Tetra Bio-Pharma to Present Key Research Findings as Part of Food and Drug Administration (FDA) Public Hearing on CBD
Momentum Public Relations
Press Releases: May 30th, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), will present key findings from its three Phase 1 and its Phase 2 cancer and non cancer investigational trials with cannabinoids, before the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds, Part 15 Public Hearing on Friday, May 31, 2019. The meeting will take place in Silver Spring, Maryland.
The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds to inform the FDA’s regulatory oversight of these products. This hearing is particularly important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334 (so called Farm Bill), which, among other things, removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act. Given the lack of safety evidence in the published literature, the FDA will hear from important stakeholders including patients, academia, manufacturing, retailers, public health and government bodies who will contribute by providing their data and experience. More than 400 different groups and entities made requests to present before the hearing.
Tetra’s presentation will be made by Rola Mazloum, Director of Regulatory Affairs and will comprise but not be limited to the following:
- Demonstrate that:
- inhalation via smoke or vapor achieves significantly superior delivery to the patient than the oral or sublingual routes;
- the oral route with capsules achieves less absorption than that of sublingual delivery;
- Provide a comparison of:
- side effects when given single dose versus repeat daily dosing.
- smoked versus vaped product;
- Present pertinent safety findings from the Phase 1 trials;
- Provide data that suggests a mechanism of tolerance to side effects;
- Present the impact of dose titration comparing smoked versus oral;
- Summarize the mycotoxin (fungi impurities) findings and how Tetra now manages this issue.
“The ground-breaking research that Tetra has and continues to advance is critical in adding to the scientific safety and efficacy data that regulators like the FDA, Health Canada and the European Medical Authority are looking for,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio Pharma. “Tetra is clearly seen as a world-class leader in conducting robust clinical studies, namely SERENITY© (Phase 3 in advanced cancer pain), REBORN© (phase 2 in breakthrough pain), OPIOSPARE© (Phase 2 to document opioid sparing effect) and others with cannabinoid-derived products to address unmet medical needs. We are privileged to share our insights and add to the body of evidence.”
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Sirona Biochem Reports Excellent Preliminary Safety Assessment of Lead Anti-Wrinkle Compound LIP-01
Momentum Public Relations
Press Releases: May 28th, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce safety testing on its lead glycoprotein compound in the anti-wrinkle program yielded excellent results and the company will immediately move to the next steps of development. This project was generously supported by BPI France and the region Haute Normandie.
The comprehensive safety analysis was performed by CEHTRA (www.cehtra.com), cosmetic toxicology specialists in Paris, France. Key in vitro measures and in silico analyses of safety were evaluated, including skin irritation, skin sensitization, ocular tolerability, phototoxicity, genotoxicity and carcinogenicity. It was concluded that there is no evidence of these issues in the testing. Also, based on in silico analysis, no systemic toxicity is expected.
“These are very encouraging results for our anti-wrinkle program. Sirona’s scientists at our French subsidiary, TFChem, will be focusing their efforts on the next set of tests and a detailed project plan to make this a priority. There is still work to be done in the lab, but we have nicely de-risked the project by conducting these safety assays”, reports Dr. Howard Verrico, CEO of Sirona Biochem.
Next steps in the program will include additional in vitro assays for a second review by CEHTRA to determine dosing. This will be followed by synthetic process refinements, synthesis of a batch for formulation, skin permeation study and clinical safety evaluation.
Loss of elasticity and degradation of fat tissue are two markers seen in aging skin, leading to the appearance of lines and wrinkles. Compounds that increase the number and volume of adipocytes (fat cells) can act as plumping, volumizing, and densifying skin agents, thereby reducing the visibility of wrinkle and potentially providing a more youthful look. Novel solutions are actively being sought out by the dermatology industry to address this.
The global anti-aging market is forecast to reach up to US$271.0 Billion by 2024.1 The anti-wrinkle product category held the largest share in the anti-aging market, with 59.3% contribution in 2017.2
The anti-wrinkle potential of LIP-01 is as a non-invasive treatment for fine wrinkles by a mechanism very different from dermal fillers and Botox®. Botox®3 is generally limited to use on the upper third of the face, specifically the frown lines between the eyebrows. Botox® also requires administration by a properly trained professional.
“Less of our team’s resources are needed on the skin lightening project as its development is now mainly focused on manufacturing. We are excited to have the opportunity to continue expanding the powerful technology platform developed by our Chief Scientific Officer Dr. Geraldine Deliencourt and her team. This anti-wrinkle compound has fascinating properties in cells and we anticipate moving it along quickly. If clinically successful, LIP-01 could exceed Botox in market potential,” Dr. Verrico concluded.
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BOTOX COSMETIC® is a registered trademark of Allergan Inc. |
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 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 press release.
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Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem’s forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem’s business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
SOURCE Sirona Biochem Corp.
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Contact:
regarding this press release, please contact: Jonathan Williams, Managing Director, Momentum PR, Phone: 1.450.332.6939, Email: jwilliams@momentumpr.com
- Published in Life Sciences, News Home, Sirona Biochem
Sirona Biochem Hires Contract Research Organization for Manufacturing Process Optimization for TFC-1067
Momentum Public Relations
Press Release: May 22, 2019
Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce it has commissioned Contract Research Organization (CRO) Roowin (www.roowin.com) to develop the final chemical process required for large scale manufacturing of TFC-1067. This is another important step in the commercialization of Sirona’s novel skin lightening agent.
Sirona anticipates the need for multiple kilogram production of TFC-1067 in the short term and is therefore taking this necessary intermediate step. Sirona will then proceed to manufacture an inventory of TFC-1067 of up to 20 kilograms to be ready for anticipated orders. Due to the high potency of the compound, each kilogram will supply Sirona’s active skin lightening ingredient to produce ten thousand consumer size (fifty milliliters) containers of finished product.
“The chemistry of TFChem (Sirona’s subsidiary) is unique and our science team has an excellent understanding of this chemistry. We have already successfully worked on production of TFC-1067 at the kilogram scale,” reports Patrice Rool, CEO of Roowin. “Our scientists will collaborate with TFChem to develop the most efficient final process to manufacture TFC-1067. We are very excited to be a part of the ongoing development of this innovative skin lightener.”
“Roowin’s expertise in manufacturing process development will move TFC-1067 closer to final commercialization. In addition, our scientists at TFChem have developed new chemistry that will further improve manufacturing efficiencies and lower cost of goods,” Dr. Verrico concluded. “The new manufacturing process for TFC-1067 we anticipate will be used at manufacturing sites globally down the road. Roowin has extensive experience with our chemistry and we are excited to be working together again.”
About Roowin
Roowin is a privately-owned Contract Research Organization (CRO) headquartered in Riom (Auvergne), France. Its core business being in high value-added fine chemistry, Roowin offers a large range of chemical services. Roowin supports customers and partners to advance their drug candidates from early research phase up to licensing out API in phase II or to the Market for small batches, about 20 kilograms.
Roowin is accredited ISO 9001. Roowin’s facilities include cGMP facilities: Kilo-laboratory / Pilot plant. Roowin can accompany its customers from early lead optimization through scale-up and small-scale GMP synthesis up to medium scale GMP manufacturing.
For more information, please visit www.roowin.com.
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 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 press release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem’s forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem’s business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
SOURCE Sirona Biochem Corp.
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2019/22/c5079.htmlv
- Published in Bio technology, Life Sciences, News Home, Sirona Biochem
Mondias CELEXT07 latest test results confirm effective suppression of grey mould on hops
Momentum Public Relations
Press Release: May 16, 2019
Mondias Naturals Inc. (“Mondias” or the “Company”) (TSXV: NHP) is pleased to announce the results from research on the use of its proprietary CELEXT07 bio-defense stimulant plant extract on hops plants, conducted in collaboration with McGill University.
Global hops production is expected to grow by 3.3% to 122,767 metric tons in 2019 (Source: IHGC – Economic Commission Summary Reports, April 26, 2019). Hops production in the United States alone reached a record high of US$618 million in 2017, up 24% from US$498 million in 2016 (Source: U.S. Department of Agriculture). The global hops market is driven by increasing demand for hops in alcoholic beverages, medicinal drugs and cosmetic formulations. Over the next five years, increased demand for various flavours in beer such as pilsner or lager and the rise in popularity for hop-based craft beer are major factors that will significantly fuel the growth of the global hops market (Source: Persistence Market Research).
The objective of the current series of tests was to measure CELEXT07’s efficacy in suppressing and preventing diseases on hops plants. Hops is a genus belonging to the same taxonomic family as cannabis. Mondias’ latest experiments on cannabis and hops served as proof-of-concept of the efficacy of the Company’s botanicals in plant protection and increasing plant survival by eliciting induced resistance.
Summary of the test results:
- Foliar applications of CELEXT07 bio-defense stimulant extract were very effective in suppressing grey mould (caused by Botrytis cinerea) infections on hops, with decreases of 86% in disease severity and 67% in disease incidence.
- A scheduled dose split over three days for the soil drench application of CELEXT07 also proved effective for the prevention/suppression of grey mould on hops, with decreases of 31% in disease severity and up to 50% in disease incidence.
- Foliar and soil drench application of CELEXT07 did not have any phytotoxic effect on hops.
“These latest results continue to confirm that CELEXT07 is very effective in suppressing and preventing a wide range of fungal and bacterial pathogens, and has applications in more than one large market,” said Jean-Philippe Gravel, Chief Executive Officer of Mondias. “As mentioned in our last release, Mondias has secured the production capacity needed to meet demand from potential clients. CELEXT07 is ready to market and we are presently looking at selling our product through various sales channels and markets, including the agriculture, horticulture, cannabis and hops markets.”
With post-harvest losses of one-third of the food produced worldwide for human consumption (Gastavsson et al., 2011) and annual economic losses of $10 billion to $100 billion worldwide due to grey mould and powdery mildew (L. Hua et al., 2018), the market potential for CELEXT07 is considerable.
About Mondias Natural Products Inc.
Mondias specializes in the commercialization and development of evidence-based botanical products for the health care, bio-agriculture and organic markets. The company sells both oral and topical botanical agents to help manage unmet medical needs through its Holizen Laboratories division. Mondias is also developing botanical-based specialty fertilizers for use on household plants, lawns and golf courses and in urban gardens, nurseries and greenhouses, in collaboration with McGill’s Faculty of Agricultural and Environmental Sciences.
For more information, visit: www.mondias.ca
- Published in Business, Life Sciences, Mondias Natural, News Home, Technology
Sirona Biochem Receives Positive Clinical Results of its Skin Lightening Compound TFC-1067 from China
Momentum Public Relations
Press Release: May 15, 2019
Sirona Biochem Corp. (TSXV: SBM) (FSE: ZSB) (“Sirona“) is pleased to announce results of a clinical trial performed in the Peoples Republic of China (China) using Sirona’s novel skin lightening agent TFC-1067. Sirona’s TFC-1067 once again demonstrated significant clinical lightening effect without any reported adverse effects.
A major distributor of cosmetics materials in China arranged clinical testing of TFC-1067 to be done by a select group of its key cosmetic customers. The formulation used in the studies was the same as that used in Sirona’s first clinical trial in the USA by Dr. Zoe Draelos. The clinical trial design protocols and the testing was conducted independently of Sirona by the cosmetic companies. The studies were conducted in Guangzhou, China.
A total of 60 participants were involved in the studies conducted over several sites. All participants applied the formulation with TFC-1067 twice daily to the face. Each study duration was 4 weeks. During the 4 weeks 90% of participant reported a brightening effect with TFC-1067. Sirona is informed by the distributor that a second set of trials with Sirona’s improved, next generation, formulation is underway.
Dr. Géraldine Deliencourt-Godefroy, Chief Scientific Officer of Sirona Biochem stated, “These are excellent clinical results. Based on the outcome from our first clinical trial, we are pleased to see such results for the short 4-week duration of the testing. This positive testing result on Asian skin with the observed lightening effect supports the clinical effect of TFC-1067 over different skin types. A longer trial is required to assess dyschromia which was assessed in Sirona’s US based clinical trial. Sirona will await feedback on the further testing currently ongoing in China with our new formulation.”
“No clinical safety issues were reported with TFC-1067 during the trial. TFC-1067 has shown a lightening effect over a short clinical trial on Asian skin types.” reports Dr. Howard Verrico, CEO of Sirona Biochem. “Although we prefer to conduct trials with a double blinded protocol using a comparative compound and a longer trial duration as we arranged in the USA, it was important to have these cosmetic companies perform their own clinical testing independently and be confident of the results. TFC-1067 continues to deliver excellent clinical results as anticipated by our preclinical assays. A strong commercial interest in TFC-1067 is already reported by the distributor based on current results.”
“Sirona’s team remains dedicated to work towards entering this market with a safe and effective alternative to current options. We are moving forward on building our relationship with the Chinese distributor with more positive news anticipated near term”, Dr. Verrico concluded.
The global skin lightening market is estimated to grow to US$31.2 billion by 20241. Asia makes up the largest and fastest growing segment of the market. A World Health Organization survey reported that nearly 40 per cent of women polled in China said they regularly used whitening products many of which are toxic2.
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1 https://www.factmr.com/report/309/skin-lightening-products-market
2 http://theglobalfool.com/tag/mercury/
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 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 press release.
- Published in Business, Life Sciences, News Home, Sirona Biochem
Tetra Bio-Pharma’s Recently acquired Wholly Owned Subsidiary Panag Pharma Provides an Update on Recent Activities
Momentum Public Relations
Press Release: May 9, 2019
PANAG Pharma Inc. (PANAG), a wholly owned subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V: TBP) (OTCQB: TBPMF), a bio-pharmaceutical company engaged in cannabinoid-based drug discovery and development, is pleased to provide investors with an update on the activities of PANAG including, but not limited, to its innovative and patented formulations for the treatment of uveitis which will enter Phase 2 in late 2019.
The acquisition of PANAG and the products at various stages of development, is a perfect fit for Tetra’s business model by providing a deeper pipeline of products to attract strategic commercial partners to distribute these products in Canada, the USA and around the world.
“As a result of this acquisition, we have added highly qualified experts in cannabinoid science and medicine as well as a wealth of drug discovery and early phase drug development expertise and experience. Panag and Tetra Bio-Pharma will join forces to achieve noteworthy regulatory and clinical milestones. Our long term looks very promising, the synergies of the two companies may yield attractive returns for our investors” said Dr. Guy Chamberland, CEO, CSO of Tetra.
The following Panag products will be available to consumers without a prescription from their physician (e.g., natural product section of the pharmacy) and will be made commercially available in late 2019.
The following products have already been approved by Health Canada and have received a Natural Product Number:
- Topical A, a cream for treating osteoarthritis, joint and muscle pain
- Beta C + Zinc, a gel for the treatment of Cold sores
- Beta C + Benzocaine a cream to be used in treating hemorrhoids
In June 2019, Tetra anticipates completion of Panag’s Phase 3 type clinical trial (Protocol ID: Panag-001) of its Topical-A pain cream.
This study consisted of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating Topical-A against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label Topical-A to be administered over the subsequent 3 weeks. The Primary Endpoint was the evaluation of improvement in pain interference as measured by the Brief Pain Inventory (BPI) in individuals who are experiencing pain due to osteoarthritis of the knee. The Secondary Endpoints were: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.
Repurposing Product Candidates
Tetra is currently repurposing existing topical products which will benefit from the addition of ß-caryophyllene (a powerful terpene) and the Multiplexed Molecular Penetration Enhancer (“MMPE™”), a patented technology developed by Tetra’s partner Crescita™. The MMPE™ will provide increased permeability of active ingredients through the skin thereby providing an improved delivery to the therapeutic target (joints & bones, muscles etc.).
Milestones (NPN products) | Key dates | |||
Results of Panag-001 (Topical-A) | June 2019 | |||
Ongoing negotiations with commercial partners | Summer 2019 | |||
Launch of two repurposed products (NPN) | Q1 2020 |
The following products are regulated as drugs and, if approved, will be prescribed (Rx) by physicians.
A pilot study with PPP-003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals
On May 2, 2019 Panag Pharma announced that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has been authorized by the Veterinary Drugs Directorate (VDD), Health Canada. VDD granted the Experimental Studies Certificate to the veterinary ophthalmologists that will be performing the clinical study for Panag.
Repurposing Product Candidates
Tetra is also currently repurposing existing topical prescription drug products which will benefit from the addition of ß-caryophyllene combined again with the Multiplexed Molecular Penetration Enhancer (“MMPE™”), a patented technology developed by our partner Crescita™. The MMPEÔ will provide increased permeability of active ingredients through the skin thereby providing improved delivery to the therapeutic target (joints & bones, muscles etc.).
Interstitial Cystitis Product Candidate
Panag has also developed therapies, along with intellectual property, for the treatment of interstitial cystitis. Tetra plans to start commercializing some of these products in 2020
Milestones (Drug development) | Key dates |
||||
Launch of the Veterinary Pilot Study in indolent corneal ulcers | June 2019 | ||||
Pre-IND Meeting with the FDA on the ophthalmic program | June 2019 | ||||
Launch of the Phase 1 and 2 in Uveitis and Painful Dry Eye | Q4 2019 | ||||
Filing of two repurposed (DIN) products with Health Canada | Q4 2019 | ||||
Medical food approval Interstitial Cystitis Milestone (first generation product) |
Q1 2020 |
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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
About Panag Pharma
Panag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world’s leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for the topical application to the skin, the eye and other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Topical A OTC provides a new approach to the treatment of chronic pain and inflammation.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of the products developed by Panag and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Contact:
Steeve Néron
Senior Vice President Marketing & Medical Affairs.
514-232-2851
Investors@tetrabiopharma.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Mondias strengthens its management structure
Momentum Public Relations
Press Release: May 8, 2019
Mondias Naturals Inc. (“Mondias” or the “Company”) (TSXV: NHP) is pleased to announce the appointment of Mr. André Rancourt as Executive Chairman, and of Mr. Derek Lindsay as Vice President, Corporate Development, effective immediately. Mr. Rancourt was previously Chairman of the Board.
“The appointment of Mr. Rancourt as Executive Chairman clearly strengthens the structure and depth of our management,” said Jean-Philippe Gravel, Chief Executive Officer of Mondias. “Mr. Rancourt’s wealth of expertise, vast network and involvement in day-to-day strategy and operations will greatly contribute to our expansion efforts.”
“We are also pleased to have Mr. Lindsay join the Mondias team. His proven expertise in raising equity and financing projects, structuring creative strategic partnerships, increasing investor awareness and completing acquisitions will be an asset for Mondias as the Company embarks on its next growth phase,” added Mr. Gravel.
Mr. Lindsay is a seasoned financial executive with extensive international experience in accelerating the growth of emerging companies. Over the course of his career, he has been instrumental in raising significant equity and debt financing, completing acquisitions and closing strategic partnerships. Mr. Lindsay holds an M.B.A. from the Tuck School of Business at Dartmouth College and a B.A. from Middlebury College, U.S.A.
Mr. Lindsay’s responsibilities with Mondias include financing, investor relations and acquisition activities, as well as participating in the identification and assessment of new business opportunities, with the goal of accelerating the Company’s growth.
The Company also announces that the board of directors has approved the granting of 650,000 stock options to directors, officers, consultants and employees under the Company’s stock option plan. The exercise price of the options is $0.235 (the closing price of the shares on May 6, 2019). The options will vest in equal instalments over a three-year period and expire on May 6, 2029. The options and the stock option plan are subject to shareholder approval at Mondias’ annual and special shareholder meeting on June 10, 2019.
Pursuant to this stock option grant, the Company has a total of 3,600,408 stock options outstanding, which represents less than 6% of the Company’s issued and outstanding common shares.
About Mondias Natural Products Inc.
Mondias specializes in the commercialization and development of evidence-based botanical products for the health care, bio-agriculture and organic markets. The company sells both oral and topical botanical agents to help manage unmet medical needs through its Holizen Laboratories division. Mondias is also developing botanical-based specialty fertilizers for use on household plants, lawns and golf courses and in urban gardens, nurseries and greenhouses, in collaboration with McGill’s Faculty of Agricultural and Environmental Sciences.
For more information, visit: mondias.ca
- Published in Life Sciences, Mondias Natural, News Home
Nass Valley Gateway Enters into Letter of Intent with CSB Supply BV to Supply CBD Products for Distribution under Nass Valley’s Brand
Momentum Public Relations
Press Release: May 6, 2019
Nass Valley Gateway Ltd. (the “Company” or “Nass Valley”), trading on the Canadian Securities Exchange (“CSE”) under the trading Symbol “NVG” and on Deutsche Boerse Frankfurt under the trading Symbol 3NVN, is pleased to announce the signing of a letter of intent (“LOI”) with CSB Supply BV (“CSB”). CSB is a global business to business wholesale supplier of CBD (Cannabidiol) products.
Under the terms of the LOI CSB will supply and Nass Valley will market and distribute CBD products nationally in the United States and Canada under the Nass Valley brand.
CSB is headquartered in Amsterdam and has been in business for over 10 years manufacturing, packaging and whole-selling a variety of CBD products. The products supplied for Nass Valley’s brand will meet the US Federal legal requirements containing less than 0.3% THC (Tetrahydrocannabinol).
John Affenita, Nass Valley’s President & CEO, commented: “We are very excited to be entering into this LOI with a prominent and well established CBD manufacturing company that meets the required quality and specification for Nass Valley’s brand. The full range of products will be available for us to sell and distribute nationally and internationally. We believe that this partnership will be financially beneficial to both parties.”
ABOUT NASS VALLEY
Nass Valley Gateway (CSE: “NVG”; Frankfurt: “3NVN”) is a diversified healthcare company which is focused to further expand the business of its acquired subsidiary Pro-Thotics Technology Inc. (“PTI”) which was established in 1988. The Company is increasing its marketing of durable medical equipment products (DME-Business) on a national level, to encompass all states of the USA and other areas of North America and is aggressively developing the marketing, production and vertical integration of Cannabidiol (CBD) products without Tetrahydrocannabinol (“THC”) content for internal use including CBD infused skin, bath, and body care products of its wholly owned subsidiary Advanced Bioceuticals Limited (“ABL”).
PTI is licensed to supply its products also to Medicare patients in the US and has established, over its more than 25 -year history, a database of more than 200,000 patients, located throughout the U.S. and Puerto Rico, who were seeking wellness from pain relief.
Through its subsidiary ABL, Nass Valley is determined to expand upon this pain relief concept of its ABL-Business and to aggressively focus on the hemp-based CBD marketplace with a global market of $3.1 billion (New Frontier Data) and expand its current New Jerseyoperations internationally.
We seek Safe Harbor.
Neither the CSE nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of the contents of this news release.
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- Published in CBD, Life Sciences, Nass Valley Gateway, News Home
Tetra Bio-Pharma’s Subsidiary, Panag Pharma, Obtains Health Canada Authorization to Commence Its First Veterinary Clinical Study
Momentum Public Relations
Press Release: May 2, 2019
Panag Pharma Inc. (Panag), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced that its pilot clinical study to evaluate the tolerability and potential efficacy of its PPP003 ophthalmic drug in the treatment of indolent corneal ulcers in companion animals has been authorized by the Veterinary Drugs Directorate (VDD), Health Canada. VDD granted the Experimental Studies Certificate to the veterinary ophthalmologists that will be performing the clinical study for Panag.
“Panag has developed a series of cannabinoid-based drugs for the pharmaceutical market,” stated Dr. Melanie Kelly, Co-Founder, Panag Pharma. “Over the last year, we have worked with Tetra to develop an ophthalmic pipeline for pain and inflammatory conditions of the eye. PPP003 is one of the most important assets in our ophthalmic portfolio.”
“PPP003 is a new chemical entity which, in addition to patent protection, would benefit from 6 years data exclusivity plus 2 years marketing exclusivity granted under the Canadian drug regulations,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “This product candidate comes from our collaboration with Panag. The granting of this authorization by VDD further reinforces the importance of our recent acquisition and our ability to meet milestones.”
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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 cannabinoids 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
About Panag Pharma:
Panag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world’s leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for the topical application to the skin, the eye and other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Topical AOTC provides a new approach to the treatment of chronic pain and inflammation.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of PPP003 and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Contact:
Guy Chamberland, Ph.D.,
Chief Executive Officer and Chief Scientific Officer
514-220-9225
Investors@tetrabiopharma.com
Investor Contact:
Pierre Boucher, CPA, CMA
Partner, Executive Vice-President
514-731-000 ext. 237
Investors@tetrabiopharma.com
Media Contact:
Energi PR
Carol Levine, APR, FCPRS
514-288-8500 ext. 226
Carol.levine@energipr.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Closes the Acquisition of Panag Pharma
Momentum Public Relations
Press Release: May 1, 2019
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that it completed today the previously-announced acquisition (the “Acquisition“) of Panag Pharma Inc. (“Panag“) pursuant to a share purchase agreement (the “Agreement“) dated January 30, 2019 between the Company and the shareholders of Panag (the “Vendors“).
Pursuant to the Agreement, Tetra acquired 100% of the issued and outstanding common shares of Panag held by the Vendors in consideration for, in aggregate, (i) $3,000,000 in cash and (ii) the issuance of 16,304,348 class A common shares of Tetra (“Common Shares“) at a price of $0.552 per Common Share. The Agreement also contemplates the payment by Tetra to the Vendors of an aggregate amount of up to $15,000,000 in cash in milestone payments upon the achievement of operational targets associated with marketing approvals and commercialization of both human and veterinary drug products by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), all as more fully described in the management proxy and information circular of the Company dated March 20, 2019.
All Common Shares issued as part of the Acquisition were issued pursuant to exemptions from the prospectus requirements of applicable securities laws.
Dr. Guy Chamberland, CEO and CSO of Tetra stated, “We are very excited by the closing of the acquisition of Panag Pharma. As of today, Tetra is no longer a small biotechnology company focused on cannabinoid-based drugs delivered by inhalation. We are now a small biopharmaceutical company with a strong pipeline of drugs for the ophthalmic and chronic inflammation markets with a unique portfolio of products ready for commercialization. From Day 1 I believed in the people that made Panag a success story. Today I am extremely proud to count them as part of the Tetra family. As a result of this acquisition, we have added highly qualified experts in cannabinoid science and medicine as well as a wealth of drug discovery and early phase drug development expertise and experience. I am confident the Tetra-Panag family will help take the Corporation to the next level of success.”
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada authorized, and FDA reviewed, clinical trials 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
About Panag Pharma:
Panag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world’s leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for the topical application to the skin, the eye and other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Topical AOTC provides a new approach to the treatment of chronic pain and inflammation.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Companybelieves, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of CAUMZ and its other drug candidates, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Contact:
Guy Chamberland, Ph.D.,
Chief Executive Officer and Chief Scientific Officer
514-220-9225
Investors@tetrabiopharma.com
- Published in Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma