Tetra Bio-Pharma Inc.
CSE : TBP
CSE : TBP.CN
OTC PINK : GRPOF

Tetra Bio-Pharma Inc.

April 03, 2017 08:00 ET

Tetra Bio-Pharma and IntelGenx Announce the Signing of a Definitive Agreement for the Development and Commercialization of a Dronabinol XL Tablet

OTTAWA, ONTARIO--(Marketwired - April 3, 2017) - Tetra Bio-Pharma Inc. ("Tetra") (CSE:TBP)(OTC PINK:GRPOF) and IntelGenx Corp. ("IntelGenx") (TSX VENTURE:IGX)(OTCQX:IGXT), today announced the signing of a definitive agreement for the development and commercialization of a drug product containing the cannabinoid Dronabinol (the "Product") for the management of anorexia and cancer chemotherapy-related pain. The U.S. cancer pain market is expected to reach $5 billion in 2018. This definitive agreement follows the binding term sheet between the two companies that was announced on February 9, 2017.

Pursuant to the definitive agreement, Tetra has exclusive rights to sell the Product in North America, with a right of first negotiation for territories outside of the United States and Canada. Tetra will make an upfront payment to IntelGenx, in addition to set future milestone and royalty payments, based on the completion of an efficacy study, approvals from the U.S. Food and Drug Association ("FDA") and Health Canada, and the commercial launch of the Product. IntelGenx will be responsible for the research and development of the Product, including clinical studies, and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology. Tetra will be responsible for funding the product development, and will own and control all regulatory approvals, including the related applications, and any other marketing authorizations. Tetra will also be responsible for all aspects of commercializing the Product.

"We are pleased to announce the closing of the definitive agreement with IntelGenx and look forward to working very hard with them to bring this much-needed product to patients suffering from cancer pain," said Andre Rancourt, CEO of Tetra Bio-Pharma Inc. "The execution of this agreement is just the beginning for Tetra as we look forward to aggressively concluding future agreements as we build a leading bio-pharmaceutical organization focused on developing medicinal cannabis as pharmaceutical drugs."

"The U.S. cancer pain market is expected to reach $5 billion in 2018, and the quick growing medical cannabis industry is poised to capture a signature portion of that opportunity," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We are pleased to be working with Tetra to bring this much-needed cannabinoid product to North American patients suffering from anorexia and cancer chemotherapy-related pain."

Background Information:

There are many clinical problems associated with the use of currently available form of Dronabinol in patients with anorexia and cancer chemotherapy-related pain. It has been demonstrated that psychoactive drugs exert their euphoria, and other psychoactive effects, when the blood levels of the drug rapidly increase. The pharmacokinetic profile of tetrahydrocannabinol ("THC") and its metabolite increases the abuse potential of cannabinoids like Dronabinol. The significant advantage of an oral mucoadhesive tablet based on IntelGenx' proprietary AdVersa® controlled-release technology is that it can be adjusted to achieve a predetermined drug release pattern by increasing the residence time, promoting intimate contact with the mucosal tissue and increasing the bioadhesive properties of the dosage form. It is believed that, by deploying this technology in the controlled-release of THC, a longer time release of the drug will be achieved and, thereby, a rapid increase in the blood will be avoided. There will also potentially be improved bioavailability and reduced gastro-intestinal side effects, making a sustained-release THC product a promising alternative in the battle for the reduction of opioids in patients with chronic pain.

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 Tetra Bio Pharma:

Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP) (OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.

Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.

The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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.

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