Alzheimer’s Drug Could Be Instant Blockbuster for Biogen Idec

24/7 Wall St. also noted very positive results in another study on Parkinson’s.

Biogen Idec announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), which demonstrated an acceptable safety profile and positive results in patients with prodromal or mild Alzheimer’s.

The PRIME study is an ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of aducanumab in patients with prodromal or mild Alzheimer’s.

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Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain, which is believed to play a key role in Alzheimer’s. The interim analysis of PRIME reflects data for 166 patients.

Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen, said:

This is effectively the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease. Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year.

The big news here is the move into Phase 3. Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement. Neurimmune said back on January 12, 2015:

At the 33rd Annual J.P.Morgan Healthcare Conference in San Francisco, Biogen Idec reported on the top line interim results from the current Phase 1b trial of Aducanumab (BIIB037) in prodromal or mild Alzheimer’s disease patients. BIIB037 significantly reduced beta amyloid in the brain of AD patients in a time and dose dependent manner and showed an acceptable safety profile to date. In addition, in exploratory analyses, BIIB037 showed a statistically significant impact on cognition at one year.

Shares of Biogen were up 7.4% at $465.90 in morning trading Friday. The stock has a consensus analyst price target of $427.83 and a 52-week trading range of $272.02 to $439.90.

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With Alzheimer’s having no effective treatments that do much against the disease, it is safe to assume that any real drug targeting this disease could instantly fall under the blockbuster drug category, with over $1 billion in annual sales. If approved, any real Alzheimer’s drug would make the blockbuster category multiple times over.