Sanofi-aventis Press Release
`
`Jevtana® (cabazitaxel) Injection Now
`Available in the U.S.
`
`- Jevtana plus prednisone is the first and only therapy approved for patients
` with metastatic hormone-refractory prostate cancer previously treated
` with docetaxel-based therapy -
`
`Paris, France – July 19, 2010 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
`that Jevtana® (cabazitaxel) Injection is now available in the United States for patients with metastatic
`hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based treatment
`regimen. The availability of Jevtana comes just one month following a priority review and approval by the
`U.S. Food and Drug Administration (FDA).
`
`“The prostate cancer community is thrilled to now have a new treatment option available for these patients
`whose disease is very difficult to treat,” said Oliver Sartor, M.D., Piltz Professor for Cancer Research at
`Tulane Medical School, New Orleans, and North American principal investigator for the pivotal TROPIC
`trial. “Jevtana will help fill a critical treatment gap, since it is the first treatment approved for patients with
`this stage of metastatic hormone-refractory prostate cancer.”
`
`Jevtana in combination with prednisone was approved based on results from the Phase 3 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% [HR=0.70 (95% CI: 0.59-0.83);
`P<0.0001] relative reduction in the risk of death in mHRPC among patients taking Jevtana in combination
`with prednisone compared with an active chemotherapy regimen consisting of a standard dose of
`mitoxantrone and prednisone. Median overall survival in the patients receiving Jevtana plus prednisone
`was 15.1 (14.1–16.3) months compared to 12.7 (11.6–13.7) months for patients receiving mitoxantrone
`plus prednisone.
`
`“For many years, treatment of advanced hormone refractory prostate cancer after docetaxel-containing
`therapy has remained an unmet medical need. The ability to introduce Jevtana for this patient population is
`an important achievement for sanofi-aventis Oncology that exemplifies our deep commitment to bringing
`innovative new therapies to the cancer community,” said Debasish Roychowdhury, M.D., Senior Vice
`President, Global Oncology, sanofi-aventis.
`
`For patients with metastatic prostate cancer, hormone therapy is frequently the first treatment offered.
`Patients who no longer respond to hormone therapy often receive chemotherapy. However, some patients
`develop chemotherapy resistance, and their disease continues to progress. Before Jevtana, no available
`second-line treatment options were proven to provide a survival benefit in mHRPC patients. The
`combination of Jevtana and prednisone is the first and only therapy to have shown a significant survival
`benefit for patients with mHRPC previously treated with a docetaxel-containing regimen in this setting.
`
`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 2218
`Mylan v. Aventis IPR2016-00712
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`

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`In the TROPIC Study, the most common (≥ 10%) grade 1-4 adverse reactions were anemia, leukopenia,
`neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain,
`hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysguesia, cough, arthralgia, and
`alopecia. The most common (≥ 5%) grade 3-4 adverse reactions in patients who received Jevtana were
`neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia. Treatment
`discontinuations due to adverse drug reactions occurred in 18% of patients who received Jevtana and 8%
`of patients who received mitoxantrone. The most common adverse reactions leading to treatment
`discontinuation in the Jevtana group were neutropenia and renal failure. Deaths due to causes other than
`disease progression within 30 days of last study drug dose were reported in 18 (5%) Jevtana patients and
`three (less than 1%) mitoxantrone-treated patients. The most common fatal adverse reactions in Jevtana
`patients were infections (n=5) and renal failure (n=4). One death was due to diarrhea-induced dehydration
`and electrolyte imbalance.
`
`About Jevtana® (cabazitaxel) Injection
`Jevtana, a microtubule inhibitor, is approved in combination with prednisone for the treatment of patients
`with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-based
`treatment regimen. Jevtana is to be administered intravenously. Jevtana was granted fast track designation
`by the FDA in November 2009. The rolling new drug application (NDA) submission was completed in
`March 2010 and was granted priority review in April 2010; Jevtana was approved by the FDA less than
`three months later. A registration dossier of Jevtana is also under regulatory review by other regulatory
`authorities, including the European Medicines Agency.
`
`Important Safety Information for Jevtana
`
`
`WARNING
`
` 
`
` Neutropenic deaths have been reported. In order to monitor the occurrence of
`neutropenia, frequent blood cell counts should be performed on all patients receiving
`JEVTANA®. JEVTANA® should not be given to patients with neutrophil counts of
`≤1,500 cells/mm3.
` Severe hypersensitivity reactions can occur and may include generalized rash/erythema,
`hypotension and bronchospasm. Severe hypersensitivity reactions require immediate
`discontinuation of the JEVTANA® infusion and administration of appropriate therapy.
`Patients should receive premedication.
` JEVTANA® must not be given to patients who have a history of severe hypersensitivity
`reactions to JEVTANA® or to other drugs formulated with polysorbate 80.
`
`
`
`CONTRAINDICATIONS
` JEVTANA should not be used in patients with neutrophil counts of ≤ 1,500/mm3.
` JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to
`cabazitaxel or to other drugs formulated with polysorbate 80.
`
`
`WARNINGS AND PRECAUTIONS
` Neutropenic deaths have been reported
`- Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is
`needed
`- Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features
` Severe hypersensitivity reactions can occur
`- Premedicate with corticosteroids and H2 antagonists
`- Discontinue infusion immediately if hypersensitivity is observed and treat as indicated
` Mortality related to diarrhea has been reported
`- Rehydrate and treat with anti-emetics and anti-diarrheals as needed
`-
`If experiencing grade ≥3 diarrhea, dosage should be modified
` Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage
`aggressively.
` Patients ≥65 years of age were more likely to experience fatal outcomes not related to disease
`progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor
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`closely.
` Patients with impaired hepatic function were excluded from the randomized clinical trial
`- Hepatic impairment is likely to increase the JEVTANA® concentrations
`-
`JEVTANA® should not be given to patients with hepatic impairment
` JEVTANA® can cause fetal harm when administered to a pregnant woman
`- There are no adequate and well-controlled studies in pregnant women using JEVTANA®
`
`
`ADVERSE REACTIONS
` Deaths due to causes other than disease progression within 30 days of last study drug dose were
`reported in 18 (5%) JEVTANA®-treated patients. The most common fatal adverse reactions in
`JEVTANA®-treated patients were infections (n=5) and renal failure (n=4)
` The most common (≥10%) grade 1–4 adverse reactions were anemia, leukopenia, neutropenia,
`thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain,
`hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia,
`and alopecia
` The most common (≥5%) grade 3–4 adverse reactions in patients who received JEVTANA® were
`neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia
`
`
`Please see full prescribing information for Jevtana, including boxed WARNING, at http://products.sanofi-
`aventis.us/jevtana/jevtana.pdf
`
`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% of patients with prostate cancer are diagnosed when the cancer has
`already metastasized.
`
`About sanofi-aventis Oncology
`Formed in March 2010, sanofi-aventis Oncology is targeting cancer on all fronts in an effort to address
`unmet medical needs for a broad range of patients. Starting with a deep understanding of the mechanisms
`by which cancer develops, grows and spreads as well as identifying the right science early in the discovery
`process, the company employs innovative approaches to bring the right medicines to the right patients.
`
`There are currently more than 10 compounds in development across a broad scientific platform, including
`cytotoxic, antimitotic, anti-angiogenic agents, antivascular agents, monoclonal antibodies and cancer
`vaccines, as well as supportive care therapies. Four of these compounds are now being investigated in
`phase 3 clinical studies aimed at multiple solid and hematologic tumors.
`
`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.
`
`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
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`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.
`
`Contacts:
`
`Marisol Peron
`Mobile: +33 (0) 6 08 18 94 78
`E-mail: marisol.peron@sanofi-aventis.com  
`
`Emmy Tsui
`Tel: 1 - (908) 981-6573
`E-mail: emmy.tsui@sanofi-aventis.com
`
`  
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