Conditional Marketing Authorization Triggers Milestone Payments to
Seattle Genetics Totaling $25 Million
BOTHELL, Wash.--(BUSINESS WIRE)--Oct. 31, 2012--
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 CD30-positive
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
in the United States, conditional marketing authorizations are granted
in the EU to medicinal products that fulfill an unmet medical need with
a positive benefit/risk assessment and 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 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. 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 www.seattlegenetics.com.
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
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 accordingly.
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
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
Source: Seattle Genetics, Inc.
Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160