BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that the validation period is complete and Health Canada has accepted for review its New Drug Submission (NDS) for the use of ADCETRIS (brentuximab vedotin) in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The NDS will be reviewed under the Health Canada policy of Notice of Compliance with Conditions (NOC/c). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in Hodgkin lymphoma and sALCL.
“Data from the pivotal clinical trials of ADCETRIS in relapsed HL and sALCL demonstrated a high objective response rate and manageable safety profile in heavily pre-treated patients,” said Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer Agency in Vancouver, Canada. “If approved in Canada, ADCETRIS would constitute a major step forward in how we are able to treat these patients.”
“Completing this submission is an important part of our goal to broaden the availability of ADCETRIS for relapsed HL and sALCL patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “During the application review period, we will work in tandem with Health Canada towards our goal of making ADCETRIS available to patients in Canada by early 2013.”
The NDS is based on results from a pivotal trial in HL patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT) and a pivotal trial in relapsed or refractory sALCL patients. Data from both trials were recently published in the Journal of Clinical Oncology (JCO).
Health Canada’s NOC/c policy is available for promising new drug therapies intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which no drug is presently marketed in Canada or that represents a significant improvement in the benefit/risk profile over existing products. Conditions associated with market authorization under the NOC/c policy include a requirement that Seattle Genetics conduct clinical trials designed to confirm the clinical benefit of ADCETRIS in these patients. The safety and efficacy of ADCETRIS is under review by Health Canada and market authorization has not yet been obtained in Canada.
ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, 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.
Seattle Genetics and Millennium: The Takeda Oncology Company are jointly developing ADCETRIS. 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. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group is solely responsible for development costs.
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. The U.S. Food and Drug Administration granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. 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 in Canada. 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 clinical trials, including our pivotal Hodgkin lymphoma trial and pivotal sALCL 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, 2012 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.