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www.fdanews.com/articles/90295-two-seattle-genetics-drugs-receive-orphan-drug-status

TWO SEATTLE GENETICS DRUGS RECEIVE ORPHAN DRUG STATUS

February 13, 2007

Seattle Genetics announced that FDA has granted orphan drug designation to SGN-33 for the treatment of acute myeloid leukemia (AML) and to SGN-35 for the treatment of Hodgkin's disease.

"SGN-33 and SGN-35 both target diseases with significant unmet medical needs and represent opportunities for well-tolerated biologics that provide improved treatment options for patients," Clay Siegall, president and CEO of Seattle Genetics, said.

SGN-33, or lintuzumab, is a humanized monoclonal antibody that targets the CD33 antigen that is currently in a Phase I clinical trial for the treatment of AML and myelodysplastic syndromes. Preliminary data from the ongoing study have shown that SGN-33 is well tolerated and has antitumor activity, including improved blood counts, decreased transfusion requirements and decreased myeloblasts.

SGN-35 is an antibody-drug conjugate that links an anti-CD30 monoclonal antibody to a potent, synthetic drug payload, monomethyl auristatin E. SGN-35 is currently being evaluated in a Phase I clinical trial for Hodgkin's disease and other CD30-positive hematologic malignancies. In preclinical studies, SGN-35 has demonstrated potent antitumor activity at well-tolerated doses.

Orphan drug designation will provide Seattle Genetics with seven years of marketing exclusivity upon market approval, as well as the opportunity to obtain grant funding from the government to defray costs of clinical trial expenses, tax credits for clinical research expenses and a potential waiver of the FDA's application user fee. The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals, according to the company.