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Food and Drug Administration #FDA confirms nonclinical and manufacturing requirements #Tetra $TBP.ca $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 8:56 AM on Thursday, October 11th, 2018

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  • Received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for PPP002, its dronabinol AdVersa™Â mucoadhesive product
  • 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

ORLEANS, Ontario, Oct. 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™Â 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

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.

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 PPP002, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine Stephanie Engel
514-288-8500 ext. 226 416-425-9143 ext. 209
[email protected] [email protected]

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Tetra Bio-Pharma $TBP.ca Moves PPP001 Closer to Commercial Manufacturing with the Issuance of a Drug Establishment License to Ford’s Pharmacy $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 9:22 AM on Wednesday, October 3rd, 2018

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  • 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

ORLEANS, Ontario, Oct. 03, 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

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.

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 PPP001, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine
514-288-8500 ext. 226
[email protected]              Stephanie Engel
416-425-9143 ext. 209
[email protected]

Tags: , , , ,
Posted in All Recent Posts, Tetra Bio-Pharma Inc. | Comments Off on Tetra Bio-Pharma $TBP.ca Moves PPP001 Closer to Commercial Manufacturing with the Issuance of a Drug Establishment License to Ford’s Pharmacy $AERO $CBDS $CGRW $APH.ca $GBLX

Tetra Bio-Pharma $TBP.ca Announces PPP002 Program Update Following Type B Meeting with U.S. FDA $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 9:02 AM on Thursday, September 27th, 2018

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  • Announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its dronabinol AdVersa™Â mucoadhesive product, PPP002
  • The purpose of the meeting was to obtain confirmation of the eligibility of PPP002 for the 505(b)(2) NDA and the requirements for marketing approval

Shorter regulatory pathway confirmed by FDA and potential for Schedule 3 classification

ORLEANS, Ontario, Sept. 27, 2018 — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its dronabinol AdVersa™Â mucoadhesive product, PPP002. The purpose of the meeting was to obtain confirmation of the eligibility of PPP002 for the 505(b)(2) NDA and the requirements for marketing approval.

The FDA confirmed the eligibility of the 505(b)(2) regulatory pathway for the product PPP002 and that the efficacy and systemic safety would be supported by the corporation’s proposed comparative bioavailability study and if successful Tetra could apply for FDA approval in Q1 2019, for Chemotherapy Induced Nausea and Vomiting as well as Anorexia associated with Weight Loss in Patients with AIDS. The FDA also provided feedback on the local safety requirements and the evaluation of the abuse potential of PPP002 for obtaining a Schedule III controlled substance classification.

“We are very pleased with the outcome of yesterday’s meeting with the U.S. FDA,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “The FDA confirmed the shorter regulatory path to the market that Tetra had promised shareholders. In addition, the FDA also provided clear guidance on the safety and drug abuse data requirements for the new drug application. With this confirmation and guidance, Tetra can now complete the execution of the clinical program for PPP002 and, if successful, anticipates submitting a New Drug Application to commercialize PPP002 in Q1 2019.”

According to the International Agency for Research on Cancer1, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US$1.88 bn by 2020, an increase from its 2013 valuation of US$1.28 bn. Based on the expected improved safety profile of delayed release dronabinol, Tetra expects that AdVersa™ could gain significant market share within three (3) years of its launch in the USA.

Reducing Opioid Use
The opioid crisis is serious and growing throughout North America. Tetra’s rich cannabinoid-derived product pipeline has the potential to play a significant role in opioid sparing, thus addressing a societal issue of critical proportion. Tetra expects to undertake a Phase II clinical trial using PPP002 up against an opioid to treat chronic pain.

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

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.

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 PPP002, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine
514-288-8500 ext. 226
[email protected]		 Stephanie Engel
416-425-9143 ext. 209
[email protected]

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Tetra Bio-Pharma $TBP.ca Takes One Step Closer to the Commercialization of Cannabis Oil-Based Retail Products $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 9:00 AM on Monday, September 24th, 2018

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  • Made significant progress in its clinical trial for PPP005 the cannabis oil-based capsules destined for the natural health products market
  • Tetra and its clinical research partner, Santé Cannabis, announced that the clinical trial in non-cancer chronic pain patients will be completed later this autumn as promised

ORLEANS, Ontario, Sept. 24, 2018 – Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), has made significant progress in its clinical trial for PPP005 the cannabis oil-based capsules destined for the natural health products market.

Tetra and its clinical research partner, Santé Cannabis, announced that the clinical trial in non-cancer chronic pain patients will be completed later this autumn as promised.  This was the first clinical trial of its kind in evaluating the safety and efficacy of different doses and ratios of cannabis oils versus placebo.  The study included a dose titration phase (gradually bringing patients to the required dose) allowing us to better understand the side effect profile of the oils as well as the development of tolerance to these effects.  Thus far, no other company in the medical cannabis space has undertaken such an exhaustive study to understand the therapeutic benefits and side effects of a cannabis oil-based capsule.

Dr. Chamberland, interim CEO and CSO added, “We continue to deliver on our business model that provides for evidence-based research to support the usage of cannabis-derived products and provide the medical community with the data they have been demanding from this sector. The trial has already provided unique valuable clinical data on both safe and efficacious dose levels of CBD and THC-CBD oils.  This data will allow Tetra to advance to the next phase of product development wherein the company is developing products for its commercial partner Genacol Corporation Canada, as well as food supplements for the retail market and finally, our capsules that we intend to use in the treatment of chronic and cancer related pain.  Tetra has already established itself as a trailblazer in the natural health product segment with the announcement of our intention to launch a Hemp Energy Drink and we intend to build on that momentum.”

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

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.

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 PPP005, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine Stephanie Engel
514-288-8500 ext. 226 416-425-9143 ext. 209
[email protected] [email protected]

 

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Posted in Featured, Tetra Bio-Pharma Inc. | Comments Off on Tetra Bio-Pharma $TBP.ca Takes One Step Closer to the Commercialization of Cannabis Oil-Based Retail Products $AERO $CBDS $CGRW $APH.ca $GBLX

Tetra Bio-Pharma $TBP.ca Announces Significant Progress on Storz & Bickel Co-Development in Treating #Fibromyalgia $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 8:09 AM on Thursday, September 20th, 2018

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  • Made significant progress in its co-development partnership with Storz & Bickel
  • The study protocol has received approval from the Independent Ethics Board (IRB Services) and was recently submitted for review to Health Canada

ORLEANS, Ontario, Sept. 20, 2018 — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), has made significant progress in its co-development partnership with Storz & Bickel.  The study protocol has received approval from the Independent Ethics Board (IRB Services) and was recently submitted for review to Health Canada.  In addition, Tetra Bio-Pharma expects to complete the identification of every compound in the PPP001 vapor generated by the Mighty Medic vaporizer later this month.  Tetra intends on initiating a Phase 1 clinical study in healthy volunteers to determine the safety and pharmacokinetics of its vaporized PPP001 drug later this year.

This clinical data and vapor compound identification will allow Tetra to bridge to its existing and future clinical data of the Phase 3.  The bridge will provide a significantly reduced time to market and reduced development cost for the commercialization of PPP001 as a treatment for fibromyalgia.

“The Independent Ethics Board approval represents a major step forward prior to obtaining approval from Health Canada and the clinical study will allow Tetra to accelerate bringing PPP001 for fibromyalgia patients,” stated Dr. Guy Chamberland, Ph.D., Interim CEO and CSO at Tetra Bio-Pharma.  “We are very confident in Tetra’s strategy to become a global leader in the development of cannabinoid derived prescription and natural health products.”

About Storz & Bickel
STORZ & BICKEL built the first factory in the world for the manufacture of medical herbal vaporizers in Tuttlingen, Germany, a town with almost 500 medical device manufacturers. Tuttlingen is reputed to be the center of medical technology, where the first factory to produce surgical instruments was established more than 150 years ago.

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

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.

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 approval of PPP001, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine
514-288-8500 ext. 226
[email protected]

Stephanie Engel
416-425-9143 ext. 209
[email protected]

Tags: , , , ,
Posted in All Recent Posts, Tetra Bio-Pharma Inc. | Comments Off on Tetra Bio-Pharma $TBP.ca Announces Significant Progress on Storz & Bickel Co-Development in Treating #Fibromyalgia $AERO $CBDS $CGRW $APH.ca $GBLX

Health Canada Reclassifies Tetra Bio-Pharma’s $TBP.ca Inhalation Device Making it Eligible for Reimbursement $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 8:20 AM on Thursday, September 13th, 2018

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  • Health Canada has re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a Class 2 Medical Device
  • The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care
  • Significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans

ORLEANS, Ontario, Sept. 13, 2018 – Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that Health Canada has re-classified the inhalation pipe device used in the delivery of its PPP001 cannabis drug to a Class 2 Medical Device.  The reclassification will help pave the way towards reimbursement for patients; a key element to patient access and care. The significance of this decision is such that if PPP001 is approved by Health Canada, both the prescription drug and the inhalation device will be eligible for insurance coverage by private and provincial public insurance plans.  Tetra Bio-Pharma is undertaking a Phase III trial with PPP001 treating late stage cancer patients looking to improve quality of life and reduce pain.  The Company also recently announced it is starting a head to head trial to investigate cannabis versus Fentanyl in managing breakthrough cancer pain.

“We are very excited by the reclassification as we believe it will provide patients with a financial benefit in terms of coverage for the device and prescription drug,” stated Dr. Guy Chamberland, Ph.D., Interim CEO and CSO at Tetra Bio-Pharma. “Many cancer patients rely on private and public insurance plans for access to their medication.  This decision by the Government of Canada is an important step forward to facilitating access to cannabis drugs. This coupled with our robust clinical trial program and the evidence we are establishing will support physicians in discussing and recommending this option with their patients.”

Dr. Chamberland further stated, “the lack of scientific data on the safety and efficacy of cannabis is a critical barrier to patient access, and something that Canadian physicians are waiting for before being comfortable to prescribe it. Equally essential is adhering to the highest standards of drug manufacturing as well as the production of the delivery mechanism – something that Tetra is committed to.  There are more than 300,000 registered users of medical cannabis in the country and we can only expect this number to rise.”

Tetra has been a pioneer in the development of several cannabis drugs. To date, the Corporation has completed several safety and pharmacokinetic studies in healthy volunteers obtaining proper dosing information and a clear understanding of the potential cardiovascular and neurological risks to patients. This information is critical to protect public health, and Tetra Bio-Pharma is engaged with Health Canada to comply with the highest drug safety standards.

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

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.

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 approval of PPP001, insurance coverage for products being developed, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.
For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine Stephanie Engel
514-288-8500 ext. 226 416-425-9143 ext. 209
[email protected] [email protected]

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Tetra Bio-Pharma $TBP.ca Accelerates its European Drug Registration Activities $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 9:24 AM on Tuesday, September 11th, 2018

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  • Announced today that it is accelerating the submission of a pre-marketing application for the registration of its cannabis drugs PPP001 and PPP005 under Directive 2001/83/EC of the European Parliament and of the Council. 
  • This directive provides Tetra Bio-Pharma with the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs

PPP001 and PPP005 Eligible for Marketing Approval

ORLEANS, Ontario, Sept. 11, 2018 — Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that it is accelerating the submission of a pre-marketing application for the registration of its cannabis drugs PPP001 and PPP005 under Directive 2001/83/EC of the European Parliament and of the Council.

This directive provides Tetra Bio-Pharma with the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs.  According to Dr. Guy Chamberland, Interim CEO and CSO, “the corporation has performed its own clinical trials and has sufficient quality and clinical trial data to initiate the application for the registration of PPP001 and PPP005 under the Directive 2001/83/EC.  Tetra intends to pursue a Full Market Authorisation since it has a dossier supporting the medicinal product’s quality, safety, and efficacy.”

All of Tetra’s clinical trials were performed with the same quality of evidence required by the National Competent authorities approving medicines/drugs.  Tetra has completed several well-designed safety, pharmacodynamic and pharmacokinetic studies in healthy volunteers and also has two ongoing, well-designed clinical trials in patients.  These trials are all double-blind, randomized and placebo controlled.

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

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.

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 approval of PPP001 and/or PPP005 by the European Medicines Agency, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert Bechard
Executive Vice-President Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
Energi PR
Carol Levine Stephanie Engel
514-288-8500 ext. 226 416-425-9143 ext. 209
[email protected] [email protected]

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Posted in All Recent Posts, Tetra Bio-Pharma Inc. | Comments Off on Tetra Bio-Pharma $TBP.ca Accelerates its European Drug Registration Activities $AERO $CBDS $CGRW $APH.ca $GBLX

Tetra Bio-Pharma $TBP.ca Secures CBD Supply Agreement for Genacol Partnership $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 8:17 AM on Wednesday, September 5th, 2018

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  • Announced that it has secured a CBD supply agreement with True North Cannabis in Alberta, Canada. 
  • Tetra Bio-Pharma will develop a cannabinoid derived oral capsule and a topical cream for treating joint pain and inflammation which will be commercialized under the previously announced partnership with Genacol

ORLEANS, Ontario, Sept. 05, 2018 – Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that it has secured a CBD supply agreement with True North Cannabis in Alberta, Canada.  Tetra Bio-Pharma will develop a cannabinoid derived oral capsule and a topical cream for treating joint pain and inflammation which will be commercialized under the previously announced partnership with Genacol.

Tetra Bio-Pharma will use its formulation and regulatory expertise and clinical trial data from its topical cannabinoid and encapsulated cannabis oil (PPP005) trials to create these innovative products for Genacol.  Tetra Bio-Pharma will work with the appropriate regulatory agencies to gain marketing authority within Genacol’s international sales network where their brand products are available in more than 40 countries, including Latin America, Europe, Asia, the Middle East, Africa and the United States. In addition, the Genacol trademark is registered in 81 countries worldwide. According to industry statistics the market for topical pain relief products exceeds $2.5 billion. The products are expected to be launched in 2019.

“We are very pleased to secure a competitive supply agreement with True North Cannabis as Tetra is committed on bringing innovative cannabinoid products to market,” says Dr. Guy Chamberland, interim CEO and Chief Scientific Officer of Tetra Bio-Pharma.  “True North Cannabis has built a state-of-the-art facility in Alberta which will provide the highest quality CBD for Tetra, at a competitive price, to develop innovative products in partnership with Genacol.  Price to consumers is a critical aspect for the viability of a commercial product in the self-care health market.  At Tetra Bio-Pharma we are focused on becoming a global leader in the development of cannabinoid derived prescription and natural health products.”

“True North Cannabis is pleased to enter into a commercial relationship to supply hemp-based CBD to Tetra Bio-Pharma,” Shayne Hamilton, Chief Executive Officer of True North Cannabis commented.  “Our business leverages the size and scale of the industrial hemp crop in Canada to provide a competitively priced, reliable source of CBD.  Tetra Bio-Pharma’s vast experience in pharmaceutical product development, along with Genacol’s robust distribution footprint, presents True North Cannabis a unique opportunity to market our product.”

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 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 True North Cannabis
True North Cannabis (TNC) is a Canadian hemp harvest service provider with a core focus on facilitating the supply of bulk, extract-ready, hemp-based CBD.

With a grower-focused service model, TNC supports industrial hemp growers across Canada to effectively commercialize the cannabinoid content from their harvest.  By providing access to state of the art infrastructure and hemp chaff expertise, TNC manages the unique challenges in bridging broad acre agriculture and the Cannabis industry.

For more information visit: www.truenorthcannabis.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.

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 ability to obtain orphan drug status, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, and the success of its natural health products development and commercialization strategies,  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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
energi PR
Carol Levine
[email protected]
514-288-8500 ext. 225
416-425-9143 ext. 225

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Tetra Bio-Pharma $TBP.ca Announces Record Date for Dividend-in-Kind of North Bud Farms Shares $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 5:12 PM on Friday, August 31st, 2018

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  • Announced today that its board of directors has declared a dividend-in-kind of 15,500,000 common shares of North Bud Farms Inc. owned by Tetra pro rata to the holders of record of outstanding common shares of Tetra as at September 7, 2018
  • North Bud Shares were acquired by the Corporation in connection with the previously announced sale by the Corporation of GrowPros MMP Inc

ORLEANS, Ontario, Aug. 31, 2018 — Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation“) (TSX VENTURE: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that its board of directors has declared a dividend-in-kind (the “Dividend”) of 15,500,000 common shares (each a “North Bud Share“) of North Bud Farms Inc. (“North Bud“) owned by Tetra pro rata to the holders of record of outstanding common shares (each, a “Tetra Share“) of Tetra (the “Shareholders of Record“) as at September 7, 2018 (the “Dividend Record Date”). The Dividend will be payable on September 12, 2018. Tetra Shares purchased on the TSX Venture Exchange (the “Exchange“) on or after September 6, 2018 will not be eligible to receive the Dividend. The Corporation would like to remind all holders of Tetra options or warrants who intend to exercise their securities and participate in the Dividend that they should proceed to do so well in advance of the ex-dividend date in order to ensure that they are eligible to receive the Dividend.

The North Bud Shares were acquired by the Corporation in connection with the previously announced sale by the Corporation of GrowPros MMP Inc., details of which are contained in the Corporation’s previous press releases issued on December 21, 2017 and February 22, 2018. The Corporation has filed a Form 3E with the TSX Venture Exchange in respect of the Dividend, notifying the TSX Venture Exchange of the Dividend Record Date.

The Dividend will be paid and satisfied in full by the Corporation transferring the North Bud Shares to the Shareholders of Record on the Record Date, on a pro rata basis, subject to certain adjustments to account for the Corporation’s withholding obligations under applicable tax laws (as described below). No fractional North Bud Shares, cash or any other form of payment will be payable under the Dividend. Any fractional interests in North Bud Shares under the Dividend will be rounded down to the nearest whole number of shares. Based upon the number of Tetra Shares currently outstanding, and without taking into account the exercise of any options or warrants currently outstanding or the effect of rounding for fractional interests, approximately 0.1012 North Bud Shares will be paid under the Dividend for every 1 Tetra Share held by a Shareholder of Record on the Record Date.

The Dividend will be an “eligible dividend” for the purposes of the Income Tax Act (Canada) and corresponding provincial legislation. The Dividend will be taxable and non-residents of Canada will be subject to Canadian withholding taxes. In order to comply with its statutory withholding obligations, Tetra will, with respect to Shareholders of Record having a registered address outside of Canada on the Record Date, withhold and retain all interest, right and title to that number of North Bud Shares required to meet the Company’s withholding obligations with respect to such shareholders (the “Withheld Shares“) and remit to the Canada Revenue Agency, in cash, the equivalent of the fair market value of the Withheld Shares. The fair market value of the North Bud Shares distributed under the Dividend shall be, subject to certain exceptions, equal to the volume weighted average trading price of the common shares in the capital of North Bud on the Exchange for a period of 5 consecutive trading days prior to the Dividend payment date. Shareholders of Record with questions regarding the tax treatment of the Dividend in their personal circumstances should consult with their own tax advisors or contact their local office of the Canada Revenue Agency and, where applicable, the provincial taxation authorities.

North Bud has filed a final prospectus on August 21, 2018 with the Ontario Securities Commission. The prospectus is available on SEDAR under North Bud’s profile at www.sedar.com. Shareholders are urged to read the prospectus in full, as it contains important information regarding the Dividend, including regarding certain risk factors and certain income tax matters.

This news release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction. The North Bud Shares may not be offered or sold in the United States by holders thereof unless registered under the U.S. Securities Act of 1933, as amended, and applicable state securities laws or an exemption from such registration is available.

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 North Bud Farms Inc.
North Bud Farms Inc., through its subsidiary GrowPros MMP Inc., is pursuing a license under the Access to Cannabis for Medical Purposes Regulations (ACMPR).  North Bud is dedicated to the production of both pharmaceutical and food grade cannabinoid inputs.  North Bud recently became a reporting issuer in Ontario and has received conditional acceptance to list its common shares on the Canadian Securities Exchange (CSE) under the symbol NBUD.

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.

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 this trial, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

 

For further information regarding North Bud Farms Inc., please contact:
Edward Miller
Vice President, Investor Relations
[email protected]

 

For further information, please contact Tetra Bio-Pharma Inc.
Bernard Lessard
Chief Financial Officer
438-899-7575 ext. 207
[email protected]

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Tetra Bio-Pharma $TBP.ca Adds New Marketing Vice-President $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 9:18 AM on Thursday, August 30th, 2018

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  • Announced that Mr. Steeve Neron has joined Tetra Bio-Pharma as Vice-President, Marketing, effective August 20, 2018
  • He will be responsible for all Tetra Bio-Pharma and Tetra Natural Heath marketing activities

ORLEANS, Ontario, Aug. 30, 2018 — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that Mr. Steeve Neron has joined Tetra Bio-Pharma as Vice-President, Marketing, effective August 20, 2018. He will be responsible for all Tetra Bio-Pharma and Tetra Natural Heath marketing activities.

Steeve has more than 32 years’ experience in the pharmaceutical industry with demonstrated success in numerous therapeutic sectors including cardiology, rheumatology, endocrinology, women’s health, asthma/COPD, OTC and dermatology where challenging the reimbursement landscape factored prominently in his role. Prior to joining Tetra Bio-Pharma he occupied a senior marketing position at Bausch Health Canada, formerly Valeant.

Steeve has held various marketing, sales, finance, material management and business development positions and has worked to launch or rejuvenate numerous market leading pharmaceutical brands including Aerius™ (antihistamine), Altace™ (hypertension), Ezetrol™ (cholesterol), Eliquis™ (anti-coagulant), Lodalis™ (cholesterol) and Contrave™ (Obesity).

“I am very proud to add Steeve to our senior management team. His vast experience will enable Tetra to achieve its high standards in executional excellence,” says Richard Giguere Executive Vice-President, Commercial Operations.

“I am very excited to have the opportunity of contributing my pharmaceutical marketing knowledge within the growing cannabinoid-based products sector,” said Steeve Neron. “Tetra has set the bar high from a clinical development standpoint and this is a critical factor to maximize the therapeutic potential of cannabis.”

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 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

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.

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 ability to obtain orphan drug status, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.

For further information, please contact Tetra Bio-Pharma Inc.

Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514
[email protected]

Media Contact
energi PR
Carol Levine
[email protected]
514-288-8500 ext. 225
416-425-9143 ext. 225

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Posted in All Recent Posts, Medical Marijuana Stocks, Tetra Bio-Pharma Inc. | Comments Off on Tetra Bio-Pharma $TBP.ca Adds New Marketing Vice-President $AERO $CBDS $CGRW $APH.ca $GBLX

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