Daehwa Pharm, a Kosdaq-listed drugmaker, announced Monday that it has garnered a favorable opinion from the Committee for Medicinal Products for Human Use (COMP) of the European Medicines Agency (EMA) for orphan drug designation (ODD) for its oral paclitaxel formulation, Liporaxel Sol, as a second-line treatment of gastric cancer.

With the committee’s positive opinion, Daehwa Pharm expects to receive ODD from EMA “in the near future,” the company said.

ODD in Europe entitles a drug to a shorter review period, reduced fees and taxes for marketing authorization applications, and exclusivity for 10 years after approval.   

Liporaxel, utilizing Daehwa's DHLASED (DaeHwa Lipid-bAsed Self-Emulsifying Drug delivery) Platform technology, stands as the world's inaugural oral formulation of paclitaxel, a poorly soluble drug. 

In September 2016, Liporaxel, an incrementally modified drug, obtained approval from the Ministry of Food and Drug Safety to treat gastric cancer.

Liporaxel exhibited non-inferiority compared to the existing intravenous therapy for the second-line treatment of gastric cancer in both a phase 3 clinical trial involving 238 patients across 12 centers in Korea and another phase 3 clinical trial with 536 patients across 53 centers in China. The Chinese study was conducted by Haihe Biopharma, a Chinese partner company that had licensed in Daehwa’s technology. Liporaxel demonstrated improved results, particularly regarding adverse reactions, including reduced hair loss and peripheral neuropathy.

Daehwa Pharm said Liporaxel is anticipated to enhance the efficiency of cancer treatment by eliminating the necessity for pre-treatment and the over three hours of medication time typically required by the existing intravenous (IV) paclitaxel therapy. Additionally, the shortened treatment time is poised to improve the operational efficiency of cancer-specialized hospitals, providing more cancer patients with the opportunity to receive treatment at such specialized facilities.

The company also said that Haihe Biopharma is seeking marketing authorization in China for the indication of gastric cancer. 

The approval and market release could happen “as early as this year,” it said.

Another multinational phase 3 clinical trial of Liporaxel is ongoing in Korea, China, and Eastern Europe for the indication of breast cancer.