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 addres 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
About Millennium: The Takeda Oncology CompanyMillennium:
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 LimitedLocated 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," "estimate," "should,"
"anticipate," "plan," "assume," "continue," "seek," "pro forma,"
"potential," "target," "forecast," "guidance," "outlook" or "intend" or
other similar words or expressions of the negative thereof.
Forward-looking statements are based on estimates and assumptions made
by management that are believed to be reasonable, though they are
inherently uncertain and difficult to predict. Investors are cautioned
not to unduly rely on such forward-looking 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.
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