Biogen (BIIB) shares rocketed higher Wednesday after the drugmaker and its Japan-based partner Eisai Co Ltd. unveiled better-than-expected results from a late-stage stud of their developing Alzheimer's treatment.
Biogen said the drug, known as lecanemab, improved the slowdown in cognitive function and functional decline of patients with early-stage Alzheimer's disease, when compared to use of a placebo in a Phase 3 trial of around 1,800 patients.
Alzheimer's disease is a progressive brain disorder that affects more than 50 million people around the world. To date, no drug has been found to address the disease, which can accelerate into dementia and other more serious cognitive conditions.
Eisai said it will apply for full approval of the treatment with the U.S. Food & Drug Administration last this year, with an aim for commercial use of the drug in late 2023.
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Biogen CEO Michel Vounatsos.
"As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities,” he added.
Biogen shares were marked 42% higher in early Wednesday trading to change hands at $280.70 each, a move that would lift the stock into positive territory for the year.
The news followed a specific reference to Biogen's own Alzheimer treatment, Aduhelm, by the Centers of Medicare and Medicaid Services Tuesday while linked its decision to limit access as a major factor in lowering premiums for Medicare Part B.
The CMS said earlier this year that it will only cover treatment with Aduhelm if patients are enrolled in a clinical trial following Biogen's move in December of 2021 to slash the price of Aduhelm by around 50%, to $28,200 per year, in order to help expand its potential reach.
"Lower-than-projected spending on both Aduhelm and other Part B items and services resulted in much larger reserves," the CMS said.
Biogen said that its Aduhelm treatment "significantly" lowered blood levels in abnormal tau proteins, which are linked to neuronal damage in neurodegeneration, including Alzheimer's disease.
Aduhelm, Biogen noted in earlier studies, has been show to erode amyloid beta, a plaque which builds up around the brain and can lead to neuron damage.
The FDA approved Aduhelm for the treatment of Alzheimer’s through its accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments, last year.
