FDA Approves Ibalizumab Manufactured In China By WuXi PharmaTech
By Cyndi Root
WuXi PharmaTech announced in a press release that the Food and Drug Administration (FDA) has approved its first batch of Ibalizumab (TMB-355). The company reports that this is the first FDA approval for a sterile biologic product manufactured in China for U.S. clinical trials.
Ibalizumab is a monoclonal antibody and a viral entry inhibitor used in the treatment of HIV/AIDS infection. TaiMed Biologics is developing the drug. Dr. James Chang, CEO of TaiMed Biologics said, "TaiMed is pleased with the speed and excellent execution of this project to ensure the success of this important drug. We look forward to the next phase of collaboration with WuXi to successfully bring the drug to marketing approval.”
TaiMed’s Ibalizumab
Ibalizumab (TMB-355) is different from other viral-entry inhibitors because it binds to the CD4 molecule and interferes with virus penetration into the cell. TMB-355 was the first virus entry blocker, catching the attention of researchers in 2003 and earning FDA Fast Track status. A Phase II trial in 2006 showed a ten-time reduction in viral load and a clean safety profile. A Phase IIb trial was considered successful and TaiMed is currently developing a subcutaneous injection delivery system.
TaiMed is also developing TMB-607, an HIV-1 protease inhibitor, first developed by Ambrilia Biopharma. TaiMed licensed TMB-607 in 2011. TMB-571 is a small molecule inhibitor of influenza virus neuraminidase licensed from Academia Sinica in 2008.
WuXi's Manufacturing Facility
WuXi manufactured Ibalizumab for TaiMed at its cell culture manufacturing facility in Wuxi city, at its newly completed manufacturing suite. The company intends to provide manufacturing to global partners. The FDA approval of the Ibalizumab batch positions the company for worldwide acceptance.
Previously in April of 2014, the company announced in a press release that the FDA had completed a general GMP inspection. WuXi believes that the successful inspection was an achievement for the company because clients would value the regulatory approvals and would trust WuXi to supply drugs consistently and gain expedited approval. The FDA also inspected clinical trial materials, packaging, and labeling facilities and found WuXi to be in compliance.