Tetra Bio-Pharma has announced the launch of its new wholly owned subsidiary Tetra Bio-Pharma Australia Pty Ltd, an Australian-based research company focused on the execution of clinical trials in Australia.
The new subsidiary follows the recent announcement of Tetra‘s partnership with Cannvalate Pty Ltd for the performance of clinical trials of Tetra’s drug candidates in Australia. Accordingly, TBP-AU will benefit from a 43.5 per cent tax credit on all money spent on clinical trials in Australia.
The development represents Tetra’s second foreign subsidiary and is in line with the company’s global expansion strategy for QIXLEE – a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements – and other future drug candidates.
Read more: Tetra Bio-Pharma receives European orphan drug designation for novel CBD cream
Tetra Bio-Pharma CEO, Dr Guy Chamberland, commented: “We look forward to working with our strategic partners and building value for our current and future investors.
“These are very exciting times for us as we continue to drive scientific excellence and deliver on the promise of cannabinoid-derived transformative medicines to improve patient health and quality of life.”
The company has also announced it has completed the Annual Licence Review process for its Health Canada Drug Establishment Licence (DEL), meeting the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain its DEL for the distribution of pharmaceuticals, like REDUVO, in Canada.
Tetra Bio-Pharma has also stated that it submitted its first New Drug Submission (NDS) for REDUVO – a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV) and weight loss and severe nausea in people living with HIV infection – to Health Canada to obtain a Drug Identification Number (DIN) for the prescription drug. The company is now in discussions with Health Canada to address final commentary on the submission.
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