47. Aemcolo

FDA
(FDA)

Active ingredient: rifamycin
Disease: travelers’ diarrhea
Peak sales estimate: $200 million to $250 million
Approved: Nov. 16
Company: Cosmo Pharmaceuticals

The scoop: Cosmo Pharmaceuticals’ antibiotic Aemcolo was approved to challenge Bausch Health’s blockbuster Xifaxan in travelers’ diarrhea. As Wells Fargo analyst David Maris sees it, the approval marked “the first step toward an eventual significant slowdown and potentially a decline in Xifaxan revenues.” Xifaxan is one of the most important products for Bausch. The Canadian pharma previously told Maris that traveler’s diarrhea accounted for less than 10% of sales, but Maris thinks Aemcolo could be a bigger threat. Most importantly, the Cosmo drug has just entered phase 2 study in the key market of irritable bowel syndrome with diarrhea and might come as a twice-daily regimen, versus Xifaxan’s three-dose-per-day schedule. Cosmo has licensed the drug’s rights in Europe to Dr. Falk Pharma. It expects to snag 20% to 25% of the U.S. travelers’ diarrhea market, with peak sales estimate of around $200 million to $250 million. — Angus Liu

47. Aemcolo

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