Sanofi-aventis Press Release
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`JEVTANA® (cabazitaxel) for Prostate Cancer
`Recommended for Approval
`in the European Union
`- Therapy provides significant survival benefit in second-line metastatic hormone-
`refractory prostate cancer in combination with prednisone or prednisolone -
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`Paris, France - January 21, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
`that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency
`(EMA) has adopted a positive opinion recommending to grant a marketing authorization in the European
`Union for JEVTANA® (Cabazitaxel – 60mg concentrate and solvent for solution for infusion) in combination
`with prednisone or prednisolone for the treatment of patients with metastatic hormone-refractory prostate
`cancer (mHRPC) previously treated with a docetaxel-containing treatment regimen.
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`The positive opinion from the CHMP needs now to be ratified by the European Commission.
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`“Sanofi-aventis welcomes the positive CHMP recommendation for the approval of JEVTANA® in the
`European Union,” said Debasish Roychowdhury, M.D., Senior Vice President and Head of Global
`Oncology, sanofi-aventis. “The response to JEVTANA® in the US has exceeded our expectations. The
`positive opinion for JEVTANA® in the European Union now strengthens sanofi-aventis Oncology’s goal of
`providing substantially beneficial cancer medicines to patients around the world.”
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`The CHMP positive opinion is based on the submission of results from the Phase III TROPIC clinical study
`involving 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.
`Results from this trial demonstrated a statistically significant 30 percent [HR=0.70 (95% CI: 0.59-0.83);
`P<0.0001] reduction in risk of death from mHRPC among patients taking JEVTANA® in combination with
`prednisone or prednisolone compared with an active chemotherapy regimen consisting of a standard dose
`of mitoxantrone and prednisone or prednisolone. In addition, the median survival of patients receiving
`JEVTANA® was 15.1 months, 2.4 months higher than patients receiving mitoxantrone, a statistically
`significant difference.
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`In the TROPIC Study, the most common (≥ 10%) adverse events (grade 1-4) were anemia, leukopenia,
`neutropenia, thrombocytopenia and diarrhea. The most common (≥ 5%) grade 3-4 adverse reactions in
`patients who received JEVTANA were neutropenia, leukopenia, anemia, febrile neutropenia and diarrhea.
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`JEVTANA® is currently approved in the United States and Brazil. JEVTANA® has also been submitted to
`regulatory agencies in 26 countries spanning four continents.
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`About JEVTANA® (cabazitaxel Injection)
`JEVTANA is an antineoplastic agent that acts by disrupting the microtubular network in cells. JEVTANA
`binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their
`disassembly. This leads to the stabilization of microtubules. JEVTANA demonstrated a broad spectrum of
`antitumor activity against advanced solid tumors xenografted in mice. JEVTANA is active in docetaxel
`sensitive
`tumors.
`In addition, cabazitaxel demonstrated activity
`in
`tumor models
`insensitive
`to
`chemotherapy including docetaxel.
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`Sanofi-aventis www.sanofi-aventis.com
`Media Relations: Tel. : (+) 33 1 53 77 44 50 - E-mail : MR@sanofi-aventis.com
`Investor Relations : Tel. : (+) 33 1 53 77 45 45 - E-mail : IR@sanofi-aventis.com
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`AVENTIS EXHIBIT 2055
`Mylan v. Aventis
`IPR2016-00627
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`The Incidence of Prostate Cancer
`Worldwide, prostate cancer ranks third in cancer incidence and sixth in cancer mortality in men. In the U.S.,
`prostate cancer remains the second most common cause of cancer death among men after lung cancer. In
`2009, an estimated 192,000 new cases were anticipated in the U.S., while 27,000 men were expected to
`have died from the disease. For many patients with prostate cancer, their disease continues to progress
`despite prior treatment – including surgical and/or hormonal castration followed by chemotherapy.
`Metastatic prostate cancer indicates that the cancer has spread to the lymph nodes or other parts of the
`body, particularly the bones. Castration resistant/hormone-refractory prostate cancer means that the
`cancer has continued to grow despite the suppression of male hormones that fuel the growth of prostate
`cancer cells. An estimated 10-20 percent of patients with prostate cancer are diagnosed when the cancer
`has already metastasized.
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`About sanofi-aventis
`Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic
`solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New
`York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com.
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`Forward-Looking Statements
`This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as
`amended. Forward-looking statements are statements that are not historical facts. These statements include projections and
`estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to
`future financial results, events, operations, services, product development and potential and statements regarding future
`performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,”
`“estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such
`forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to
`various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could
`cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking
`information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and
`development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the
`EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product
`candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential
`of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful,
`the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth
`opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis,
`including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’
`annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does
`not undertake any obligation to update or revise any forward-looking information or statements.
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`Contacts:
`
`Megan Humphrey
`Oncology Division Communications
`Tel: 1 (617) 665-4596
`E-mail: megan.humphrey@sanofi-aventis.com
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`Marisol Peron
`Corporate Media Relations
`Tel: +33 (0) 1 53 77 45 02
`Mobile : +33 (0) 6 08 18 94 78
`E-mail: marisol.peron@sanofi-aventis.com
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