The House's passage of the National Alzheimer's Project Act yesterday — should it be signed into law by President Obama — could help expedite the approval process for new drugs targeting the disease, sources say.
Alzheimer's disease, a form of dementia, has been the target of numerous clinical studies over the past 10 years, with mostly lackluster results. With the ratification of Rep. Ed Markey's (D-MA) National Alzheimer's Project Act (NAPA), and at least two novel, late-stage drug candidates in the pipeline, however, new products could emerge as early as 2013, according to a Datamonitor report.
Two of the most promising late-stage drugs in development according to Datamonitor — Pfizer and Johnson & Johnson's bapineuzumab and Eli Lilly's solanezumab — are both potential blockbusters, and represent a new therapeutic class for the treatment of Alzheimer's disease. Pfizer and Elan's Aricept, which had global sales topping $3 billion this year, lost patent protection in November, although FDA approved a stronger dose of the brand drug in July.
Robert Egge, VP, public policy and advocacy at The Alzheimer's Association, a not-for-profit health organization, said NAPA, which aims to “accelerate the development of treatments that would prevent, halt, or reverse the course of Alzheimer's,” as stated in the bill, will provide “a much larger scale of investment” into pharmaceutical research, which will in turn lead to a “larger pipeline” for Alzheimer's drugs. The Act would also precipitate a “systematic review” of how the government helps patients with the disease, said Egge. The Alzheimer's Association, in partnership with Pfizer, launched an unbranded online virtual community (TimeToFaceAlz.org) last week.
Louise Mehrotra, VP, investor relations at J&J, said in a Q3 earnings call in October that bapineuzumab “has the greatest potential for [Alzheimer's] disease modification,” adding that the drug would be first in class, if approved. “If you look at the cost associated with Alzheimer's disease, it's estimated in the US to be about $150 billion,” which presents a “tremendous opportunity,” said Mehrotra. J&J plans to submit the drug for approval “in 2012-2013,” Mehrotra said on the call.
In a statement, Secretary Kathleen Sebelius applauded the passage of NAPA. “The disease currently afflicts more than five million Americans, and that number is likely to double in the coming years,” said Sebelius. “I look forward to implementing the legislation's provisions swiftly and effectively.”