AbbVie, Alvine to develop new celiac disease drug

In a move that coincides with May's Celiac Awareness Month, AbbVie and Alvine Pharmaceuticals have entered into a $70 million global collaboration to develop a new novel oral treatment for patients with celiac disease. The investigational oral therapy, ALV003, is currently in phase 2 clinical trials development.

Under terms of the agreement, AbbVie will make an initial upfront payment of $70 million to Alvine for an exclusive option to either acquire the assests relating to ALV003 or the equity of the company. Alvine will remain responsible for phase 2 clinical developments, as well as being entitled to receive a milestone payment upon AbbVie's initiation of phase 3.

"Celiac disease is an area with significant unmet medical need. Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment. AbbVie has significant experience within immunology and gastroenterology and the exclusive option to acquire this asset complements AbbVie's broad mid-stage pipeline."

Scott Brun, M.D., vice president, pharmaceutical development, AbbVie.

ALV003 is an investigational oral therapy composed of 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, and may reduce the symptoms and intestinal injury associated with celiac disease in patients attempting to adhere to a gluten-free diet.

Data from a phase 2a study in 2012 reported a reduction of intestinal inflammation in patients exposed to gluten and treated with ALV003 compared to patients treated with placebo.

AbbVie is a spin-off company of Abbott Laboratories that was launched as an independent biopharma company in January 2013. Alvine Pharmaceuticals, Inc., is a California-based privately held biotechnology company that focuses on autoimmune/ inflammatory diseases.