Namenda

In October of 2003, Forest Laboratories announced FDA approval of Namenda™ (memantine HCL) for moderate-to-severe Alzheimer’s disease. This new therapy is the first of a new class of drugs for Alzheimer’s disease known as NMDA antagonists. Namenda is thought to decrease the affinity of the NMDA receptor for a neurotransmitter known as glutamate, which plays an integral role in the neural pathways associated with learning and memory. The company recently announced plans to submit a supplementary application to the FDA that will broaden the indication to include the mild-to-moderate spectrum of the disease. A 1998 American Journal of Public Health article cited the prevalence of Alzheimer’s disease in the United States as 2.32 million (range: 1.09 to 4.58 million). It is projected that the prevalence will nearly quadruple in the next 50 years by which time approximately 1 in 45 Americans will be afflicted with the disease. Currently, the number of new or incident cases is approximately 360,000/year.

A 28-week study published in the New England Journal of Medicine compared memantine with placebo in persons with moderate-to-severe Alzheimer’s disease. Among the patients who completed the study, memantine appeared to confer benefit in terms of activities of daily living and other measures. A second study published in the Journal of the American Medical Association concluded that: “In patients with moderate to severe AD receiving stable doses of donepezil (Aricept), memantine resulted in significantly better outcomes than placebo”. These results together with previous studies, suggest that memantine represents a new approach for the treatment of patients with moderate to severe AD. Currently advertised Internet prices place the cost of treatment at approximately $6.00/day or $2190/year for 112 tabs (from www.memantine-supple.com, accessed Jan 30, 2004). This is comparable to the cost of Aricept. The study in JAMA raises the possibility of Namenda being used in addition to Aricept in the control of Alzheimer’s and would represent an approximate doubling of direct drug costs per patient. Wall Street analysts have estimated sales for Namenda in the $800, 000, 000/year range. Forest Laboratories have announced recent substantial increase in sales force to support anticipated sales requirements.

We think that Forest Laboratories’ Namenda has the potential to become a High Impact health technology and therefore recommend pharmacy and therapeutic programs begin some early assessment activities. Particular attention should be paid to therapeutic regimens using Namenda in addition to Aricept as this represents a significant direct cost increase.

Technology Details
Target Disease / Indication: Alzheimer’s Disease (moderate to severe)
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine
Regulatory Status: Approved
BioHorizon Impact Score: 75/100 – High