Biogen (BIIB) In-Licenses ALS Candidate BIIB067 From Ionis

 | Dec 06, 2018 10:31PM ET

Biogen Inc. (NASDAQ:BIIB) announced that it has obtained a worldwide license to develop and commercialize Ionis Pharmaceuticals’ (NASDAQ:IONS) pipeline candidate, BIIB067 (IONIS-SOD1RX). This will enable the company to exercise an option per the deal it inked with Ionis in April.

In April, Biogen informed about a new 10-year collaboration with Ionis Pharmaceuticals to develop novel antisense drug candidate, which can treat a broad range of neurological diseases. Back then, Biogen reserved the option to in-license any new gene-based therapy emerging from the deal and thereafter develop and commercialize the product.

BIIB067 is an investigational candidate, currently evaluated for the treatment of amyotrophic lateral sclerosis (ALS) patients with superoxide dismutase 1 (SOD1) mutations.

SOD1 ALS is a familial form of ALS, accounting for approximately 2% of all ALS cases.

Biogen’s decision was based on positive interim data from a phase I study on the candidate that demonstrated proof-of-biology and proof-of-concept for BIIB067.

The study enrolled 70 patients, who were administered with single and multiple-ascending doses of BIIB067. It showed treatment with the highest dose of BIIB067 over a three-month period led to a statistically significant lowering of SOD1 protein levels in the cerebrospinal fluid and slowing of clinical decline as measured by the ALS Functional Rating Scale-Revised compared with placebo.

Following these encouraging results, Biogen plans to initiate a pivotal clinical program on BIIB067.

As part of the agreement, Biogen will pay $35 million to Ionis and will be eligible to pay up to $55 million in milestones and low-to-mid-teen royalties on net sales of the product on its potential approval and launch. Henceforth, Biogen will bear the entire future costs and expenses incurred for the development and commercialization of BIIB067.

Biogen expects to present final data from the phase I study at a future scientific forum.

Shares of Biogen have gained 2.6% so far this year against the Zacks Investment Research

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