RedHill Biopharma Announces FDA Approval of Talicia for Treatment of Adult Helicobacter Pylori Infection

On November 18, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biopharmaceutical company RedHill Biopharma (RedHill) announced that its antibiotic drug Talicia had received FDA approval for marketing. It is indicated for the treatment of adult patients with Helicobacter pylori infection to reduce the risk of H. pylori-associated gastric cancer and to address bacterial antibiotic resistance.

Following the approval of Talicia, Redhill’s share price on the Tel Aviv Stock Exchange rose by more than 13%. In addition, the company secured a $59 million strategic investment led by Cosmo Pharmaceuticals.

Talicia is the first FDA-approved triple-combination oral capsule based on the antibiotic rifabutin. In December 2018, Redhill announced the results of Talicia’s Phase 3 confirmatory trial, which demonstrated an *Helicobacter pylori* eradication rate of up to 84%, with no evidence of bacterial resistance. This achievement offers significant hope for patients at risk of gastric cancer.

It is reported that over 50% of the global population has been infected with Helicobacter pylori. This bacterium, which spreads via the fecal-oral route, commonly colonizes gastric mucus or gastric mucosal cells in environments with lower stomach acidity, and can easily induce gastritis or even gastric cancer. Due to the misuse of antibiotics, 25% to 40% of infected patients fail to achieve eradication of the gastrointestinal infection. Now, Redhill Biopharma’s biologic drug Talicia offers a promising new treatment option.

RedHill, founded in 2009, is a biopharmaceutical company that holds a leading position in bringing patented drugs to market. The company boasts an experienced management team, with its headquarters located in Tel Aviv, Israel, and its commercial operations hub in North Carolina, United States. In addition to Talicia, RedHill will continue to develop new therapies for gastric diseases to meet patients’ medical needs.

In recent years, bacterial resistance to antibiotics has become a persistent and significant concern. According to a study published in 2015 in Clinical Gastroenterology and Hepatology, a clinical research project based on a sample of 656 male veterans showed that Helicobacter pylori resistance to clarithromycin (Biaxin) increased substantially over a five-year period.

Dr. Colin Howden, Director of the Center for Health Sciences in the Division of Gastroenterology at the University of Tennessee, stated: “Helicobacter pylori is a primary cause of peptic ulcers and gastritis. Due to increasing bacterial resistance, patients have lacked effective treatment options over the past decade, making the management of H. pylori–associated diseases an increasingly serious challenge.”

Due to the relatively low price of antibiotics and their stringent storage requirements, many biopharmaceutical companies on the market lack the incentive to develop them, creating dual scientific and economic challenges for the creation of new antibiotics. With up to 2 million patients in the United States requiring treatment for Helicobacter pylori infection annually, Redhill Biopharma will continue to develop innovative drugs for such conditions and expand the sales market for its products.

(Compiled by Xu Xiaoxue)