Mallinckrodt Pharmaceuticals has reached an agreement to divest and transfer the Investigational New Drug (IND) application for experimental drug adrabetadex (VTS-270) to Mandos, LLC (“Mandos”). Additionally, Mallinckrodt plans to work with Mandos in an effort to secure production of additional drug supply for children who are suffering from the ultra-rare and devastating Niemann-Pick Type C1 disease (“NPC1”).
The planned supply is expected to allow access to adrabetadex for potentially up to two years for patients who are eligible to continue treatment under expanded access or other future potential development programs. The decision to plan for additional drug supply comes after Mallinckrodt’s careful consideration of the needs and concerns of children with NPC1 and the ability to make drug supply available for the continuous treatment of NPC1 patients in the near-term, as allowable.
Under the agreement, Mallinckrodt will transfer sponsorship of its IND application for adrabetadex, which is filed with the U.S. Food and Drug Administration, to Mandos at closing. The agreement and the closing of the transaction is subject to approval of the U.S. Bankruptcy Court for the District of Delaware as part of Mallinckrodt’s Chapter 11 filing.
As we published on the Cyclodextrin News blog 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. However the Company is aware of and acknowledges that some parents and treating physicians report observing benefit in children being treated with adrabetadex.