The US 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.
Caused by a critical exposure to radiation, acute radiation syndrome includes neutropenia, nervous system damage, and pneumonia with high fatality rate. US government encourages development of new drugs for ARS in response to increasing threat of bioterrorism.
Enzychem Lifesciences is now qualified to receive benefits throughout its orphan drug development program. Benefits include a seven-year term of market exclusivity upon FDA approval of the orphan drug and tax credits for clinical research costs. The US 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.
Enzychem Lifesciences’ EC-18 is a small molecule compound designed for oral administration that could have a role in treating immune and inflammatory related diseases, including psoriasis, rheumatoid arthritis, asthma, atopic dermatitis, and sepsis. Currently Enzychem Lifesciences conducts phase II clinical trials on indications of chemotherapy-induced neutropenia and chemo-radiotherapy induced oral mucositis in the United States.
Once EC-18 gets approval for ARS drug, there is also a potential that it will be awarded Priority Review Voucher (PRV) from FDA as a drug against bioterrorism. PRV is tradable and allows companies to develop various strategies regarding utilization of PRV. From the previous transactions on sales of PRV, the average market price is $200M.
Enzychem Lifesciences Chief Executive Officer Ki Young Sohn noted, “with award of the Orphan Drug Designation for EC-18, Enzychem aims to develop medicines that enhance patients’ health and, especially, to address unmet clinical needs from the current market.”
About Enzychem Lifesciences CorporationEnzychem Lifesciences, Corp. (KONEX: 183490) is a global new drug development biopharmaceutical company founded in 1999. With R&D driven approach and corporate mission of “Saving Human Lives by Overcoming Unmet Medical Needs”, Enzychem is developing innovative treatments which can address significant unmet medical needs. Enzychem is the largest life sciences company by market capitalization in South Korea’s KONEX Stock Exchange. The company is headquartered in Seoul, South Korea.
For more information on Enzychem Lifesciences, visit http://www.enzychem.com/.
This discussion may include predictions, estimates or other information that might be considered forward-looking. While these forward-looking statements represent Enzychem’s current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially. You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of this announcement. Please keep in mind that Enzychem is not obligating itself to revise or publicly release the results of any revision to these forward-looking statements in light of new information or future events.
The information included in this press release concerns a drug use that has not been approved by the Food and Drug Administration.