RARE Daily

Mallinckrodt Reaches Agreement to Sell Experimental NPC-1 Drug Adrabetadex to Mandos

May 21, 2021

Mallinckrodt said it agreed to sell its experimental drug Adrabetadex for the ultra-rare condition Niemann-Pick type C1 to Mandos.

It said it will work with Mandos to secure production of additional drug supply for children with the condition and will produce up to an additional two-year supply subject to approval from the U.S. Bankruptcy Court in Delaware. Mallinckrodt filed for chapter 11 bankruptcy in October 2020 to manage legal liabilities relating to its role in the opioid epidemic.

Mallinckrodt said it plans to produce up to an additional two years’ supply of drug for eligible patients under expanded access or other future potential development programs. The agreement is subject to approval by U.S. Bankruptcy Court in Delaware.

Mallinckrodt announced in January of this year that it would discontinue the development of adrabetadex following a comprehensive analysis of clinical data that did not show clear evidence of benefit for NPC1 patients. Nevertheless, some parents and treating physicians report observing benefit in children being treated with adrabetadex.

“Recognizing both the critical need for new treatment options for Niemann-Pick disease and the concerns of the NPC patient community—who we have worked closely with since acquiring adrabetadex in 2018—MNK has worked judiciously to identify an entity that would seek to find a path forward for the drug,” said Steven Romano, executive vice president and chief scientific officer at Mallinckrodt. “We are hopeful Mandos will further advance both the understanding of the disease and the potential to develop the drug as a future treatment option for NPC patients.”

Author: Rare Daily Staff

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