AbbVie secures exclusive option to acquire global rights to ALV003

ALV003 has the potential to be the first non-dietary therapy to treat celiac disease

Watch the CSA website for upcoming Clinical Trial Recruitment Information. "The strength of this association assures the continued development of pharmaceutical options for the celiac patient community," stated Mary Schluckebier, Celiac Support Association Executive Director.

The world’s leading health organizations supporting celiac disease awareness and education Celiac Support Association, Celiac Disease Foundation, Gluten Intolerance Group of North America, National Foundation for Celiac Awareness and the American Celiac Disease Alliance applaud the efforts of Alvine Pharmaceuticals and AbbVie in addressing the significant unmet medical need for therapeutic treatment of celiac disease.

For entire press release

May 14, 2013

NORTH CHICAGO, Ill. and SAN CARLOS, Calif., May 14, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, announced today that they have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development.  This collaboration builds on AbbVie's expertise and leadership in the field of gastroenterology with its on-market products to treat Crohn's disease, ulcerative colitis, and diseases associated with exocrine pancreatic insufficiency.

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 reported at Digestive Disease Week (DDW) 2012, showed reduction of intestinal inflammation in patients exposed to gluten and treated with ALV003 compared to patients treated with placebo.

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

"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, 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."

Under the terms of the agreement, AbbVie will make an initial upfront payment of $70 million for an exclusive option to either acquire the assets relating to ALV003, or the equity of the company. Alvine will maintain responsibility for Phase 2 clinical development, and upon successful completion of the approximately 500 patient Phase 2b study, AbbVie may exercise its option for the agreed upon additional consideration.  Alvine will also be entitled to receive a milestone payment upon AbbVie's initiation of Phase 3 development.  In collaboration with AbbVie Biotech Ventures, Inc., a subsidiary of AbbVie dedicated to making early investments in emerging biotech and pharmaceutical companies, AbbVie was an early investor in Alvine Pharmaceuticals.