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WILMINGTON, Del.—Global biopharmaceutical AstraZeneca PLC and New Haven, Conn.-based private biotech firm Axerion Therapeutics Inc. have joined forces to develop an effective treatment for Alzheimer's disease.
Axerion and Gaithersburg, Md.-based MedImmune, the global biologics arm of AstraZeneca, announced May 1 that they have entered into a research collaboration and sublicense arrangement to develop and commercialize a biologic approach for the treatment of Alzheimer's.
The agreement with Axerion is the first collaboration signed within the new Neuroscience Innovative Medicines Unit that AstraZeneca announced in February 2012. Under this model, AstraZeneca and MedImmune will conduct neuroscience discovery research and early development for small and large molecules by tapping into the best available external science and sharing cost, risk and reward with other research partners active in psychiatry, neurology and pain research.
Under the terms of the agreement, Axerion has granted AstraZeneca's unit an exclusive sublicense to research, develop and commercialize a preclinical biologic that targets the binding of A-beta oligimers to prion proteins. The license is based on research conducted by Dr. Stephen Strittmatter, and the associated intellectual property is exclusively licensed to Axerion from Yale University.
In exchange, the AstraZeneca unit will provide Axerion with certain upfront and milestone payments plus research and development funding during the time both companies are working together on the program. Additionally, Axerion will earn royalties on product sales. The financial terms of the deal have not been disclosed.
The two companies will collaborate to develop a biologic approach that blocks the toxic effects of amyloid-beta (A-beta) mediated through binding of A-beta oligomers to cellular prion protein in the brain, according to AstraZeneca. This drug development effort will build on published preclinical results which demonstrate that cellular prion protein mediates A-beta oligomer-induced memory dysfunction and synaptic toxicity, and that inhibition of this interaction can have favorable therapeutic effects. Directly targeting toxic A-beta oligomer binding has the potential to provide superior safety and efficacy versus agents that affect amyloid processing or clearance.
The joint project is in the preclinical stage and expected to remain there in the next three to five years. If all goes well, human trials will follow, McBrinn says. Past biologic experiments on mouse models with Alzheimer's have been successful.
Michael Poole, head of the NIMU, stated in a news release, "A close collaboration with Axerion in this area of breaking science will greatly enhance our chances of bringing a medicine to market for people with Alzheimer's disease. This biologic approach is an example of the promising science that fuels our commitment to neuroscience research."
Sylvia McBrinn, Axerion's CEO and president, added, "We are confident that this collaboration will accelerate the development of an urgently needed therapy for Alzheimer's disease … It is our hope that this collaboration will advance a novel therapy that works quite differently from the Alzheimer's drug candidates currently in development."
The novel therapy is actually an injectable, McBrinn says, which differs from the usual small-molecule approach of taking pills.
"Keep in mind," says McBrinn, "the solution to alleviating the symptoms of Alzheimer's could consist of a cocktail of therapies. The problem is, nothing will be 100- percent effective."
An estimated 5.1 million people in the United States are living with Alzheimer's, according to the U.S. National Institute of Health (NIH), which also predicts that by the year 2050, 11 million additional people in the United States—and 115.4 million worldwide—will have Alzheimer's. The NIH also estimates $1.1 trillion will be spent in the United States on caregiving costs connected to Alzheimer's patients, compared with $200 billion this year.
President Obama signed the National Alzheimer's Project Act into law in January 2011, which called for a coordinated national plan to fight Alzheimer's, including a push for a $156 million increase in funding for Alzheimer's research over the next two years—in addition to the $450 million already being spent.