Alzheimer’s research has long been a divided field. Either you believe amyloid-beta is a central cause of the disease, or you point the finger at tau tangles in the brain.
On Thursday, Merck took the stance of an independent by licensing a preclinical anti-tau antibody from Tokyo, Japan-based Teijin Pharma. This adds to Merck’s existing Alzheimer’s candidate verubecestat, which tries to prevent the build-up of amyloid-beta by targeting an enzyme known as BACE1.
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A Merck spokeswomen declined to comment on the licensing agreement, beyond what has already been disclosed in the media release. Financial terms of the deal have not been released.
Numbers aside, Merck’s move is interesting on several fronts — not least because the field crushed its most recent attempt at defeating the disease.
In February of this year, Merck revealed that it was pulling the plug on its 2,000-patient Phase 2/3 trial of verubecestat after an interim analysis revealed the trial had virtually no chance of statistical success.
That study had enrolled patients with mild-to-moderate AD. Merck now believes it has to target an even earlier stage, known as prodromal Alzheimer’s disease, to intervene before the person begins losing function.
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It’s the same approach Eli Lilly took with solanezumab, but many millions of dollars later, the drug still failed to show efficacy.
That’s why another shot on goal may be appealing. The drugs are expensive to study in clinical trials, but given the size of the market, any FDA approval would quickly repay years of R&D costs.
In 2015, approximately 46 million people were living with some form of dementia, including Alzheimer’s disease. That number is set to almost double every 20 years as populations age and life spans increase in low- and middle-income nations.
It’s a long game. Teijin Pharma has done the preclinical heavy lifting on the anti-tau antibody; it’s now up to Merck to move it into the clinic.
In return, the pharma giant will make an upfront payment to Teijin, along with possible development, regulatory and sales milestone payments. Teijin will also get a cut of the royalties on any product sales. However, given the oft-quoted 99 percent failure rate of Alzheimer’s drugs, it would be unwise to count on that revenue. Pivotal studies are many years away.
As for verubecestat, Merck expects clinical data from the prodromal AD studies in February 2019.
Meanwhile, Axovant is looking ahead to a data readout on its Phase 3 Alzheimer’s study in September of this year. After the failure of Accera’s late-stage asset, Axovant is one of the only candidate vying for a near-term FDA approval.
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