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Pipeline Plus

Cautious Optimism for Growth In Alzheimer’s Disease Treatments

Jessica Cherian PharmD, RPh
Kunj Gohil PharmD, RPh

Alzheimer’s disease (AD), the most common form of dementia, is a progressive neurodegenerative condition that alters cognition, behavior, and functional status.1 AD has devastating effects not only for patients but also for caregivers, who often endure physical and emotional consequences as a result of their efforts.

As of 2014, approximately 5.2 million Americans had AD, which was the sixth leading cause of death in the U.S. 2 Most AD cases occur in people older than 65 years of age. 1 As the proportion of Americans falling into this group continues to increase, the focus on AD and its treatments is also growing.

Available pharmacological options include small-molecule medications in two drug classes known as cholinesterase inhibitors and n-methyl-d-aspartate receptor antagonists. These therapies, with results that vary from person to person, are used only for symptomatic improvement—they cannot cure the disease or halt its progression.1 Estimated U.S. sales of marketed treatments totaled $2.4 billion in 2013, a figure that is expected to more than triple to $7.6 billion in 2023 with the addition of new medications.3

Unmet needs in the competitive landscape of AD treatment leave significant room for future disease-modifying therapies, many of which are biologic medications.4 Along with a promising AD pipeline, there remains an urgent need for continued research to identify curative and preventive therapies. This has become increasingly apparent as support for federal research funding grows. In addition, manufacturers, advocacy groups, and academic institutions have formed a rare partnership to evaluate upcoming AD therapies.5,6 Such unique partnerships and increased support will facilitate the development of disease-modifying therapies for AD.

Future Therapies

Drug
Manufacturer
Status Regimen Information Pivotal Studies Expected Approval Anticipated Peak Year Sales/Pricing
TRx-0237 (leucomethyl-thioninum chloride)
TauRx Therapeutics
Phase 3 75, 100, or 125 mg orally twice daily NCT01689246
NCT01689233
2016 $178.8M in 2023; expected to be priced at 20–30% premium to marketed therapies but lower than mAb therapies
LuAE-58054 (idalopirdine)
Lundbeck
Phase 3 30 or 60 mg orally once daily STAR studies 2016 $338.5M by 2023; expected to be priced higher than medications now available
ARC-029 (nilvadipine)
Archer Pharmaceuticals
Phase 3 8 mg orally once daily NILVAD 2017 $1.0M in 2023; expected to be priced higher than marketed therapies but lower than mAb therapies
TTP-488
TransTech Pharma
Phase 3 5 mg orally once daily NCT02080364 2017 $260.8M in 2023; expected to be priced at 30–40% premium to marketed therapies and in reference to MS, stroke, and ALS medications
EVP-6124 (encenicline)
Forum Pharmaceuticals
Phase 3 Orally once daily; low and high dose being evaluated NCT01969123
NCT01969136
2017 $137.1M by 2023; expected to be priced higher than medications now available
Albutein 20% + Flebogamma 5%
Grifols
Phase 2/3 High-dose and low-dose IV infusion is being studied AMBAR 2017 $31.4M by 2023; expected to be priced in reference to Flebogamma and Albutein
AB-1010 (masitinib)
AB Science
Phase 3 3 or 4.5 mg/kg per day orally NCT01872598 2017 $88.6M by 2023; expected to be priced at 30–40% premium to marketed AD treatments
MK-8931
Merck
Phase 3 12, 40, or 60 mg orally once daily EPOCH: mild/moderate
APECS: amnestic mild cognitive impairment
2018 $947.7M in 2023; expected to be priced at 50–60% premium to marketed medications and to use ALS medications as reference
RG-1450 (gantenerumab)
Hoffmann-La Roche
Phase 3 SC injection every 4 weeks Marguerite RoAD 2019 $502.2M in 2023; expected to be priced at 1–2% discount to Eli Lilly’s solanezumab and in reference to IV biologic MS medications
LY-2062430 (solanezumab)
Eli Lilly
Phase 3 400 mg IV infusion every 4 weeks EXPEDITION 2019 $2.2 billion in 2023; as a potential first-in-class agent, not expected to be discounted
AZD-3293
AstraZeneca
Phase 2/3 20 or 50 mg orally once daily AMARANTH 2019 $687.7M by 2023; expected to be priced at a 1–4% premium to Merck’s MK-8931 and medications used in MS and ALS
Pioglitazone (AD-4833)
Takeda
Phase 3 Sustained release 0.8 mg orally once daily TOMMORROW 2020 $14.9M in 2023; expected to be priced in reference to Actos

ALS = amyotrophic lateral sclerosis; B = billions; IV = intravenous; mAb = monoclonal antibody; M = millions; MS = multiple sclerosis; SC = subcutaneous

Sources: FDA; GlobalData; manufacturers’ websites; ClinicalTrials.gov

Current Therapiesa

Drug
Manufacturer
Approval Date Indicationb Regimen Informationc Cost of Course of Therapy per Yeard
Combination Cholinesterase Inhibitor and N-methyl-d-aspartate Receptor Antagonist
Namzaric (memantine/donepezil) Actavis December 23, 2014 AD 28 mg/10 mg (memantine/donepezil) orally once daily Not available
Cholinesterase Inhibitor
Exelon Patch (rivastigmine transdermal system) Novartis July 6, 2007 AD 9.5 mg patch/24 hours $5,487
Razadyne ER (galantamine), Janssen December 22, 2004 AD 24 mg orally once daily $4,254
Razadyne (galantamine), Janssen February 28, 2001 AD 12 mg orally twice daily $2,127
Exelon (rivastigmine) Novartis April 21, 2000 AD, PD 6 mg orally twice daily $5,021
Aricept (donepezil), Eisai November 25, 1996 AD 10 mg orally once daily $6,723
N-methyl-d-aspartate Receptor Antagonist
Namenda XR (memantine), Forest/Actavis June 21, 2010 AD 28 mg orally once daily $4,334
Namenda (memantine), Forest/Actavis October 16, 2003 AD 10 mg orally twice daily $4,562

aThis list is not all-inclusive; additional therapies may be available for this disease state.

bAbbreviated indication provided; for full indication, please refer to prescribing information.

cRegimens based on the recommended dosage and maintenance phases from prescribing information; typical doses and titration schedules may vary based on patient-specific requirements.

dCosts calculated using average wholesale price and regimen provided and rounded to the nearest dollar.

Sources: Red Book; Drugs@FDA; and prescribing information for all medications

AD = Alzheimer’s disease; ER = extended release; PD = Parkinson’s disease

Author bio: 
Dr. Cherian and Dr. Gohil are Central Services Managers with Medical Services at MediMedia Managed Markets in Yardley, Pennsylvania.

References

  1. DiPiro J, Talbert RL, Yee G, et al. Alzheimer’s disease. Pharmacotherapy: A Pathophysiologic Approach 9th edNew York, New York: McGraw-Hill. 2014;817–833.
  2. Alzheimer’s Association. 2014 Alzheimer’s disease facts and figures. Alzheimers Dement 2014;10;(2):e47–e92.
  3. GlobalData. Alzheimers Disease—Global Drug Forecast and Market Analysis to 2023 February 2015;
  4. National Institute on Aging. Developing new treatments for Alzheimer’s disease. Available at: https://www.nia.nih.gov/alzheimers/publication/2011-2012-alzheimers-disease-progress-report/developing-new-treatments. Accessed March 6, 2015
  5. Strobel G. DIAN trial picks gantenerumab, solanezumab, maybe BACE inhibitor. Alzforum October 102012;Available at: https://www.alzforum.org/news/conference-coverage/dian-trial-picks-gantenerumab-solanezumab-maybe-bace-inhibitor. Accessed March 12, 2015
  6. Alzheimer’s Association, Alzheimer’s Advocates Center. Public policy victories. Available at: http://www.alz.org/advocacy/victories.asp. Accessed March 12, 2015