Alba Therapeutics Corporation said it inked a strategic collaboration deal with Shire plc, to jointly develop AT-1001, Alba's lead inhibitor of barrier dysfunction in various gastrointestinal ("GI") disorders.
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 II 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.
Shire will receive rights to commercialise all forms of AT-1001 outside of the United States and Japan. Alba will retain all rights to commercialise AT-1001 in the United States and Japan.
"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 commercialisation will greatly enhance our efforts to bring these novel therapies to patients," said Dr. Blake M. Paterson, president & CEO, Alba.
"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," said Matthew Emmens, CEO, Shire:
Alba will lead worldwide development operations through the end of phase II 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.
This partnership is another step in Alba's evolution as a biopharmaceutical company and provides a significant validation of our barrier function technology platform, specifically applied to gastrointestinal disease. The partnership will also enhance our ability to provide solutions for other inflammatory and immune related diseases, both acute and chronic, said a company press release.
AT-1001 is an inhibitor of barrier dysfunction that has been shown to block intestinal permeability and the genesis of some autoimmune diseases, both through the reduction of antigen presentation to the body's immune system and the inhibition of cytokine production. AT-1001 is orally formulated and is currently in phase II studies for Celiac disease, a gastrointestinal autoimmune disease. INDs for oral AT-1001 in beta cell preservation (Type 1 Diabetes) and Crohn's disease have also been filed and cleared FDA review.
Alba Therapeutics Corporation is a privately held, clinical-stage biopharmaceutical company based in Baltimore, Maryland. Alba is dedicated to development and commercialisation of disease modifying therapeutics to treat autoimmune and inflammatory disease, drug delivery agents and mucosal vaccine adjuvants by exploiting its technology to regulate the assembly and disassembly of tight junction proteins in cells throughout the body.