Investment Opportunities in Advanced Bioengineered Drug Delivery

NetworkNewsWire Editorial Coverage: Hydrogels have been in limited commercial use for more than two decades. However, advancements in drug delivery, and thus hydrogel technology, are driving rapid growth in the global market, which is now projected to surge to over $22 billion by 2022 with a compound annual growth rate (CAGR) of 6.3 percent (http://nnw.fm/GWv2x), according to BCC Research.  In what may prove to be a groundbreaking approach in this field of exponential opportunity, PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H) (PRVCF Profile) is engineering a unique sol-gel nose-to-brain drug delivery platform to provide clinical relief of multiple physical maladies. Other recognized companies that have embraced new methods of drug delivery and hydrogel delivery systems include Johnson & Johnson (NYSE: JNJ), Valeant Pharmaceuticals International Inc. (VRX: NYSE), UroGen Pharma Ltd. (NASDAQ: URGN) and GW Pharmaceuticals PLC (GWPH: NASDAQ).

Hydrogel Market Driven by Drug Delivery Advances

For most of modern history, pharmaceuticals have consisted of simple, fast-acting chemical compounds administered orally or by injection. However, the continual evolution of the understanding of the human body has triggered an explosion of new and potentially lifesaving treatments. These new pharmaceutical therapeutics require revolutionary new techniques of administration. The objective of modern drug delivery systems is to deploy medications intact to specifically targeted parts of the body through a medium that can control the therapy’s administration and enhance bioavailability. To achieve this goal, researchers have turned to advances in hydrogel materials, which have demonstrated efficacy in enhancing drug targeting specificity by helping medications cross the blood-brain barrier — lowering systemic drug toxicity, improving treatment absorption rates and mitigating biochemical degradation.

Hydrogels are three-dimensional molecular structures capable of absorbing large amounts of water or biological fluids. Due to their porosity and supple consistency, they closely simulate natural living tissue — more so than any other class of synthetic biomaterials. Their resemblance to living tissue opens vast opportunities for applications in biomedical arenas. Currently, hydrogels are used for manufacturing contact lenses, hygiene products, tissue engineering scaffolds and, now, drug delivery systems.

PreveCeutical’s Novel Approach

PreveCeutical Medical (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H), a preventive health sciences company initiating a broad spectrum of preventive and curative therapies, is engineering what it believes to be the world’s first nose-to-brain hydrogel platform. Following several years of research and development by PreveCeutical’s chief research officer, Dr. Harendra Parekh, Ph.D., the company’s novel sol-gel technology is designed for superior time-released delivery of cannabinoid (CBD)-based medications. Bypassing typical delivery techniques, this nasal spray formulation is meticulously engineered to rapidly gel and deliver drugs in a controlled fashion across target tissue, which in the case of nose-to-brain delivery is the olfactory mucosal epithelium within the nasal cavity.

Conventional drug delivery, whether through oral or injectable mediums, moves drugs into the bloodstream where they are then passed through the liver. The drugs are unable to directly impact the targeted area as the liver first filters then metabolizes the drugs, which also affects release times and reduces potency. In a potentially transformative technique of drug delivery, PreveCeutical’s platform circumvents the blood-brain barrier and liver through application directly onto nasal mucosal tissue. The blood-brain barrier has long challenged effective medicine delivery due to the filtering mechanism of the capillaries that carry blood to the brain and block the passage of certain substances.

PreveCeutical’s novel sol-gel drug delivery platform is designed for use in both children and adults. Once or twice daily dosing should be reduced to once or twice a week with the product. The formulation is in liquid form when it is sprayed into the nose, then rapidly turns to a gel and is retained on the nasal mucosa. Initially targeting cannabinoid delivery, sol-gels are a platform that can be applied to numerous medicines for extended release and vastly improved bioavailability.

The proprietary sol-gel formulations are anticipated to be commercially launched with licensed medical cannabis companies within 18 months and have potential for drug delivery applications far beyond cannabinoids.

Promising Pipeline

Not a one-trick-pony, PreveCeutical has already brought one product to market and is developing a diverse portfolio of research and development programs that address large market diseases.  PreveCeutical Medical’s first commercial product, CELLB9®, is an oral dilute solution infused with select peptides and proteins isolated from Caribbean Blue Scorpion venom. The active ingredients in CELLB9 have been used around the world for over 25 years and have generated volumes of anecdotal reports about their efficacy. PreveCeutical’s research team is now using proprietary chemistry to generate Nature Identical™ peptides (http://nnw.fm/B9bBj) for a range of ailments. PreveCeutical and its Australian research commercialization partner, UniQuest, are currently screening these peptides for use against some of the most aggressive diseases where there exist unmet clinical needs.

In conjunction with leading Australian research centers, PreveCeutical is also pursuing dual-gene therapy research as both a preventative measure and possible treatment for type 2 diabetes and obesity. Over five years of multi-disciplinary research has generated convincing results in disease models that a single gene may be implicated in Type 2 diabetes and obesity. PreveCeutical’s gene-silencing technology would effectively turn off the genetic signal that leads to the over-production of a key protein molecule, in turn reducing blood sugar levels and preventing the body from storing excessive fat. As Dr. Parekh stated in a press release, “…gene-silencing does not represent a mere management for diabetes and obesity, it represents the potential for a bona fide cure…”

In what may be a quantum leap in addressing the critical demand for non-additive pain medications, PreveCeutical and its partner UniQuest are expanding the use of their disulphide linker technology to develop non-addictive analgesics for moderate-to-severe pain (http://nnw.fm/4TQgv). The four-phase research program will be led by Dr. Parekh and carried out in collaboration with pain and inflammation pharmacology experts at the University of Queensland.

PreveCeutical’s pain program is of considerable importance in light of America’s opioid epidemic. As the National Institute on Drug Abuse reports, prescription opioid abuse costs the United States more than $78 billion per year. The loss of life is even more devastating, with more than 115 Americans dying from opioid overdose each day (http://nnw.fm/7nExT).

Read more on PreveCeutical’s pain program in this editorial entitled, ‘Promising New Approaches in Pain Management’: http://nnw.fm/3tQ5s.

Others Leading Delivery Platforms

Recognizable household brand Johnson & Johnson (NYSE: JNJ) also has its hand in hydrogel technology. In July 2016 the company’s Johnson & Johnson Vision Care, Inc. launched its silicone hydrogel contact lens, Acuvue Vita. As noted in a press release, the design of Acuvue Vita addressed contact lens wearer discomfort by increasing hydration, thanks to “a noncoated silicone hydrogel material that maximizes and maintains hydration all month long” (http://nnw.fm/4ArJ9).  In April 2017, Johnson & Johnson released Acuvue Vita for monthly wear, and provided some insight into its HydraMax technology (http://nnw.fm/Tt31U).

Valeant Pharmaceuticals (NYSE: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. Through its wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, Valeant Pharmaceuticals introduced an innovative bi-weekly silicone hydrogel contact lens that helps the lens maintain 95 percent of its moisture up to a full 16 hours and provides patients maximum comfort throughout the day. In another example of hydrogel efficacy, silicone hydrogel lenses allow significantly more oxygen to reach the eye than regular soft lenses.

UroGen Pharma (NASDAQ: URGN), is a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology. Its RTGel™ product is a proprietary, sustained-release hydrogel-based formulation designed for potentially improving therapeutic profiles of existing drugs. BotuGel is the company’s proprietary RTGel-based formulation of Allergan Pharmaceuticals’ BOTOX® branded drug, as a potential treatment option for overactive bladder (http://nnw.fm/5nHPn).

Though not involved with hydrogels, biopharmaceutical company GW Pharmaceuticals (NASDAQ: GWPH) demonstrates the market demand and opportunity for advanced drug delivery systems. GW Pharmaceuticals develops and commercializes novel therapeutics from its proprietary cannabinoid product platform. Among the drugs in its portfolio is Sativex, a medicinal cannabis extract indicated for the relief of multiple sclerosis symptoms and the treatment of severe neuropathic-related cancer pain. For efficacious delivery of Sativex, GW also patented a metered valve pump spray device to deliver its liquid cannabis extract, in propylene glycol and ethanol, for dosing of a patient’s sublingual mucosa. Sativex oromucosal spray has been approved for use in 30 countries outside the United States.

To accommodate advances in pharmaceutical development, the practice of drug delivery has changed dramatically over the past few decades. Even greater changes are expected as innovative new therapeutics are discovered. Innovative pharmaceutical treatments require innovative methods of administration, and the companies that develop these new delivery platforms have the potential to see rapid appreciation.

For more information on PreveCeutical, visit  PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE: 18H)

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