AbbVie ($ABBV) has landed a deal to bolster its autoimmune business anchored by the blockbuster Humira. The pharma giant has secured rights to an experimental therapy for celiac disease from Alvine Pharmaceuticals for $70 million in upfront payments and the promise of more money down the road.
The deal centers on San Carlos, CA-based Alvine's AVL003, an oral therapy that combines two recombinant protease enzymes to break down inflammation-triggering gluten in the guts of patients with celiac disease and reduce intestinal injury. With no approved drug for the disease, patients rely on gluten-free diets to avoid painful symptoms and dangerous complications of the autoimmune ailment.
In a Phase IIa study, Alvine reported that patients on the therapy showed decreased intestinal inflammation, a key biomarker of celiac disease, and the results made the study the first midstage trial success in drug development for the illness, James Watson, the company's chief business officer, told FierceBiotech.
This year Alvine plans to begin a Phase IIb study of 500 patients with celiac disease with the primary endpoint of impact on intestinal inflammation, Watson said. If the study is successful, North Chicago-based AbbVie has an exclusive option to acquire the assets associated with Alvine's AVL003 or buy the company. Beyond the $70 million upfront payment, the companies declined to disclose any of the financial details of the pact.
Alvine is among a pack of biotech groups partnered with AbbVie, which is eyeing ways to build on the monster success of Humira, a $9.27 billion seller in 2012. AbbVie is partnered with biotech heavyweight Biogen Idec ($BIIB) on the development therapy for multiple sclerosis known as daclizumab, for instance, and the pharma company has grabbed rights to a drug from Enanta Pharmaceuticals ($ENTA) for use in an interferon-free combo treatment against hepatitis C virus.
Celiac disease affects about 6 million people in the U.S. and Europe, and Alvine's therapy could open the door to a large market for AbbVie.
"Celiac disease is an area with significant unmet medical need," Dr. Scott Brun, AbbVie's vice president, pharmaceutical development, said in a statement. "Patients who currently are unable to completely avoid gluten in their diets could potentially benefit from this promising investigational treatment."
AbbVie, which previously invested in Alvine via its venture unit, has experience with other gastrointestinal disorders. Some of the uses of Humira include ulcerative colitis and Crohn's disease. The company also markets the enzyme supplement Creon, which aids digestion for patients with exocrine pancreatic insufficiency.
- here's the release
- see the article from Fox News