Axerion and Gaithersburg, Md.-based MedImmune, the globalbiologics arm of AstraZeneca, announced May 1 that they have entered into aresearch collaboration and sublicense arrangement to develop and commercializea biologic approach for the treatment of Alzheimer's.
The agreement with Axerion is the first collaboration signedwithin the new Neuroscience Innovative Medicines Unit that AstraZenecaannounced in February 2012. Under this model, AstraZeneca and MedImmune willconduct neuroscience discovery research and early development for small andlarge molecules by tapping into the best available external science and sharingcost, risk and reward with other research partners active in psychiatry,neurology and pain research.
Under the terms of the agreement, Axerion has grantedAstraZeneca's unit an exclusive sublicense to research, develop andcommercialize a preclinical biologic that targets the binding of A-betaoligimers to prion proteins. The license is based on research conducted by Dr.Stephen Strittmatter, and the associated intellectual property is exclusivelylicensed to Axerion from Yale University.
In exchange, the AstraZeneca unit will provide Axerion withcertain upfront and milestone payments plus research and development fundingduring the time both companies are working together on the program.Additionally, Axerion will earn royalties on product sales. The financial termsof the deal have not been disclosed.
The two companies will collaborate to develop a biologicapproach that blocks the toxic effects of amyloid-beta (A-beta) mediatedthrough binding of A-beta oligomers to cellular prion protein in the brain,according to AstraZeneca. This drug development effort will build on publishedpreclinical results which demonstrate that cellular prion protein mediatesA-beta oligomer-induced memory dysfunction and synaptic toxicity, and thatinhibition of this interaction can have favorable therapeutic effects. Directlytargeting toxic A-beta oligomer binding has the potential to provide superiorsafety and efficacy versus agents that affect amyloid processing or clearance.
The joint project is in the preclinical stage and expectedto remain there in the next three to five years. If all goes well, human trialswill follow, McBrinn says. Past biologic experiments on mouse models withAlzheimer'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 willgreatly enhance our chances of bringing a medicine to market for people withAlzheimer's disease. This biologic approach is an example of the promisingscience that fuels our commitment to neuroscience research."
Sylvia McBrinn, Axerion's CEO and president, added, "We areconfident that this collaboration will accelerate the development of anurgently needed therapy for Alzheimer's disease … It is our hope that thiscollaboration will advance a novel therapy that works quite differently fromthe 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 alleviatingthe symptoms of Alzheimer's could consist of a cocktail of therapies. Theproblem is, nothing will be 100-percent effective."
An estimated 5.1 million people in the United States areliving with Alzheimer's, according to the U.S. National Institute of Health(NIH), which also predicts that by the year 2050, 11 million additional peoplein the United States—and 115.4 million worldwide—will have Alzheimer's. The NIHalso estimates $1.1 trillion will be spent in the United States on caregivingcosts connected to Alzheimer's patients, compared with $200 billion this year.
President Obama signed the National Alzheimer's Project Actinto law in January 2011, which called for a coordinated national plan to fightAlzheimer's, including a push for a $156 million increase in funding forAlzheimer's research over the next two years—in addition to the $450 millionalready being spent.