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Biopharmaceuticals FDA

 News Release - February 13, 2007

Seattle Genetics Receives Orphan Drug Designations for its SGN-33 and SGN-35 Programs

BOTHELL, Wash.--(HSMN NewsFeed)--Seattle Genetics, Inc. (Nasdaq:SGEN ) announced today that the U.S. Food and Drug Administration (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," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "We are aggressively pursuing the development of SGN-33, and expect to advance into two combination clinical trials during 2007, including a phase II study in combination with low dose chemotherapy for older patients with AML. With SGN-35, we are conducting an ongoing phase I dose-escalation study with plans to report data at the ASH annual meeting in December 2007. Orphan drug designation provides several benefits to the company, including market exclusivity for seven years, and is an important part of our overall development strategy for these novel drugs."

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 (MDS). Preliminary data from the ongoing phase I study have shown that SGN-33 is well-tolerated and has antitumor activity, including improved blood counts, decreased transfusion requirements and decreased myeloblasts in multiple patients with AML or MDS. AML is the most common type of adult leukemia, with an estimated 13,000 new cases diagnosed each year in the United States according to the National Cancer Institute. More than 80 percent of elderly AML patients die within a year of diagnosis.

SGN-35 is an antibody-drug conjugate (ADC) that links an anti-CD30 monoclonal antibody to a potent, synthetic drug payload, monomethyl auristatin E (MMAE). 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. Of the more than 500,000 people in the United States with lymphoma, approximately 134,000 have Hodgkin's disease. The National Cancer Institute estimates that there will be more than 8,000 new cases of Hodgkin's disease diagnosed in the United States during 2007.

Orphan drug designation provides Seattle Genetics with seven years of marketing exclusivity upon market approval, as well as the opportunity to obtain grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and 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 in the United States.

About Seattle Genetics

Seattle Genetics is a biotechnology company developing monoclonal antibody-based therapies for the treatment of multiple types of cancer, including lymphoma, multiple myeloma, leukemia and solid tumors. The company has an exclusive worldwide license agreement with Genentech to develop and commercialize SGN-40. In addition, Seattle Genetics has developed proprietary antibody-drug conjugate (ADC) technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. The company has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Genentech, Bayer, CuraGen, Progenics and MedImmune, as well as an ADC co-development agreement with Agensys. More information can be found at

Certain of the statements made in this press release are forward-looking. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Specifically, the statements regarding planned clinical trials and the potential therapeutic benefit of SGN-33 or SGN-35 are forward-looking and actual results may differ materially from these statements for various reasons. Factors that may cause such a difference include difficulties encountered during the clinical stage of SGN-33 and SGN-35, including adverse clinical results, or the inability of Seattle Genetics to obtain necessary regulatory approvals to continue development of such products. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's filings with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Seattle Genetics

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