PharmAla Biotech and Filament Health Announce Release of GMP MDMA Capsules
April 11 2023 - 8:00AM
PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE:MDMA), a Canadian
biotechnology company dedicated to the research and development of
clinical-grade LaNeo™ MDMA and novel MDXX compounds, and Filament
Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”), a
clinical-stage natural psychedelic drug development company, today
announced the GMP release of MDMA capsules at the Metro Vancouver
facility operated by Filament’s subsidiary Psilo Scientific.
“PharmAla has been working for some time to fill the backlog of
MDMA for clinical researchers all over the world. As the
psychedelics industry matures, the amount of clinical research for
MDMA is set to grow,” said Nick Kadysh, CEO at PharmAla Biotech.
“We’re happy to have reached this important milestone which will
allow PharmAla to further distribute finished MDMA drug product to
qualified researchers, and are grateful to Filament for their
partnership. Our eyes are now fully set on jurisdictions like
Australia, which will require full commercial-scale manufacturing
of both GMP API and drug product to fulfill demand for patients -
and those jurisdictions still to come.”
Filament and PharmAla have entered into a partnership whereby
Filament’s subsidiary Psilo Scientific was contracted to
manufacture MDMA capsules for PharmAla, utilizing PharmAla’s
previously-manufactured GMP LaNeo™ MDMA Active Pharmaceutical
Ingredient (API). The capsules are destined for distribution to
clinical trial customers and authorized patients in Canada and
globally. The MDMA was encapsulated at Psilo Scientific’s
GMP-compliant, Health Canada licensed facility.
“The GMP release of MDMA drug product is an exciting step for
the psychedelic industry, and indicative of our manufacturing
capability,” said Benjamin Lightburn, CEO and Co-Founder of
Filament Health. “MDMA has shown promise for treating a range of
health conditions and we’re proud to support PharmAla’s efforts to
improve access.”
PharmAla will present its vision for the future of the
commercial MDMA market at the Benzinga Psychedelics Capital
Conference in Miami on April 13th.
ABOUT PHARMALA BIOTECH
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a
biotechnology company focused on the research, development, and
manufacturing of MDXX class molecules, including MDMA. PharmAla was
founded with a dual focus: alleviating the global backlog of
generic, clinical-grade MDMA to enable clinical trials, and to
develop novel drugs in the same class. PharmAla is the first
publicly-traded company to manufacture clinical-grade MDMA.
PharmAla’s research and development unit has completed
proof-of-concept research into ALA-002, PharmAla’s lead drug
candidate. PharmAla is a “regulatory first” organization, formed
under the principle that true success in the psychedelics industry
will only be achieved through excellent relationships with
regulators.
For more information, please contact:Nicholas
KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email:
press@PharmAla.caPhone: 1-855-444-6362
Website: www.PharmAla.ca
ABOUT FILAMENT HEALTH (OTCQB:FLHLF)
(NEO:FH) (FSE:7QS)Filament Health is a clinical-stage
natural psychedelic drug development company. We believe that safe,
standardized, naturally-derived psychedelic medicines can improve
the lives of many, and our mission is to see them in the hands of
everyone who needs them as soon as possible. Filament’s platform of
proprietary intellectual property enables the discovery,
development, and delivery of natural psychedelic medicines. We are
paving the way with the first-ever natural psychedelic drug
candidates.
Learn more at www.filament.health and on
Twitter, Instagram and LinkedIn.
MEDIA RELATIONSAnna Cordon,
Director of Communications778.245.9067anna@filament.health
INVESTOR
RELATIONSir@filament.health
FORWARD LOOKING
INFORMATIONCertain statements and information contained
herein may constitute “forward-looking statements” and
“forward-looking information,” respectively, under Canadian
securities legislation. Generally, forward-looking information can
be identified by the use of forward-looking terminology such as,
“expect”, “anticipate”, “continue”, “estimate”, “may”, “will”,
“should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and
similar expressions are intended to identify forward-looking
statements or information. Forward-looking statements herein
include, but are not limited to, statements regarding the benefits
of the agreement between the Companies and the commercialization of
Filament’s natural psilocybin drug candidate, PEX010 (25 mg). There
are numerous risks and uncertainties that could cause actual
results and the Companies’ plans and objectives to differ
materially from those expressed in the forward-looking information.
Actual results and future events could differ materially from those
anticipated in such information. These and all subsequent written
and oral forward-looking information are based on estimates and
opinions of management on the dates they are made and are expressly
qualified in their entirety by this notice. Accordingly, readers
should not place undue reliance on forward-looking statements and
forward-looking information. The Companies will not update any
forward-looking statements or forward-looking information that are
incorporated by reference herein, except as required by applicable
securities laws.
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