Mandos, LLC Completes Acquisition of Adrabetadex from Mallinckrodt Pharmaceuticals
NPC1 is a rare progressive genetic disorder characterized by an inability of the body to transport cholesterol and other fatty substances (lipids) inside of cells. This leads to the abnormal accumulation of these substances within various tissues of the body, including brain, liver, spleen and lung tissue. As the disease progresses, NPC1 can lead to loss of cognition, speech, the ability to swallow, mobility and eventually death.
Over the coming days and weeks, Mandos will work diligently with Mallinckrodt to complete the transfer of drug sponsor obligations from Mallinckrodt to Mandos. Mallinckrodt will continue to wind down existing clinical trials. Mandos, in cooperation with regulators, will work to continue the North American Expanded Access Programs (EAPs), Investigator-initiated studies, and advance its plan towards a development program for approval of Adrabetadex for the treatment of NPC1.
Pursuant to the purchase agreement, Mandos and Mallinckrodt will work to secure additional drug supply that will provide an opportunity for the continuation of the EAP and investigator-initiated studies in North America for NPC1.
Regarding a potential development path for Adrabetadex in NPC1, Mandos will also begin a full re-analysis of the available data and will initiate conversations with investigators, other members of the scientific and medical community, third-party contract research organizations, suppliers, and government regulators in order to support these activities.
"We appreciate the dedication and commitment of this passionate community, many of whom have already reached out to us in support. We are committed to advancing the understanding of this disease for the benefit of patients and families with NPC1. We have a busy few months ahead as we begin this transition and will look forward to providing regular updates to the community on our progress," said Scott Riccio, EVP, Patient & Community Engagement at Mandos.
Source: Mandos, LLC