CrystalGenomics, a clinical stage biopharmaceutical company, has received approval from the Korean Ministry of Food and Drug Safety (MFDS) for Acelex (polmacoxib) for the treatment of osteoarthritis. Pre-commercialisation will commence immediately and a commercial launch partner for the Korean market will be announced very shortly.
Acelex is the first, tissue-specific once-a-day osteoarthritis drug with a novel mode of action that specifically targets affected joints to relieve pain and restore mobility, while simultaneously preserving the integrity and safety of the gastrointestinal and cardiovascular systems. The results from the phase 3 study suggest that Acelex 2mg once-a-day provides more rapid onset of relief from the signs and symptoms of osteoarthritis in comparison to celecoxib 200mg once-a-day, without added safety risk.
"We are very proud of this achievement as a Korean biopharmaceutical company. Today's approval is a pivotal milestone for our company and shows the strength of our science and innovation, and our belief in helping patients in need," says chairman and cief executive officer, of CrystalGenomics, Dr. Joong Myung Cho.
Acelex is expected to rapidly capture at least 10 per cent of the arthritis market in Korea that is estimated to be worth more than KRW 500 billion per year as of 2013. Osteoarthritis is quite common in Korea, as it affects about 50 per cent of the population aged 65 years or older. Moreover, the overall number of patients is growing rapidly due to an aging population coupled with an increasing prevalence of obesity.
CrystalGenomics Inc. is a clinical stage biopharmaceutical company focussed in the discovery and development of novel drugs in therapeutic areas of unmet medical needs including inflammation, oncology, and infectious disease.