MicuRx Pharmaceuticals, Inc., a privately-held biopharma company developing next-generation antibiotics, and Shanghai Zhangjiang Biomedical Industry Venture Capital have established Shanghai MengKe Pharmaceuticals, Inc., a joint venture formed to fund the development and commercialisation of MRX-I for the Chinese market.
MRX-I is a novel, oral oxazolidinone antibiotic targeting infections due to multi-drug resistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). MRX-I is differentiated from marketed antibiotics in its class by its enhanced potency against MRSA and a markedly improved safety profile. The joint venture expects to complete clinical trials and apply for marketing MRX-I in China by 2017.
“The formation of this strategic alliance between MicuRx and ZhangJiang effectively merges the exceptional science of MicuRx with substantial resources of ZhangJiang to ensure that MRX-I progresses rapidly through clinical development to commercialization in China. China is recognized as a leading growth market for pharmaceuticals,” said Zhengyu Yuan, president and CEO of MicuRx Pharmaceuticals and chairman of the board of directors for Shanghai MengKe Pharmaceuticals.
Dr Yuan continued, “We believe that the successful clinical development and commercialization of MRX-I will be facilitated effectively by the depth and breadth of Zhangjiang’s resources – financial, clinical and scientific -- and we look forward to a very productive and dynamic partnership. This strategic alliance will also benefit the development of MRX-I in the United States and other worldwide markets, where MicuRx maintains all rights for this new promising antibiotic.”
Under the terms of the agreement, MicuRx will license all rights for development and commercialization in China to MRX-I to the joint venture. Zhangjiang Biomedical Industry Venture Capital will contribute 60 million RMB ($9.6 million), the sum required for the completion of the anticipated clinical development program through filing a New Drug Application (NDA) with the China State Food and Drug Administration (SFDA). MicuRx will retain the controlling interest of the joint venture and is responsible for managing its daily operations. Currently, MicuRx also plans to initiate a phase II clinical study in the US for MRX-I in 2013.
“We are extremely pleased to partner with MicuRx to develop new antibacterial drugs capable of competing in the world market to address the growing problem of multi-drug resistant bacteria,” commented Haibo Wang, head of Shanghai Source Investment Co., which is managing the investment for Zhangjiang fund. “At SSIC, we are committed to the development of promising new drugs with the potential for meeting global health needs.”
MRX-I is a next-generation oral oxazolidinone antibiotic for treating Gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE). In April 2012, MicuRx announced positive Phase I clinical results demonstrating that MRX-I is safe and well tolerated in human subjects, with no signs of myelosuppression, a major toxicity concern for most oxazolidinone agents, including linezolid. In preclinical studies, MRX-I cures in vivo infections due to Gram-positive bacteria including MRSA and VRE effectively. In addition, MRX-I exhibits 2-fold improved activity against MRSA strains as compared to linezolid.