The treatment of Alzheimer’s disease (AD) offers a compelling commercial opportunity for the pharmaceutical industry because of the large and growing patient population and the high level of unmet need. As the baby boomer generation begins to turn 65, the AD population is expected to expand dramatically. Despite this growing patient pool (and thus the need to manage the disease in such a large number of patients), treatment options for AD are at present limited to symptomatic therapies with modest efficacy of limited duration at best.
These therapies include the acetylcholinesterase inhibitors (AChEIs) donepezil (Eisai/Pfizer’s Aricept, generics), galantamine (Ortho-McNeil Neurologic’s Razadyne, Razadyne ER, generics), and rivastigmine (Novartis’s Exelon, generics, and the Exelon patch) as well as the NMDA receptor antagonist memantine (Forest Laboratories’ Namenda).
Disease-modifying therapies that could slow, halt, or reverse the progression of the disease are of critical need in this market and are eagerly anticipated by physicians. Potentially disease-modifying therapies in development for the treatment of mild to moderate AD include the anti-beta-amyloid monoclonal antibodies solanezumab (Eli Lilly) and bapineuzumab (Janssen Alzheimer Immunotherapy/Pfizer), as well as Baxter’s intravenous immunoglobulin product Gammagard.
However, the efficacy and safety of these products remain to be demonstrated in their ongoing Phase III trials, and the recent history of disease-modifying therapies in late-stage development for AD has set a grim precedent for such therapies. Nevertheless, we expect the U.S. AD landscape will shift dramatically over the next three to five years as novel disease-modifying therapies launch beginning in 2014 into a drug market dominated by generically available symptomatic therapies.
Source: Decision Resources, Inc