BrainStorm Seeking Approval To Distribute NurOwn® in Canada

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced an agreement with CCRM, a Toronto-based company developing and commercializing regenerative medicine technologies, and cell and gene therapies, to support the market authorization request for NurOwn®. BrainStorm Cell Therapeutics is a developer of adult stem cell technologies for neurodegenerative diseases,
As quoted in the press release:

At this time, CCRM is helping Brainstorm explore the opportunity to access Health Canada’s early access pathway for treatment of patients with Amyotrophic Lateral Sclerosis (ALS).  If NurOwn® qualifies for Health Canada’s “Notice of Compliance with Conditions” pathway, it could be authorized in Canada for distribution in early 2018.
“We are pleased to partner with CCRM as we continue our efforts to develop and make NurOwn available commercially to patients with ALS as quickly as possible,” says Chaim Lebovits, president and CEO of BrainStorm.  “We look forward to discussing with Health Canada staff the results of our ALS clinical program to date, which we believe shows compelling evidence of safety and efficacy and may qualify for rapid review under Canada’s regulatory guidelines for drugs to treat serious or life-threatening conditions.”
“Regulatory affairs is an essential part of the commercialization process which is why CCRM has developed in-house expertise to offer consulting to our academic and industry partners,” explains Dr. Michael May, president and CEO, CCRM. “Patrick Bedford is working with BrainStorm to support its efforts to bring a treatment for ALS to patients in Canada.”

Click here for the full press release.