April 19, 2024

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[THE INVESTOR] South Korean drug maker Yuhan is betting on its modified version of Pfizer’s pregabalin drug Lyrica following the country’s approval of the pain reliever’s late-stage clinical trials this week, according to sources Nov. 30.

The Ministry of Food and Drug Safety on Nov. 25 gave the green light to Yuhan to conduct phase 3 clinical trials of its YHD1119, an incrementally modified version of pregabalin for the once-daily oral treatment of pain. The recommended dose of Pfizer’s blockbuster drug Lyrica is two times a day.

Yuhan President Lee Chung-hee

The pharmaceutical company plans to evaluate safety and efficacy of the drug candidate in treating patients with peripheral neuropathy pain during the upcoming trials.

Lyrica was initially developed as a treatment for epilepsy but also used as pain relief. However, further research showed it could also help patients suffering from neuropathic pain and most prescriptions are now written for pain.

“The pain relieving drug market has been showing double-digit growth in recent years which is encouraging Korean drug makers including Yuhan to eye the lucrative market,” an industry source said.

The approval comes as Pfizer is fighting legal battles to protect its patent for Lyrica from global competitors hoping to launch low-price generic versions.

In South Korea, seven generic drug makers have already received approval to conduct bioequivalence tests on their generic drugs referencing Lyrica, including Celltrion, JW Shinyak and Theragen Etex.

The patent for Lyrica as a drug for pain relief remained active until August 2017, while the original patent on pregabalin hasn’t been registered here.

The successful commercialization of YHD1119 has become increasingly crucial for Yuhan after suffering setbacks in clinical studies of its other drug candidates such as high blood pressure medication YM22189.

In October, Yuhan’s potential breakthrough drug YH14618, a degenerative disk treatment, flunked phase 2 clinical trials as it failed to show anticipated benefits.

By Park Han-na (hnpark@heraldcorp.com)