Takeda Announces EMA Acceptance of Marketing Authorization Application for ADCETRIS(TM) (Brentuximab Vedotin)
By Takeda Pharmaceutical Company Limited, PRNESunday, June 26, 2011
OSAKA, Japan and CAMBRIDGE, Massachusetts, June 27, 2011 -
Takeda Pharmaceutical Company Limited (TSE:4502) together with
its wholly-owned subsidiary Millennium: The Takeda Oncology
Company, today announced that the European Medicines Agency (EMA)
has accepted the filing of the Marketing Authorization Application
(MAA) for ADCETRIS™ (brentuximab vedotin) for the treatment of
relapsed or refractory Hodgkin lymphoma (HL) and relapsed or
refractory systemic anaplastic large cell lymphoma (sALCL). The MAA
was filed by Takeda Global Research & Development Centre
(Europe). Acceptance of the MAA confirms that the submission is
sufficiently complete to permit a substantive review.
“This filing brings us a step closer to providing a new
treatment option to patients in the European Union with relapsed or
refractory HL and relapsed or refractory sALCL — two areas of
unmet medical need,” said Nancy Simonian, M.D., Chief Medical
Officer, Millennium. “We look forward to working with the EMA on
this submission.”
The MAA contains data from pivotal phase II studies in relapsed
or refractory Hodgkin lymphoma and relapsed or refractory sALCL.
Top line results from these studies were presented at the 52nd
American Society of Hematology (ASH) Annual Meeting in December
2010.
In January 2009 ADCETRIS received orphan product designations
for the treatment of patients with HL and sALCL in the European
Union from the Committee for Orphan Medicinal Products (COMP).
Orphan medicinal product designation is conferred upon products for
diseases that affect no more than 5 in 10,000 people in the E.U. at
the time of the submission.
About ADCETRIS™ (Brentuximab
Vedotin)
ADCETRIS™ (brentuximab vedotin) is an antibody-drug conjugate
(ADC) comprising an anti-CD30 monoclonal antibody attached by a
protease-cleavable linker to a potent, synthetic drug, 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. This approach allows for the
selective targeting of CD30-expressing cancer cells.
Seattle Genetics is jointly developing ADCETRIS with Millennium:
The Takeda Oncology Company. 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 Takeda
Located in Osaka, Japan, Takeda is a research-based global
company with its main focus on pharmaceuticals. As the largest
pharmaceutical company in Japan and one of the global leaders of
the industry, Takeda is committed to strive towards better health
for patients worldwide through leading innovation in medicine.
Additional information about Takeda is available through its
corporate website, www.takeda.com.
About Millennium
Millennium: The Takeda Oncology Company, a leading
biopharmaceutical company based in Cambridge, Mass., markets
VELCADE, a first-in-class proteasome inhibitor, and has a robust
clinical development pipeline of product candidates. Millennium
Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company
Ltd. in May, 2008. The Company’s research, development and
commercialization activities are focused in oncology. Additional
information about Millennium is available through its website,
Editors’ Note: This press release is also available under the
Media section of the Companies’ websites at:
Robert Gallo
Takeda Pharmaceuticals Europe
+44-203-116-8829
Millennium
Manisha Pai
+1-617-510-9193
Takeda
Corporate Communications Department
+81-3-3278-2037
.
Tags: Japan, Japan And Cambridge, June 27, Massachusetts, Osaka, Takeda Pharmaceutical Company Limited
