PHARMADRUG ENTERS
DEFINITIVE AGREEMENT FOR ACQUISITION OF SAIRIYO
THERAPEUTICS INC. WHO
RECENTLY RECEIVED
ORPHAN
DRUG DESIGNATION
FROM FDA FOR
ESOPHAGEAL CANCER
Toronto, Ontario
-- January 25, 2021-- InvestorsHub
NewsWire -- PharmaDrug Inc. (CSE:
BUZZ) (OTC: LMLLF) ("PharmaDrug"
or the "Company"),
a specialty pharmaceutical company focused on the development and
commercialization of controlled-substances and natural medicines
such as psychedelics, cannabis and naturally-derived approved
drugs, today
announced that it has entered into the definitive agreement in
respect of the previously announced (see press release dated
January 12, 2021) proposed acquisition of Sairiyo Therapeutics Inc.
("Sairiyo")
on January
12, 2021. Management of the
Company believe that the proposed acquisition will strengthen
PharmaDrug's product pipeline, intellectual property portfolio and
pharmaceutical development expertise.
Sairiyo
is a biotechnology
company focused on repurposing and
developing improved formulations of naturally derived compounds for
serious, rare, and life-threatening diseases with the aim to
obtain European Medicines Evaluation
Agency and U.S. Food and Drug
Administration ("FDA") approval. Sairiyo is advancing
the clinical development of its lead drug candidate, Cepharanthine,
a repurposed and reformulated naturally-derived
compound for the
potential treatment of cancer, neurological, inflammatory and
infectious diseases. Research and development
efforts will be led by Dr. Paul Van Slyke. Dr. Van Slyke is a
biotechnology entrepreneur, scientist, and serial inventor. A
previous biotech co-founder and Chief Scientific Officer, Dr. Van
Slyke brings to Sairiyo a breadth of experience in
preclinical and IND-enabling activities. Paul's previous research
interests, complementary to those of Sairiyo, span a number of indications
including acute respiratory distress syndrome, acute kidney injury,
vascular inflammatory disease, sepsis and oncology.
More information
about Sairiyo is available on the company's
website which is located at
www.sairiyothera.com
Cepharanthine is a
natural product and an approved drug used for more than 70 years in
Japan to treat a variety of acute and chronic diseases. In
clinical research, Cepharanthine exhibits multiple pharmacological
properties including anti-oxidative, anti-inflammatory,
immuno-regulatory, anti-cancer, anti-viral and anti-parasitic
properties.1 Sairiyo has an exclusive license from a research and
development organization to develop and commercialize reformulated
Cepharanthine for all diseases and exclusive rights to the patent,
method of manufacturing, clinical supply, pre-clinical data and
know-how to support FDA clinical trials.
Sairiyo
is currently
focused on advancing the clinical development of Cepharanthine to
treat rare cancer diseases. Sairiyo recently received FDA orphan
drug designation for Cepharanthine in the treatment
of esophageal cancer.
The global
esophageal cancer drugs market is estimated to grow by USD $1.5
billion during 2019-2023 (Technavio 2019). According to the World
Health Organization, esophageal cancer is currently the sixth most common
cause of cancer death in the world and is estimated to have caused
over 508,000 deaths in 2018. The American Cancer Society estimates
that there will be approximately 18,000 new cases diagnosed in
[insert time frame], and approximately 16,000 deaths with an
estimated 20% survival rate at least five years after a
diagnosis.
Sairiyo is
preparing its pre-Investigational New Drug ("pre-IND") meeting
request and pre-IND briefing documents for submission to the FDA to
support the clinical development of Cepharanthine in certain
cancers and infectious diseases.
Sairiyo will also
support PharmaDrug's initiatives of evaluating novel uses of
psychedelic and cannabinoid compounds and delivery
systems.
Daniel Cohen,
Chairman and CEO of PharmaDrug commented, "PharmaDrug is extremely
excited to work with the Sairiyo team upon the closing of the
acquisition on several fronts. Firstly, to prepare for the upcoming
FDA pre-IND meeting request and secondly to explore other
opportunities for Cepharanthine and its immense potential across
various rare and life-threatening diseases. The Company also plans
to use Sairiyo's clinical research capabilities to potentially
launch clinical studies in the pharmaceutical psychedelic
space".
Under the terms of
the agreement,
PharmaDrug proposes to acquire all of the issued and
outstanding shares of Sairiyo in consideration for the issuance of
an aggregate of 75,000,000 units of PharmaDrug
("Units").
Each Unit will be comprised of one common share of
PharmaDrug and one common share
purchase warrant (a "Warrant") of PharmaDrug. Each Warrant will
entitle the holder thereof to acquire one common share in the
capital of PharmaDrug at any time on or before
the 18 month anniversary of the issuance of the Warrants at an
exercise price of $0.10 per share. Following completion of
the transaction Sairiyo will be a wholly-owned
subsidiary of the
Company.
Completion of the
transaction is subject to customary closing conditions, including
completion of due diligence, negotiation of definitive agreements
and receipt of all necessary approvals. If such conditions are not
satisfied it is possible that the proposed transaction will not be
completed on the terms set forth herein or at all. The
parties anticipate that the transaction will be completed in
by the end of
January 2021.
About
PharmaDrug Inc.
PharmaDrug Inc. is
a specialty pharmaceutical company focused on the development and
commercialization of controlled-substances and natural medicines
such as psychedelics, cannabis and naturally-derived approved
drugs. The Company owns 80% of
Pharmadrug GmbH, a German medical cannabis distributor, with a
Schedule I European Union narcotics license and German EuGMP
certification allowing for the importation and distribution of
medical cannabis to pharmacies in Germany and throughout the
EU. The Company also
owns 100% of Super Smart, a Dutch company
building a modern adult use psychedelic retail business with an
elevated and educational focus.
For further
information, please contact:
Daniel Cohen,
Chairman and CEO
dcohen@pharmadrug.co
(647)
202-1824
Caution Regarding
Forward-Looking Information:
THE CANADIAN
SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT
RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS
RELEASE.
This press
release contains "forward-looking information" within the meaning
of applicable securities legislation. All statements, other than
statements of historical fact, included herein is forward-looking
information. Generally, forward-looking information may be
identified by the use of forward-looking terminology such as
"plans", "expects" or "does not expect", "proposed", "is expected",
"budgets", "scheduled", "estimates", "forecasts", "intends",
"anticipates" or "does not anticipate", or "believes", or
variations of such words and phrases, or by the use of words or
phrases which state that certain actions, events or results may,
could, would, or might occur or be achieved. In particular, this
press release contains forward-looking information in relation to:
the timing and ability to close the proposed transaction; the
anticipated development of the Sairiyo
business;
the ability to get FDA approvals for Sairiyo's products; the
ability for the Company to be able to execute on its
plans;
and the
Company's current liquidity. This forward-looking information
reflects the Company's current beliefs and is based on information
currently available to the Company and on assumptions the Company
believes are reasonable. These assumptions include,
but are not
limited to: the ability of the Company to successfully satisfy the
conditions to closing the proposed transaction; the ability of the
Company to successfully execute on its plans
for the Company and Sairiyo; and the
Company's continued response and ability to navigate the COVID-19
pandemic being consistent with, or better than, its ability and
response to date.
Forward-looking
information is subject to known and unknown risks, uncertainties
and other factors that may cause the actual results, level of
activity, performance or achievements of the Company to be
materially different from those expressed or implied by such
forward-looking information. Such risks and other factors may
include, but are not limited to: general business, economic,
competitive, political and social uncertainties; general capital
market conditions and market prices for securities; the actual
results of the Company's future operations; competition; changes in
legislation affecting the Company; the ability
to obtain and maintain required permits and approvals,
the timing
and availability of external financing on acceptable terms; lack of
qualified, skilled labour or loss of key individuals; risks related
to the COVID-19 pandemic including various recommendations, orders
and measures of governmental authorities to try to limit the
pandemic, including travel restrictions, border closures,
non-essential business closures, service disruptions, quarantines,
self-isolations, shelters-in-place and social distancing,
disruptions to markets, economic activity, financing, supply chains
and sales channels, and a deterioration of general economic
conditions including a possible national or global recession; and a
deterioration of financial markets that could limit the Company's
ability to obtain external financing.
A
description of additional risk factors that may cause actual
results to differ materially from forward-looking information can
be found in the Company's disclosure documents on the SEDAR website
at www.sedar.com. Although the Company has attempted to identify
important factors that could cause actual results to
differ materially from those contained in forward-looking
information, there may be other factors that cause results not to
be as anticipated, estimated or intended. Accordingly, readers
should not place undue reliance on forward-looking information.
Readers are cautioned that the foregoing list of factors is not
exhaustive. Readers are further cautioned not to place undue
reliance on forward-looking information as there can be no
assurance that the plans, intentions or expectations upon which
they are placed will occur. Such information, although considered
reasonable by management at the time of preparation, may prove to
be incorrect and actual results may differ materially from those
anticipated.
The
Company's securities have not been registered under the U.S.
Securities Act of 1933, as amended (the "U.S. Securities Act"), or
applicable state securities laws, and may not be offered or sold
to, or for the account or benefit of, persons in the United States
or "U.S. Persons", as such term is defined in Regulations under the
U.S. Securities Act, absent registration or an applicable exemption
from such registration requirements. This press release shall not
constitute an offer to sell or the solicitation of an offer to buy
nor shall there be any sale of the securities in the United States
or any jurisdiction in which such offer, solicitation or sale would
be unlawful.
Forward-looking
information contained in this press release is expressly qualified
by this cautionary statement. The forward-looking information
contained in this press release represents the expectations of the
Company as of the date of this press release and, accordingly, are
subject to change after such date. However, the Company expressly
disclaims any intention or obligation to update or revise any
forward-looking information, whether as a result of new
information, future events or otherwise, except as expressly
required by applicable securities law.
References:
-
Bailly, C., 2019. Cepharanthine: An update of its mode of action,
pharmacological properties and medical applications. Phytomedicine
62, 152956.