, $1,885) |
| Stalevo* (carbidopa/entacapone/levodopa) Novartis |
June 11, 2003 | PD | 50 mg/200 mg/200 mg BID | $3,515 (generic, $2,257) |
| Tasmar (tolcapone) Valeant Pharma |
January 29, 1998 | PD | 100 mg TID | $40,041 |
| Dopamine Agonists | ||||
| Neupro (rotigotine) UCB Inc. |
May 9, 2007 | PD, RLS | Early stage: 2 mg/24 hr patch daily Late stage: 4 mg/24 hr patch daily |
$6,012 (early and late stage) |
| Requip* (ropinirole) GlaxoSmithKline |
September 19, 1997 (Requip) July 1, 2008 (Requip XL) |
PD; RLS (IR only) | Requip: 0.25 mg TID Requip XL: 2 mg daily |
Requip: $4,028 (generic, $551) Requip XL: $1,079 (generic, $787) |
| Mirapex IR*, ER (pramipexole) Boehringer Ingelheim |
IR: July 1, 1997 ER: May 23, 2010 |
PD, RLS | IR: 1.5 mg TID ER: 0.75 mg QD |
IR: $5,245 (generic, $161) ER: $4,963 |
| Apokyn (apomorphine hydrochloride) Britannia Pharmaceuticals |
April 20, 2004 | PD | 2 mg (0.2 mL) injection for each off episode | $11,940‡ |
| Monoamine Oxidase-B Inhibitors | ||||
| Azilect (rasagiline mesylate) Teva Pharmaceuticals |
May 16, 2006 | PD | 1 mg daily | $5,816 |
BID = twice daily; CR = controlled release; ER = extended release; IR = immediate release; PD = Parkinson’s disease; QD = once daily; RLS = restless legs syndrome; TID = three times daily
Generic available
Cost calculated using wholesale acquisition cost and regimen provided and rounded to the nearest dollar.
Based on the use of one 3-mL cartridge per month in an injector pen
Sources: GlobalData, Red Book, Drugs@FDA, prescribing information for each medication
REFERENCES
- 1.National Institute of Neurological Disorders and Stroke NINDS Parkinson’s Disease Information Page. Sep 8, 2014. Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm. Accessed September 9, 2014.
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