3/3/2016 Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U .S.A. and Europe | Takeda Pharmaceutical Com pan. ..
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`June 19, 2014
`
`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
`wvvw.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, wvvw.mi||ennium.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, wvviN.takeda.com.
`
`This press release contains fon/vard-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," "wi , " "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. Fon/vard-looking statements are based on estimates and
`assumptions made by management that are believed to be reasonable, though they are inherently uncertain
`
`https://www.takeda.com/news/2014/20140619_6615.html
`
`JANSSEN EXHIBIT 2075
`Mylan v. Janssen IPR2016-01332
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`3/3/2016 Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A. and Europe | Takeda Pharmaceutical Com pan. ..
`
`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 fon/vard-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:
`wvvw.mi||ennium.com/|nTheNews.aspx.
`
`###
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