Biovitrum wins contract to manufacture pharmaceutical substance for Resistentia's clinical phase III trials
clinical phase III trials of new protein-based drug candidate for the treatment of allergy
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Biovitrum has entered an agreement with the Uppsala-based biotech company Resistentia Pharmaceuticals AB for process development and manufacturing of the biopharmaceutical substance RES 08 intended for use in clinical phase III trials of Resistentia's new protein-based drug candidate for the treatment of allergy.
With the onset of an allergic reaction, allergy antibodies (IgE, immunoglobulin E, a specific protein in our immune system) are formed against a specific substance, for example pollen, dust, etc. Resistentia has developed a protein drug candidate (RES 08) that blocks the effect of IgE preventing an allergic reaction. RES 08 is a recombinant fusion protein (a protein with a compound structure produced by biotechnical methods) that initially is intended for the treatment of IgE-mediated allergies. Biovitrum's assignment is to develop the existing process for the biotechnical manufacturing of RES 08 to a standard that meets the high demands of a clinical phase III trial, and furthermore to manufacture sufficient amounts of the substance for the trial. The project will run for more than two years beginning in November 2006.