The World Economic Forum this week launched its partnership with the Davos Alzheimer’s Collaborative (DAC) in a global effort to accelerate the discovery, testing and delivery of precision interventions for Alzheimer’s disease.
The public-private partnership is taking a comprehensive approach to collecting diverse population data, conducting clinical trials, supporting health system preparedness and creating a global innovation system to speed and scale up the global response, lower costs and bring new treatments and diagnostics to market.
“This disease is a global story,” George Vrandenburg, a DAC convenor and chairman and co-founder of UsAgainstAlzheimer’s, told BioWorld.
Following the models of Gavi and the Coalition for Epidemic Preparedness Innovations, the new global Alzheimer’s initiative is prioritizing three main areas: the building of a global cohort with high-quality, detailed data on a well-characterized, diverse population; the creation of a clinical trial network with participants from Australia, China, Colombia, Europe, Japan, Singapore and South Korea; and the implementation of global commitments and strategies to ensure health system preparedness for tackling Alzheimer’s.
The effort comes at a time when hope is running high that the first disease-modifying drugs will soon be available for patients with Alzheimer’s. Vrandenburg noted that phase III trial results for three to four potential disease-modifying drugs will read out within the next few years. Meanwhile, more than 100 candidates, with a variety of targets, are in the Alzheimer’s pipeline.
Endo, Impax under antitrust scrutiny again
Endo International plc, of Dublin, and Impax Laboratories LLC, of Hayward, Calif., are back in the antitrust crosshairs of the U.S. Federal Trade Commission (FTC), as is Impax’s parent company, Amneal Pharmaceuticals Inc., of Bridgewater, N.J.
The FTC is suing the companies, alleging that an agreement they reached in 2017 violated antitrust law by eliminating competition for extended-release oxymorphone. Ironically, Endo and Impax entered that agreement even as a separate FTC case was pending over what the commission determined was an illegal pay-for-delay patent settlement, from 2010, in which Endo promised not to launch an authorized Opana ER (oxymorphone) generic during the first generic filer 180-day exclusivity and paid Impax more than $112 million not to compete.
The 2017 agreement came after Endo withdrew, at the FDA’s request, what was considered an abuse-deterrent formulation of Opana for safety reasons. The withdrawal meant Impax’s generic of the original formulation was the only extended-release oxymorphone product available on the U.S. market.
Arising from a breach-of-contract case related to the earlier settlement, the 2017 agreement allowed Impax to maintain its oxymorphone ER monopoly while giving Endo a share of the profits. The FTC characterized the agreement as paying Endo to stay out of the market.
More on EMA cyberattack
Bit by bit, the EMA is releasing more information about last year’s cyberattack that breached confidential information about COVID-19 vaccines.
Earlier this month, the EMA disclosed that the documents included email correspondence that was made public through the Internet and subsequently picked up by some media.
“A closer investigation of the published material has revealed that not all of the documents were published in their integral, original form and may have been taken out of context,” the EMA said in a Jan. 25 update.
While leaked individual emails are authentic, “data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines,” the agency said.