Daewoong Pharmaceutical said its new drug Fexuprazan will challenge the potassium-competitive acid blocker (P-CAB) market, dominated by CJ HealthCare’s K-Cab.
Pharmaceutical industry sources said Friday Daewoong has completed phase-3 trials on Fexuprazan and applied for marketing approval this month.
P-CAB is regarded as the next-generation medicine to replace proton pump inhibitors (PPI), often used for gastroesophageal reflux disease (GERD). Although PPIs have a strong effect of inhibiting gastric acid secretion, they are slow in acting. They also have drug interaction problems and affect mealtime. P-CAB medicines can complement the disadvantages of PPIs.
In a phase-3 study that compared K-Cab with esomeprazole, a PPI, esomeprazole-treated patients showed “nocturnal acid breakthrough,” or the presence of intragastric pH level of less than four from 1 a.m. for at least one hour, event through patients took esomeprazole twice a day – before breakfast and dinner. In contrast, patients who received K-Cab once a day had their intragastric pH at 4 or higher for 24 hours, having nocturnal acid breakthrough suppressed.
In a phase-3 trial on Daewoong’s Fexuprazan in 260 patients with erosive GERD at 25 hospitals from October 2018, in comparison with esomeprazole, the drug showed a 99 percent treatment rate and good tolerability in endoscopic mucosal defects up to eight weeks.
If Daewoong gets the nod for Fexuprazan next year as desired, the drug will be the third P-CAB available in the local market. The second P-CAB, Vocinty (ingredient: vonoprazan) by Takeda Pharmaceuticals Korea, obtained the domestic license in April but has not arrived in the market yet.
With no other rival product, K-Cab has sold over 18 billion won ($15.2 million) over the eight months since the market launch in Korea. It has expanded its market by adding an indication of stomach ulcers.
When Taketa rolls out Vosinty, along with Daewwong’s Fexuprazan, the P-CAB market is expected to heat up with the severe competition.
Daewoong is going all out to strengthen the latecomer Fexuprazan’s competitiveness with trials to evaluate the safety, tolerability, and pharmacokinetic interactions of the drug when combined with three nonsteroidal anti-inflammatory drugs (NSAIDs).
To prevent gastric mucosal damage from taking NSAIDs, physicians use H2 antagonists or PPIs. Daewoong’s trial aims to encourage the use of Fexuprazan in combination with NSAIDs. As H2 antagonists are being replaced due to the carcinogenic risk of N-nitrosodimethylamine (NDMA), pharmaceutical companies are intensively competing in this combo drug market.
“With follow-up indication and unique data, we will make Fexupraza the ‘best-in-class’ drug,” Daewoong said in a press release.