[THE INVESTOR] Enzychem Lifesciences said on Dec. 27 that the US Food and Drug Administration has granted orphan drug designation for EC-18, which is being developed as a treatment for patients with acute radiation syndrome.
According to the company, EC-18 is a mid-stage experimental oral compound for chemoradiotherapy-induced neutropenia, an abnormally low concentration of neutrophils in the blood caused by cancer chemotherapy and radiotherapy.
After completing the phase 1 study in Korea and the US, the Daejeon-based company is working on the next-stage clinical programs which focuse on augmenting proof of concept data for EC-18 in management of severe chemotherapy-induced neutropenia patients with advanced breast cancer.
“The designation helps EC-18 become recognized as a highly valued therapy and shortens the period of drug development,” Enzychem Lifesciences CEO Sohn Ki-young said.
The FDA Orphan Drug designation program provides incentives to companies that are developing therapies for rare diseases which affect fewer than 200,000 people in the US.
Enzychem Lifesciences is now qualified to receive benefits throughout its orphan drug development program including a seven-year term of market exclusivity upon FDA approval of the orphan drug and tax credits for clinical research costs. The FDA will provide a streamlined and cost-effective path through to commercialization, helping the company to bring the lead candidate to the market after phase 2 clinical trials with conditions attached.
Meanwhile, the biopharmaceutical firm plans to move its shares to the second-tier KOSDAQ from KONEX, the country’s third stock market for small firms, on Jan. 31. It is the largest stock on KONEX with a market cap of 342.5 billion won (US$318.42 million).
The company aims to raise up to 28.5 billion won from the listing with a price band between 27,000 won and 37,000 won per share.
It will use the IPO funds for research and development to earmark 13.1 billion won for a neutropenia therapy and 3 billion for an oral mucositis treatment, according to the firm.