Xoma wins $65 million federal contract for botulism drugs

The contract is the third that National Institute of Allergy and Infectious Diseases has awarded to Xoma for the development of botulinum antitoxins and brings the program’s total to nearly $100 million. This award furthers Xoma’s plans to develop anti-botulism antibody products to protect against natural, accidental or intentional human exposure to botulism.

This program is said to be the first of its kind to combine multiple human antibodies to target a broad spectrum of the most toxic botulinum toxins.

Another goal of the program will be to develop an injectable form of highly potent antibodies that can be given at very low doses for mass casualty events. This would provide an easier method of administration and safety advantages compared to currently available therapies that use legacy technologies such as lower potency animal-derived antibodies given by time-consuming intravenous methods, the company said.

In general, Xoma plans to initiate testing of its first drug candidate in human safety and animal efficacy studies in 2009. Depending on positive results, continued government funding and additional human safety studies, Xoma plans to file the data package necessary to begin production of drug candidates for the strategic national stockpile. Following positive discussions with the FDA, Xoma plans to prepare and submit a biologics license application.

Xoma will develop, evaluate and produce the clinical supplies to support an investigational new drug filing with the FDA and conduct preclinical studies required to support human clinical trials. The project is fully funded under federal contract and Xoma expects to receive $65 million in revenues as work is conducted over a six-year period.