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`Takeda Announces Termination of Orteronel (TAK-700) Developm...
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`June 19, 2014
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`Takeda Pharmaceutical Company Limited
`
`Takeda Announces Termination of Orteronel (TAK-700) Development for
`Prostate Cancer in Japan, U.S.A. and Europe
`
`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," "estimate," "should," "anticipate," "plan," "assume,"
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`002009002038
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`AVENTIS EXHIBIT 2038
`Mylan v. Aventis, IPR2016-00712
`
`
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`Takeda Announces Termination of Orteronel (TAK-700) Development fo...
`
`http://www.takeda.com/news/2014/20140619_6615.html
`
`"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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`Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate
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`Zacras® Combination Tablets LD and Zacras® Combination Tablets HD, Fixed-Dose
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