Biogen has filed a new drug application to Japan’s regulator for the approval of aducanumab, its investigational treatment for Alzheimer’s disease, which it is developing together with local partner Eisai.
Biogen (BIIB) said that the New Drug Application (J-NDA) for aducanumab was submitted to the country’s Ministry of Health, Labor and Welfare (MHLW), and is now under regulatory review in Japan, Europe and the US.
Aducanumab, a human monoclonal antibody, has been shown in clinical trials to remove amyloid beta in the brain and “significantly” slow clinical decline in patients with mild cognitive impairment (MCI) as a result of Alzheimer’s disease and mild Alzheimer’s disease dementia.
“Japan is the third market where we have applied for regulatory approval for aducanumab, and the filing represents continued progress on our commitment to bring this therapy to patients around the world,” said Biogen CEO Michel Vounatsos. “Japan has met the challenges of a rapidly aging population by demonstrating global leadership in setting policies that aim to increase support for Alzheimer’s disease patients and caregivers.”
According to data from Japan’s Health, Labor and Welfare Ministry, about 4.6 million people live with dementia and about 4 million people live with MCI in the country. Alzheimer’s disease is estimated to represent around 60-70% of dementia cases.
Eisai’s CEO Haruo Naito stated that as Japan has the oldest population in the world, it is expected that the social burden of Alzheimer’s disease will continue to grow.
“Aducanumab also has the potential to help address the public health challenges our aging population faces in Japan,” Naito commented.
In addition to the filing in Japan, aducanumab is under priority review by the US Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) deadline set for March 7, 2021. The human monoclonal antibody treatment is also under review by the European Medicines Agency.
In the US, more than 5.8 million people are living with Alzheimer’s disease. By 2050, this number is projected to more than double. Alzheimer’s disease was the sixth leading cause of death in the US and the fifth leading cause for people aged 65 years and older in 2018.
Biogen last month announced a deal to acquire a $650 million stake in Sage Therapeutics to jointly develop and sell treatments for depression and other neurological disorders.
Commenting on the deal, J. P. Morgan analyst Cory Kasimov decided to stick to a Hold rating on the stock, while arguing that it makes sense for Biogen regardless of the aducanumab outcome.
“This was a much-needed and welcomed late-stage transaction that meaningfully diversifies the ex-Alzheimer’s pipeline (should zuranolone, and to a lesser extent, SAGE-324, work),” Kasimov wrote in a note to investors. “This does beg the question as to “the read-through to aducanumab.” (See BIIB stock analysis on TipRanks)
“That’s difficult to say given the wildcard that asset has been to date, but we’re still skeptical,” the analyst added.
Meanwhile, the rest of the Street is in line with Kasimov’s outlook. The Hold analyst consensus shows 11 Buys versus 13 Holds and 5 Sells. With shares down 18% so far this year, the average price target of $293.74 implies 20% upside potential to current levels.
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