By Joe Hoppe

Arecor Therapeutics said that Hikma Pharmaceuticals has had a positive pre-investigational new drug application meeting with the U.S. Food and Drug Administration, over the ready-to-use injectable medicine AT307, which Arecor licensed to Hikma.

The biopharmaceutical group is eligible to receive development milestone payments from Hikma in addition to future recurring revenue from royalty payments upon commercialisation of AT307, under the terms of a 2020 co-development and license agreement.

Arecor said Thursday that Hikma has communicated its intention to continue development of AT307 in the U.S. using an FDA regulatory pathway, 505(b)(2). This pathway provides companies a shortened regulatory review process when evidence of safety and clinical efficacy made for a product is deemed suitable to be relied upon in new marketing applications.

"We are very pleased with this confirmatory news that Hikma is able to pursue an abbreviated 505(b)(2) approval pathway for AT307, providing an opportunity to progress the development and regulatory review process and bring this medicine to patients more rapidly than through a traditional new drug approval route," Chief Executive Sarah Howell said.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

September 07, 2023 05:20 ET (09:20 GMT)

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