2nd P-CAB Fexclu to be released into the 800 bil market

Daewoong’s Fexclu to be listed for reimbursement next month… 28% cheaper than K-CAB

Will rise as a variable in the PPI class and P-CAB class drug prescription market worth ₩800 billion

Industry’s expectations on Fexclu’s success rise due to its marketability that was verified by K-CAB and Daewoong’s sales power

Daewoong Pharmaceutical’s new drug, ‘Fexclu’ will be released next month.

 

The industry’s eyes are on whether the drug will raise a storm in the PPI class and P-CAB class antiulcer medication prescription market that is estimated to be worth over ₩800 billion.

 

The industry is also eyeing competition between Fexclu and K-CAB abroad.

 

◆Fexclu to be applied reimbursement from next month… prepares to target the ₩800 billion PPI·P-CAB market

According to industry sources on the 29th, Daewoong Pharmaceutical’s Fexclu will be listed for NHI reimbursement starting next month.

 

With the reimbursement approval, the drug will be released in the market 6 months after it received approval on December 30th.

 

Fexclu’s insurance price cap was set at ₩939, which is 27.8% cheaper than its same-class drug K-CAB (₩1,300) Fexclu is a P-CAB class drug that treats gastroesophageal reflux disease (GERD).

 

The drug was approved for the indication of treating erosive gastroesophageal reflux disease (GERD).

 

P-CAB class antiulcer drugs competitively bind to the proton pump and potassium ion located in the final stage of acid secretion from the stomach wall to inhibit gastric acid secretion.

 

This class of drugs has quickly settled in the market since HK inno.N introduced its first P-CAB type of new drug ‘K-CAB’ in 2018.

 

Fexclu will be mainly targeting the PPI class and P-CAB class antiulcer drug market, which raised ₩842.1 billion in prescriptions last year.

 

The PPI class market made ₩732.5 billion and the P-CAB class market ₩109.6 billion last year.

 

The industry sees a high possibility of Fexclu’s success in the market.

 

K-CAB had already demonstrated the marketability of P-CAB class anticancer drugs during the past 3 years.

 

According to UBIST, K-CAB had raised ₩109.6 billion in outpatient prescriptions 3 years into its release last year, which is the first time a single brand of a homegrown novel drug had made annual prescriptions exceeding ₩100 billion.

 

K-CAB had created a sensation selling ₩30.9 billion in the first year of its release and has continued its rapid growth in 2020 and last year.

 

K-CAB’s sales continued to grow due to its advantages - having a faster onset of action than PPIs, is allowed to be taken regardless of meal ingestion, demonstrating superior symptom improvement, and showing longer-lasting night-time gastric acid suppression.

 

With HCPs and patients in the field already showing high satisfaction with P-CAB class antiulcer medications using K-CAB, Fexclu is expected to make a relatively easier way into the market.

 

Also, Fexclu’s insurance cap, which was set 30% lower than that of K-CAB may act as an advantage in the prescription market.

 

However, K-CAB owns a total of 4 indications, rendering it difficult for Fesclu to completely replace K-CAB in the market.

 

In addition to the treatment for erosive and non-erosive GERD, K-CAB sequentially secured additional indications as a combination therapy with an antibiotic for Helicobacter pylori eradication in patients with peptic ulcer or chronic atrophic gastritis.

 

Among the indications, insurance reimbursement is applied to K-CAB for the treatment of GERD and stomach ulcers.

 

Fexclu will also be targeting PPI-class drugs that account for the largest amount of the antiulcer drug market, as a significant amount of K-CAB prescriptions arise from patients who have switched to K-CAB from PPIs.

 

Last year, the amount of outpatient prescriptions for PPI class drugs recorded ₩732.5 billion.

 

This is a twofold increase in 5 years from the ₩372.4 billion in 2016 and is continuing to record high growth.

 

◆Fexclu·K-CAB accelerates entry to overseas market… competition in overseas performance of the two drugs also a point of interest The overseas market competition between Fexclu and K-CAB is also a point of interest.

 

Daewoong Pharmaceuticals had signed 6 export agreements with 15 countries in North America, Latin America, China, Middle East to export Fexclu.

 

In 2020, the company signed a contract with the Mexican pharmaceutical company Moksha8 and Brazil's EMS for the local marketing and sales rights of Fexclu and paved the way for Fexclu’s entry into Central and South America.

 

In March last year, the company signed a $384.5 billion contract with China's Shanghai Haini Pharmaceutical.

 

Status of Fexclu export agreements (Source: Daewoong Pharmaceutical))

In June last year, the company made a technology transfer agreement with U.S.

 

company Neurogastrx and handed over the development, authorization, and sales rights of Fexclu in the US and Canada.

 

Through the agreement, Daewoong Pharmaceutical secured a 5% stake in Neurogastrx as an upfront, non-refundable fee, and was assured up to $430 million in development, regulatory, and sales milestone payments.

 

It then signed 2 additional export contracts to enter 10 countries in Central and South America and the Middle East.

 

In total, Daewoong secured up to ₩1.2 trillion through export agreements for Fexclu.

 

K-CAB has entered the market of a total of 34 countries through technology or finished product exports.

 

HK Inno.N had first signed a technology export agreement with the Chinese company Shandong Luoxin Pharmaceutical in 2015.

 

The deal was to receive $18.5 million in upfront payments and clinical development, regulatory, and sales milestone payments.

 

The company estimated that the agreement amount would rise to $95.29 million with royalties incurred after the local commercialization of K-CAB.

 

Also, HK InnoN signed an export agreement for the finished K-CAB product with the Mexican pharmaceutical company Laboratorios Carnot in February 2019 to export K-CAB to 17 countries in Central and South America.

 

Its export amount, including supply price, has amounted to $84 million over the past decade.

 

Exports agreements have been more actively made after K-CAB was released in Korea.

 

In September 2019, contracts were signed to supply the finished drugs to Indonesia, Thailand, and the Philippines, and in 2020, export agreements were made to export K-CAB to Mongolia and Singapore.

 

Last year, the company also signed export contracts with companies in Vietnam, Malaysia, the US, and Canada.