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Tetra Bio-Pharma $TBP.ca accelerates submission of New Drug Application to FDA & Expects to Commercialize Dronabinol XL Tablet Ahead of Schedule in the US $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 5:29 PM on Tuesday, November 28th, 2017

Logo tetrabiopharma rgb web

  • Announced that it is partnering with a major manufacturer of controlled active pharmaceutical ingredients (APIs) in the USA for the manufacturing of Dronabinol XL AdVersa® 
  • Company accelerates its plans to submit a 505(b)(2) New Drug Application for the treatment of chemotherapy-induced nausea and vomiting (CINV) and anorexia associated with weight loss in patients with AIDS

OTTAWA, ONTARIO–(Nov. 28, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP) (OTCQB:TBPMF), a global leader in cannabinoid-based drug development, today announced that it is partnering with a major manufacturer of controlled active pharmaceutical ingredients (APIs) in the USA for the manufacturing of Dronabinol XL AdVersa® as the Company accelerates its plans to submit a 505(b)(2) New Drug Application (NDA) for the treatment of chemotherapy-induced nausea and vomiting (CINV) and anorexia associated with weight loss in patients with AIDS.

According to market research by the International Agency for Research on Cancer 2, the global chemotherapy-induced nausea and vomiting (CINV) market will reach a valuation of US$1.88 bn by 2020, rising from its 2013 valuation of US$1.28 bn. Based on the expected improved safety profile of a delayed release Dronabinol, Tetra expects that the Adversa® tablet can gain an important share of this market within three (3) years of its launch in the USA, with sales of Adversa® that could potentially reach $30,000,000 USD at the end of the third year of sales.

In March 2017, Tetra licensed the Dronabinol XL AdVersa® technology from IntelGenx and entered into a co-development agreement to bring this controlled release formulation of Dronabinol (tetrahydrocannabinol; THC) to the market. Tetra is looking to accelerate its commercialization plans in the USA by seeking marketing approval by the Food and Drug Administration (FDA) for the following therapeutic indications, which are identical to those of Marinol® (dronabinol capsules): “Use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.” It’s buccal administration in cases of nausea makes it an attractive therapeutic option for cancer patients.

Tetra’s partnership with a major manufacturer in the USA that has been manufacturing dronabinol for years to develop the commercial manufacturing of this innovative patent-protected new drug is key in its submission to the FDA. The submission of an NDA under 505(b)(2) to the U.S. Food and Drug Administration (FDA) requires demonstration that the new controlled release formulation provides similar systemic exposure to the listed/approved drug dronabinol. The data generated by IntelGenx demonstrated that the new formulation increases bioavailability of the THC and the new route of administration results in a lower level of the metabolite 11-hydroxy THC. The implications are that a lower dose of THC will be required. The Dronabinol XL AdVersa® formulation is absorbed by the buccal mucosa thereby limiting exposure to the gastrointestinal tract. These differentiating points, along with other characteristics of the new drug Dronabinol XL AdVersa®, are expected to result in a diminution of the side effects traditionally described with dronabinol capsules thus in a more optimal product for patients.

In 2018, Tetra will perform a comparative pharmacokinetic study of Dronabinol XL AdVersa® versus the listed drug. This study, along with the manufacturing file, will be part of the basis for the Tetra’s planned 505(b)(2) new drug application. The Company expects to complete the analysis of the trial data and announce results in the fourth quarter of 2018, followed by a potential NDA submission in 2019 and will request classification under Schedule III of the Schedules of Controlled Substances.

Dr. Guy Chamberland commented that “in parallel to the preparation of the NDA file, Tetra and IntelGenx will continue the development of PPP002 (Dronabinol XL AdVersa®) as an adjunct therapy for opioid sparing in chronic cancer pain. The commercialization of Dronabinol XL AdVersa® will allow the co-development team to focus its attention on the clinical development activities in opioid sparing. Once completed these Phase III clinical trials will allow Tetra to submit supplements to the NDA and expand the indications of drug approval.”

1: Completion of NDA file expected late 2018/early 2019 followed by a 505(b)(2) NDA submission 1 year ahead of original plans.

2: https://www.transparencymarketresearch.com/cinv-market.html

Market Info CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV)2:

According to market research by the International Agency for Research on Cancer (IARC), in 2012, there were 14 million new cases of cancer diagnosed and approximately 4 million people per year receiving chemotherapy globally. CINV affects nearly 70-80% of patients undergoing chemotherapy.

505(b)(2) New Drug Application:

The 505(b)(2) application is one of three established types of new drug application (NDA). It is defined in The Federal Food Drug and Cosmetics Act (FDC Act) as an NDA containing investigations of safety and effectiveness that are being relied upon for approval and were not conducted by or for the applicant, and for which the applicant has not obtained a right of reference. These applications rely in part on the FDA’s findings of safety and/or effectiveness for a previously approved drug (Marinol®(Dronabinol capsules)).

The 505(b)(2) NDA also differs from an abbreviated NDA (ANDA) for generic drugs (Section 505(j) of the FDC Act). An ANDA is an application containing information to demonstrate that the new product is identical to a previously approved product.

About IntelGenx:

IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform. Established in 2003, the Montreal-based company is listed on the TSX-V and OTC-QX. IntelGenx highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx state-of-the art manufacturing facility, established for the VersaFilm™ technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to our clients. More information is available about the company at: www.intelgenx.com.

About PPP002 /Dronabinol XL AdVersa®:

PPP002 /Dronabinol XL AdVersa® is a sustained release formula of THC in the form of a buccally absorbed tablet.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma

Correction to Tetra Bio-Pharma’s previous press release announcing Stock Options Grants

Company also wishes to announce a correction to the information disclosed in its press release dated October 4th, 2017 regarding the grant of an aggregate of 1,400,000 incentive stock options to certain members of its board of directors (“Board of Directors“) and executive officers on October 3rd, 2017. Contrary to what was disclosed in such press release, such grant was not finalized due to a corporate deficiency related to the Board of Directors’ approval.

On November 27, 2017, such deficiency was corrected and, in accordance with the Company’s stock option plan and subject to the approval of the Canadian Securities Exchange, the Board of Directors granted an aggregate of 1,400,000 incentive stock options (“options“) to certain directors, officers and consultants. Each option, vesting immediately upon grant or vesting once certain pre-determined milestones are met, as applicable, entitles the holder thereof to purchase one common share in the capital of the Company at a price of $0.71 per share until November 28, 2018 or November 28, 2021, as applicable.

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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Dronabinol XL AdVersa® product offering; guidance on expected sales volumes associated with the Dronabinol XL AdVersa® product offering; approval by the FDA of the Dronabinol XL AdVersa® clinical trial, competition; regulation and anticipated and unanticipated costs and delays, 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.

Deal-Making in the #Cannabis Industry Hits an All-Time High: What It Means for #Marijuana Stocks $TBP.ca $N.ca $MCOA $ATT.ca $ABCN.ca $ACG.ca $ACB

Posted by AGORACOM-JC at 10:12 AM on Monday, November 27th, 2017

Could more deals mean more dollars for marijuana stock investors?

  • If it seems like there’s been a spurt of deals and potential deals going on in the cannabis industry lately, it’s because that’s exactly what’s happening.
Keith Speights
Nov 27, 2017 at 9:16AM

Canopy Growth Corporation (NASDAQOTH:TWMJF) scored what was probably the most highly publicized deal with large beverage company Constellation Brands (NYSE:STZ) buying a 9.9% stake in the Canadian marijuana grower for $245 million. But Canopy has also forged other agreements with smaller companies both before and after the Constellation partnership.

More recently, Aurora Cannabis (NASDAQOTH:ACBFF) launched a takeover bid for CanniMed Therapeutics. Aurora had wanted CanniMed’s board of directors to agree to an acquisition proposal made last week. When the board failed to respond, Aurora moved forward with its unsolicited takeover attempt.

Major deal-making in the cannabis industry is hitting an all-time high. Here are three ways it impacts not just the parties involved but marijuana stocks in general.

Image source: Getty Images.

1. Acceptance of the cannabis industry

While it’s true that more people have accepted legalization of both medical and recreational marijuana than ever before, the cannabis industry hasn’t entirely been viewed as part of the mainstream economy in the past. I think Constellation Brands’ partnership with and investment in Canopy Growth changes that significantly.

Constellation Brands isn’t a small fish in the pond. The company is a member of the S&P 500 and has a market cap of $43 billion. Its decision to partner with Canopy Growth amounted to an endorsement of the cannabis industry — at least in Canada. However, Constellation’s move could also lead to greater acceptance of the cannabis industry in the U.S.

The company’s CEO, Rob Sands, said in an interview with The Wall Street Journal, that Constellation thinks that legalization of recreational marijuana in the U.S. is “highly likely, given what’s happened at the state level.” Although Constellation Brands is echoing the stance taken by Canopy Growth of only selling marijuana in markets where it’s legal at a federal level, the prospects of future legalization throughout the U.S. can only be helped by a major company like Constellation making a big investment in a marijuana grower.

2. Acceleration of more deal-making

There have been plenty of deals that haven’t received quite as much attention as Constellation’s investment in Canopy Growth and Aurora Cannabis’ takeover attempt of CanniMed. For example, Canopy Growth recently acquired small Canadian medical marijuana grower TerrAscend. Earlier this month, Aurora increased its stake in Hempco Food and Fiber to more than 50%.

Image source: Getty Images.

There’s something of a “me, too” factor when mergers and acquisitions activity picks up. Companies that haven’t been making big deals can be spurred to action in fear of missing out.

Canopy Growth is currently the biggest marijuana grower in Canada. I have no doubt that its size made a difference in Constellation Brands choosing Canopy Growth as a partner. But Aurora Cannabis could become the largest marijuana grower (at least in terms of market cap) if its attempt to buy CanniMed is successful.

Just imagine what’s going through the minds of the executives running other major marijuana growers in Canada. If you’re the CEO of MedReleaf (NASDAQOTH:MEDFF) or Aphria (NASDAQOTH:APHQF), you have to at least be thinking about making some deals of your own.

In fact, MedReleaf recently announced a stock offering that will generate $100.5 million. What will this money be used for? The company intends “to finance the acquisition and/or construction of additional cannabis production and manufacturing facilities in Canada as well as in other jurisdictions with federal legal cannabis markets.” In other words, expect an acceleration of deal-making in the cannabis industry.

3. Attraction of more investors

My view is that deal-making in any industry attracts more investors to stocks in that industry. I see it happen frequently in the bopharmaceutical world, where the possibility of mergers and buyouts tends to bring some individual investors off the sidelines. I suspect that’s what is happening already and will only pick up in the months ahead.

There are several factors that could contribute to this. Size matters for many investors who are leery of putting their money into companies that are small. Deals also make headlines, and therefore bring the involved stocks to the attention of more investors.

Another key reason why I suspect the recent deals for marijuana stocks could attract more investors is the bandwagon effect. That’s especially applicable with Constellation Brands’ investment in Canopy Growth. Some individual investors are likely to think, “If a big company like Constellation thinks it’s a good investment, it probably is a good investment.” I’m not saying that line of thinking is necessarily correct, but I’d bet plenty of people have similar thoughts.

Adding it all up

So what does all of this mean for marijuana stocks in general? It should be good news.

Smaller companies could find themselves takeover targets of somewhat larger companies, just like the situation with CanniMed and Aurora Cannabis. Relatively larger companies like Aurora, Aphria, and MedReleaf could attract the attention of other alcoholic beverage makers not wanting to be left behind by Constellation Brands in a potential cannabis-infused beer market.

I think these and other Canadian marijuana stocks should go higher in the coming months. This won’t be driven entirely by mergers and acquisitions, though. Legalization of recreational marijuana in Canada in 2018 will be the biggest catalyst.

At the same time, investors shouldn’t throw out all the traditional rules of investing in stocks. Look at the underlying businesses, growth prospects, and valuations before investing in any stock. After all, the most important deal is the one that requires you to put your own hard-earned money at stake.

Tom Gardner: Forget Aurora Cannabis Inc.! This buying opportunity is bigger than I ever imagined…

A few months ago, Motley Fool CEO Tom Gardner recently discovered what he considers the greatest buying opportunity he’s seen in more than a decade… within a group of stocks no one is talking about. On Monday, November 27, at 9:30 A.M. ET, Tom is making an important announcement where he will discuss this buying opportunity and how it potentially impacts any investor in the market today. To learn how to access Tom’s timely update, click the button below.

Source: https://www.fool.com/investing/2017/11/27/deal-making-in-the-cannabis-industry-hits-an-all-t.aspx

Tetra Bio-Pharma’s $TBP.ca Business Model and Commercialization Strategy In Line with the Canadian Government’s Proposed Approach to the Regulation of Cannabis $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 5:08 PM on Wednesday, November 22nd, 2017

Logo tetrabiopharma rgb web

  • Canadian Government’s Proposed Approach to the Regulation of Cannabis further confirms the strategic direction of its business model,
  • Company is in an excellent position to commercialize natural health products and drugs post-legalization for both the pet and human markets

OTTAWA, ONTARIO–(Nov. 22, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced that the Canadian Government’s Proposed Approach to the Regulation of Cannabis further confirms the strategic direction of its business model, and that the company is in an excellent position to commercialize natural health products and drugs post-legalization for both the pet and human markets.

In the Proposed Approach to the Regulation of Cannabis, Health Canada stated that “[the] Cannabis Actwill maintain a scientific, evidence-based approach for health products with cannabis that are approved with health claims. These products will be subject to the requirements of the FDA and applicable regulations, including requirements for safety, efficacy and quality“. The evidence-based approach applied by Health Canada is consistent with that of Tetra’s business model, and given that the primary goal of regulatory agencies is to protect the health and welfare of consumers, there were no surprises within the recently proposed act. The proposed approach to regulation recommends that cannabis-based health products are still subject to scientific review and must show significant efficacy, meet strict safety requirements and be of sufficient quality in order to gain market approval as a drug or as a natural health product. The burden of evidence and subsequent scientific review process prior to market approval is not required to sell products or medical cannabis through the proposed Cannabis Act, and currently through the Access to Cannabis for Medical Purposes Regulations (ACMPR). However, products made and sold under the current ACMPR/ future Cannabis Act are subject to distinct limitations, such as limits on the allowable cannabinoid concentration, the available dosage and restrictions on health claims, that are not applied to health products which have undergone and received approval by Health Canada.

These regulatory distinctions make Tetra unique from many other businesses within the legalized cannabis industry. Tetra places patients and consumers first in its business model, where providing safe, high quality products that are proven to work is central to the company mission; this will continue to be the company’s vision going forward. Accordingly, the company has initiated multiple clinical research programs aimed at obtaining critical data to address the anticipated pre-marketing requirements for safety and efficacy of their products under development. In parallel, Tetra has also developed the necessary analytical tools to assess and demonstrate the quality of both raw cannabis materials and that of the finished products. Both of these core activities will remain essential parts of the business, as Tetra focuses on becoming a leader in the commercialization of cannabinoid-based health products for humans and pets.

Over the coming months, Tetra will be preparing the implementation of its product launch strategies and preparing for commercialization in accordance with the regulatory framework described in the proposed Cannabis Act.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Rx Princeps product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, 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 Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
www.tetrabiopharma.com

INTERVIEW: Tetra Bio-Pharma $TBP.ca Discusses Clinical Study for Smoked #Marijuana #CBD #MMJ $AERO $CBDS $CGRW $APH.ca $GBLX

Posted by AGORACOM-JC at 8:21 AM on Friday, November 17th, 2017

Tetra Bio-Pharma is no ordinary Medical Cannabis company. As a true Cannabis Bio-Pharma company, the company is the FIRST and ONLY pharmaceutical company in clinical trials for smoked marijuana, which is currently set to enter the valuable Phase 3 part of the trial.

AGORACOM Sat Down With President, Bernard Fortier To Discuss The Following:

1. How conducting clinical trials is massive differentiator from other companies.
2. The duration of Phase 3
3. The size of the market that will be available upon successful completion of Phase 3
4. How a successful Phase 3 can help solve the opioid crisis
5. Why the Company believes its’ inhalation device will generate $1.5M in revenue for Fiscal 2018
6. The Company’s distribution partnership with Aphria
7. Where the Medical Cannabis industry will be within 5 years

Tetra Bio-Pharma Inc. $TBP.ca Rx Princeps(TM) Now Available for Patients through Licensed Producer Partner Aphria $APH.ca $AERO $CBDS $CGRW $GBLX

Posted by AGORACOM-JC at 8:23 AM on Thursday, November 16th, 2017

Logo tetrabiopharma rgb web

  • Announced that Rx Princeps™, unique blend of dried medical cannabis used in its PPP001 clinical trials, is now available through licensed producer Aphria Inc.

OTTAWA, ONTARIO–(Nov. 16, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced that Rx Princeps™, unique blend of dried medical cannabis used in its PPP001 clinical trials, is now available through licensed producer Aphria Inc. (“Aphria”) under Access to Cannabis for Medical Purposes Regulations (ACMPR).

Based on the most recent ACMPR market data from the Government of Canada, it is estimated that the sales of dried medical cannabis in Canada from April 2017 to March 2018 will be over $188M; Tetra is now entering this lucrative market and plans on progressively grabbing a significant share of it over the next two years. Mr Fortier, CEO of Tetra, stated last week “We are expecting to generate around $1.5 million in sales, in fiscal 2018 in our initial launch. Through our promotion and education efforts in Quebec, New Brunswick and part of Ontario, we estimate that over eight thousand patients will start using Rx Princeps™ under prescription from their doctors over in the next twelve months.”

Rx Princeps™ is a new option for doctors who want to prescribe medical cannabis. Prescribing Rx Princeps™ with the Rx Princeps™ inhalation device enables their patients to optimize the benefits of medical cannabis through the intake of a fixed dose of product, thereby ensuring consistency of treatment with a standardized high-quality product.

Aphria grows and produces medical cannabis under a strict quality management program. Tetra chose Aphria as its partner because their production processes were adopted from the highly restricted and regulated pharmaceutical industry, and go above and beyond cannabis industry regulations mandated by Health Canada. As a result, Aphria’s products are in line with the strict quality standards Tetra is establishing for the medical community and its patients.

200,000 patients are already registered under the ACMPR program and around 1.5 million adults in Canada suffer from chronic pain and are considered non-responders to opioids; medical cannabis could be a new therapeutic choice for those patients but physicians need bioavailability and safety data to prescribe medical cannabis with confidence. According to Health Canada, less than 3,000 physicians actually prescribe cannabis to their patients. Tetra is committed to provide them rigorous safety and bioavailability data. Tetra has begun educating pain clinics and the medical profession across Canada on Rx Princeps™, including its advantages for patients.

In Quebec, Tetra is working closely with Sante Cannabis in order to educate patients and support them in their medical journey with cannabis. Sante Cannabis is the first cannabinoid clinic and medical marijuana resource centre in Quebec.

About Rx Princeps™:

Rx Princeps™ is a unique blend of 3 strains of medical cannabis. Its production has been standardized in order to ensure a lot-to-lot consistent composition in its active ingredients (THC and CBD). Rx Princeps™ is composed of the same medical cannabis blend used to produce PPP001, which has demonstrated its safety in the Phase 1 clinical trial of PPP001. Patients who want to purchase Rx Princeps™ in Canada need a prescription from their physicians and to register with Licensed Producer Aphria.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Rx Princeps product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, 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 Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
www.tetrabiopharma.com

Compound in #cannabis could ease #asthma #CBD #MMJ $MCOA $TBP.ca

Posted by AGORACOM-JC at 12:58 PM on Thursday, November 9th, 2017

 

Hebrew University Prof. Raphael Mechoulam, known as the “father” of the medical cannabis industry, will lead a team investigating the benefits of non-psychoactive cannabis components for treating asthma and other respiratory conditions.

In 1964, Mechoulam, was the first scientist to successfully isolate the THC component in cannabis. He was then a young researcher at Israel’s Weizmann Institute of Science.

Of the 140 cannabinoid molecules in the cannabis plant, the two main components are THC (the psychoactive component) and CBD, which has anti-inflammatory properties. CBD is the focus of much of Israel’s burgeoning medical cannabis research on diabetes, heart disease, autism, fracture healing and inflammatory bowel disease.

Mechoulam will conduct studies on CBD and asthma together with Prof. Francesca Levi-Schaffer at the Hebrew University’s recently established Multidisciplinary Center on Cannabis Research. The research has been commissioned by CIITECH, a UK-Israeli biotech startup headed by Clifton Flack, who cofounded iCAN-Israel Cannabis. The latter is beginning clinical testing on a cannabis formulation for insomnia.

Allergic diseases including asthma, allergic rhinitis, atopic dermatitis and food allergies affect approximately 20 percent of the global population.

Mechoulam’s asthma research aim is to identify “a possible inhibitory effect of a derivative of cannabidiol (CBD) on allergic airway inflammation.”—More…

Source: http://canadafreepress.com/article/compound-in-cannabis-could-ease-asthma

Tetra Bio-Pharma $TBP.ca Concludes its First Sale of Rx Princeps(TM) Inhalation Device

Posted by AGORACOM-JC at 8:16 AM on Thursday, November 9th, 2017

Tbp large new

  • Announced its first sale of its Rx Princeps™ inhalation device
  • Sale of this inhalation device is the first step towards the sale of Rx Princeps™. 

OTTAWA, ONTARIO–(Nov. 9, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced its first sale of its Rx Princeps™ inhalation device. The sale of this inhalation device is the first step towards the sale of Rx Princeps™.

“I am happy to announce the first batch order of our medical cannabis inhalation devices. This is the first step in generating a steady revenue stream and it is the beginning of a new phase in our development. Sales of Rx Princeps ™ inhalation device will be an additional revenue stream for Tetra. Our inhalation device is a unique, high quality, CSA-approved customized titanium pipe, designed by our partner, Ford Pharmacy. With this launch Tetra is providing a high quality, standardized treatment with clinical data to patients in need.” As Rx Princeps™ (dried cannabis) will soon be launched under ACMPR through Aphria, and we are expecting to generate around $1.5 millions in sales, in fiscal 2018. Through our promotion and education efforts in Quebec, New Brunswick and part of Ontario, we estimate that over eight thousand patients will start using Rx Princeps™ under prescription from their doctors over in the next twelve months.” states Bernard Fortier, CEO of Tetra.

Mr Fortier highlights that “It is important to consider that only 4 % of physicians today consider prescribing cannabis. A fixed-dose approach, as we are promoting based on our original clinical data, is attractive to doctors because the treatment dose is standardized. We have a huge opportunity in educating doctors on our clinical approach.”

Tetra has received its first sales order from Sante Cannabis. Sante Cannabis is the first cannabinoid clinic and medical marijuana resource centre in Quebec. Healthcare professionals from Sante Cannabis support patients in their medical journey with cannabis.

Rx Princeps™ allows patients to optimize the benefits of medical cannabis through the intake of a standardized amount of product. The Rx Princeps™ inhalation device is an essential accessory to ensure consistency of treatment, as well as optimize the potency of the product, while minimizing wastes for the patient.

200,000 patients are already registered under the ACMPR program and around 1.5 million adults in Canada suffer from chronic pain and are considered non-responders to opioids; medical cannabis could be a therapeutic answer for those patients but physicians need bioavailability and safety data to prescribe medical cannabis with confidence. According to Health Canada, less than 3,000 physicians actually prescribe cannabis to their patients. Tetra is committed to provide them this data. Tetra has begun educating pain clinics and the medical profession across Canada on Rx Princeps™, including its advantages for patients. The Tetra medical team was at the Academic Pain Day hosted by the Ontario Pain Foundation this Wednesday to inform pain physicians about the benefits of Rx Princeps™. This was also an opportunity to introduce to them Tetra’s phase 1 data on its drug candidate PPP001.

Based on the most recent ACMPR market data from the Government of Canada, it is estimated that the sales of dried medical cannabis in Canada from April 2017 to March 2018 will be over $188M; Tetra is now entering this lucrative market and plans on progressively grabbing a significant share of it over the next two years.

About Rx Princeps™:

Rx Princeps™ is a unique blend of 3 strains of medical cannabis. Its production has been standardized in order to ensure a lot-to-lot consistent composition in its active ingredients (THC and CBD). Rx Princeps™ is composed of the same medical cannabis blend used to produce PPP001, which has demonstrated its safety in the Phase 1 clinical trial of PPP001. Rx Princeps™ will be available across Canada, through Licensed Producer Aphria Inc., for patients who have a prescription from their physicians.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Rx Princeps product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, 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.

Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@tetrabiopharma.com
(514) 360-8040 Ext. 210
www.tetrabiopharma.com

Tetra Bio-Pharma $TBP.ca Goes After the #Cannabis Oil Medical Market and Launches a Phase 4 Trial with Cannabis Oils in Partnership with #SantéCannabis

Posted by AGORACOM-JC at 8:29 AM on Thursday, October 26th, 2017

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  • Announced the launch of a medical cannabis oil program as it targets penetrating the lucrative cannabis oil market and strengthens its plans to generate revenues from the medical cannabis market
  • vision is to develop an evidence-based approach similar to that of any other prescription drug, thereby allowing physicians and pharmacists to prescribe and dispense these medicines to patients in need

OTTAWA, ONTARIO–(Oct. 26, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced the launch of a medical cannabis oil program as it targets penetrating the lucrative cannabis oil market and strengthens its plans to generate revenues from the medical cannabis market.

Last year Tetra launched several drug development programs to commercialize cannabis-based prescription drugs making it one of the world leaders in cannabinoid pharmaceuticals. Tetra’s vision is to develop an evidence-based approach similar to that of any other prescription drug, thereby allowing physicians and pharmacists to prescribe and dispense these medicines to patients in need. Despite the growing popularity of cannabis oils, physicians and pharmacists across Canada are hesitant to support the use of these products because of the lack of data supporting its medical use; even though healthcare professionals have to offer the best available care to patients, they also need to ensure that the treatment dispensed by pharmacists does no harm.

Since 2015, the Canadian cannabis oil market has grown from below 600 kg in the first quarter (Jan-Mar) of 2016 to over 6000 kg in the same first quarter of 2017, and it is expected that this market will continue to show significant growth according to a July 26, 2017 report by Eight Capital. Based on an estimated average sales price of $75-100 per 60 ml for cannabis oil, the 2017 global cannabis oil sales in Canada could exceed 30 million dollars.

According to Tetra’s Chief Executive Officer (CEO), Bernard Fortier,” Tetra is in a good position to penetrate this market. We have been preparing for months how to differentiate ourselves within this market while maintaining our corporate vision of an evidence-based approach. The cannabis oil market will be no different for Tetra. The corporation is dedicated to providing evidence and supporting physicians and other healthcare professionals while making cannabis accessible to their patients. We are on target to initiate our sales strategy by March 2018 to carve out a solid position within the Canadian market. We expect to generate revenues in the cannabis oil market in 2018 and we will grow these revenues as physicians become aware of our scientific approach and patient care programs. Based on a conservative market penetration estimate, we are targeting to grow our share of the cannabis oil business to over 1 million in revenues by 2019.”

Furthermore, Tetra is announcing that it is supporting a post-marketing study (phase 4 clinical trial) of the use of cannabis oil in the treatment of chronic pain. This trial is driven by the medical experts of Santé Cannabis and will provide much needed safety and efficacy data in this patient population. Tetra will be supporting Santé Cannabis in this important endeavor with its internal regulatory and scientific team. Data generated by this study will help Tetra’s medical team in educating physicians on the potential of cannabis oils to treat patients suffering from chronic pain. Once completed, this trial will allow Tetra to penetrate even further into the cannabis oil market making it one of the key players as it continues to grow its share of this over 30-million-plus dollar market.

Tetra’s scientific team is also supporting the sales strategy by initiating a safety and pharmacokinetic study in healthy volunteers (phase 1 clinical trial) to characterize the safe use of these cannabis oil medicines in humans. Combined with the study in patients suffering from chronic pain, Tetra will have a solid and credible position in the medical cannabis oil market. Dr. Chamberland, Tetra’s Chief Scientific Officer (CSO), commented that” physicians are concerned about the potential side effects and well-being of patients using cannabis oil. It is this type of data that continues to allow Tetra to differentiate itself in the medical cannabis market as we become leader in the field. Over and over, physicians and pharmacists welcome the pharmaceutical approach used by Tetra as it is a proven model for bringing safe and efficacious therapies to patients. Patients are expecting their healthcare professionals to treat cannabis like a medicine and help ensure that they safely consume these products. This expectation from patients will soon be fulfilled by Tetra’s strategic approach to patient care.”.

From a business point of view, these studies are part of the sales and marketing strategy required to effectively penetrate a physician-pharmacist product market. The outcome of these studies will also support Tetra’s overall drug development strategy and it is expected that this will allow Tetra to reduce the overall time-to-market for a number of its cannabis-based prescription drugs. The company will also use this data to create novel new products that will allow Tetra to further increase its revenues in the cannabis oil market.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, 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.

Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@tetrabiopharma.com
(514) 360-8040 Ext. 210
www.tetrabiopharma.com

FEATURE: Tetra Bio-Pharma $TBP.ca – Only Pharma Company To Have Clinical Studies for Smoked #Marijuana #MMJ #CBD

Posted by AGORACOM-JC at 11:38 AM on Tuesday, October 24th, 2017

WHY TETRA BIO-PHARMA?

 

  • Only pharmaceutical company to have clinical studies for smoked marijuana;
  • Signed a letter of intent with a major player of the healthcare specialty industry
  • Will benefit from the intellectual property created within the cannabis health research Chair from the University of New Brunswick
  • Company is financially sound, with enough cash to pay for the $1.2 million Phase III clinical trials of PPP001.
  • Filing a clinical trial application in the coming weeks to therapeutic products directorate to initiate its Phase 3 clinical trial of PPP001 in terminal cancer patient
  • Focused on expanding commercialization partnerships internationally for product pipeline – Interest has been shown from the USA, Germany, Ireland, Brazil and Mexico;
  • Initial demand forecasted in New Brunswick for PPP001 using the ACMPR license is more than expected

Tetra Bio-Pharma $TBP.ca Hires Medical Science Liaison to Promote Rx Princeps(TM) and Presents its New Corporate Image

Posted by AGORACOM-JC at 8:07 AM on Thursday, October 19th, 2017

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  • Announced the hiring of Dr. Vincent Jourdain, Ph. D. as medical science liaison (MSL).
  • Will be responsible for the medical information of Rx Princeps™ and will be educating the medical community about the benefits of this controlled and standardized blend of medical cannabis

OTTAWA, ONTARIO–(Oct. 19, 2017) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, today announced the hiring of Dr. Vincent Jourdain, Ph. D. as medical science liaison (MSL).

Dr. Jourdain will be responsible for the medical information of Rx Princeps™ and will be educating the medical community about the benefits of this controlled and standardized blend of medical cannabis. Dr. Jourdain has extensive training and knowledge in pharmacology and neuroscience and is a critical addition to the Tetra team. An important part of his role will be to support the sales of Rx Princeps™ through New Brunswick and the Maritimes, as well as in Quebec, by presenting the safety, pharmacokinetic, and pharmacodynamic data gathered in Tetra’s Phase 1 clinical trial of PPP001.

“The addition of Dr. Jourdain demonstrates our strategic intention to position Tetra Bio-Pharma as the leader in the medical cannabis market. Bringing an individual with the level of scientific knowledge and expertise of Dr. Jourdain shows our organization’s commitment to the medical community; they can continue to count on Tetra Bio-Pharma as a credible and professional source of information for their practice and their patients. We are looking forward to further developing relationships with opinion leaders in the field as we continue to advance our clinical program and work on bringing new drug alternatives for patients and their treating healthcare professionals.” states Dr. Guy Chamberland, Chief Scientific Officer of Tetra.

Tetra also reveals today its new logo and corporate image, thereby aligning its corporate image with its medical strategy. The evolution of The Company’s image highlights Tetra’s objective to be the reference for the medical community in prescribed cannabinoids’ safety, efficacy, and quality. Tetra is focused on bringing to the ACMPR market the highest quality medical cannabis; the Company remains committed to receive the first drug approval from Health Canada’s Therapeutic Products Directorate for a medical cannabis drug.

About RxPrinceps:

Rx Princeps™ is a unique blend of 3 strains of medical cannabis. Its production has been standardized in order to ensure a lot-to-lot consistent composition in its active ingredients (THC and CBD). Rx Princeps™ is composed of the same medical cannabis blend used to produce PPP001, which has demonstrated its safety in the Phase 1 clinical trial of PPP001.

Rx Princeps™ will soon be available across Canada, through our partner Aphria’s customer service, for patients who have a prescription from their physicians.

About Dr. Vincent Jourdain, Ph.D.:

Dr. V. Jourdain, Ph.D. is a graduate from the pharmacy program at Laval University in Quebec City, where he specialized in neurological disorders. He completed his postdoctoral training at the Feinstein Institute for Medical Research in New York. He used brain imaging to study metabolic and neurovascular changes in Parkinson’s disease and pharmacologically-induced side effects. Dr. Jourdain possesses a broad, yet specialized, knowledge in Neurology and accumulated close to 10 years of experience in basic and clinical research. He published over 15 peer-review publications and won several awards and scholarships.

About Tetra Bio-Pharma:

Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

More information at: 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, 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.

Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@tetrabiopharma.com
(514) 360-8040 Ext. 210