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BrainStorm Granted SME Status by the European Medicines Agency

June 15 2020 - 09:00AM

GlobeNewswire Inc. Print

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) Micro, Small and Medium-Sized Enterprise (SME) office.
The newly granted SME status allows BrainStorm to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities as well as fee waivers for selective EMA pre and post-authorization regulatory filings, including Orphan Drug and PRIME designations.

Brainstorm is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

“This is an additional and timely step in our global strategy as we continue to engage with the EMEA,” said David Setboun, Pharm.D, MBA, Chief Operating Officer of BrainStorm. “Our ALS investigational product received orphan drug status in Europe in July 2013 and we will benefit from the enhanced interaction and early dialogue allowing us to optimize development plans and speed up evaluation in Europe. EMA is facilitating pathways such as PRIME designation that enables critical medicines for major unmet medical need like NurOwn® to reach patients earlier.”

The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies such as BrainStorm to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options like NurOwn.

https://finance.yahoo.com/news/brainstorm-granted-sme-status-european-130010725.html