NetworkNewsWire Editorial Coverage:
The U.S. pharmaceutical industry is pocked with pitfalls that make
it difficult for the development of cannabis-based drugs. To
receive FDA approval, drug manufacturers must produce a consistent,
pharmaceutical-grade product. Drug researchers with cannabis-based
candidates are largely dependent on cannabis producers to access
their drug raw materials. And therein lies the issue. The cannabis
production sector has had its share of product recalls, and is
saddled with pricey cost of commercial cultivation. The roadblocks
are considerable - from legal and execution standpoints - making
these efforts not quite impossible but certainly, currently,
difficult. Canada-based biopharmaceutical company InMed
Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF) (IMLFF
Profile) is taking these challenges head-on, and has
broken new ground with an innovative, proprietary biosynthesis
process that reliably creates pure cannabinoids. This process is
capable of making any of the 90+ individual cannabinoids, under
strict quality control resulting in >95% purity with no
pesticides, and in a consistent fashion – factors that current
plant growing methods of production cannot accomplish.
Biosynthesized product with consistently high purity and quality
poses a considerable advantage over the medical marijuana used by
companies like CanniMed Therapeutics, Inc. (TSX: CMED)
(OTC: CMMDF) (FRA: 0GB), which cultivates its own cannabis
for its product pipeline. Any biotech company seeking to develop
cannabinoid-based drugs could benefit from InMed’s unique approach.
Currently, these biotech companies are dependent on growers like
Aurora Cannabis, Inc. (TSX: ACB) (OTCQX: ACBFF),
Canopy Growth Corp. (TSX: WEED) (OTC: TWMJF) and
Aphria, Inc. (TSX: APH) (OTC: APHQF) to supply the
raw flower or specific cannabinoid extracts needed, albeit only a
few cannabinoids can be economically extracted from the plant. Such
extracted product may not have the purity or consistency required
to qualify as an FDA-approved pharmaceutical ingredient.
The extraction techniques from plant-growing operations are
subject to high fluctuation in drug concentration, as flowers from
the same marijuana plant display high fluctuations in drug
composition. A key factor in receiving formal drug approval from
regulatory authorities includes product consistency, which may be
one reason the FDA, to date, has never approved a
botanically-derived marijuana drug. A few synthetic
cannabinoid-based drugs have, however, been approved by the FDA
(http://nnw.fm/dyD4o), and experts believe
marijuana’s only future as a medicine in the U.S. is through its
isolated, pure cannabinoid components and their synthetic
counterparts.
While manufacturing synthetic cannabinoids is a potential means
of sidestepping the various prohibitive aspects of agricultural
cannabis production, many development efforts in this area have
failed. Various companies have attempted to chemically synthesize
cannabinoid compounds for pharmaceutical application, but the
primary restrictive factor is the difficulty of duplicating these
compounds in a way that makes them identical to the
naturally-occurring ones. Even a slight variation in structure can
mar the efficacy and safety of synthetic cannabinoid compounds,
and, as with natural sourcing, the time drain, expense and tedium
of the synthetic manufacturing process (along with the large
quantities of chemical waste it creates) make it a problematic
enterprise.
InMed
Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)
breakthrough biosynthesis process allows it to control the entire
drug development process, in house – and without the inherent
challenges of traditional agricultural cultivation methods.
Biosynthesis, or the process of producing complex molecules
within living organisms or cells, is currently employed in various
industrial applications, including using bacteria or yeast-based
systems to produce pharmaceuticals. InMed’s proprietary, pioneering
approach to cannabinoid biosynthesis is truly a drug development
game changer that has the potential to overcome FDA regulatory
hurdles and bypass the other shortcomings associated with botanical
cannabis cultivation. This process could open up several
possibilities in terms of improving consistency and enabling
biotechs to harness the potential of all cannabinoids.
InMed employs an E. coli-based expression system for
manufacturing cannabinoids that has proven internally to be much
more efficient and robust than other microbial platforms, and this
system enables the high-yield manufacturing of all 90+ naturally
occurring cannabinoids, combining the intrinsic safety and known
effectiveness of natural drug structures with the control, quality
and convenience of lab-based manufacturing.
Employing this exclusive process in a controlled lab setting,
scientists at InMed are able to create cannabinoid compounds that
are identical to those that occur naturally while eliminating
problems associated with inconsistency and contamination from
pesticides.
Aside from inconsistency issues, another stumbling block on the
botanical marijuana side is the difficulty of extracting compounds
from the cannabis plant in adequate amounts and purities to
pharmaceutically test them. Natural sourcing of most cannabinoid
compounds is very time-consuming, difficult, expensive,
inconsistent (as previously mentioned) and low-yielding. The
natural sourcing process only yields about two or three
cannabinoids that can be derived in adequate quantities for
research, while the rest of the cannabinoid compounds only manifest
themselves in trace amounts that are not accessible through
extraction from plants.
InMed’s biosynthesis method is can reduce the costs and time
required to manufacture cannabinoid compounds that are
pharmaceutically active. It is also capable of manufacturing not
just some but all naturally occurring cannabinoids.
InMed is effectively bringing cannabis-based drug development
into a new era, shaking up the established, agriculture-based
mentality of “plant, grow, harvest, extract and purify” that has
long been the norm in the area of manufacturing raw cannabinoid
material.
The benefits of InMed’s novel approach are several and
include:
- Substantial cost savings in comparison to traditional
agricultural methods
- Easier path to scale-up and systems optimization
- Superior production, purification, quality control as compared
to agricultural approaches and better structural integrity in
comparison with other chemical manufacturing practices
- Ability to access minor cannabinoids for which plant-based
extraction methods are currently economically unfeasible
InMed recently announced a provisional patent application filing
for this proprietary cannabinoid manufacturing biosynthesis
program—the first of many to come (http://nnw.fm/Z30dH). Once this inaugural patent
application is converted into an international Patent Cooperation
Treaty (PCT) application and is pursued on a global scale in
important jurisdictions, InMed will have significant commercial
protection for its biosynthesis program. The company plans to
actively convert this initial patent filling and subsequent
provisional patents into national-stage filings in all major
commercial jurisdictions.
In terms of InMed’s internal drug development abilities, a
recent press release from the company (http://nnw.fm/EZ0Gk) validates its capability to
conduct a broad array of drug development activities that are
crucial to obtaining eventual FDA approval for cannabinoid-based
drugs. As discussed in the press release, InMed has successfully
and consistently biosynthesized a pharmaceutical-grade cannabinoid
using its novel E. coli-based system; packaged the
cannabinoid as a nanoparticle; formulated a cannabinoid drug
candidate into a novel, tissue-specific delivery vehicle; and
confirmed drug delivery and diffusion into a target tissue.
The press release announced the results of a study co-sponsored
by InMed and the University of British Columbia, which is, to the
company’s knowledge, the very first study to ever report
hydrogel-mediated cannabinoid nanoparticle delivery to the eye.
This resulted in bolstered drug uptake through the cornea and lens.
Ordinary ocular formulations, like eyedrops, are almost instantly
washed away following administration because of blinking. In the
study, however, InMed’s proprietary hydrogel delivery method
demonstrated distinctive rheological characteristics that enabled
it to form a thin, uniform coating over the cornea through
blinking. The gel-like “lens” that was created over the cornea held
the drug in place, allowing trans-corneal absorption of the drug to
occur. The drug was then able to diffuse within the eye. The
overall drug delivery achieved through this hydrogel nanoparticle
formulation was three times higher than the control
formulation.
"Importantly, this study offers further validation of InMed's
capabilities in moving the science of cannabinoid pharmaceuticals
forward,” InMed President and CEO Eric A. Adams said in the press
release. "Results like this, combined with our expanding patent
portfolio and list of publications, on-going R&D, and renowned
scientific team and collaborators demonstrates our depth of
know-how and supports our trajectory to becoming an industry
leader."
InMed’s drug pipeline – developed using its biosynthesis process
- currently includes two products: INM-085 for the treatment of
glaucoma and INM-750 for the treatment of epidermolysis bullosa.
This pipeline is founded on the company’s ability to produce its
own pharmaceutical-grade cannabinoids for use in its products,
which enables InMed to manage the entire drug development cycle.
Using bioinformatics—a proprietary, computer-based drug/disease
targeting platform developed by InMed—the company is also able to
identify novel cannabinoids that could be utilized in targeting
specific diseases. InMed can then biosynthesize those cannabinoids
for product development.
This groundbreaking work is not only helping InMed toward
overcoming drug approval barriers but could also have a huge impact
on the efforts of other drug development companies within the
cannabis sector that are striving to create cannabinoid-based
therapies to treat various medical conditions.
InMed’s ability to consistently manufacture pharmaceutical-grade
cannabinoids demonstrates the company’s favorable cost-savings and
quality aspects compared with traditional cannabis producers. While
such producers are working to meet the demands of biotech
companies, which are, in turn, striving to satisfy regulatory
standards, these producers may face many challenges.
One of the biggest marijuana growers in the world is
Canopy Growth Corp. (TWMJF), which operates more
than half-a-million square feet of production space. Despite its
size and market domination, Canopy is dependent on significant
capital and large parcels of land and is also handicapped by huge
operating costs and the typical quality control issues seen with
agricultural operations.
Another large producer, Aurora Cannabis (TSX: ACB)
(OTCQX: ACBFF) operates a 55,200-square-foot cultivation
and harvesting facility in the Rocky Mountains, and the company is
in the process of adding an additional 840,000 square feet across
two other sites in Canada. Aurora owns a 19.9% stake in the first
Australian company licensed to cultivate and conduct research on
medical cannabis, and it owns a leading Germany-based wholesale
importer, exporter and distributor of medical cannabis. In January
2017, Aurora announced a Type II
recall of its products, as some of its marketed offerings
contained “residual levels of myclobutanil and/or bifenazate that
exceed any of the levels permitted in food production for these two
pesticides.”
Aphria (TSX: APH) (OTC: APHQF), a producer of
medical-grade cannabis as well as capsules, vaporizers and
orally-administered cannabis oil droppers, initiated a Type III
recall of its own in March 2017 due to mislabeling of the
delta-9-tetrahydrocannabidiol (THC) content of some of its
products.
The obstacles faced by cannabis cultivators and the subsequent
disadvantages to the drug development companies that rely on them
attest to the importance of the revolutionary biosynthesis process
InMed has pioneered. Despite continued federal restrictions on
cannabis research and cultivation in the U.S., InMed’s innovations
have the potential to help biotechs clear the hurdles and create
biosynthesized cannabinoid-based pharmaceutical products of
unparalleled consistency and quality required to meet the FDA’s
standards. Additionally, the ability to manufacture every type of
cannabinoid, which is made possible by InMed’s process, is poised
to be one of the most exciting innovations the medical cannabis
sector has seen.
For more information on InMed Pharmaceuticals, please visit:
InMed
Pharmaceuticals, Inc. (CSE: IN) (OTCQB: IMLFF)
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