- Mallinckrodt has received pushback from the Food and Drug Administration, which issued a Complete Response Letter for the specialty pharma's investigational drug stannsoporfin. The drug was under review for the treatment of babies born at 35 weeks of gestation or more who are at risk of developing severe jaundice.
- The letter shouldn't come as a surprise after an FDA advisory committee voted 21 to 3 earlier this year that the risk-benefit profile of stannsoporfin did not support approval.
- Mallinckrodt said it won't make a decision related to future stannsoporfin efforts or investment until it has met with regulators.
It's been a challenging few years for Mallinckrodt. The company faced litigation after one its subsidiaries, Questcor, sharply increased the price of Acthar Gel (repository corticotropin injection) and then acquired a competitor only to shelve it, creating a de facto monopoly.
Mallinckrodt also got caught up in investigations around opioid drug marketing and sales. Sales for its specialty and generics brands, meanwhile, are struggling.
Since then, Mallinckrodt spent 2017 rebuilding its pipeline, picking up InfaCare Pharmaceutical and stannsoporfin in August 2017 for $80 million upfront. Ocera Therapeutics was also brought on board in a November 2017 deal worth up to $117 million, before Mallinckrodt finished up the year with a $1.2 billion buy of Sucampo Pharmaceuticals.
Yet Mallinckrodt's hopes for stannsoporfin aren't panning out — at least for the moment — as the company has a CRL to take care of.
"The letter from the FDA was not unexpected following the outcome at the recent Advisory Committee meeting," said Steven Romano, Mallinckrodt's chief scientific officer, in a statement. "We are evaluating the Agency's guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward."
The future is now unclear for stannsoporfin. Following the committee meeting, Mallinckrodt said it was "evaluating alternatives for this development program." And in announcing its rejection letter, the company said the FDA had offered guidance "regarding areas of further evaluation for resubmitting" stannsoporfin, but noted that any further steps will be dependent on its meeting with regulators.