BrainStorm Granted SME Status by the European Medicines Agency
June 15 2020 - 9:00AM
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.
About NurOwn®NurOwn®
(autologous MSC-NTF) cells represent a promising investigational
therapeutic approach to targeting disease pathways important in
neurodegenerative disorders. MSC-NTF cells are produced from
autologous, bone marrow-derived mesenchymal stem cells (MSCs) that
have been expanded and differentiated ex vivo. MSCs are converted
into MSC-NTF cells by growing them under patented conditions that
induce the cells to secrete high levels of neurotrophic factors.
Autologous MSC-NTF cells can effectively deliver multiple NTFs and
immunomodulatory cytokines directly to the site of damage to elicit
a desired biological effect and ultimately slow or stabilize
disease progression. BrainStorm has fully enrolled a Phase 3
pivotal trial of autologous MSC-NTF cells for the treatment of
amyotrophic lateral sclerosis (ALS). BrainStorm also recently
received U.S. FDA acceptance to initiate a Phase 2
open-label multicenter trial in progressive MS and enrollment began
in March 2019.
About BrainStorm Cell Therapeutics
Inc.BrainStorm Cell Therapeutics Inc. is a leading
developer of innovative autologous adult stem cell therapeutics for
debilitating neurodegenerative diseases. The Company holds the
rights to clinical development and commercialization of the NurOwn®
technology platform used to produce autologous MSC-NTF cells
through an exclusive, worldwide licensing agreement. Autologous
MSC-NTF cells have received Orphan Drug status designation from
the U.S. Food and Drug Administration (U.S. FDA) and
the European Medicines Agency (EMA) in ALS. BrainStorm
has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056),
investigating repeat-administration of autologous MSC-NTF cells at
six U.S. sites supported by a grant from
the California Institute for Regenerative Medicine (CIRM
CLIN2-0989). The pivotal study is intended to support a filing
for U.S. FDA approval of autologous MSC-NTF cells in ALS.
BrainStorm also recently received U.S. FDA clearance to
initiate a Phase 2 open-label multicenter trial in progressive
Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells
in patients with progressive MS (NCT03799718) started enrollment
in March 2019.
Safe-Harbor
Statement Statements in this announcement other than
historical data and information, including statements regarding
future clinical trial enrollment and data, constitute
"forward-looking statements" and involve risks and uncertainties
that could cause BrainStorm Cell Therapeutics
Inc.'s actual results to differ materially from those stated
or implied by such forward-looking statements. Terms and phrases
such as "may", "should", "would", "could", "will", "expect",
"likely", "believe", "plan", "estimate", "predict", "potential",
and similar terms and phrases are intended to identify these
forward-looking statements. The potential risks and uncertainties
include, without limitation, BrainStorm's need to raise additional
capital, BrainStorm's ability to continue as a going concern,
regulatory approval of BrainStorm's NurOwn® treatment candidate,
the success of BrainStorm's product development programs and
research, regulatory and personnel issues, development of a global
market for our services, the ability to secure and maintain
research institutions to conduct our clinical trials, the ability
to generate significant revenue, the ability of BrainStorm's
NurOwn® treatment candidate to achieve broad acceptance as a
treatment option for ALS or other neurodegenerative diseases,
BrainStorm's ability to manufacture and commercialize the NurOwn®
treatment candidate, obtaining patents that provide meaningful
protection, competition and market developments, BrainStorm's
ability to protect our intellectual property from infringement by
third parties, heath reform legislation, demand for our services,
currency exchange rates and product liability claims and
litigation,; and other factors detailed in BrainStorm's annual
report on Form 10-K and quarterly reports on Form 10-Q available
at http://www.sec.gov. These factors should be considered
carefully, and readers should not place undue reliance on
BrainStorm's forward-looking statements. The forward-looking
statements contained in this press release are based on the
beliefs, expectations and opinions of management as of the date of
this press release. We do not assume any obligation to update
forward-looking statements to reflect actual results or assumptions
if circumstances or management's beliefs, expectations or opinions
should change, unless otherwise required by law. Although we
believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee future results,
levels of activity, performance or achievements.
CONTACTS
Investor Relations: Preetam Shah, MBA, PhD
Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone:
+1-862-397-1860 pshah@brainstorm-cell.com
Media:Sean Leous Westwicke/ICR PR Phone:
+1-646-677-1839 sean.leous@icrinc.com
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Sep 2023 to Sep 2024