AbbVie, Alvine Pharmaceuticals to collaborate on potential celiac disease treatment

NORTH CHICAGO, Ill.—AbbVie and Alvine Pharmaceuticals haveannounced the establishment of a global collaboration for the development of anovel oral treatment for patients suffering from celiac disease. Alvine bringsforward its expertise as a biopharmaceutical company specializing in developingbiologics to treat autoimmune and inflammatory diseases, including celiacdisease, which AbbVie complements as a leader in the field of gastroenterology.

"A collaboration between Alvine and AbbVie combines our respectivestrengths and expertise in the development of what could become the firsttherapeutic option for this major unmet medical need," Abhay Joshi, Ph.D.,president and CEO of Alvine, commented in a statement about the agreement. "Weare pleased to have an industry leader in gastroenterology as a collaborator,whose considerable global development reach can be focused on getting thisnovel therapy to more patients."

Per the terms of the collaboration, AbbVie will make aninitial upfront payment of $70 million for an exclusive option to eitheracquire the assets relating to ALV003—is an investigational oral therapycomposed of two recombinant, gluten specific enzymes—or the equity of Alvine.For its part, Alvine will be responsible for Phase II clinical development ofthe compound. If the Phase IIb study is successfully completed, AbbVie maychoose whether to exercise its option. In addition, Alvine would be eligiblefor a milestone payment upon the initiation of Phase III development by AbbVie.

ALV003 consists of a cysteine protease (EP-B2) and a prolylendopeptidase (PEP), which have been shown to degrade gluten in vitro as well as in human clinical testing. the compoundis thought to hold potential for reducing the symptoms and intestinal injuryceliac patients face. In May 2012, Alvine announced the presentation of theresults of the Phase IIa trial for ALV003, in which the compound met theprimary endpoint of "demonstrating that oral ALV003, administered in thecontext of a gluten-free diet, can diminish gluten-induced intestinal mucosalinjury in well-controlled celiac disease patients." No serious adverse eventswere reported during the study, and "non-serious adverse events consistentlyoccurred more frequently in the placebo-treated patients."

Alvine announced in September 2012 that the U.S. Food andDrug Administration had granted ALV003 Fast Track designation for the treatmentof celiac disease.

"Celiac disease is an area with significant unmet medicalneed," Scott Brun, M.D., vice president of pharmaceutical development atAbbVie, said in a press release. "Patients who currently are unable tocompletely avoid gluten in their diets could potentially benefit from thispromising investigational treatment. AbbVie has significant experience within immunologyand gastroenterology and the exclusive option to acquire this asset complementsAbbVie's broad mid-stage pipeline."

Celiac disease is an acquired autoimmune disorder thatdevelops in certain individuals, who are already genetically vulnerable, afterthey are exposed to dietary gluten. It results in chronic gastrointestinalsymptoms and can lead to more serious medical issues such as malabsorption,anemia, osteoporosis, infections and malignancies. Celiac disease is the mostcommon autoimmune disease, with current estimates of roughly 6 million peoplesuffering from the condition in the United States and European Union. Noapproved therapies currently exist.

SOURCE: AbbVie press release