M&A

Mallinckrodt bags late-stage infantile jaundice drug in $425M InfaCare buyout deal

It’s been more than 10 long years since InfaCare Pharmaceutical got rolling with its Series A round, making slow progress with a lead drug designed to treat hyperbilirubinemia in newborns. And with a pathway to a possible approval finally in view, Mallinckrodt $MNK is stepping in to buy the biotech with $80 million in cash and up to $345 million in milestones.

CEO Mark Trudeau

The spotlight at InfaCare is on stannsoporfin (Stanate), a heme oxygenase inhibitor designed to prevent jaundice by inhibiting the formation of bilirubin. Trevose, PA-based Infacare, though, has been a very low-profile operation — underscored by word on its web site that it’s been raising a Series C, 9 years after the B round from HealthCare Ventures, Longitude Capital, FirstMark Capital and Atlas Venture came through.

Back in 2008, Infacare was talking about launching a Phase III for the same lead drug.

Mallinckrodt is stepping in as it struggles to shed a rep as a price gouging pharma company, not helped after it was recently slapped with a $100 million fine for illegally maintaining its monopoly price of its franchise drug Acthar. Bowing out of PhRMA, which wants to keep the industry spotlight on big players who commit billions to R&D each year, Mallinckrodt remains a regular dealmaker in search of new products.

Now Mallinckrodt will angle for an approval after Infacare wangled a deal with the FDA to seek an approval based on a confirmatory Phase IIb study. That set up a rolling NDA submission now underway, with Mallinckrodt looking to gain a new portfolio drug OK in 2018.

“Severe hyperbilirubinemia can result in serious complications in infants, including brain damage and, rarely, death,” said Steven Romano, CSO of Mallinckrodt. “We look forward to bringing this much-needed treatment option to babies at greatest risk for the consequences of this condition.”


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RAPS Regulatory Convergence 2017