Biogen (BIIB) In-Licenses ALS Candidate BIIB067 From Ionis
Biogen Inc.BIIB announced that it has obtained a worldwide license to develop and commercialize Ionis Pharmaceuticals’ 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 industry’s decline of 16.9%.
We remind investors that in 2016, Biogen exercised its option to develop and commercialize its now successful spinal muscular atrophy (SMA) treatment, Spinraza. The drug has performed beyond expectations so far witnessing a strong patient uptake in the United States and internationally. Spinraza recorded sales of $1.2 billion during the first nine months of 2018.
Alexion’s earnings estimates have been revised 5.3% upward for 2018 and 2.1% for 2019 over the past 60 days. The stock has inched up 1.2% year to date.
Gilead Sciences’ earnings estimates have been raised 5% for 2018 and 4.8% for 2019 over the past 60 days.
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