Recommended as Treatment for Relapsed or Refractory Hodgkin Lymphoma
and Systemic ALCL
BOTHELL, Wash.--(BUSINESS WIRE)--Jul. 20, 2012--
Seattle
Genetics, Inc. (Nasdaq:SGEN) today announced that its collaborator, Millennium:
The Takeda Oncology Company, a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited, has received a positive recommendation
from the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) for the conditional marketing
authorization of ADCETRIS (brentuximab vedotin) for two indications: (1)
the treatment of adult patients with relapsed or refractory
CD30-positive Hodgkin lymphoma (HL) following autologous stem cell
transplant (ASCT) or following at least two prior therapies when ASCT or
multi-agent chemotherapy is not a treatment option, and (2) for the
treatment of adult patients with relapsed or refractory systemic
anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug
conjugate (ADC) directed to CD30.
“The positive opinion from CHMP and broad label recommendation is a key
step in the European regulatory process for ADCETRIS and brings us
closer to our goal of making this important new therapy globally
available to patients with relapsed Hodgkin lymphoma or systemic ALCL,”
said Clay B. Siegall, Ph.D., President and Chief Executive Officer of
Seattle Genetics. “If approved in the European Union, ADCETRIS will
represent the first new therapeutic advance for relapsed Hodgkin
lymphoma patients in several decades and further validates the potential
of ADCs in the treatment of cancer.”
The European Commission, which has the authority to approve medicines
for use in the European Union, generally follows the recommendations of
the CHMP and typically renders a final decision within three months of
the CHMP opinion. If the CHMP recommendation is formally adopted by the
European Commission, ADCETRIS would be approved for marketing in all 27
member states of the European Union.
European Commission approval will trigger two milestone payments, one
for each indication, totaling $25 million to Seattle Genetics under the
collaboration agreement between Seattle Genetics and Millennium: The
Takeda Oncology Company. Seattle Genetics is also entitled to tiered
double-digit royalties with percentages starting in the mid-teens and
escalating to the mid-twenties based on net sales of ADCETRIS within
Millennium’s territories, subject to offsets for royalties paid by
Millennium to third parties.
About ADCETRIS
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.
ADCETRIS received accelerated approval from the U.S. Food and Drug
Administration (FDA) in August 2011 for relapsed HL and sALCL.
Seattle Genetics and Millennium 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 will be 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 FDA 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 potential for
approval in the European Union and the milestone payment triggered upon
approval by the European Commission. 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 the pivotal clinical trials will not
support marketing approval for the submitted indications by the European
Commission despite the positive opinion of CHMP. 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.
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com
