Pharmaceutical Business review

AbbVie, Alvine to jointly develop new therapy for celiac disease

The investigational therapy that is currently in Phase 2 development comprises two recombinant, gluten specific enzymes (a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP)), that degrade gluten in-vitro and in human clinical testing.

The symptoms and intestinal injury associated with celiac disease may be reduced by ALV003 in patients following a gluten-free diet.

AbbVie pharmaceutical development vice president Scott Brun said, "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment."

According to the deal, AbbVie will pay initial upfront fee of $70m to Alvine for an exclusive option to either acquire the assets relating to ALV003, or the equity of the company.

Alvine that is also eligible for a milestone payment upon AbbVie’s initiation of Phase 3 development, will be responsible for Phase 2 clinical development.

If the Phase 2 development gets completed successfully, AbbVie may exercise its option for the agreed upon additional consideration.

Alvine president and chief executive officer Abhay Joshi said, "A collaboration between Alvine and AbbVie combines our respective strengths and expertise in the development of what could become the first therapeutic option for this major unmet medical need."