BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) announced that NASDAQ has halted trading of the company’s common stock. The U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting today to discuss the company's Biologics License Applications (BLAs) for ADCETRIS™ (brentuximab vedotin). ODAC will review the BLA for the treatment of relapsed or refractory Hodgkin lymphoma during the morning session and the BLA for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) during the afternoon session. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and ALCL.
Seattle Genetics announced on May 2, 2011 that the FDA had accepted for filing two BLAs for ADCETRIS, including one for the treatment of relapsed or refractory Hodgkin lymphoma and one for the treatment of relapsed or refractory systemic ALCL. The FDA has granted a six-month priority review of both applications, and has established an action date of August 30, 2011 under the Prescription Drug User Fee Act (PDUFA).
Seattle Genetics’ management will host a conference call and webcast to discuss the ODAC recommendations. The call will be held tomorrow, July 15, 2011, at 8:30 a.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at www.seattlegenetics.com, under the Investors and News section, or by calling 800-762-8779 (domestic) or 480-629-9771 (international). The access code is 4456034.
About ADCETRIS
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
Seattle Genetics is developing ADCETRIS in collaboration with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Millennium announced in June 2011 that the European Medicines Agency accepted the filing of the Marketing Authorization Application for ADCETRIS for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic ALCL.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.
According to the American Cancer Society, more than 8,800 cases of Hodgkin lymphoma will be diagnosed in the United States during 2011 and approximately 1,300 people are expected to die from the disease. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.
About Systemic ALCL
ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30. Although front-line combination chemotherapy can result in durable remissions, approximately 50 percent of ALCL patients relapse or are refractory to front-line treatment and have few therapeutic options. In the United States, approximately 2,000 systemic ALCL patients are diagnosed annually.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The FDA has granted priority review to BLAs for its lead product candidate, ADCETRIS, for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has five other clinical-stage programs: SGN-75, ASG-5ME, ASG-22ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s expectations for regulatory approval and commercial launch of ADCETRIS. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that data from our pivotal Hodgkin lymphoma trial and phase II systemic ALCL trial of ADCETRIS will not support marketing approval for the submitted indications. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended March 31, 2011 filed 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.