XOMA Receives European Certification To Manufacture Investigational Medicinal Products
XOMA Ltd. (Nasdaq:XOMA) today announced that its cGMP pharmaceutical manufacturing facilities have received Investigational Medicinal Products certification from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom. The MHRA certification approves XOMA's manufacturing facilities for the production of biological investigational medicinal products to be used in clinical trials in the European Union.
"This is an important development for XOMA since we have a number of our own and partnered drugs in development that are candidates for clinical trials in Europe," said Rob Tenerowicz, XOMA's vice president of operations. "In addition, the MHRA certification positions XOMA to manufacture European investigational drugs on a contract basis for other organizations, which is part of XOMA's strategy for maximizing the utilization of our assets and driving the company to profitability."
About XOMA
XOMA is a leader in the discovery, development, and manufacture of therapeutic antibodies, with a therapeutic focus that includes cancer and immune diseases. XOMA has royalty interests in RAPTIVA (efalizumab), a monoclonal antibody product marketed worldwide (by Genentech, Inc. and Serono, SA) to treat moderate-to-severe plaque psoriasis, and LUCENTIS (ranibizumab injection), a monoclonal antibody product marketed worldwide (by Genentech and Novartis AG) to treat neovascular (wet) age-related macular degeneration.
The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display libraries and XOMA's proprietary Human Engineering and bacterial cell expression (BCE) technologies. More than 45 companies have signed BCE licenses. XOMA's development collaborators include Lexicon Genetics, Inc., Novartis, Schering-Plough Corporation and Takeda Pharmaceutical Company Limited. With a fully integrated product development infrastructure, XOMA's product development capabilities extend from preclinical sciences to product launch. For more information, please visit the company's Web site at www.xoma.com.
Source: XOMA