Jeil Pharma's new OAB treatment ‘vibegron’ nears release

In addition to completing Phase I trial for domestic manufacturing, patient enrollment for the bridging study is near complete

May be released within this year at earliest… whether it will rise as a rival to the market leading Betmiga gains attention

Vibegron product that is being sold by Kyorin Pharmaceutical

‘Vibegron,' a new drug indicated for the treatment of overactive bladder (OAB) that Jeil Pharmaceutical acquired a domestic license for from Kyorin Pharmaceutical, is soon to be approved in Korea.

 

Two clinical trials related to the domestic approval and manufacturing of Vibegron have been completed or are near completion.

 

At the earliest, it is expected that the drug may be released within this year.

 

According to industry sources on the 14th, Jeil Pharmaceutical had recently completed its Phase I clinical trial on vibegron.

 

The trial investigated the safety and pharmacokinetics of JLP-2002 in comparison with the original drug.

 

The trial was conducted for the purpose of receiving approval for Jeil Pharmaceutical's direct manufacturing of Vibegron in Korea.

 

Prior to this study, Jeil Pharmaceutical had received approval for its IND application and conducted the trial on 33 patients in Korea in January this year.

 

In addition, the bridging study (Phase III trial) for the domestic approval of Vibegron is also in its final stages of completion.

 

Jeil Pharmaceutical had started the bridging study for the domestic approval of Vibegron in May last year.

 

The study was conducted on 201 patients in 20 hospitals in Korea, including the Seoul Asan Medical Center.

 

The company enrolled its final subject mid-last month.

 

The investigation for the last participant is expected to be completed near the end of this month.

 

Jeil Pharmaceutical plans to proceed with the domestic production and marketing approval procedures as soon as the clinical trial results are released.

 

This raises the possibility that the product may be released in the market within this year at the earliest.

 

Jeil Pharmaceutical had signed an exclusive domestic licensing agreement for vibegron with Japan's Kyorin Pharmaceuticals in 2019.

 

Vibegron, Kyorin’s new overactive bladder (OAB) treatment, was in-licensed by Kyorin from MSD, and released as ‘Beova’ in Japan in November 2018.

 

The drug received U.S.

 

FDA's approval last December.

 

In the U.S., Urovant Sciences received approval for the drug under ‘Gemtesa.’ Urovant Sciences is a subsidiary of Japan’s Sumitomo Dainippon Pharma.

 

After vibegron is released, the OAB market in Korea is expected to heat up from its full-scale competition with the existing market leader ‘mirabegron (Betmiga).’ Betmiga is the most-prescribed treatment for overactive bladder in Korea.

 

According to the pharmaceutical market research frim UBIST, out-patient prescription sales of Betmiga recorded 65.1 billion won last year.

 

Also, Betigma's prescriptions recorded 15.4 billion won in the first quarter of this year.

 

Vibegron's mechanism of action is similar to mirabegron's as the two drugs are both selective β3-adrenoceptor agonists.

 

The recommended dosage is also 50mg once daily for both.

 

However, medication adherence is known to be higher for vibegron as it has fewer adverse events than existing treatments.

 

Vibegron's has also shown positive sales in Japan.

 

According to Kyorin Pharmaceutical's annual report, sales of vibegron recorded 4.3 billion yen (about 43.8 billion won) in 2019 and 7.3 billion yen (about 74.3 billion won) in 2020 in Japan.