Tetra Bio-Pharma Inc., (“Tetra” or the “Company”) a leader in cannabinoid-based drug discovery and development (TSX VENTURE:TBP) (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 (TBP.V) (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