Mallinckrodt Pharmaceuticals, a specialty pharmaceutical company, has agreed to acquire InfaCare Pharmaceutical, a Trevose, Pennsylvania-based specialty pharmaceutical company focused on neonatal and pediatrics drugs, in a deal worth up to $425 million.

Under the deal, Mallinckrodt, will make an upfront payment of $80 million with additional payments of up to $345 million dependent on regulatory and sales milestones.

InfaCare’s lead product, stannsoporfin, is a pharmacologic treatment currently in development for neonatal jaundice, known clinically as hyperbilirubinemia. The drug is currently under US regulatory review. In December 2016, the US Food and Drug Administration granted stannsoporfin fast-track designation. Fast-track is process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. It allows for a rolling NDA data submission that has recently begun, and the company expects a approval decision in the first half of 2018.

The company estimates the transaction will close in the second half of 2017, subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Source: Mallinckrodt Pharmaceuticals