Tetra Bio-Pharma accelerates submission of New Drug Application to FDA & Expects to Commercialize Dronabinol XL Tablet Ahead of Schedule(1) in the US
OTTAWA, ONTARIO–(Marketwired – 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.
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.
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
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