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Roche promises fair Alzheimer's drug price as US FDA accelerates review

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Roche promises fair Alzheimer's drug price as US FDA accelerates review

Roche Holding AG will set a reasonable price for its experimental Alzheimer's treatment gantenerumab should the drug show an "unequivocal benefit" in trials, the company's pharmaceuticals division CEO said.

Gantenerumab, which received the U.S. Food and Drug Administration's breakthrough therapy tag Oct. 8, is one of four potential Alzheimer's treatments in mid- or late-stage clinical development that target the reduction of amyloid plaques in the brain, a hallmark of the progressive disease. Breakthrough therapy designation is intended to speed up the review of medicines for serious or life-threatening conditions that show evidence of a substantial improvement over available therapies.

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The ease of subcutaneous administration compared with an infused therapy in a clinical setting and the clarity of the data from two large ongoing phases 3 studies due to read out next year could make gantenerumab one of the Basel, Switzerland-based drugmaker's biggest medicines, Roche Pharmaceuticals CEO Bill Anderson told S&P Global Market Intelligence.

"We hope that with the design [of the studies] and with this molecule, we'll see a clear, unequivocal benefit in Alzheimer's disease," Anderson said in an interview.

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Roche Pharmaceuticals CEO Bill Anderson
Source: Roche

The anti-amyloid approach to Alzheimer's disease won its first-ever approval in June, in the form of Biogen Inc. and Eisai Co. Ltd.'s aducanumab. Marketed as Aduhelm, the therapy sparked controversy following a negative recommendation from an FDA advisory committee, after phase 3 trials were halted for futility. Further combing through the clinical data showed the drug's efficacy at removing amyloid plaques at high doses — one of the trial's endpoints — and Aduhelm was approved under the breakthrough designation.

But with a price tag of $56,000 a year, Aduhelm has incurred pushback from a number of payers, who will not reimburse the monthly infusion, and some medical centers, including the Cleveland Clinic.

Should gantenerumab gain approval, Anderson said Roche would price its own Alzheimer's drug moderately.

"We try to price our medicines such that the people in the field would say, 'Hey, this is a fair price, this is very reasonable,'" the executive said.

Investor interest growing

After decades of research and numerous setbacks in the Alzheimer's field, researchers remain focused on the role of two proteins: the plaque-causing amyloid beta or abeta, and a tangle of proteins that accumulate within the brain called tau. With an estimated 10% of people aged 65 and older and 50% of those over 85 experiencing Alzheimer's disease projected to total some 78 million people worldwide by 2030 the need for effective medicines is pressing. In the U.S. alone, Cowen estimates the cost of the memory-robbing disease amounts to $80 billion to $100 billion annually from healthcare costs and lost wages.

The Aduhelm approval has not only galvanized drug companies researching and developing dementia medicines — now that there is the potential to use different biomarkers to show disease progression in a clinical trial — but it has spurred investment in an area previously viewed as high risk. The potential for shorter timelines, lower costs and a greater likelihood of regulatory approval makes the field an attractive investment target, said Laurence Barker, partner of the Dementia Discovery Fund, a venture fund established in 2015 to invest in early-stage drug discovery and development for the condition.

Barker pointed to the FDA's decision to approve Aduhelm based on a surrogate biomarker — in this case a reduction in amyloid plaques — rather than the typical measure of increased survival or quality of life. Surrogate endpoints are sometimes used by regulators instead of stronger indicators because the results of a trial can be measured sooner.

"With the events around aducanumab recently, and the FDA's approval there, that has absolutely stimulated ... a recognition that surrogate biomarkers may now be an opportunity to obtain approval for new medicines in this field," Barker said in an interview.

"This is new for this field of neuroscience," Barker added. "But it's not new for the sector, as we've seen in other areas before oncology is perhaps the best example."

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As in cancer care, where drugs are often combined to hit different targets, Alzheimer's researchers are trying to define the precise mechanism of disease and identify those patients in whom they think that this mechanism is most clearly a driver.

"Alzheimer's disease is a complex disorder with different cell types involved, different stages with complex genetics," said Bart De Strooper, professor and director of the U.K. Dementia Research Institute at University College London. "I don't think there is a golden bullet which is going to solve it this is not an infection, this is a systems failure."

The need for more effective and targeted medicines, combined with the controversial approval of Aduhelm, may ignite the Alzheimer's field and pave the way for a stream of competitors to hit the market from the likes of Eli Lilly and Co. and Roche, among others. Total sales of Alzheimer's drugs are expected to soar from $300 million in 2020 to $14 billion in 2025, according to Cowen.

With increased spending usually comes increased scrutiny from watchdogs like ICER, which have already said Aduhelm is not effective enough to warrant a price above $3,000 to $8,400 per year.

"As a scientist, I don't think [Aduhelm] delivered the proof which you would expect from rigorous science," De Strooper told Market Intelligence. "But I also follow the reasoning from the FDA and what's clear is that the target was hit in a way which has never been done before by anti-amyloid therapies."

While gantenerumab now benefits from breakthrough therapy designation, it has a checkered past and failed two late-stage trials in 2014. But with better-designed trials, a similar anti-amyloid approach to Aduhelm and the convenience of subcutaneous administration, scientists and investors have renewed optimism.

"With the type of proof you have at the moment, I don't dare to predict that [Aduhelm] is really a breakthrough," De Strooper said. "But it has made it possible to test a couple of other [drugs], and I would be surprised if none of these antibodies gives at least some benefit to patients."