The company also announced a $15m investment by Perrigo to acquire approximately 7% of Transition’s common shares. ELND005 is an oral drug candidate that is being evaluated in three studies: a Phase II study for agitation and aggression in Alzheimer’s disease, a Phase II study for bipolar disorder and a Phase IIA study in Down syndrome.
After a series of transactions, Perrigo has transferred all of its ELND005 rights and assets to Irish subsidiary. Transition has acquired Irish subsidiary, which is now a 100% wholly-owned, subsidiary of Transition. In parallel with this acquisition, Perrigo has invested $15m and will receive 2,255,640 Transition common shares representing approximately a 7% ownership stake in Transition.
Perrigo will also be eligible to receive up to $40m in approval and commercial milestone payments and a 6.5% royalty on net sales of ELND005 products and sublicense fees received. Going forward, Irish subsidiary will be responsible for all future development and commercialization activities of the ELND005 drug candidate.
Transition chairman and CEO Dr Tony Cruz noted ELND005 is a unique drug candidate that has been shown to have an acceptable safety profile in six clinical studies and reduced the emergence of multiple neuropsychiatric effects including agitation, aggression, depression and anxiety in a Phase II clinical study.
"By acquiring the ELND005 rights, Transition has the opportunity to complete the two current large Phase 2 studies underway in Agitation and Aggression in Alzheimer’s Disease, and mood changes in Bipolar Disorder.
"This drug candidate acts through a distinct mechanism of action by reducing brain myo-inositol levels associated with mood/behavioral changes. We believe this approach provides a unique opportunity to achieve therapeutic benefit for patients with neuropsychiatric symptoms. We are very pleased to work with Perrigo and look forward to completing the current late-stage trials of ELND005," Dr Cruz added.