After positive results from a Phase IIa trial with Alvine's AVL003 experimental drug, showing less intestinal inflammation, Abbvie, the recent Abbott offshoot, has secured rights to the treatment. There are no current treatments for celiac disease, which results from a sensitivity to the gluten protein commonly found in grains such as wheat and oats. Celiac disease affects more than six million people in the U.S. and Europe with no current treatment options besides diet modification to remove all gluten products from consumption.

Abbvie agreed to pay $70 million in upfront costs to Alvine in exchange for either exclusive rights to the drug or equity in the company. Alvine is now in preparation to begin a Phase IIb trial which would involve 500 patients and could receive milestone payments after initiation of Phase III clinical trials.

"Celiac disease is an area with significant unmet medical need," said Scott Brun, M.D., vice president of pharmaceutical development at AbbVie. "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."

The drug works in a way comparable to lactase pills that many take for lactose intolerance, where an enzyme in pill form breaks down a chemical that the body cannot deal with. The drug, ALV003, contains two proteases (enzymes that chop up proteins, which are specific for gluten). The enzymes used are a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP), both of which have been shown to be effective and safe in Phase I and Phase IIa clinical trials compared to placebo.

"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," said Abhay Joshi, Ph.D., president and chief executive officer at Alvine. "We are pleased to have an industry leader in gastroenterology as a collaborator, whose considerable global development reach can be focused on getting this novel therapy to more patients."

The drug can be on the market in as little as five years, as the Food and Drug Administration gave fast-track status to the drug in September 2012.