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news.Xoma has announced that, in light of Cubist Pharmaceuticals' recent decision to cease investment in its HepeX-B product due to stringent FDA approval requirements, Xoma has placed its production process development work for Cubist on hold and issued a notice of contract termination.
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HepeX-B is a combination of two fully human monoclonal antibodies that target the hepatitis B virus (HBV) surface. The product, which has been granted orphan drug status in both the US and the European Union, has been under evaluation for the prevention of HBV re-infection in liver transplant patients.
In September 2005, Xoma and Cubist signed a letter agreement under which Xoma’s extensive antibody development and manufacturing capabilities were to be used to develop new processes to manufacture HepeX-B.
The two companies have now begun discussions to consider other development options for the drug candidate.