Amgen Picks Provention to Continue Development of Celiac Disease Drug

Xconomy New York — 

For the second time in three years, Amgen is turning to a smaller biotech to continue clinical development of an experimental celiac disease drug that was developed in its labs.

Under a deal announced Monday, Provention Bio (NASDAQ: PRVB) will license the Amgen (NASDAQ: AMGN) drug, AMG714, and test it in a mid-stage study. Amgen had previously licensed the compound to Celimmune, which tested it in two mid-stage studies, then was acquired by the Thousand Oaks, CA, pharmaceutical giant last year. Now further development of the antibody drug falls to Oldwick, NJ-based Provention.

Provention’s stock price jumped more than 8 percent following the announcement of the deal.

Celiac disease is an autoimmune and inflammatory disorder triggered by the body’s response to gluten, a protein found in barley, wheat, and rye. There are no FDA-approved drugs to treat celiac disease; patients manage the condition by maintaining a gluten-free diet.

AMG714 is an monoclonal antibody that binds to interleukin 15 (IL 15), an immune system protein. Amgen had initially developed the drug for rheumatoid arthritis, and later studied it as a potential treatment for celiac disease. In 2015, the company licensed the drug to Celimmune, which tested it in two separate Phase 2a studies, one in celiac disease and the other in refractory celiac disease type II (RCD-II), a form of the disease that does not respond to a gluten-free diet. Following those studies, Amgen acquired Celimmune.

The agreement with Amgen calls for Provention to conduct and finance a Phase 2b clinical trial. Amgen will manufacture the drug for the clinical trial. Upon completing the study, Provention will be eligible for a $150 million milestone payment, and potentially more if Amgen decides to take the drug through late-stage studies. In addition, Amgen has agreed to invest $20 million in Provention the next time the company raises money, subject to terms and conditions that were not disclosed. If the celiac disease drug reaches the market, Provention would receive royalties from sales.

Provention is a relatively new company. It formed two years ago and went public in July. But some of Provention’s executives are already familiar with AMG714. President and CEO Ashleigh Palmer was Celimmune’s executive chairman; chief scientific officer Francisco Leon was Celimmune’s CEO and chief medical officer.

Provention’s drug pipeline includes a late-stage candidate for type 1 diabetes and two mid-stage drug candidates for inflammatory bowel diseases.

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