Tetra Bio-Pharma (TSX:TBP, OTCQB:TBPMF) Inc said that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on its application for orphan drug designation (ODD) for its investigational medicine QIXLEEF as a potential treatment for complex regional pain syndrome (CRPS), a chronic neuropathic pain condition.
The Ottawa-based pharmaceutical firm said the positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days.
Based on a majority of 30 out of 31 votes, the COMP concluded that QIXLEEF, a botanical inhaled drug product with a fixed ratio of THC and CBD, satisfies the criteria for such designation and recommends the granting of orphan medicinal product designation, Tetra added.
READ: Tetra Bio-Pharma advancing breakthrough pain drug QIXLEEF to late clinical development stage
"The positive opinion issued by the COMP is excellent news as Tetra continues to execute its regulatory strategy in Europe,” Tetra's CEO and chief regulatory officer Dr Guy Chamberland said in a statement.
“An ODD brings several unique advantages, from a cost reduction in drug development to an accelerated review process and market exclusivity for 10 years. Such strategy is cost and time effective and allows the company to easily gain market shares in a competitive free environment,” he added.
The COMP determined that QIXLEEF qualifies as an orphan drug for CRPS indication as it is intended to treat a chronic debilitating condition, the estimated prevalence of this rare condition is 4.4 in 10,000 persons in the European Union, and available data from published literature shows improvement in peripheral neuropathic pain in patients treated with cannabinoid-based medicinal products.
“If granted, this would represent QIXLEEF's second ODD as a potential treatment for CRPS, in addition to the ODD granted by the US FDA in March 2018,” Chamberland continued. “We firmly believe that QIXLEEF will be a safe and effective medicine for pain management and an alternative to opioids."
The EMA grants orphan drug designation to encourage the development of drugs intended to treat rare and life-threatening diseases and therefore provides incentives to sponsors, such as protocol assistance, a specific type of scientific advice that allows the agency to address sponsors' questions about clinical trials.
Since QIXLEEF will be intended to treat an orphan condition, clinical studies will be performed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralized procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval, Tetra said.
Furthermore, once approved the drug will be eligible for 10 years of market exclusivity. Tetra Bio-Pharma would also benefit from reduced regulatory fees and administrative and procedural assistance, the company concluded.
Tetra Bio-Pharma is a leader in cannabinoid-derived drug discovery and development with an FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
Its evidence-based scientific approach has enabled us to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. 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 biopharma industry by regulators, physicians and insurance companies.
Contact the author at stephen.gunnion@proactiveinvestors.com