SEOUL, South Korea, Jan. 12, 2016 /PRNewswire/ -- CrystalGenomics, Inc. has announced that it has signed a License and Supply Agreement with TR-Pharm for the commercialization of Acelex® (polmacoxib) in Turkey and the Middle East and North Africa (MENA) region.
Under the terms of the agreement, TR-Pharm will secure exclusive rights to Turkey and 18 additional countries in the MENA region to sell and market Acelex 2mg capsule, a novel NSAID developed by CrystalGenomics for the treatment of osteoarthritis. CrystalGenomics will receive up to USD 12 million in License Fee for upfront and milestone payments from TR-Pharm and will also be entitled to receive royalty payments from the sales of Acelex, which is expected to rapidly capture a significant portion of the NSAID market within the rheumatology and orthopedic markets in the licensed region. Based on the current projections, it is anticipated that the cumulative sales of Acelex will reach USD 253 million in the licensed region over the course of the term of the Agreement.
About Acelex® (polmacoxib)
Acelex is the first, tissue-selective, once-a-day osteoarthritis drug with a novel mode of action that specifically targets affected joints to relieve pain and restore mobility. 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.
In the Phase 3 study, both polmacoxib and celecoxib groups demonstrated significant improvements compared to placebo and polmacoxib was at least non-inferior to celecoxib on all of the primary and secondary efficacy endpoints.
Polmacoxib's results at Week 3 were better than celecoxib in two of the efficacy endpoints. The first such endpoint was the difference in the LS mean change of WOMAC-Physical Function Subscale scores from baseline to Week 3. While the difference between the placebo and celecoxib groups was not statistically significant (p=0.069), the difference between the placebo and polmacoxib groups was statistically significant (p=0.003). Also, based on the Physician's Global Assessment (PGA), while the changes from baseline to Week 3 of both the polmacoxib and celecoxib groups were significantly different from those observed in the placebo group (p<0.001, p=0.029, respectively), the change from baseline to Week 3 was significantly better (much improved and minimally improved) in the polmacoxib group compared with the celecoxib group (p=0.005).
There were no drug-related serious adverse events in either of the polmacoxib or celecoxib treatment groups. Most of the adverse events were mild to moderate and were expected to happen in this type of trial. There were no statistically significant differences in all three groups.
Acelex was approved by the Korean MFDS in February of 2015 and was launched in September of that year.
CrystalGenomics, Inc. is a commercial stage biopharmaceutical company focused in the structure-based drug discovery and development in therapeutic areas of unmet medical needs including inflammation, oncology, and infectious disease. For more information, please visit: www.cgxinc.com
TR-Pharm is a pharma start-up focused on innovation with investments into R&D and a cutting edge biotechnological manufacturing capability with the aim of becoming a regional commercial player based out of Turkey. TR-Pharm focuses on the launch of new and innovative medicines starting from registration and accomplishment of clinical programs in all phases, as well as building a biotech manufacturing facility in Turkey for the supply of monoclonal antibodies to CIS and MENA region besides the local market. TR-Pharm has a wide product portfolio, led by oncology, virology, inflammatory and rare diseases. For more information please visit: www.trpharm.com
SOURCE CrystalGenomics, Inc.