Daehwa Pharm, a Kosdaq-listed drugmaker, said Friday it received orphan drug designation (ODD) from the European Medicines Agency (EMA) for Liporaxel Solution, an oral paclitaxel, for the second-line treatment of gastric cancer on Feb. 26.
Daehwa explained that the orphan drug designation for Liporaxel Solution will allow the company to receive benefits, such as a shorter review period for new drug applications in Europe, reduced fees and taxes for marketing authorization applications, and exclusivity for 10 years after approval.
“In Europe, paclitaxel does not have a licensed indication for gastric cancer,” the company noted, adding that the authorization will help it expand new paclitaxel treatment options in Europe.
Liporaxel Solution is the first oral formulation of paclitaxel, the world's first poorly water-soluble drug, using its DHLASED (DaeHwa Lipid-bAsed Self-Emulsifying Drug delivery) platform technology. Liporaxel Solution was approved by the Ministry of Food and Drug Safety in September 2016 for treating gastric cancer.
Liporaxel Solution eliminates the pretreatment and three-hour dosing time required for intravenous (IV) paclitaxel therapy and has shown improved outcomes compared to IV therapy in clinical trials for gastric cancer, particularly regarding hair loss and peripheral neuropathy, the company said.
Daehwa Pharmaceutical expects Liporaxel Solution to improve patient convenience and efficiency of cancer treatment by shortening treatment time and providing more patients with the opportunity to receive treatment.
"We are looking forward to the approval and launch of paclitaxel for gastric cancer in China within the year, as well as the completion of phase 3 clinical trial for breast cancer, where paclitaxel is most commonly used," a Daehwa Pharmaceutical official said. "We are proud to contribute to the globalization and development of the Korean pharmaceutical industry by having our independently developed drugs recognized overseas. We look forward to becoming a global blockbuster as a new paclitaxel preparation."