Alba Therapeutics Corporation announced that it has entered into a strategic collaboration with Shire plc, to jointly develop AT-1001, Alba's lead inhibitor of barrier dysfunction in various gastrointestinal (“GI”) disorders.
Shire will receive rights to commercialize all forms of AT-1001 outside of the United States and Japan. Alba will retain all rights to commercialize AT-1001 in the United States and Japan.
Under the terms of the collaboration, Alba will receive an initial, non-refundable licensing payment of US$ 25 million. Joint development costs toward global approval of AT-1001 will be shared 50/50 after the completion of two Phase 2 studies for Celiac disease. Alba is eligible to receive over US$ 80 million if certain clinical, regulatory and launch milestones are met for certain GI indications.
Additional milestone payments totaling over US$ 40 million per indication will also be payable to Alba if the Collaboration is expanded beyond GI indications. Alba is also eligible to receive up to US$ 220 million in sales-based milestones, as well as tiered royalties.
Not including royalties and cost sharing, the deal is valued at over US$ 325 million if all milestones are achieved.
Dr. Blake M. Paterson, Alba's President & CEO said: "We are pleased to enter into this partnership with Shire, which leverages the unique experience and expertise of both companies in developing therapies for GI disorders. The combination of Alba's barrier function technology and autoimmune development capabilities with Shire's proven track record in GI drug development and commercialization will greatly enhance our efforts to bring these novel therapies to patients."
Matthew Emmens, Shire's CEO said: "Alba's products have the potential to be an excellent addition to our current gastrointestinal business. This technology should provide significant benefit to patients with serious autoimmune and inflammatory conditions."
Alba will lead worldwide development operations through the end of Phase 2 clinical trials in Celiac disease. The companies will share responsibility for Phase 3 clinical trial execution and for the pursuit of additional indications such as Crohn’s disease.
This will leverage Shire's regulatory and clinical experience, as well as its commercial infrastructure.