Tetra Bio-Pharma’s PPP002 on Track After Type C Meeting with FDA
Momentum Public Relations
Press Release: October 11, 2018
Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced it received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for PPP002, its dronabinol AdVersa™ mucoadhesive product. The meeting was held to confirm that the proposed chemistry and manufacturing and non-clinical development plan for PPP002 for the 505(b)(2) is acceptable.
The FDA established that Tetra Bio-Pharma’s proposed bridging strategy fulfilled all the requirements of the 505(b)(2) regulatory pathway for the product PPP002. The FDA also provided feedback on the chemistry and manufacturing aspects of the drug development plan. The FDA further confirmed that the product control strategy, ensuring the identity, potency, purity and quality of the PPP002 buccal tablets was acceptable thereby determining that Tetra Bio-Pharma’s plan is on track for drug approval.
“We have now completed our meetings with the U.S. FDA and Tetra is well on its way to finalizing the development plan to bring PPP002 to market,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “With both the Type B and C meetings now behind us, we are able to move forward with executing the clinical program for PPP002 and subsequently submit the New Drug Application to commercialize PPP002.”
Tetra, along with its partner IntelGenx Corp, is developing this product in the United States under the accelerated 505(b)(2) pathway for the indication of chemotherapy-induced nausea and vomiting, and anorexia and weight loss in people with AIDS. These are the same indications that have already been approved for Marinol®. The 505(b)(2) speciality Contract Research Organization, Camargo, is guiding the regulatory submissions to the FDA. Tetra is also developing PPP002 in Canada as an adjunct therapy for opioid reduction in patients with chronic pain.
According to the International Agency for Research on Cancer, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US $1.88 billion by 2020, an increase from its 2013 valuation of US$1.28 billion. Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that AdVersa™ can gain significant market share within three years of its launch in the USA.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Sirona Biochem to Present at the 2018 Arctic Circle Assembly
Momentum Public Relations
Press Release: October 11, 2018
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company”) announced today that Chief Scientific Officer, Dr. Geraldine Deliencourt-Godefroy will attend and present at the Arctic Circle Assembly. This conference will take place October 19th – 21st at the Harpa Conference Center in Reykjavik, Iceland.
The Arctic Circle Assembly is the largest international gathering on the future of the Arctic. As described by the organizers, this annual event invites attendees from 60 countries, ranging from heads of states and governments, ministers, members of parliament, officials, experts, scientists, entrepreneurs, business leaders, indigenous representatives, environmentalists, students, activists and others from the growing international community of partners and participants interested in the future of the Arctic. The Assembly covers a wide variety of topics designed in collaboration with partner organizations.
Dr. Deliencourt-Godefroy will be presenting in the Science and Traditional Knowledge Program. She’ll be discussing her work on glycoproteins based on arctic fish, a project she has been passionate about since her career began. In her post-doctoral research, Dr. Deliencourt-Godefroy was inspired by the naturally occurring antifreeze glycoproteins in the bloodstream of some fish that allow them to survive sub-zero temperatures. She has since developed a novel, patented family of compounds with a unique ability to resist stress, that are suitable for numerous commercial applications.
For over fifteen years, Dr. Deliencourt-Godefroy has continued to receive recognition for her innovative research and development within Europe, especially by the French Government. Prior to the Arctic Circle Assembly, Dr. Deliencourt-Godefroy will be attending Cosmetic 360 in Paris, France. At this global cosmetic trade fair, Sirona will be attending pre-arranged meetings as well as continuing to build networks with top industry representatives in cosmetics.
About the Arctic Circle Assembly
Established in 2013, the Arctic Circle Assembly is organized by the Arctic Circle, a non-profit organization creating a dialogue to discuss the future of the Arctic. Attended by over 2000 people from 60 countries each year, political figures, environmental experts, business leaders and scientists gather to raise global awareness of this region.
Alongside the assembly, the Arctic Circle organizes smaller forums around the world, to focus on specific environments and facilitate further discussion. For more information, visit: http://www.arcticcircle.org/
About Cosmetic 360
Cosmetic 360 is an innovative-centered trade fair for the cosmetic industry. The conference brings together professionals and industry representatives from all over the world. All facets of the cosmetic industry are represented at the conference including raw materials, formulation, packaging, testing and analysis, finished products, and distribution. More information on the conference can be found at https://www.cosmetic-360.com/en/
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For more information regarding this press release, please contact:
Christopher Hopton, CFO
Sirona Biochem Corp.
Phone: 1.604.282.6064
Email: chopton@sironabiochem.com
- Published in Business, Medical Marijuana, News Home, Sirona Biochem
CROP’s California Harvest in and ‘first Revenue’ Close
Momentum Public Relations
Press Release: October 11, 2018
CROP Infrastructure Corp. (CSE: CROP) (OTC: CRXPF) (“CROP”) announced today its California tenant has now finished harvesting the entire 30,000 square feet of production area.
The crop tally stands at approximately 2,100 pounds consisting of ~300 lbs of dried flower, ~1,100 lbs which is currently drying, and an additional ~700 lbs of lower tier production for extracts, etc. In line with CROP’s standardized growing protocols, the greenhouses have now been repopulated and the plants are already in flower for a further Q4 harvest.
CROP Infrastructure CEO, Michael Yorke, stated: “CROP is now only steps away from first revenue as the tenant’s sales cycle has been initiated. Of particular significance too, we can also report that the tenant’s temporary cannabis licenses have now been converted to a permanent California state license. CROP looks forward to having its California operations rapidly becoming profitable.”
The cannabis will now be trimmed and packaged to the specifications of the various distributors the tenant is contracting with. The crop strains are 707 OG, Forbidden Fruit, Green Crack, Birthday Cake, and Girl Scout Cookie. In addition, the tenant has added a new sought-after strain, Insane OG.
The company is awaiting construction permits to build out 12 proprietary light supplemented greenhouses totaling 44,000 sq. feet.
About CROP
CROP Infrastructure Corp. is publicly listed on the Canadian Securities Exchange and trades under the symbol “CROP” and in the US under the symbol “CRXPF”. CROP is primarily engaged in the business of investing, constructing, owning and leasing greenhouse projects as part of the provision of turnkey real estate solutions for lease-to-licensed cannabis producers and processors offering best-in-class operations. The Company’s portfolio of projects includes cultivation properties in California, two in Washington State, a 1,000-acre Nevada Cannabis farm, an 1,865 acre CBD farm, extraction in Nevada with international focuses in Jamaica and Italy and a joint venture on West Hollywood and San Bernardino dispensary applications.
CROP has developed a portfolio of assets including Canna Drink, a cannabis infused functional beverage, US and Italian distribution rights to over 55 cannabis topical products and a portfolio of 16 Cannabis brands.
Company Contact
Michael Yorke – CEO, Director
E-mail: info@cropcorp.com
Website: www.cropcorp.com
Phone: (604) 484-4206
- Published in Business, CROP Infrastructure, Medical Marijuana, News Home
CROP Hemp-CBD Farm Enters Toll Processing Deal to Produce CBD Isolate as it Readies for Harvest
Momentum Public Relations
Press Release: October 10, 2018
CROP INFRASTRUCTURE CORP. (CSE: CROP) (OTC: CRXPF) (Frankfurt: 2FR)announced today that its tenant has signed a toll processing deal whereby it will provide its dried hemp-CBD biomass to a processor who will then provide 50% of the finished product as ISO certified CBD isolate to CROP’s tenanted farm. The CBD isolate will be sold under the company’s brands Hempire, Tiff CBD, infused in to the company’s CannaDrink and sold under white label.
CROP’s tenant, at its Nye County hemp-CBD farm in Nevada, has already begun equipment readiness preparations as the harvest is imminent.
CROP will also be working with the toll processor to enter into further agreements to develop its own ISO extraction facility for its production capacity which is now expanded to over 1,800 acres for 2019. The processor has consulted with numerous Canadian ACMPR and US licensed cannabis cultivators and processors to develop GMP and ISO conforming extraction facilities.
According to cannabis industry analysts, The Brightfield Group, it is estimated the hemp CBD market alone could hit $22-billion by 2022.
CROP CEO, Michael Yorke, stated: “Being in a position to have CBD isolate from the 2018 harvest will enable the company to begin infusing products like the CannaDrink beverage line and begin developing relationships with bulk buyers in preparation for 2019. Even with a toll cost, upgrading CBD biomass to isolate should significantly increase the value of our tenant harvest. This new strategic-alliance opens up additional mutually beneficial opportunities, specifically those in developing our own extraction facilities, both in the US and Europe, which will be necessary to maximize the potential of our portfolio’s ongoing hemp-CBD and Cannabis-THC production.”
About CROP
CROP has a portfolio of cannabis projects including cultivation properties in California, two in Washington State, two in Nevada consisting of 2,800 acres, 3 dispensary applications, with international focuses in Jamaica and 2 farms in Italy. CROP has developed a portfolio of assets including CannaDrink and a portfolio of 16 Cannabis brands. with US and Italian distribution rights to over 55 topical products.
Company Contact
Michael Yorke – CEO & Director
E-mail: info@cropcorp.com
Website: www.cropcorp.com
Phone: (1) 604-484-4206
- Published in Business, CROP Infrastructure, Life Sciences, Medical Marijuana, News Home
CROP to Infuse its ‘CannaDrink’ Functional Beverage With Naturally Splendid’s HempOmega™
Momentum Public Relations
Press Release: October 3, 2018
CROP Infrastructure Corp. (CSE: CROP) (CSE: CROP.CN) (OTC: CRXPF)(Frankfurt: 2FR) (“CROP“ or the “Company“) announces that further to its LOI with Naturally Splendid Enterprises (TSX-V: NSP)(OTCQB: NSPDF) (previously announced on August 14th 2018) CROP will utilize NSP’s proprietary HempOmega™ powder created from microencapsulated hemp seed oil in its ‘CannaDrink’ functional beverage line currently being developed.
CannaDrink will now be available in all other jurisdictions containing HempOmega™ where CBD products are not yet approved. CROP’s new cannabis-infused line of soft drinks called CannaDrink will be a zero calorie, non-GMO, ketogenic-friendly line of soda pop, tea, and coffee variations.
HempOmega™ is a unique and proprietary homogenous powder created from microencapsulated hemp seed oil. It is a high-quality and sustainable omega fatty acid alternative ingredient. Due to its unique powder format, it solves the formulation challenge manufacturers face when trying to add oil to existing products and has proven to increase the bioavailability of omega fatty acids. The global carbonated soft drinks market is projected to reach USD 605.6 billion by 2025, according to a March 2018 report by Grand View Research, Inc.
In addition to its CannaDrink beverage line, CROP is working with Naturally Splendid to develop a “Hempire” branded hulled hemp seed and protein powder product line. CROP and Naturally Splendid are currently testing a variety of flavors and formulations created by NSP specifically for the Hempire Brand that will be enhanced with NSP’s HempOmega™.
Naturally Splendid CEO Mr. Douglas Mason states, “We are pleased to be working with CROP to create quality, white-labelled hemp products for the Hempire brand as well as providing our proprietary HempOmega™ ingredient for CROP’s innovative CannaDrink functional soft drink line. CannaDrink is formulated to deliver superior omega nutrition, by utilizing Naturally Splendid’s proprietary HempOmega™it provides ‘first mover advantage’ for Naturally Splendid and CROP to formulate cannabis formulated beverages and edibles as HempOmega™ has been approved for product fortification without the concern or restrictions of cannabinoid formulated beverages and edibles
Michael Yorke, CEO and Director of CROP Infrastructure states: “We believe in the nutritional spectrum and health benefits of both hemp and CBD so adding a consumer goods vertical was a logical progression as consumer data shows strong trends in plant-based foods and nutritional products. We see it as a tremendous opportunity for CROP Infrastructure’s branding & IP portfolio.”
About CROP
Crop has a portfolio of cannabis projects including cultivation properties in California, two in Washington State, two in Nevada consisting of 2,800 acres including extraction, 3 dispensary applications, with international focuses in Jamaica and Italy. CROP has developed a portfolio of assets including Canna Drink with US and Italian distribution rights to over 55 topical products and a portfolio of 16 Cannabis brands.
Disclaimer for Forward-Looking Information
Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events, and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970. Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding CannaDrink; the technological effects of CannaDrink; the intention to expand its portfolio; and execute on its business plan. Such statements are qualified in their entirety by the inherent risks and uncertainties surrounding the regulatory and legal framework regarding the cannabis industry in general among all levels of government and zoning; risks associated with applicable securities laws and stock exchange rules relating to the cannabis industry; risks associated with maintaining its interests in its various assets; the ability of the Company to finance operations and execute its business plan and other factors beyond the control of the Company. Such forward-looking statements should therefore be construed in light of such factors, and the Company is not under any obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
The CSE has not reviewed, approved or disapproved the content of this press release.
Company Contact
Michael Yorke – CEO & Director
E-mail: info@cropcorp.com
Website: http://www.cropcorp.com
Phone: +1-604-484-4206
- Published in Business, CROP Infrastructure, Medical Marijuana, News Home
Tetra Bio-Pharma Moves PPP001 Closer to Commercial Manufacturing with the Issuance of a Drug Establishment License to Ford’s Pharmacy
Momentum Public Relations
Press Release: October 3, 2018
Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), in partnership with Ford’s Family Pharmacy and Wellness Center, have developed and implemented a pharmaceutical quality system for Canada’s first botanical-based prescription drug PPP001. The Good Manufacturing Practices, Regulatory Operations and Regions Branch, Health Canada completed the inspection of Ford’s manufacturing facility. A Drug Establishment License (DEL) was granted after having inspected and assessed the facility as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations thereby allowing Ford’s to conduct the fabrication, packaging and labeling of PPP001.
Dr. Guy Chamberland, M.Sc., Ph.D., Interim CEO and CSO of Tetra Bio-Pharma stated, “This is a significant accomplishment for Tetra and Ford’s. The manufacturing of a botanical drug is a complex operation and we have demonstrated to Health Canada that we are able to manufacture PPP001 in compliance with the requirements for a prescription drug. The DEL was required not just to manufacture the commercial lots but simply to enable Tetra to apply for approval and obtain the Drug Identification Number (DIN). Tetra is now in an excellent position to focus its activities on scale-up to ensure that we can supply the market demand for a first cannabis botanical drug. The DEL, a recognition of the pharmaceutical GMP quality process by Health Canada, was a critical milestone for Tetra to achieve thereby allowing the corporation to accelerate its plans to register cannabis drugs around the world including Europe and the USA.”
Dr. Peter Ford, CEO of Ford’s Family Pharmacy and Wellness Centre stated, “This has been a true team effort between Tetra and Ford’s and will potentially represent the very first smokable dosage form in Canada and beyond. We are both very much committed to the DIN application.”
Ofer Yifrach-Stav, Tetra Bio-Pharma Vice President, Pharmaceutical Compliance and Quality, said, “Tetra is proud to present a significant milestone in the development of PPP001, a prescription drug that contains a botanical ingredient, manufactured under the stringent requirements and regulations of Health Canada. The GMP inspection addressed a wide range of production activities, and the results demonstrate our consistent adherence to establish procedures at every step of the production process, as well as our ability to provide a high-quality, clean, safe and reliable product. We are excited to take the next steps in the development of cannabis botanical drugs with the potential of making them widely available to the public.”
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
About Ford’s Family Pharmacy and Wellness Centre
Since 1997, Ford’s Family Pharmacy & Wellness Centre has helped clients improve and prolong their health, wellness and vitality by providing personalized compounding and wellness solutions. Our team, which currently consists of four pharmacists: Peter Ford, Bryan Sinclair, Candy Aguinaga, and Taylor White, 14 pharmacy technicians/assistants and two registered nurses, is attentive, compassionate, courteous and responsive. We pride ourselves on providing innovative solutions to complex medical problems, and work with Canadian healthcare providers (including physicians, veterinarians and dentists) to create well-rounded, comprehensive natural and compounding treatment plans. Our consultative approach, state-of-the-art technology and unique “Functional Medicine” position means we will work with you one-on-one to understand the root cause of your pain or other health issues and apply all our resources to developing the treatment that is right for you.
For more information visit: www.fordrx.com
Source: Tetra Bio-Pharma
- Published in Business, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Crop Announces Major Expansion in Italy
Momentum Public Relations
Press Release: October 1, 2018
CROP INFRASTRUCTRE CORP. (CSE: CROP) (OTC: CRXPF)(Frankfurt: 2FR) announced today that it has leased a 87,120 square foot greenhouse facility in Italy through its joint venture with XHemplar. Work has already begun on upgrading the site security which includes cameras and fencing.
In addition, CROP will be working with XHemplar to open two retail locations before the end of the year, as well as build a state-of-the-art extraction facility.
CROP Infrastructure CEO, Michael Yorke, stated: “This will allow for low-cost and high-quality pure CBD isolate and CBD products to be sold domestically as well as into the European CBD market. The joint venture’s CBD products will be branded under the XHemplar and CROP brands Tiffany CBD and Hempire Italia.
“This is a major increase in our European footprint. Not only will this expand our growing capacity and quality control, but, very importantly, the build-out of an extraction facility will allow CROP to provide European markets with quality CBD isolate.”
According to cannabis industry analysts the Brightfield Group, it is estimated the hemp-CBD market alone could hit $22 billion by 2022.
About CROP
Crop Infrastructure Corp. is publicly listed on the Canadian Securities Exchange and trades under the symbol “CROP” and in the US under the symbol “CRXPF”. CROP is primarily engaged in the business of investing, constructing, owning and leasing greenhouse projects as part of the provision of turnkey real estate solutions for lease-to-licensed cannabis producers and processors offering best-in-class operations. The Company’s portfolio of projects includes cultivation properties in California, two in Washington State, a 1,000-acre Nevada Cannabis farm, a 1,865 acre CBD farm, extraction in Nevada with international focuses in Jamaica and Italy and a joint venture on West Hollywood and San Bernardino dispensary applications.
CROP has developed a portfolio of assets including Canna Drink, a cannabis infused functional beverage, US and Italian distribution rights to over 55 cannabis topical products and a portfolio of 16 Cannabis brands.
Company Contact
Michael Yorke – CEO & Director
E-mail: info@cropcorp.com
Website: www.cropcorp.com
Phone: (1) 604-484-4206
- Published in Business, CROP Infrastructure, Medical Marijuana, News Home