FDA Grants Orphan Drug Designation of Nucleic Acid Drug TRK-250
Bonac Corporation (HQ: Kurume, Fukuoka Prefecture, CEO: Hirotake Hayashi) announced today that Toray Industries, Inc. (Head Office: Chuo-ku, Tokyo; President: Akihiro Nikkaku; hereinafter referred to as "Toray") has designated TRK-250 (Toray Development Code: TRK-250), a nucleic acid drug currently undergoing Phase I clinical trials in the United States for patients with idiopathic pulmonary fibrosis (hereinafter referred to as "IPF"), as an orphan drug. With this designation, the drug will be granted exclusive first marketing rights in the U.S. for seven years, and will also be eligible for tax credits for clinical research expenses and partial exemption from filing fees.
For more information, please refer to the following documents.
A Nucleic Acid Drug, TRK-250, Receives Orphan Drug Designation1 from the FDA