Daewoong Pharm expands Fexuclue to Latin American market

Daewoong Pharmaceutical has officially launched Fexuclue, a potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment, in Mexico, Ecuador, and Chile.

According to IQVIA, a drug market research firm, the combined market for anti-ulcer drugs in these countries was valued at $300 million in 2023.

Fexuclue, Korea’s 34th homegrown new drug launched in July 2022, improves the shortcomings of existing GERD treatments, including H2RA (histamine-2 receptor antagonist) and PPI (proton pump inhibitor) drugs, by quickly and reliably suppressing stomach acid secretion, according to the company.

The drug's half-life is nine hours, the longest among GERD medications. It also improves patient convenience by requiring only one dose daily, with or without meals.

With the addition of Mexico, Ecuador, and Chile, Fexuclue is now available in five countries, including Korea and the Philippines.

Daewoong Pharmaceutical previously held symposiums in these Latin American nations where local medical professionals strongly supported Fexuclue as a potential replacement for existing PPI treatments, citing its efficacy.

In Mexico, Dr. Miguel Angel Valdovinos Diaz, a professor of gastroenterology at the National Autonomous University of Mexico, highlighted the unmet needs in GERD treatment due to the instability and short half-life of PPIs, along with their dietary impact.

"Fexuclue can address these issues and establish itself as a replacement therapy,” Diaz was quoted as saying.

Recent clinical trials also bolstered local support during the conference.

For instance, Professor Kim Do-hoon from Asan Medical Center recently highlighted Fexuclue's potential to overcome the slow onset, incomplete acid suppression, and high drug interaction risks associated with PPIs.

"Fexuclue, a next-generation P-CAB, can resolve the slow onset of action, incomplete acid suppression, and high risk of drug interactions seen with PPIs,” Kim said.

Kim presented two foundational studies during the Digestive Disease Week 2024 in May, demonstrating Fexuclue's additional anti-inflammatory benefits, including inhibiting pyroptosis pathways in esophageal cells and protecting gastric epithelial cells from Helicobacter pylori-induced damage.

“It is meaningful that Fexuclue is recognized by Latin American healthcare providers as a next-generation treatment for GERD,” CEO Park Sung-soo said. “Daewoong Pharmaceutical will accelerate the approval process to ensure rapid market penetration across the region and strive to achieve our goal of entering 100 countries by 2027.”