PharmaTher Engages Alcami for
Clinical and Commercial Manufacturing of Novel Ketamine
Products
-
Leading
U.S.-based CDMO to manufacture PharmaTher's proprietary ketamine
products for FDA Phase 3 clinical studies and global
commercialization.
-
Expected FDA
clinical and commercial supply in H2-2022.
-
Unlocking
potential partnership opportunities with research labs, clinics and
pharmaceutical companies globally.
TORONTO, October 19, 2021 -- InvestorsHub NewsWire --
PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB:
PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech
company, announces it
has entered into an agreement with Alcami Corporation
("Alcami"), a global pharmaceutical contract
development and manufacturing organization (CDMO) with extensive
experience in cGMP sterile fill-finish products and handling of
controlled substances, for the clinical and commercial
manufacturing of the Company's proprietary ketamine
products.
PharmaTher is focused on building a specialty ketamine-based
product pipeline to support its internal product pipeline,
including rare and near-rare neurological disorders such as
Parkinson's disease and ALS (Lou Gehrig's
disease).
The ability to manufacture and supply ketamine products in
different dosage forms enables PharmaTher to not only guarantee
delivery on its product pipeline but creates opportunity to partner
in other value creation opportunities. The Company expects to form
partnerships with research labs, ketamine clinics and
pharmaceutical companies that are: seeking a secure supply of cGMP
ketamine and ketamine products for current portfolios; exploring
alternative dose forms for multiple existing indications; and
requiring support to develop and eventually commercialize specific
ketamine products for new indications. It is expected that
PharmaTher's proprietary ketamine drug product(s) will be available
for FDA Phase 3 clinical studies and commercial use in
H2-2022.
On September 29, 2021,
Alcami announced an additional $31 million investment to expand its
sterile development and manufacturing operation in Charleston, SC,
that will substantially increase its fill-finish and lyophilization
capacity.
This expansion will also be
able to support PharmaTher's ketamine product development and
commercialization plans globally.
"We are thrilled to work with PharmaTher and offer our
expertise in GMP sterile fill-finish manufacturing and
controlled-substances to support PharmaTher's ketamine product
programs," commented Patrick Walsh, Chairman & Chief Executive
Officer of Alcami. "The support we have been
engaged to provide is a testament to our broad capabilities,
technical expertise, and ability to collaborate with customers to
consistently deliver high quality results," added Mr.
Walsh.
"PharmaTher is evolving to become a leader in ketamine-based
solutions for mental health, neurological and pain disorders, and
partnering with Alcami as our exclusive manufacturer for the
clinical and commercial supply of ketamine allows us to fulfill our
objectives in serving these large markets and future partnering
opportunities globally," said Fabio Chianelli, CEO of
PharmaTher.
About Alcami
Corporation
Alcami is a contract development
and manufacturing organization headquartered in North Carolina with
over 40 years of experience advancing products through every stage
of the development lifecycle. Leveraging four US-based scientific
campuses, Alcami serves biologics and pharmaceutical companies of
all sizes providing customizable and innovative solutions for
development, clinical to commercial sterile and oral solid
manufacturing, packaging, microbiology, and analytical services.
Alcami's private equity owners include Madison Dearborn Partners
and Ampersand Capital Partners. For more information, please
visit alcaminow.com,
mdcp.com, or ampersandcapital.com.
About PharmaTher Holdings
Ltd.
PharmaTher Holdings Ltd.
(OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company
focused on the research, development and commercialization of novel
uses, formulations and delivery methods of psychedelics, such as
ketamine, to treat mental health, neurological and pain
disorders. PharmaTher is currently initiating an
FDA approved phase 2 clinical study with ketamine to treat
Parkinson's disease and is developing a novel microneedle patch for
the intradermal delivery of psychedelics.
Learn more
at:
PharmaTher.com and follow us on
Twitter and
LinkedIn.
For more information about PharmaTher, please
contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com
Neither
the Canadian Securities Exchange nor its Regulation Services
Provider have reviewed or accept responsibility for the adequacy or
accuracy of this release.
Cautionary
Statement
This
press release contains 'forward-looking information' within the
meaning of applicable Canadian securities legislation. These
statements relate to future events or future performance. The use
of any of the words "could", "intend", "expect", "believe", "will",
"projected", "estimated", "potential", "aim" and similar
expressions and statements relating to matters that are not
historical facts are intended to identify forward-looking
information and are based on PharmaTher Holdings Ltd. (the
"Company") current belief or assumptions as to the outcome and
timing of such future events. Forward-looking information is based
on reasonable assumptions that have been made by the Company at the
date of the information and is subject to known and unknown risks,
uncertainties, and other factors that may cause actual results or
events to differ materially from those anticipated in the
forward-looking information. Given these risks, uncertainties and
assumptions, you should not unduly rely on these forward-looking
statements. The forward-looking information contained in this press
release is made as of the date hereof, and Company is not obligated
to update or revise any forward-looking information, whether as a
result of new information, future events or otherwise, except as
required by applicable securities laws. The foregoing statements
expressly qualify any forward-looking information contained herein.
Factors that could cause actual results to differ materially from
those anticipated in these forward-looking statements are described
under the caption "Risk Factors" in Company's management's
discussion and analysis for the period of May 31, 2021
("MD&A"), dated September 7, 2021, which
is available on the Company's profile at
www.sedar.com.
This news
release does not constitute an offer to sell or the solicitation of
an offer to buy, and shall not constitute an offer, solicitation or
sale in any state, province, territory or jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
state, province, territory or jurisdiction.
