It is estimated that in excess of 300, 000 patients are diagnosed with Alzheimer’s disease annually in the United States. Biohorizon assigns Alzheimer’s disease a value of 33/100 for the Burden of Illness variable.

Current approved therapies for Alzheimer’s include Aricept® and Namenda®. Biohorizon is following 43 emerging drug therapies for Alzheimer’s disease. Seven of these therapies are in Phase III or beyond in their development. Neurochem contends that Alzhemed is a novel small molecule part of a new class of therapies that it calls ‘GAG (glycosaminoglycan) mimetics’. Glycosaminonglycans are thought to play a role in the formation of amyloid plaques. In theory, interrupting the assembly of these plaques could alter the clinical course of disease. This unique approach earns Alzhemed an Innovation score of 75/100.

If approved, Alzhemed would represent a first in class therapy for a common, chronic disease. We see potentially significant demand and diffusion pressures, but at this time have assigned a 10/100 score to the Predicted Demand/Diffusion variable. Overall, Alzhemed is placed in Biohorizon’s Moderate Impact Technology category with an Impact Score of 51/100. We do not recommend any preliminary assessment activities for our health services clients at this time; however, favorable Phase III results could dramatically alter this position.

Technology Details
Target Disease / Indication: Alzheimer’s Disease
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Neurology
Regulatory Status: Phase III
BioHorizon Impact Score: 51/100 – Moderate

Nicotine by itself does not induce an antibody or immune response. However, when conjugated with an immunogenic protein such as recombinant cholera protein, an immune response is generated. These anti-nicotine antibodies may bind to the nicotine in a smoker’s blood and decrease or reduce the positive effects that nicotine creates in the smoker. In the Phase I trial, TA-NIC was delivered by 5 vaccinations over 8-20 weeks with a booster given 9 months after the first injection.

According to the 2001 National Health Interview Survey, approximately 22.8% of American adults (46.2 million) are currently smokers. Smoking rates in the United States have been declining since 1965.

The Biohorizon Emerging Health Technology Database contains two other emerging technologies for the treatment of Nicotine Addiction/Smoking Cessation, NicVax and Acomplia™. Notably, Nabi Pharmaceutical’s NicVax is another Phase I therapeutic vaccine, while Sanofi’s Acomplia™ is a Phase III drug therapy under development for both obesity and smoking cessation.

TA-NIC is an early stage therapeutic vaccine for smoking cessation with interesting Phase I trial results and substantial obstacles in the form of pivotal Phase 3 trials to overcome. We currently recommend no assessment activities for health services clients at this time.

Technology Details
Target Disease / Indication: Smoking Cessation/Nicotine Addiction
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Addictions
Regulatory Status: Phase I
BioHorizon Impact Score: 53/100 – Moderate

The purpose of the double-blind, placebo-controlled study is to evaluate the efficacy and safety of dexanabinol as a neuroprotectant agent in severe TBI patients. Enrolled patients were given a single dose of 150mg dexanabinol or placebo within six hours after injury and received the standard care normally provided to TBI patients in intensive care units. The primary endpoint for the study will be patient outcome as measured on the Glasgow Outcome Scale – Extended (GOSE) six months after injury.

Physical trauma to the brain triggers a complex network of cascades that produce neuronal damage and death far beyond that caused by the initial insult. Dexanabinol, a tricyclic dextrocannabinoid, is thought to exert its neuroprotective effect through three mechanisms of action that suppress these toxic and inflammatory cascades induced by TBI: the inhibition of NMDA stimulated calcium influx, the inhibition of TNF alpha and other inflammatory cytokines, and free radical scavenging.

Annually in the United States, there are about two million emergency room visits for head injury, about 300,000 admissions for head trauma, and approximately 52,000 deaths. According to Pharmos Corporation, the annual market potential for a drug treating new TBI victims in the U.S. is over $500 million. Currently, there is no FDA approved product for the treatment of severe head injury.

Dexanabinol remains a Moderate Impact Technology in the Biohorizon Emerging Health Technology Database, with no assessment activities recommended at the present time for clients operating trauma programs. However, Dexanabinol has the potential to transform the management of patients with severe TBI and as such should be monitored closely over the coming months.

Technology Details
Target Disease / Indication
Traumatic Brain Injury

Technology Classification
Drug

Body System
Nervous System

Program Area
Medicine/Neurology

Regulatory Status
Phase III

BioHorizon Impact Score
51/100 – Moderate