- RedHill Biopharma has added another marketed product to its portfolio, snapping up a license to Entera Health's medical food product that helps regulate digestion.
- The gastrointestinal-focused drugmaker won't have to fork over any upfront or milestone payments for exclusive U.S. rights to EnteraGam (serum-derived bovine immunoglobulin/protein isolate). Rather, RedHill has agreed to tiered royalties on net sales of the product. Last year, EnteraGam net sales totaled more than $5 million, according to an April 5 statement announcing the deal.
- EnteraGam comes from proteins found in cows' blood. The product aims to help people, particularly those with illnesses such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), metabolize nutrients. As a medical food, EnteraGam does not need to comply with any of the Food and Drug Administration's standards for pharmaceuticals.
RedHill has used M&A in recent months to get its sea legs before the potential commercialization of its own candidates.
Earlier this year, the Israeli drugmaker gained marketing rights to the IBS medication Donnatal (phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide), from private pharmaceutical company Concordia. The product yielded $50 million in annual revenue in 2013 — the last year it was owned by a public company — and added to RedHill's small list of revenue-drivers, which also includes foreign sales of its migraine drug Rizaport.
The FDA rejected Rizaport's initial New Drug Application a few years ago, issuing a complete response letter in early 2014 related to the manufacturing and labeling of the product, according to RedHill. The company plans to resubmit Rizaport, as well as kick off a confirmatory study of a different treatment for H. pylori bacterial infection, in the first half of 2017.
EnteraGam stands to further diversify RedHill's offerings, particularly because pharmaceutical companies don't often acquire rights to medical foods, which present their own set of challenges. While the FDA has relatively minimal clout over the products, it can issue warning letters for good manufacturing practice violations or when a medical food is indicated for disease that has no "distinctive nutritional requirement."
Founded in 2011, Entera Health is owned by The Lauridsen Group, Inc., an Ankeny, Iowa-based company protein developer that serves a wide variety of industries, from life sciences to food to animal health.