Mallinckrodt Resubmits Application for Terlipressin in Hepatorenal Syndrome

By Michael Dabaie

Biopharmaceutical company Mallinckrodt PLC said it resubmitted its new drug application to the U.S. Food and Drug Administration for terlipressin in adults with hepatorenal syndrome involving rapid reduction in kidney function.

The resubmission follows ongoing discussions with the FDA resulting from a complete response letter, which indicates an application isn't ready for approval, received on Feb. 18.

In the two weeks prior to the Prescription Drug User Fee Act date of Feb. 18, it became necessary to identify a new third-party packaging and labeling facility, the company said. While Mallinckrodt identified a new facility, an FDA inspection of the facility couldn't be completed by the February PDUFA date, resulting in the receipt of the letter.

The Dublin-based company also said Monday it expects to complete its reorganization process, emerge from Chapter 11 and complete the Irish Examinership proceedings in the coming days.

On the effective date of emergence, all of Mallinckrodt's existing ordinary shares will be cancelled and the company said it expects to issue 13.2 million new ordinary shares to its guaranteed unsecured noteholders.

The company said it also plans to issue to opioid claimants 3.3 million warrants, with a strike price of $103.40. Mallinckrodt's new shares are anticipated to trade over-the-counter until the company relists on a national securities exchange.

Mallinckrodt in October 2020 initiated Chapter 11 proceedings.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

June 13, 2022 08:40 ET (12:40 GMT)

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