Epe to Launch at a Price in the 'High 100,000-Won Range,' Challenging Wegovy and Mounjaro

Weight-loss efficacy is somewhat lower, but price and tolerability are strengths
Attention also turns to how existing products respond to the late entrant's pricing strategy

Hanmi Pharmaceutical's "Epeo Autoinjector Injection (Epe)," the first GLP-1 (glucagon-like peptide-1) obesity treatment developed in South Korea, is expected to launch as early as late October, intensifying competition in the domestic obesity-treatment market. Although Epe is somewhat less effective at reducing weight than competing products Wegovy and Mounjaro, it is expected to cause fewer gastrointestinal side effects and be priced relatively lower. Its value for money is therefore seen as a key factor in determining its competitiveness.

According to industry sources on October 8, the supply price for a four-week course of Epe at its lowest dose (2 mg), which received approval as a new drug from the Ministry of Food and Drug Safety on October 7, is reportedly under discussion in the upper KRW 100,000 range. Treatment starts at 2 mg, with the dose gradually increased to 4, 6 and 8 mg over 12 weeks, before 10 mg is administered as the maintenance dose.

At the lowest dose, the supply price is KRW 216,000 for Wegovy and KRW 278,000 for Mounjaro (2.5 mg). If Epe launches at a lower price, it could secure a price advantage as a latecomer. "Hanmi Pharmaceutical is reluctant to price it too low, given that it is a product the company developed with pride," an industry source said. "The company seems to be giving the matter of pricing a great deal of thought."

Hanmi Pharmaceutical's caution in setting the price is believed to stem from Epe's lower weight-loss rate compared with competing products, a key measure of competitiveness for obesity treatments. According to the Ministry of Food and Drug Safety's approval information, the average weight reduction in the Epe treatment group over 40 weeks was 9.02%. This figure, which includes patients who dropped out of the trial, is somewhat lower than the 9.75% the company disclosed in October last year. The placebo group had a weight reduction rate of 0.89%, while 75.05% of patients saw their weight decrease by at least 5%.

In representative clinical trials using the same method of calculation, average weight reductions for Wegovy and Mounjaro were 14.9% over 68 weeks and 20.9% over 72 weeks, respectively. In a Wegovy trial involving Korean and Japanese participants, the reduction was also higher than Epe's, at 13.2% over 68 weeks. However, the gap narrows when comparing trials with similar treatment periods. In a 44-week Wegovy trial conducted in South Korea, China and other countries, the additional weight reduction compared with placebo was 8.5 percentage points, similar to Epe's 8.13 percentage points.

The effects of long-term treatment are also likely to become a factor in patients' choices. Epe's clinical trial ran for 64 weeks in total, comprising a 40-week placebo-controlled period followed by a 24-week open-label extension. The approval information states that weight loss tended to be maintained through week 64, but does not disclose the additional weight reduction after week 40.

Epe's strengths include tolerability and a stable supply. Over 40 weeks, nausea occurred in 16.6% of the Epe treatment group and vomiting in 11.6%. In a 68-week Wegovy trial, nausea occurred in 43.9% of participants and vomiting in 24.5%. The proportion of patients who discontinued treatment because of gastrointestinal side effects was also lower for Epe, at 1.2%, than for Wegovy, at 4.3%. It takes 12 weeks to reach the maintenance dose, shorter than the 16 weeks required for Wegovy. Production at a bioplant in Pyeongtaek, Gyeonggi Province, is also seen as an advantage. Wegovy received approval in South Korea in April 2023, but took 18 months to launch because of supply shortages.

However, in terms of safety, the increase in heart rate was greater than with competing drugs. The average heart rate in the Epe treatment group increased by 6.8 beats per minute over 40 weeks. The average increase was 3 beats per minute for Wegovy and up to 3 to 5 beats per minute for Mounjaro in a Phase 3 trial involving patients with diabetes. This could be a factor to consider when prescribing the drug to patients with impaired heart function.

Competitors' responses are also expected to have a major influence on whether Epe gains a foothold in the market. In August last year, ahead of Eli Lilly's launch of Mounjaro, Novo Nordisk cut the supply price of lower-dose Wegovy by 42%. "In the obesity-treatment market, if a latecomer lowers its price, established products can respond on price as well," an industry source said.

This content was produced with the assistance of AI translation services.