MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF)
(FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in
specialized, research-driven pharmaceutical-quality cannabis
extraction, distillation and derivative products, today announced
that its Australian operation –
MediPharm Labs Australia
Pty. Ltd. (“MediPharm Labs Australia”) – has received an
important enabling amendment to its Good Manufacturing Practice
(“GMP”) Certification and Licence to Manufacture Therapeutic Goods.
The licence expansion, granted under Section 40B
of the Australian Therapeutic Goods Act 1989 by the Therapeutic
Goods Administration of the Australian Government’s Department of
Health, provides MediPharm Labs with the ability to manufacture
Active Pharmaceutical Ingredient (“API”) derived from cannabis and
cannabis intermediates – such as resins, extracts and isolates – as
well as medicinal cannabis finished products including oral
liquids, soft-gel capsules and oil. This is one of very few
licenses of its kind for dedicated medicinal cannabis manufacture
in Australia.
MediPharm Labs Australia is poised to service
the entire Australian patient population. July was a record month
in Australia with over 5560 SAS-B medical cannabis approvals, an
increase of 20% from June (4,630). As of 31 July 2020, the TGA
approved over 56,000 SAS Category B applications for unapproved
medicinal cannabis products(1). At current levels, MediPharm Labs
anticipates more than 70,000 patient approvals could be achieved by
the end of 2020.
“This licence amendment paves the way for
MediPharm Labs Australia to immediately begin using our facility as
it was intended: to manufacture the highest quality APIs and
finished medical cannabis formulations for our rapidly growing base
of customers,” said Warren Everitt, CEO, Asia Pacific, MediPharm
Labs. “We are extremely proud of this achievement and the MediPharm
Labs Australia team that made it happen as it reflects our
longstanding commitment to GMP standards and pharma principles of
production.”
MediPharm Labs Australia was certified by the
Therapeutic Goods Administration (“TGA”) as meeting GMP quality
standards of practice and secured a Licence to Manufacture
Therapeutic Goods in May 2020 and is already generating revenue.
MediPharm Labs Australia reported over $600,000 revenue in Q2 2020
from the final packaging of products, originally bulk manufactured
in its Canadian headquarters, for sale to Australian customers. As
the Company’s Canadian facility was TGA GMP certified in late 2019,
MediPharm Labs boasts a global pharmaceutical-quality supply chain
that is qualified to serve emerging medical markets
internationally.
“Whether we manufacture in Canada or now
Australia, or a combination thereof, for our current worldwide
demand, MediPharm Labs meets the most rigorous standards set out by
established health authorities and this licence update serves as
another reminder of that very important fact,” said Pat McCutcheon,
Chief Executive Officer of MediPharm Labs. “As a
multi-jurisdictional GMP-certified producer, licences such as this
differentiate us in the marketplace, serve as a door-opener to
sophisticated new pharma and consumer packaged goods customer
accounts and represent a highly sought after, valuable and
irreplaceable asset that we will protect. Now that we have the
green light to manufacture a variety of products and formulations
in Australia, we intend to make the most of our first-mover
advantage.”
MediPharm Labs also holds Australian Office of
Drug Control (ODC) Import and Export Licences covering cannabis
resin and extracts, bulk medicinal cannabis oil and finished
medicinal cannabis products. It received State Licences for
cannabis substances from the Department of Health and Human
Services in Victoria, Australia in December 2019 when it completed
construction of its manufacturing facility.
MediPharm Labs Australia features multi-phase
supercritical CO2 extraction equipment, clean rooms and testing
laboratories. The Company also has capabilities to manufacture soft
gels, oral liquids and oils and API. It was modelled on the
Company’s state-of-the-art facility in Barrie, Ontario.
More Details of the Licence
Update
Under the updated licence, MediPharm Labs may
manufacture medicinal cannabis finished therapeutic goods intended
for: registration in Australia (Registered Therapeutic Goods);
Clinical Trial use (excluding labelling activities); and products
for export or which are exempt from registration and listing on the
Australian Register of Therapeutic Goods under the provisions of
Section 18(1) or Section 19 (1)(a) of the Therapeutic Goods Act.
MediPharm Labs Australia may also manufacture API intended for
Further Manufacture by other licensed manufacturers.
1) https://www.tga.gov.au/access-medicinal-cannabis-products-1
About MediPharm Labs
Founded in 2015, MediPharm Labs specializes in
the production of purified, pharmaceutical-quality cannabis oil and
concentrates and advanced derivative products utilizing a Good
Manufacturing Practices certified facility with ISO standard-built
clean rooms. MediPharm Labs has invested in an expert, research
driven team, state-of-the-art technology, downstream purification
methodologies and purpose-built facilities with five primary
extraction lines for delivery of pure, trusted and precision-dosed
cannabis products for its customers. Through its wholesale and
white label platforms, MediPharm Labs formulates, develops
(including through sensory testing), processes, packages and
distributes cannabis extracts and advanced cannabinoid-based
products to domestic and international markets. As a global leader,
MediPharm Labs has completed commercial exports to Australia and
completed commercialization of its Australian extraction facility
which generated its first revenues in H1 2020. MediPharm Labs
Australia was established in 2017.
For further information, please
contact:Laura Lepore, VP, Investor Relations and
CommunicationsTelephone: 416-913-7425 ext. 1525 Email:
investors@medipharmlabs.com Website:
www.medipharmlabs.com
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING INFORMATION:
This news release contains “forward-looking
information” and “forward-looking statements” (collectively,
“forward-looking statements”) within the meaning of the applicable
Canadian securities legislation. All statements, other than
statements of historical fact, are forward-looking statements and
are based on expectations, estimates and projections as at the date
of this news release. Any statement that involves discussions with
respect to predictions, expectations, beliefs, plans, projections,
objectives, assumptions, future events or performance (often but
not always using phrases such as “expects”, or “does not expect”,
“is expected”, “anticipates” or “does not anticipate”, “plans”,
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“intends” or variations of such words and phrases or stating that
certain actions, events or results “may” or “could”, “would”,
“might” or “will” be taken to occur or be achieved) are not
statements of historical fact and may be forward-looking
statements. In this news release, forward-looking statements relate
to, among other things, supply of products to Hybrid Pharm for
distribution pursuant to the agreement. Forward-looking statements
are necessarily based upon a number of estimates and assumptions
that, while considered reasonable, are subject to known and unknown
risks, uncertainties, and other factors which may cause the actual
results and future events to differ materially from those expressed
or implied by such forward-looking statements. Such factors
include, but are not limited to: general business, economic,
competitive, political and social uncertainties; the inability of
MediPharm Labs to obtain adequate financing; the delay or failure
to receive regulatory approvals; and other factors discussed in
MediPharm Labs’ filings, available on the SEDAR website at
www.sedar.com. There can be no assurance that such statements will
prove to be accurate, as actual results and future events could
differ materially from those anticipated in such statements.
Accordingly, readers should not place undue reliance on the
forward-looking statements and information contained in this news
release. Except as required by law, MediPharm Labs assumes no
obligation to update the forward-looking statements of beliefs,
opinions, projections, or other factors, should they change.
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