Cannabis and OTC Medications Gain Health Canada Approval with Rise of Cannabis/Wellness Market
Point Roberts, WA and Delta, BC - June 18, 2019 (Investorideas.com Newswire) Investorideas.com, a leading investor news resource covering biotechnology, pharmaceutical and cannabis stocks releases a sector snapshot reporting on how, as the now legalized cannabis industry has gained heavy traction federally with Health Canada approvals, this potentially helps open the doors for other OTC medications and wellness products.
Companies featured include Innovus Pharmaceuticals, Inc. (OTCQB: INNV), Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT), WeedMD Inc. (TSXV:WMD) (OTCQX:WDDMF) and Cesca Therapeutics (NASDAQ: KOOL).
Innovus Pharmaceuticals, Inc. (OTCQB: INNV), an emerging commercial-stage pharmaceutical company that delivers safe, innovative and effective over-the-counter medicine and consumer care products to improve men's and women's health and respiratory diseases, recently announced that it has made significant progress on the regulatory and manufacturing steps needed to obtain market authorization from Health Canada to commercialize its FlutiCare® brand in Canada. The Company expects to secure the needed market authorization, manufacturing and supply of the product from an existing Canadian manufacturer during the second half of 2019, pending Health Canada approval. The product is expected to be available as an over the counter drug ("OTC") in that country and will not require a prescription.
"We are pleased to announce progress relating to our plans to commercialize FlutiCare® in Canada as this is will be our first international market for the product if approved by Health Canada," said Innovus Pharma CEO, Dr. Bassam Damaj. "In addition to Canada, we are working with the regulatory bodies of several other countries to assess the requirements needed to file for market authorization in those countries."
In addition to FlutiCare®, the Company recently jointly announced with its former distribution partner, Acerus Pharmaceuticals, Inc., (a Canadian company ["Acerus"]), that it would be receiving back all the rights to its product UriVarx®, approved for the relief of symptoms of overactive bladder and urine incontinency by Health Canada. "Receiving the rights to the product back from Acerus, which allows Innovus Pharma to fully commercialize it under our sales and marketing platform, was the most logical step for us to take to ensure the full market potential of UriVarx® in Canada. We currently expect additional revenues of at least $1.5 million a year from the sales of the product in Canada versus the $0.5 million recognized for the previous year," added Dr. Damaj.
"The Company continues to assess the performance of its partners in Canada and around the world and will continue to take steps to ensure that they perform to achieve maximum sales potential of our products. To that effect, the Company will no longer supply Apeaz® to Showcase, Inc., (a Canadian company), as the marketing requirements through their platform as compared to the sales achieved by them from this product were not satisfactory to Innovus Pharma. Under our sales and marketing platform, Apeaz® is now our second-best performing product in Canada that we sell directly there, after Diabasens® and is on track to achieve over $2 million in revenues for 2019," stated Dr. Damaj.
The Company has 13 products approved and commercialized in Canada including Zestra®, Zestra Glide®, Uxor®, DiabaSens®, Vesele®, RecalMax®, UriVarx®, ProstaGorx®, BH Testosterone®, AllerVarx®, Xyralid® Cream, Xyralid® Suppositories, and Apeaz® and has filed or is in the process of filing for six additional products including, FlutiCare®, PeVarx®, Healthifeet®, Breastlift®, ArthriVarx® and CarvaNum™.
Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT) recently announced that its wholly owned subsidiary, 9354-7537 Quebec Inc. has received a notification letter from Health Canada indicating that all requested license amendments have been approved.
The scope of the amendment received from Health Canada permits expansion of cannabis operation areas to include an additional extraction room where Neptune will perform cold ethanol extraction. Ethanol extraction is faster and more cost effective than the CO2 extraction currently used and will increase Neptune's input capacity from 30,000 kg to 200,000 kg.
The amendment from Health Canada also includes expansion for an encapsulation room where Neptune will produce cannabis oil capsules using the Licaps® technology licensed from Lonza Group AG. The encapsulation equipment is commissioned and ready for commercial operations with a capacity of up to 200 million capsules annually. The Licaps® technology supports differentiated product offerings through its various delivery systems, colors and branding possibilities. Furthermore, this is an effective technology for variable and multiple product formulation runs.
Neptune's Board of Directors recently approved an investment of $7 million to establish additional formulation, manufacturing and packaging infrastructure. This investment will allow Neptune to provide formulation services for new expected product forms such as vape pens, topicals, beverages, sprays, and others. A $4 million investment has also been approved, due to strong customer demand, to increase extraction capacity to a total of 1,500,000 kg, under Neptune's Phase IIIA expansion plans, targeted for completion before the end of calendar year 2019.
With this approval, Neptune is now positioned to submit further license amendments to incorporate the manufacturing of additional product forms, and packaging capabilities, as well as for the Phase IIIA extraction capacity expansion.
Another Cannabis company, WeedMD Inc. (TSXV:WMD) (OTCQX:WDDMF), a federally-licensed producer and distributor of medical-grade cannabis who recently secured Health Canada approval for 27 acres of low-cost, outdoor cultivation on its Strathroy, Ontario property, recently announced that it is the first licensed producer (LP) to be included in Shoppers Drug Mart and TruTrace Technologies' medical cannabis verification pilot project.
As recently announced by Shoppers and TruTrace at The Second Annual World Cannabis Congress, the Pilot Project is built on TruTrace's proprietary StrainSecure™ platform, which focuses on testing and verification to confirm the origin, authenticity and quality assurance of cannabis products. Link here to read. WeedMD has been a medical cannabis supplier to Shoppers since February 2019 and was the first licensed producer to partner with TruTrace and utilize the StrainSecure™ platform to register its genetics in late 2018.
"We registered 40 of our proprietary cannabis strains with TruTrace last October, recognizing the importance of strain validation as cannabis products advance through the medical and pharmaceutical channels," said Keith Merker, CEO of WeedMD. "We're proud to be the first LP to be included in Shoppers and TruTrace's recently announced pilot project. Patients and their medical practitioners expect traceability and origin assurance of their cannabis strains as it goes a long way to building continued trust and accountability in our industry."
ThermoGenesis Corp., a wholly owned subsidiary of Cesca Therapeutics (NASDAQ: KOOL) and a market leader in automated cellular processing recently announced that it has received Health Canada approval of its next-generation AXP®II system for cord blood processing.
The AXP® II, together with the company's companion, single-use, cell separation set, provides automated, rapid and reproducible harvesting of stem and progenitor cells from collected units of umbilical cord blood in a "functionally-closed" sterile system. The system, which received 510(k) market clearance from the US Food & Drug Administration (FDA) in November 2018, is used by premier public and private cord blood banks worldwide. It provides customers with upgraded functionality, user interface and compatibility with newer operating systems, and features an improved docking station and XpressTRAK® software to maintain compliance with Current Good Manufacturing Practice (cGMP) and Current Good Tissue Practice (cGTP) regulations.
Haihong Zhu, President of ThermoGenesis stated, "Health Canada's approval of the AXP® II - following its approval of the PXP® System earlier this year - marks the achievement of yet another key milestone and should allow us to meaningfully expand our footprint with a best-in-class system that today continues to hold a market-leading position. That said, we look forward to building on our customer base by offering Cord Blood Banks throughout Canada with the ability to undertake cord blood processing with a system that generates mononuclear cell (MNC) recoveries of >90% and CD34+ stem and progenitor cell recoveries of > 95%."
With the current Canadian federal legalization of cannabis and the forthcoming expected regulation updates due this October, both the pharmaceutical and wellness sectors are taking notice and following some of the same paths towards approval in the legal cannabis market. While this may be beneficial to those companies in the cannabis, pharmaceutical and wellness sectors, the real winner will be the Canadian consumer, who will no longer be cornered into having only one option as their medical/health treatment.
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