[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 22nd that it has successfully completed the Phase 3 clinical trial of the osteoarthritis pain relief and anti-inflammatory drug Aselex (generic name: Polmacoxib) for Russian market approval.
The clinical trial was conducted at eight hospitals in Russia with 250 knee joint patients, divided into two groups: one receiving Aselex 2mg once daily and the other receiving Pfizer's Celebrex 200mg (valued at $1.17 billion as of 2019). The study used a non-inferiority test method to verify treatment efficacy and safety, confirming that Aselex was at least as effective as Celebrex.
The clinical results demonstrated non-inferior therapeutic effects in all evaluation measures, including the WOMAC OA Index (assessing joint pain, function, and stiffness), VAS (Visual Analog Scale for pain), 15-meter walking time, OMERACT-OARSI (symptom improvement assessment), Lequesne index (comprehensive pain, function, and disability scale), and CGI-I (clinical global impression of improvement).
A company representative explained, "CrystalGenomics' Aselex showed effectiveness even though it was administered at only one-hundredth the dose of Celebrex."
Previously, in 2018, CrystalGenomics signed an export contract worth $121.5 million (approximately 195 billion KRW) with Russian pharmaceutical company Pharmatis International for Aselex 2mg capsules. The minimum purchase obligation is $43.8 million (approximately 48.2 billion KRW), and additionally, after new drug approval, milestone payments of $77 million (approximately 85 billion KRW) based on sales will be received.
The Russian non-steroidal anti-inflammatory drugs (NSAIDs) market is about 850 billion KRW annually, and among this, the COX-2 inhibitor market, to which Aselex belongs, shows the highest annual growth rate exceeding 30%, indicating rapid market expansion potential in the future.
Aselex is a drug that 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. It is designed to overcome gastrointestinal side effects (such as stomach cramps and digestive disorders) commonly associated with NSAIDs.
CrystalGenomics plans to prepare the final clinical study report (CSR) of the Phase 3 trial and submit a New Drug Application (NDA) to the Russian regulatory authority for Aselex market approval.
A company representative stated, "Through the Russian clinical trial, we confirmed Aselex's efficacy in Caucasians as well," adding, "Based on these results, market expansion is expected to Eurasian Economic Union member countries such as Belarus, Kazakhstan, Armenia, and Kyrgyzstan."
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