CrystalGenomics Submits New Drug 'Aselex' Approval Application in Brazil

[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 17th that it has completed the New Drug Application (NDA) for the approval of the osteoarthritis pain and anti-inflammatory drug 'Aselex (active ingredient: Polmacoxib)' with the Brazilian Health Regulatory Agency (ANVISA).

Prior to this, CrystalGenomics signed an export contract for Aselex 2mg capsules with the Brazilian pharmaceutical company 'Apsen Farmac?utica (hereafter Apsen)' in 2018.

The total contract value is $178.58 million (approximately 195 billion KRW), and CrystalGenomics will receive success fees including $165 million (approximately 180 billion KRW) in milestones based on sales. The contract period extends up to 10 years after market approval, with Apsen responsible for market approval, marketing, and distribution within Brazil.

Aselex is the first new drug developed by a domestic bio venture company in Korea. It selectively inhibits COX-2 (cyclooxygenase-2), one of the two isoenzymes (COX-1 and COX-2) involved in the formation of prostaglandins that cause inflammation and pain in the body.

This drug is designed to overcome gastrointestinal side effects (such as stomach cramps and digestive disorders) caused by traditional nonsteroidal anti-inflammatory drugs (NSAIDs) that inhibit both COX-1 and COX-2.

A CrystalGenomics representative stated, "Upon new drug approval, since a marketing and distribution company has already been selected in Brazil, it will actively serve as a cash cow based on sales."

Starting with Brazil, CrystalGenomics plans to establish a foothold for expanding Aselex's market in Latin America and aims to extend its reach throughout the entire Latin American region in the future.