Pharma Focus Asia

Enzychem Lifesciences announces the FDA Orphan Drug Designation granted to EC-18 on Acute Radiation Syndrome (ARS)

Monday, January 22, 2018

Enzychem Lifesciences, Corp., announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS).

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."

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