Raleigh drug firm lands FDA approval for treatment of intestinal infection affecting millions

RALEIGH – RedHill Biopharma has received FDA approval for a treatment of a potentially deadly intestinal disease that affects 2 million people annually in the US and millions more worldwide.

The company announced early Monday the OK for its drug to treat H. pylori infection. The bacteria is very resistant to current treatment, and RedHill says its Talicia is “designed to the address the high resistance.”

The baceteria is considered a carcinogen and is seen as a strong risk factor for peptic ulcers, gastritis and non-cardia gastric cancer, RedHill notes. An estimated 35 percent of the US populations has the bacteria according to a Foster Rosenblatt market analysis last year.

The targeted H. pylori bacteria live in the digestive tract and people also can develop stomach cancer. The market for therapies to treat H. pylori infection was about $4.83 billion in 2015.

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work,” said Dror Ben-Asher, Chief Executive Officer of RedHill, in a statement.

“We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket.”

RedHill (Nasdaq: RDHL) says it will expand its sales force – currently some 140 people – and launch the drig early next year.

The company has headquarters in both Raleigh and Israel.

RedHill was established in 2009 in Tel-Aviv and opened its U.S headquarters in Raleigh in 2017. It is a specialty biopharmaceutical company focused primarily on late clinical-stage development and commercialization of drugs to treat gastrointestinal diseases and cancer. RedHill’s shares are publicly traded on the Nasdaq stock market and the Tel-Aviv Stock Exchange.

(The N.C. Biotech Center contributed to this report.)