NetworkNewsWire Editorial Coverage:
The potential of cannabis for the treatment of an array of medical
conditions is a hot topic, and, while many states in America have
legalized the use of marijuana in one form or another, the Food and
Drug Administration (FDA) is loath to approve drugs from this
source. The FDA has concerns with the consistency of drugs
extracted from marijuana, and current Good Manufacturing Practices
(GMP) regulations are difficult to implement with naturally-sourced
products, dissuading most pharmaceutical companies from pursuing
this avenue. A possible solution to the FDA’s concern with quality
and consistency lies in the biosynthesis of cannabinoids.
Biosynthesis gives manufacturers the ability to produce a
high-quality and consistent active ingredient every time,
eliminating concerns of crop variability and pesticide contaminants
while greatly reducing cost. InMed Pharmaceuticals, Inc.
(CSE: IN) (OTCQB: IMLFF) (IMLFF
Profile) stands out as a unique
biotech drug development company in this regard, positioning it
among the ranks of bigger companies like Zynerba
Pharmaceuticals, Inc. (NASDAQ: ZYNE), a clinical-stage
pharmaceutical company developing proprietary synthetic
(chemistry-based) cannabinoid treatments for transdermal delivery,
and GW Pharmaceuticals plc (NASDAQ: GWPH), which
is also at the forefront of pre-clinical research and development
of cannabinoids that are extracted from plants. Canopy
Growth Corp. (OTC: TWMJF) (TSX: WEED) and
Aurora Cannabis, Inc. (OTCQX: ACBFF) (TSX: ACB)
are major suppliers of high-quality, medical-grade marijuana, which
is critical for many biotech companies who need a source of
plant-based starting materials.
The issue is that plant-based processes (planting, growing,
harvesting, extracting and purifying) result in active ingredients
at varying concentration levels with inconsistent qualities,
including impurities such as pesticides. Companies interested in
this approach for their products need to establish vast and
high-volume marijuana greenhouse growing operations. This is a huge
expense, further compounded by the complex process to produce
pharmaceutical grade cannabinoids that meet the GMP requirements
for FDA approval. InMed
Pharmaceuticals (CSE: IN) (OTCQB: IMLFF) has taken the
inside track in the industry and has just completed the world’s
first-ever recorded study that successfully stitched together
several key components in the drug development continuum for
cannabinoid therapies, including:
- biosynthesizing a cannabinoid;
- packaging the cannabinoid as a nanoparticle;
- formulating the nanoparticles into a novel tissue-specific
delivery vehicle;
- and confirming delivery and diffusion into the target
tissue.
This study is significant in validating InMed’s wide spectrum of
cannabinoid know-how for pharmaceutical development, which ranges
from discovery and manufacturing to formulation and delivery.
Whereas other companies are in the process of researching or
testing only the two main cannabinoids found in marijuana (THC and
CBD), InMed is using its proprietary bioinformatics and
manufacturing process to research the physiological impact of all
90+ cannabinoids found in the plant. The company’s biosynthesis
process results in pharmaceutical grade (>95%) purity and is
bioidentical to the plant’s cannabinoids. Importantly, by making
individual cannabinoid compounds, InMed can avoid any contamination
by tetrahydrocannabinol (THC) – the mind-altering chemical in the
cannabis plant – and, therefore, InMed products will have no
psychoactive properties.
Building on this capability, InMed has also achieved an industry
first with its development of a cannabinoid nanoparticle hydrogel
as the delivery mechanism for its INM-085 candidate, which is
formulated to treat glaucoma by reducing elevated intra-ocular
pressure and providing protection to the retinal nerves. Glaucoma
treatment is usually administered via eyedrops, which are typically
washed away immediately due to blinking. As a result, patient
compliance with their drug administration schedules is poor in this
disease. A hydrogel delivery mechanism, however, has a huge
advantage in that it forms a medicated gel-like lens over the eye.
INM-085 is intended as a once-per-day eyedrop administered
immediately prior to the patient's bedtime, intending to assist in
reducing the high rate of non-compliance and to maximize drug
absorption from a single drop.
Following this success, InMed is scaling its manufacturing
process and pursuing research into other medical conditions by
leveraging its know-how in cannabinoid drug development. Because
biosynthesized cannabinoids are identical to those found in nature,
they have potentially fewer adverse events associated with varying
drug structures and may confer better efficacy. Biosynthesis also
avoids several of the drawbacks associated with growing marijuana,
including elimination of pesticides that can be toxic to people and
harmful to the environment.
As favorable evidence of cannabis for therapeutic applications
expands, the medicinal marijuana market continues to swell with
innovation. Much focus is placed on biotechs, such as InMed, that
are actively engaged in the development of cannabinoids for various
therapeutic applications. Notably, InMed has a significant
advantage in its ability to create biosynthetic cannabinoids in a
controlled laboratory setting. The company’s breakthrough approach
to cannabinoid biosynthesis has incredible potential in helping
other companies with their cannabis-related drug development
efforts.
Another company deeply invested in the manufacturing of
synthetic (chemistry-based) cannabinoids is Zynerba
Pharmaceuticals (NASDAQ: ZYNE). The
clinical-stage pharmaceutical company is focused on developing
proprietary synthetic cannabinoid treatments designed for
transdermal delivery and targeting patients with unmet medical
needs. Zynerba is currently working on two products: a synthetic
CBD gel for patients with osteoarthritis, epilepsy and Fragile X
syndrome, and a synthetic THC transdermal patch targeting
fibromyalgia and peripheral neuropathic pain. With a market cap of
$128 million (as of October 20, 2017) and a recent stock price
surge following the announcement of positive results from a
clinical study into the effects of its transdermal CBD gel on
pediatric and adolescent patients with Fragile X syndrome, Zynerba
looks set to become a leading synthetic CBD manufacturer and a
highly attractive investment opportunity on the fast-growing
cannabinoid-based pharmaceutical market.
Cannabinoid synthesis or biosynthesis can have a highly positive
impact on companies such as GW Pharmaceuticals (NASDAQ:
GWPH), which has developed commercial-stage cannabinoid
products for both orphan and non-orphan indications in neurological
conditions. The company also created a CBD product for the
treatment of certain epilepsy syndromes and developed the world’s
first cannabis-based prescription medicine for the treatment of
spasticity in sufferers of multiple sclerosis. While it is a
leading cannabis biotech in terms of market cap ($2.7 billion as of
October 23, 2017), without the ability to create biosynthetic
cannabinoids in-house, GW Pharmaceuticals outsources the
cultivation of cannabis for its products to UK-based British Sugar.
Though British Sugar’s crop yield is expected to support the
development of GW Pharmaceutical’s childhood epilepsy drug, the
cultivation comes at considerable expense due to electricity,
lighting, heating, real estate, manpower and other resources.
Other biotech companies turn to the green fields in Canada,
where roughly 38 licensed cannabis producers are scrambling to keep
up with the demand for legalized medicinal marijuana and impending
demand for recreational marijuana (expected to be legalized July
2018).
Currently Canada’s largest producer of marijuana, Canopy Growth
Corp. (OTC: TWMJF) (TSX: WEED) has over half a
million square feet of greenhouse cannabis capacity and has
committed to developing 1.3 million square feet of greenhouse
growing capacity in British Columbia. The company is partnered with
Bedrocan BV, a company based in Holland, to produce and distribute
medical-grade cannabis via one of its core brands, Bedrocan Canada,
demonstrating the need for high quantities of medicinal-grade
cannabis. Due to its consistently high quality, Canopy Growth’s
products are used extensively in clinical research in several
European countries. In addition, the company recently launched the
EQUAL Study to evaluate the effects of medical cannabis use on
quality of life. Notably, this is one of the largest marijuana
studies in the world.
In August, Canopy Growth reported first quarter fiscal 2018
revenue of C$15.8 million, marking a year-over-year increase of
127.4 percent and an increase of 8 percent compared to the fourth
quarter of fiscal 2017 revenues.
"Our focus in the first half of calendar 2017 has been preparing
our business to lead the legal recreational market that is set to
open in Canada in 2018, while continuing to be the clear leader in
the ongoing medical market," Canopy Growth chairman and CEO Bruce
Linton stated in the earnings release.
Another cultivator benefitting from most biotech companies’ need
for cannabis products is Canada-based Aurora
Cannabis (OTCQX: ACBFF) (TSX: ACB), a
leading producer and distributor of medical cannabis. The company
also operates a portal for registered physicians and patients that
makes it easier to prescribe and fill prescriptions. Aurora
recorded fourth-quarter 2017 revenues of $5.9 million, citing
growth in patient numbers and an increase in the average price per
gram of product sold, which now includes high-margin cannabis oils.
Also in the fourth quarter, Aurora acquired Peloton
Pharmaceuticals, including a 40,000-square-foot facility that, upon
completion, is expected to generate its first harvest shortly after
calendar-year end.
With the successful development of its biosynthetic cannabinoid
for the treatment of glaucoma, InMed continues to make strides down
the pathway toward making biosynthesized cannabinoid pharmaceutical
products a reality. The company opened the door to further
developments in the application of cannabinoids for many other
therapies.
For more information on InMed Pharmaceuticals, please visit:
InMed
Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)
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