Pharmaceutical Business review

Daiichi Sankyo, Amplimmune to jointly develop autoimmune disease therapeutic

The companies expect to commence Phase 1 study of the AMP-110 immune modulation therapy, which targets autoimmune diseases by blocking inflammatory T cell differentiation, in the first half of 2013.

Daiichi Sankyo senior executive officer, R&D global head Glenn Gormley said immune modulation therapy has the potential to meet an unmet medical need in the area of autoimmune diseases.

"As a Global Pharma Innovator, identifying and meeting unmet medical needs is an important part of Daiichi Sankyo’s mission," Gormley added.

Under the agreement, Amplimmune will take care of manufacturing clinical supplies, regulatory filings and clinical trials of the therapeutic candidate through a Proof of Concept (POC) study in autoimmunity.

The companies might further collaboarate to advance the AMP-110 research in order to analyze its characteristics in addition to identifying potential biomarkers that indicate patient response against the candidate.

Amplimmune president and chief executive officer Michael Richman said, "This unique transaction allows Amplimmune to collaborate with an important and well-respected partner and positions the program for an acquisition that will provide significant value for both Daiichi Sankyo and our shareholders."

According to the deal, Amplimmune will earn an undisclosed option fee, approximately $50m for past and future AMP-110 development costs besides additional program milestone payments from Daiichi.

Daiichi Sankyo will fund POC study of the investigational candidate through which it will hold an exclusive option to obtain the AMP-110 program.

In case of executing the option to take over the AMP-110 program, Daiichi will be responsible for all future development, manufacturing and commercialization activities.