Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A. and Europe

  Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate
  Cancer in Japan, U.S.A. and Europe

Business Wire

OSAKA, Japan -- June 19, 2014

Takeda Pharmaceutical Company Limited (TSE:4502) announced today that it has
voluntarily decided to end the development program for orteronel (TAK-700) for
prostate cancer. The decision follows the results of two Phase 3 clinical
trials in metastatic, castration resistant prostate cancer (mCRPC). The
studies found while orteronel plus prednisone could extend the time patients
lived before their cancer progressed, it did not extend overall survival in
these patients. After careful consideration of the data from these trials, the
company has determined that the drug has not demonstrated a clinical profile
sufficient to move forward in mCRPC, given the availability of other
therapies.

On May 14, 2014, Takeda announced results from ELM-PC4, a pivotal,
international, double blind, randomized Phase 3 trial in men with mCRPC who
had not received chemotherapy, which showed that orteronel plus prednisone
improved radiographic progression free survival (rPFS) compared to prednisone
alone, one of the study’s two primary endpoints, but did not show a
statistically significant improvement in the study’s second primary endpoint
of overall survival (OS). A previously reported Phase 3 trial, ELM-PC5, in men
with mCRPC that had progressed during or following chemotherapy, was unblinded
in 2013 after a pre-specified interim analysis indicated that orteronel plus
prednisone would likely not meet the primary endpoint of improved overall
survival when compared to the control arm. The interim analysis did show an
advantage for orteronel plus prednisone for the secondary endpoint,
radiographic progression-free survival over the control arm. There were no
significant safety concerns in either study.

Takeda is in communication with trial investigators and the relevant
regulatory authorities, to provide them with updated and current information
in compliance with local regulations. Takeda is working with trial
investigators and local regulatory authorities to ensure that patients who
participated in the orteronel (TAK-700) trials are transitioned to appropriate
therapies so that trial participants receive appropriate care. Patients
enrolled in the orteronel (TAK-700) clinical trials are urged to consult their
study investigators to address any questions, and before making any changes to
their medication. For additional information, please visit www.takeda.com.

Takeda remains committed to oncology and to the treatment of prostate cancer.

About Millennium: The Takeda Oncology Company
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company
based in Cambridge, Mass., markets a first-in-class proteasome inhibitor and
has a robust pipeline of oncology product candidates. Additional information
about Millennium is available through its website, www.millennium.com.

About Takeda Pharmaceutical Company Limited
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 people worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, www.takeda.com.

This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook, strategies,
results for the future, and other statements that are not descriptions of
historical facts. Forward-looking statements may be identified by the use of
forward-looking words such as "may," "believe," "will," "expect," "project,"
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believed to be reasonable, though they are inherently uncertain and difficult
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statements.

Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements. Some of these risks and
uncertainties include, but are not limited to, (1) the economic circumstances
surrounding Takeda's business, including general economic conditions in Japan,
the United States and worldwide; (2) competitive pressures and developments;
(3) applicable laws and regulations; (4) the success or failure of product
development programs; (5) actions of regulatory authorities and the timing
thereof; (6) changes in exchange rates; (7) claims or concerns regarding the
safety or efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as
of the date of this press release, and Takeda undertakes no obligation to
revise or update any forward-looking statements to reflect new information,
future events or circumstances after the date of the forward-looking
statement. If Takeda does update or correct one or more of these statements,
investors and others should not conclude that Takeda will make additional
updates or corrections.

Editor’s Note: This press release is also available under the Media section
at: www.millennium.com/InTheNews.aspx.

Contact:

Takeda Pharmaceutical Company Limited
Corporate Communications Department, +81-3-3278-2037
or
Elizabeth Pingpank, 617-444-1495
 
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