Type B & C Meetings Move TBP Closer to Market Approval
ORLEANS, Ontario, July 26, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-based drug discovery and development (TSX VENTURE:TBP) (OTCQB:TBPMF) today announced that it received two meeting granted letters from the United States Food and Drug Administration (FDA), for Type B and C meetings, to discuss requirements for obtaining marketing approval under the 505(b)(2) regulatory pathway for its dronabinol AdVersa™ mucoadhesive product, PPP002.
Tetra, along with its partner IntelGenx Corp, is developing this product in the USA under the accelerated 505(b)(2) pathway for chemotherapy-induced nausea and vomiting and anorexia and weight loss in people with AIDS (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. The corporation 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 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™ can 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. The Corporations research and development team is exploring the application of cannabis for other painful therapeutic indications such as the multi-billion-dollar fibromyalgia market, which would vastly increase the potential market as well shareholder value.
“Confirmation of these two meetings with FDA marks an important milestone in gaining accelerated marketing approval in the USA for PPP002. Tetra will use the information provided by the FDA in these meetings to finalize preparation of the NDA file,” said Dr. Guy Chamberland, Interim CEO and Chief Scientific Officer of Tetra Bio-Pharma.
Alongside these meetings, Tetra and IntelGenx are working together to finalize the Clinical Trial Applications (CTAs) for the upcoming comparative pharmacokinetic and opioid sparing trials, to support development for the 505(b)(2) and opioid sparing indications, respectively. Tetra expects to file these CTAs with Health Canada in Q3 2018.
Established in 2003, 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. IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s 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 its clients. More information about the company can be found at www.intelgenx.com
Camargo Pharmaceutical Services is the global development and commercialization partner with a proven ability to help bring life-changing therapies to the market faster and more cost-effectively. Founded in 2003, the company offers a full portfolio of pharmaceutical services from concept through commercialization to improve medicines. Camargo has emerged as one of the recognized experts and industry leaders utilizing the FDA 505(b)(2) approval pathway. The company is passionate about the client’s success and the differences they can make in the lives of others. Camargo’s global reach and client base extends to more than 25 countries. Camargo is headquartered in Cincinnati, Ohio. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com.
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. More information at: www.tetrabiopharma.com
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.
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 this or any other clinical trial, 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
For investors information, please contact:
416-425-9143 ext. 201
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.