MACROGENICS' DIABETES TREATMENT GETS ORPHAN DRUG STATUS

MacroGenics announced that its lead product candidate, MGA031, a humanized, Fc-engineered anti-CD3 monoclonal antibody, has received orphan drug designation from the FDA for treatment of recent-onset Type 1 diabetes mellitus. MacroGenics anticipates initiating a Phase II/III trial to study MGA031 in the fourth quarter of 2006. MGA031 is the designation for hOKT3-gamma-1 (Ala-Ala) manufactured by MacroGenics.

"In previous clinical trials, this anti-CD3 monoclonal antibody was shown to interfere with the autoimmune mechanism underlying Type 1 diabetes, potentially slowing its progression, and therefore improving the health and quality of life of patients with diabetes," said Scott Koenig, president and CEO of MacroGenics. "We believe that MGA031 represents a novel mechanism of action that has the potential to change the treatment paradigm for Type 1 diabetes. We also believe that MGA031 may have applicability in other autoimmune diseases, including psoriatic arthritis and multiple sclerosis."

Orphan drug designation is a special status given to products for rare diseases or conditions upon request of a sponsor and approval from the FDA. Orphan drug designation qualifies MacroGenics for exclusive marketing rights in the United States for seven years if the company is first to receive marketing approval for an anti-CD3 monoclonal antibody of the same sequence for the indication. The designation also positions MacroGenics to benefit from certain tax credits and waives the company's obligation to pay application user fees for this product.

CD3 is a key signaling cluster of molecules within the T-cell receptor complex. MGA031 is a humanized monoclonal antibody that binds to an epitope of the CD3-epsilon chain expressed on mature T-cells.