Transition Therapeutics (NASDAQ:TTHI; TSX:TTH) and Perrigo plc (NYSE,TASE:PRGO) have amended the development and commercialization program for their ELND005 drug candidate, which is being investigated for multiple neuropsychiatric indications.
After a series of transactions, Perrigo has transferred all of its ELND005 rights and assets to an Irish subsidiary, which has been acquired by Transition. In addition, Perrigo has acquired 2,255,640 new shares of Transition, or about a 7% stake, at a cost of $15-million.
Perrigo also will be eligible to receive up to $40-million 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.
ELND005 is an oral drug candidate that is being evaluated in three studies: a Phase 2 study for Agitation and Aggression in Alzheimer’s Disease, a Phase 2 study for Bipolar Disorder and a Phase 2A study in Down Syndrome.
“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 2 clinical study,” Transition chairman and CEO Tony Cruz said in a statement.
By acquiring the ELND005 rights, Transition will complete the two current large Phase 2 studies underway in Agitation and Aggression in Alzheimer’s disease, and mood changes in Bipolar Disorder.
Dr. Cruz said ELND005 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,” he added.
Perrigo chairman and CEO Joseph Papa said the company is delighted to be strengthening its partnership with Transition and “we believe this transaction enhances the opportunity for success of the ELND005 program, given Transition’s long history with the molecule and focus on innovative science.”
