Pharmacor

Introduction:

Last Updated 2 September 2010
Despite a large and rapidly growing patient population, the treatment of Alzheimer’s disease (AD) consists only of symptomatic therapies that do not halt the underlying cause of the disease. Accordingly, disease-modifying therapies are a critical need in this market. Several agents with this potential are likely to launch during our ten-year forecast period, dramatically expanding the AD therapy market.

Questions Answered in This Report:

  *   Several therapies with potentially disease-modifying capabilities are forecast to launch for AD in the next ten years, dramatically altering the landscape of the AD market. Among the three potentially disease-modifying therapies in late-stage development (Eli Lilly’s solanezumab, Johnson & Johnson/Pfizer’s bapineuzumab, and Baxter’s IVIg [Gammagard]), which will be first to market? How will these drugs perform in this market, given that they will likely launch within a few years of one another? What factors will constrain the use of disease-modifying drugs?

  *   Current treatments for AD provide only modest symptomatic relief, and so therapies with disease-modifying potential are greatly needed. What will the impact of disease-modifying therapies be on the use of the acetylcholinesterase inhibitors donepezil (Eisai/Pfizer’s Aricept, Bracco’s Memac), galantamine (Shire Pharmaceuticals/Janssen/Ortho-McNeil Neurologics’ Reminyl/Razadyne/Razadyne ER, generics), and rivastigmine (Novartis’s Exelon/Exelon Patch, Esteve/Biofutura’s Prometax, generics) and the NMDA receptor antagonist memantine (Merz Pharmaceuticals/Grünenthal’s Axura, Lundbeck’s Ebixa, Forest Laboratories’ Namenda)? How do physicians anticipate incorporating both symptomatic and disease-modifying therapies into the AD treatment algorithm?

  *   Although many emerging therapies have the potential to slow the course of AD, they may be associated with greater safety risks. What effect will safety risks have on these agents’ use? What do experts say about their safety profiles, in particular the monoclonal antibodies solanezumab and bapineuzumab? To which patient segments will neurologists prescribe such drugs? What will happen to the AD market if these antibodies fail to launch due to safety concerns?

  *   The development of improved diagnostic tools will not only enable earlier and more-accurate diagnosis of AD but also influence therapy selection and treatment rates. We provide separate estimates for the prevalence of AD and pre-AD. Which emerging therapies will neurologists prescribe to pre-AD patients, and what is the market potential of this population?

  *   The failure of Pfizer/Medivation’s latrepirdine (Dimebon) in the Phase III CONNECTION clinical trial in mild to moderate AD and its discontinuation for the moderate to severe AD population raises questions about the drug’s efficacy in AD and about its future market potential. How has physician perception of latrepirdine changed in light of these developments? What impact will latrepirdine’s failure in the CONNECTION trial have on its commercial potential? How will this news affect the uptake of currently available AD therapies?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 29 country-specific interviews with thought leaders.

Epidemiology: Prevalence of AD and pre-AD (a population of patients who will likely convert to AD, segmented into patients who will likely convert to AD within two years and patients likely to convert between three and five years) by region.

Population segments in the market forecast: AD, pre-AD (patients who will likely convert to AD within two years).

Emerging therapies: Phase II: 27 drugs; Phase III: 4 drugs; coverage of 12 preclinical and Phase I products.

Market forecast features: Incorporating pharmacological treatment of mild, moderate, and severe AD, we forecast annualized drug sales for AD and pre-AD populations through 2019.

Alternate market scenarios: (1) Latrepirdine does not achieve regulatory approval owing to lack of efficacy in Phase III trials; (2) Latrepirdine launches, but its use and uptake in the AD market are hindered by limited efficacy in mild to moderate AD and negative Phase III trial results in the CONNECTION study; (3) monoclonal antibodies do not achieve regulatory approval because of a low benefit-to-risk ratio; (4) monoclonal antibodies have severely restricted patient share owing to safety concerns; (5) diagnostic tools and biomarkers for AD do not launch by 2019.