Genencell said that it has signed an exclusive distributorship agreement with Ordi Pharma FZ-LLC, a UAE-based pharmaceutical company, for the exclusive distribution rights of ES16001, an oral Covid-19 treatment, in Middle East countries and Turkey.
Ordi Pharma is a subsidiary of DEM Pharmaceuticals, a Turkish pharmaceutical company. Under the accord, the two companies will produce, license, distribute, and supply ES16001.
The two companies first aim to receive approval for ES16001 as a biopharmaceutical over-the-counter (OTC) drug without additional clinical trials in Turkey. They then will move on to obtain additional approval as an ethical drug (ETC), according to the intermediate results of Genencell's ongoing multinational phase 2 and 3 clinical trials, Genencell said.
Ordi Pharma plans to sell 150,000 units in Turkey alone by the first half of next year. It predicts the market will keep expanding even after Covid-19 becomes endemic.
Also, the two companies plan to advance to Middle Eastern countries, including Kuwait, Saudi Arabia, Oman, Iran, and Iraq, in a similar way as in Turkey.
Depending on Genencell's multinational clinical trials results, Ordi Pharma may apply for conditional approval in each country or, if necessary, conduct a bridging clinical trial for local residents.
Ordi Pharma plans to send local licenses and business plans to Genencell within 15 days of signing this contract, and the two companies will finalize the agreed price policy and Turkish brand in 45 days.
"Professor Kang Se-chan, the developer of the original technology and chairman of Genencell's Technology Management Committee, met with Ordi Pharma CEO Gharehgozloo A to explain our treatment's features and sign the contract," Genencell CEO Lee Sung-ho said. "We will do our best to become the first company to export a homegrown oral Covid-19 treatment."
ES16001 is a material-based new drug candidate extracted from the leaves of Dampalsu, a plant in Korea, which inhibits the infection and replication of the Covid-19 virus.