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Pipeline Plus

Steady Progress on Parkinson’s Disease

Kunj Gohil PharmD, RPh

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. September 82014;Available at: http://www.ninds.nih.gov/disorders/parkinsons_disease/parkinsons_disease.htm. Accessed September 9, 2014
  2. Global Data. Parkinson’s Disease—Global Drug Forecast and Market Analysis to 2022 March 2014;
  3. Chen J, Swope D. Parkinson’s Disease. In: DiPiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach 9th ed.New York, New York: McGraw-Hill. 2014;911–924.
  4. Mao CJ, Chen JP, Zhang XY, et al. Parkinson’s disease patients with pain suffer from more severe non-motor symptoms. Neurol Sci 2014;Sep 6[Epub ahead of print]
  5. Parkinson’s Disease Foundation. The Parkinson’s Pipeline. Available at: http://www.pdf.org/en/parkinson_pipeline. Accessed September 9, 2014