Seattle Genetics Announces ADCETRIS® Receives European Commission
Conditional Marketing Authorization
Conditional Marketing Authorization Triggers Milestone Payments to Seattle
Genetics Totaling $25 Million
BOTHELL, Wash. -- October 31, 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, announced that the European Commission has
granted conditional marketing authorization for ADCETRIS (brentuximab
vedotin). ADCETRIS was approved 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). As a result, under
the collaboration Seattle Genetics will receive two milestone payments from
Millennium, one for each indication, totaling $25 million. ADCETRIS is an
antibody-drug conjugate (ADC) directed to CD30.
“The approval of ADCETRIS by the European Commission marks a significant
milestone for the product and for the many relapsed or refractory HL and
systemic ALCL patients in need of effective new treatment options in Europe,”
said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle
Genetics. “In addition to the U.S. and EU approvals of ADCETRIS, we are making
regulatory progress for approval in Canada while Millennium and Takeda are
pursuing regulatory approvals in other countries. Complementing these
regulatory activities is a robust ADCETRIS clinical development program to
support our goal of establishing it as the foundation of therapy for
The conditional marketing authorization for ADCETRIS is valid in the 27 member
states of the European Union (EU) as well as Norway, Liechtenstein and
Iceland. Similar to accelerated approval regulations inthe United States,
conditional marketing authorizations are granted in the EU to medicinal
products that fulfill an unmet medical need with a positive benefit/risk
assessmentand whose immediate availability would result in a significant
public health benefit. Conditional marketing authorization by the European
Commission includes obligations to provide additional clinical data at a later
stage to confirm the positive benefit-risk assessment. The ADCETRIS Marketing
Authorization Application was filed by Takeda Global Research & Development
Centre (Europe) to the European Medicines Agency.
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
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.
Seattle Genetics is entitled to royalties based on a percentage of
Millennium's net sales in its territory at rates that range from the mid-teens
to the mid-twenties based on sales volume, subject to offsets for royalties
paid by Millennium to third parties.
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
U.S. Important Safety Information
Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting
in PML and death can occur in patients receiving ADCETRIS.
Concomitant use of ADCETRIS and bleomycin is contraindicated due to pulmonary
Warnings and Precautions:
*Peripheral neuropathy: ADCETRIS treatment causes a peripheral neuropathy
that is predominantly sensory. Cases of peripheral motor neuropathy have
also been reported. ADCETRIS-induced peripheral neuropathy is cumulative.
Treating physicians should monitor patients for symptoms of neuropathy,
such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning
sensation, neuropathic pain or weakness and institute dose modifications
*Infusion reactions: Infusion-related reactions, including anaphylaxis,
have occurred with ADCETRIS. Monitor patients during infusion. If an
infusion reaction occurs, the infusion should be interrupted and
appropriate medical management instituted. If anaphylaxis occurs, the
infusion should be immediately and permanently discontinued and
appropriate medical management instituted.
*Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS
and consider more frequent monitoring for patients with Grade 3 or 4
neutropenia. If Grade 3 or 4 neutropenia develops, manage by dose delays,
reductions or discontinuation. Prolonged (≥1 week) severe neutropenia can
occur with ADCETRIS.
*Tumor lysis syndrome: Patients with rapidly proliferating tumor and high
tumor burden are at risk of tumor lysis syndrome and these patients should
be monitored closely and appropriate measures taken.
*Progressive multifocal leukoencephalopathy (PML): JC virus infection
resulting in PML and death has been reported in ADCETRIS-treated patients.
In addition to ADCETRIS therapy, other possible contributory factors
include prior therapies and underlying disease that may cause
immunosuppression. Consider the diagnosis of PML in any patient presenting
with new-onset signs and symptoms of central nervous system abnormalities.
Evaluation of PML includes, but is not limited to, consultation with a
neurologist, brain MRI, and lumbar puncture or brain biopsy. Hold ADCETRIS
if PML is suspected and discontinue ADCETRIS if PML is confirmed.
*Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with
ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and
administer appropriate medical therapy.
*Use in pregnancy: Fetal harm can occur. Pregnant women should be advised
of the potential hazard to the fetus.
ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials.
Across both trials, the most common adverse reactions (≥20%), regardless of
causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea,
anemia, upper respiratory tract infection, diarrhea, pyrexia, rash,
thrombocytopenia, cough and vomiting.
Patients who are receiving strong CYP3A4 inhibitors concomitantly with
ADCETRIS should be closely monitored for adverse reactions.
For additional important safety information, including Boxed WARNING, please
see the full U.S. prescribing information for ADCETRIS at
www.seattlegenetics.com or www.ADCETRIS.com.
Certain of the statements made in this press release are forward looking, such
as those, among others, relating to the potential commercial opportunity for
ADCETRIS in the EU and the potential for approval of ADCETRIS in other
countries, including 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
ADCETRIS will not be widely adopted by physicians in the EU or reimbursement
may be difficult to secure in certain countries of the EU. In addition, data
from the pivotal clinical trials may not support marketing approval for
submitted indications in other countries despite approval in the US and EU.
More information about the risks and uncertainties faced by Seattle Genetics
is contained in the company’s 10-Q for the quarter ended June 30, 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.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
Tricia Larson, 425-527-4180
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