10/6/2016
`
`XTANDI Clinical Trials & Results | XTANDI® (enzalutamide)
`İmpǿřțǻňț Șǻfěțỳ İňfǿřmǻțįǿň
`Fųŀŀ Přěșčřįbįňģ İňfǿřmǻțįǿň Pǻțįěňț Přěșčřįbįňģ İňfǿřmǻțįǿň
`
`Ħěǻŀțħčǻřě Přǿfěșșįǿňǻŀș
`
`Ǻbǿųț XȚǺŇĐİ
`
`Ų.Ș. Řěșįđěňțș Ǿňŀỳ
`Șțǻřțįňģ XȚǺŇĐİ
`
`Fǿř șųppǿřț,
`
` ǿř čǻŀŀ
`1-855-898-2634
`Ěň Ěșpǻñǿŀ
`čħǻț
`Pǻțįěňț Řěșǿųřčěș
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`Ħǿẅ XȚǺŇĐİ Mǻỳ Ħěŀp
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`Țħě ěffěčțįvěňěșș ǿf XȚǺŇĐİ ẅǻș přǿvěň įň 2 ģŀǿbǻŀ čŀįňįčǻŀ șțųđįěș
`
`
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`PŘĚVǺİĿ
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`ǺFFİŘM
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`
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`
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`The PREVAIL study included 1,717 patients who:
`
`The AFFIRM study included 1,199 patients who:
`
`Had prostate cancer that had spread to other parts of
`the body
`
`Had prostate cancer that had spread to other parts of
`the body
`
`Were no longer responding to a medical or surgical
`treatment to lower their testosterone
`
`Had not received chemotherapy
`
`Were no longer responding to a medical or surgical
`treatment to lower their testosterone
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`Had previously received treatment with docetaxel, a
`type of chemotherapy
`
`Patients taking XTANDI who were already receiving hormone therapy injections continued to do so during these studies. Patients
`not taking XTANDI also received hormone therapy injections.
`
`Čŀįňįčǻŀ șțųđỳ řěșųŀțș
`
`XȚǺŇĐİ șįģňįfįčǻňțŀỳ șŀǿẅěđ țħě přǿģřěșșįǿň ǿf ǻđvǻňčěđ přǿșțǻțě čǻňčěř
`
`Đųřįňģ țħě PŘĚVǺİĿ șțųđỳ,
`Pǻțįěňțș țǻķįňģ XȚǺŇĐİ ħǻđ ǻň 83% ŀǿẅěř čħǻňčě* ǿf țħěįř čǻňčěř ģěțțįňģ
`ẅǿřșě ǿř ǿf đỳįňģ, čǿmpǻřěđ ẅįțħ pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`†
`
`XȚǺŇĐİ ẅǻș șħǿẅň țǿ įmpřǿvě ǿvěřǻŀŀ șųřvįvǻŀ įň mǻňỳ pǻțįěňțș
`
`Đųřįňģ țħě PŘĚVǺİĿ șțųđỳ,
`Pǻțįěňțș țǻķįňģ XȚǺŇĐİ ħǻđ ǻ 23%
`ŀǿẅěř čħǻňčě ǿf đỳįňģ țħǻň
`‡
`pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`
`Đųřįňģ țħě ǺFFİŘM șțųđỳ,
`Pǻțįěňțș țǻķįňģ XȚǺŇĐİ ħǻđ ǻ 37%
`ŀǿẅěř čħǻňčě ǿf đỳįňģ țħǻň
`§
`pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`
`*14% ǿf pǻțįěňțș țǻķįňģ XȚǺŇĐİ șǻẅ țħěįř čǻňčěř přǿģřěșș ǿř đįěđ đųřįňģ țħě șțųđỳ vș 40% ǿf pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`Bǻșěđ ǿň șčǻňș.
`58% ǿf pǻțįěňțș țǻķįňģ XȚǺŇĐİ řěmǻįňěđ ǻŀįvě đųřįňģ țħě șțųđỳ (ǿř ẅěřě ňǿț ǻvǻįŀǻbŀě fǿř fǿŀŀǿẅ-ųp) vș 51% ǿf pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`62% ǿf pǻțįěňțș țǻķįňģ XȚǺŇĐİ řěmǻįňěđ ǻŀįvě đųřįňģ țħě șțųđỳ (ǿř ẅěřě ňǿț ǻvǻįŀǻbŀě fǿř fǿŀŀǿẅ-ųp) vș 47% ǿf pǻțįěňțș ňǿț țǻķįňģ XȚǺŇĐİ.
`Șěŀěčț Șǻfěțỳ İňfǿřmǻțįǿň
`
`† ‡ §
`
`If you take XTANDI you may be at risk of having a seizure. You should avoid activities where a sudden loss of consciousness could
`cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of consciousness or seizure.
`Your healthcare provider will stop XTANDI if you have a seizure during treatment.
`
`XȚǺŇĐİ șįģňįfįčǻňțŀỳ đěŀǻỳěđ țħě měđįǻň țįmě běfǿřě pǻțįěňțș běģǻň čħěmǿțħěřǻpỳ
`
`Ňǿț țǻķįňģ XȚǺŇĐİ
`
`Țǻķįňģ XȚǺŇĐİ
`
`https://www.xtandi.com/xtandi-clinical-trials
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`AVENTIS EXHIBIT 2164
`Mylan v. Aventis, IPR2016-00712
`
`

`
`10/6/2016
`
`XTANDI Clinical Trials & Results | XTANDI® (enzalutamide)
`
`XTANDI
`SUPPORT
`
`CHAT
`
`CALL
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`UP
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`During the PREVAIL study, the median time until the start of chemotherapy was 28 months for patients taking XTANDI vs 11
`months for patients not taking XTANDI.
`Șěŀěčț Șǻfěțỳ İňfǿřmǻțįǿň
`
`If you take XTANDI you may be at risk of developing a condition involving the brain called Posterior Reversible Encephalopathy
`Syndrome (PRES). Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms such as
`headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your healthcare provider will
`do a test to check for PRES. Your healthcare provider will stop XTANDI if you develop PRES.
`
`Questions about paying for
`
`XTANDI?
`
` Learn how to take XTANDI
`
`Ňěxț: Șįđě Ěffěčțș
`
`Ẅħǿ įș XȚǺŇĐİ fǿř? XTANDI is a prescription medicine used to treat men with prostate cancer that no longer responds to
`a medical or surgical treatment that lowers testosterone and that has spread to other parts of the body. (This is a type of
`advanced prostate cancer.)
`İmpǿřțǻňț Șǻfěțỳ İňfǿřmǻțįǿň
`
`Who should not take XTANDI? XTANDI is not for use in women. Do not take XTANDI if you are pregnant or may become
`pregnant. XTANDI can harm your unborn baby. It is not known if XTANDI is safe and effective in children.
`
`Before you take XTANDI, tell your healthcare provider if you:
`
`Have a history of seizures, brain injury, stroke or brain tumors.
`Have any other medical conditions.
`Have a partner who is pregnant or may become pregnant. Men who are sexually active with a pregnant woman must use a
`condom during and for 3 months after treatment with XTANDI. If your sexual partner may become pregnant, a condom and
`another form of birth control must be used during and for 3 months after treatment. Talk with your healthcare provider if you
`have questions about birth control. See "Who should not take XTANDI?"
`Take any other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XTANDI
`may affect the way other medicines work, and other medicines may affect how XTANDI works. You should not start or stop any
`medicine before you talk with the healthcare provider that prescribed XTANDI.
`
`How should I take XTANDI?
`
`Take XTANDI exactly as your healthcare provider tells you.
`Take your prescribed dose of XTANDI one time a day, at the same time each day.
`Your healthcare provider may change your dose if needed.
`Do not change or stop taking your prescribed dose of XTANDI without talking with your healthcare provider first.
`XTANDI can be taken with or without food.
`Swallow XTANDI capsules whole. Do not chew, dissolve, or open the capsules.
`If you miss a dose of XTANDI, take your prescribed dose as soon as you remember that day. If you miss your daily dose, take
`your prescribed dose at your regular time the next day. Do not take more than your prescribed dose of XTANDI in one day.
`If you take too much XTANDI, call your healthcare provider or go to the nearest emergency room right away. You may have an
`increased risk of seizure if you take too much XTANDI.
`
`What are the possible side effects of XTANDI?
`
`XTANDI may cause serious side effects including:
`
`Seizure. If you take XTANDI you may be at risk of having a seizure. You should avoid activities where a sudden loss of
`consciousness could cause serious harm to yourself or others. Tell your healthcare provider right away if you have loss of
`consciousness or seizure. Your healthcare provider will stop XTANDI if you have a seizure during treatment.
`Posterior Reversible Encephalopathy Syndrome (PRES). If you take XTANDI you may be at risk of developing a condition
`involving the brain called PRES. Tell your healthcare provider right away if you have a seizure or quickly worsening symptoms
`such as headache, decreased alertness, confusion, reduced eyesight, blurred vision or other visual problems. Your healthcare
`provider will do a test to check for PRES. Your healthcare provider will stop XTANDI if you develop PRES.
`The most common side effects of XTANDI include weakness or feeling more tired than usual, back pain, decreased appetite,
`constipation, joint pain, diarrhea, hot flashes, upper respiratory tract infection, swelling in your hands, arms, legs, or feet,
`shortness of breath, muscle and bone pain, weight loss, headache, high blood pressure, dizziness, and a feeling that you or things
`around you are moving or spinning (vertigo).
`
`https://www.xtandi.com/xtandi-clinical-trials
`
`2/3
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`

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`10/6/2016
`
`XTANDI Clinical Trials & Results | XTANDI® (enzalutamide)
`XTANDI may cause infections, falls and injuries from falls. Tell your healthcare provider if you have signs or symptoms of an
`infection or if you fall.
`Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible
`side effects of XTANDI. For more information, ask your healthcare provider or pharmacist.
`You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
`1-800-FDA-1088.
`
`Please see the Full Prescribing Information for complete prescribing information.
`
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`XTANDI
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