|[January 17, 2014]
Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Approval in Japan for the Treatment of Relapsed or Refractory Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma
BOTHELL, Wash. --(Business Wire)--
Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator,
Takeda Pharmaceutical Company Limited (Takeda), has received approval of
ADCETRIS (brentuximab vedotin) from the Japanese Ministry of Health,
Labour and Welfare (MHLW) for the treatment of patients with
CD30-positive relapsed or refractory Hodgkin lymphoma (HL) and
anaplastic large cell lymphoma (ALCL). As a result, Seattle Genetics
will receive two milestone payments from Takeda totaling $9 million upon
final pricing agreement in Japan. ADCETRIS is an antibody-drug conjugate
(ADC (News - Alert)) directed to CD30, a defining marker of classical HL and known to
be expressed in some types of non-Hodgkin lymphoma, including ALCL.
"Until now, patients in Japan with relapsed or refractory Hodgkin
lymphoma or ALCL had few therapeutic treatment options, and the approval
of ADCETRIS represents a significant milestone in making this innovative
targeted therapy available to these patients in need," said Clay B.
Siegall, Ph.D., President and Chief Executive Officer of Seattle
Genetics. "ADCETRIS is now approved in 39 countries, and we continue to
work with our collaborator, Takeda, to expand regulatory approvals
globally. Through both our regulatory activities and robust clinical
development program, our goal is to establish ADCETRIS as the foundation
of therapy worldwide for patients with CD30-positive malignancies."
The approval of the new drug application was based on two global pivotal
phase 2 clinical trials of ADCETRIS, as well as a phase 1/2 clinical
trial conducted in Japan, for patients with relapsed or refractory
CD30-positive HL and ALCL. In March 2012, the Japanese MHLW granted
ADCETRIS orphan drug designation for the treatment of patients with HL
and ALCL, which triggered priority review in Japan.
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 for intravenous injection received accelerated approval from
the U.S. Food and Drug Administration (FDA) and approval with conditions
from Health Canada for two indications: (1) the treatment of patients
with HL after failure of autologous stem cell transplant (ASCT) or after
failure of at least two prior multi-agent chemotherapy regimens in
patients who are not ASCT candidates, and (2) the treatment of patients
with sALCL after failure of at least one prior multi-agent chemotherapy
regimen. The indications for ADCETRIS are based on response rate. There
are no data available demonstrating improvement in patient-reported
outcomes or survival with ADCETRIS.
ADCETRIS was granted conditional marketing authorization by the European
Commission in October 2012 for two indications: (1) for the treatment of
adult patients with relapsed or refractory CD30-positive 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) the treatment of adult patients with relapsed or
refractory sALCL. ADCETRIS has received marketing authorization by
regulatory authorities in more than 35 countries. See important safety
Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the
terms of the collaboration agreement, Seattle Genetics has U.S. and
Canadian commercialization rights and Takeda has rights to commercialize
ADCETRIS in the rest of the world. Seattle Genetics and Takeda are
funding joint development costs for ADCETRIS on a 50:50 basis, except in
Japan where Takeda will be solely responsible for development costs.
Seattle Genetics is entitled to royalties based on a percentage of
Takeda'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 Takeda to third parties.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development
and commercialization of innovative antibody-based therapies for the
treatment of cancer. Seattle Genetics is leading the field in developing
antibody-drug conjugates (ADCs), a technology designed to harness the
targeting ability of antibodies to deliver cell-killing agents directly
to cancer cells. The company's lead product, ADCETRIS®
(brentuximab vedotin) is an ADC that, in collaboration with Takeda
Pharmaceutical Company Limited, has been approved for two indications in
more than 35 countries, including the U.S., Canada, Japan and members of
the European Union. Additionally, ADCETRIS is being evaluated broadly in
more than 30 ongoing clinical trials. Seattle Genetics is also advancing
a robust pipeline of clinical-stage ADC programs, including SGN (News - Alert)-CD19A,
SGN-CD33A, SGN-LIV1A, ASG-22ME and ASG-15ME. Seattle Genetics has
collaborations for its ADC technology with a number of leading
biotechnology and pharmaceutical companies, including AbbVie, Agensys
(an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and
Pfizer. More information can be found at www.seattlegenetics.com.
ADCETRIS (brentuximab vedotin) 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. Monitor patients for symptoms of neuropathy,
such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a
burning sensation, neuropathic pain or weakness and institute dose
Infusion reactions: Infusion-related reactions, including anaphylaxis,
have occurred with ADCETRIS. Monitor patients during infusion. If an
infusion reaction occurs, interrupt the infusion. If anaphylaxis
occurs, immediately and permanently discontinue the infusion.
Hematologic toxicities: Grade 3 or 4 anemia, thrombocytopenia and
prolonged (=1 week) severe neutropenia can occur with ADCETRIS.
Febrile neutropenia has been reported with ADCETRIS. Monitor complete
blood counts prior to each dose of ADCETRIS and consider more frequent
monitoring for patients with Grade 3 or 4 neutropenia. Closely monitor
patients for fever. If Grade 3 or 4 neutropenia develops, manage by
G-CSF support, dose delays, reductions or discontinuation.
Serious infections and opportunistic infections: Infections such as
pneumonia, bacteremia and sepsis/septic shock (including fatal
outcomes) have been reported in patients treated with ADCETRIS.
Closely monitor patients during treatment for the emergence of
possible bacterial, fungal or viral infections.
Tumor lysis syndrome: Closely monitor patients with rapidly
proliferating tumor and high tumor burden.
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 (SJS): SJS has been reported with ADCETRIS.
If SJS occurs, discontinue ADCETRIS and administer appropriate medical
Embryo-fetal toxicity: Fetal harm can occur. Advise pregnant women 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.
Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp
inhibitors, has the potential to affect the exposure to MMAE.
Use in Specific Populations:
MMAE exposure is increased in patients with hepatic impairment and
severe renal impairment.
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 Japan and the potential for
approval of ADCETRIS in other countries. 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
Japan or reimbursement may be difficult to secure. In addition, data
from the pivotal clinical trials may not support marketing approval for
submitted indications in other countries despite approval in the U.S.
and E.U. More information about the risks and uncertainties faced by
Seattle Genetics is contained in the company's 10-Q for the quarter
ended September 30, 2013 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.
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