Toviaz®
`
`(fesoterocline fu marate)
`
`Don't Let Overactive Bladder Stop You In
`
`Your Tracks...
`
`'." . '.“___. so
`
`Q
`
`\
`
`-4,.
`
`‘
`
`4
`
`.
`
`:9.
`
`~
`
`~
`
`L
`
`James Ahearn, Michelle Miller, Casey Murdock, Michelle
`
`Shemkovitz, Ben Yudin
`
`' Tovl cu‘
`ft soterodine fumarate
`an-on -tun ulna In. in! lag
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 1
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 1
`
`

`
`What is Overactive Bladder?
`
`- Urgency: having a strong need to urinate
`
`right away
`
`- Frequency: having to urinate often
`
`- Urgency incontinence: involuntary loss of
`
`urine
`
`- Nocturia: waking up > 2 times
`
`Source: International Continence Society
`
`'
`' T '
`femgtxnlegngate
`ntea-Ml II-haw mum 01 III! Iraq
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 2
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 2
`
`

`
`OAB Prevalence
`
`200 million people globally
`
`33 million men and women in the U.S.
`
`1 in every 6 persons who are over the age of 40
`
`Source: Global Industry Analysts
`
`.
`
`l.§'.§3.l?L9.‘.li.llS.f"m“'““
`-Iv"i9.iiI¢In;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 3
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 3
`
`

`
`OAB Treatment
`
`First Line Therapy
`
`Behavioral therapy; physical therapy; lifestyle changes
`
`Bladder training, pelvic floor muscle therapy, change in diet
`
`Prescription Medication
`
`Detrol LA, Enablex, Vesicare, Sanctura, Botox, Ditropan XL
`
`Similar results in terms of safety and efficacy
`
`Half of patients stop taking medication
`
`Source: Consumer Reports
`
`I
`
`'
`
`..,
`
`fest:-terodtiliigfumarate
`cmndrd mom
`km and In;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 4
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 4
`
`

`
`OAB Market Growth
`
`GlobalData
`
`- Market Worth $1.8 billion in 2011
`
`- Market Worth $1.3 billion in 2019
`
`Patent Expires of key drugs
`
`Source: Regen ceRx Pharmacy Benefit Management
`
`" Toviar
`fesoterodine fumamg
`um-Ieii mus: ubmi. mg ml In;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 5
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 5
`
`

`
`Current Trends
`
`Increased awareness
`
`OAB as an under diagnosed condition
`
`Women Wait 6.5 years for diagnosis
`
`2/3 of men and Women never discuss their symptoms of OAB with their
`
`doctor
`
`Aging population
`
`Development of novel drugs
`
`Past unmet needs
`
`Common side effects and inability of drugs to offer complete compliance
`
`Source: Global Industry Analysts
`
`0
`
`_,
`
`I
`Tovlaz
`fesoterodine furnarate
`emri-MI rune uum {mg IIII In;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 6
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 6
`
`

`
`
`
`Population 55+ byAge: 1900-2050
`souloe: U.S. Buleau ofme census
`
`100,ll0B,flll0
`
`90,000,000—
`
`mm.”
`r0,00o,o00
`
`60,0003!!!
`
`50,llID,flIll
`
`l0,M0,°W
`
`3ll,[II0,0llI
`
`2fl,IIIU,flIlI
`
`flmnberofPerson:85+
`
`WW
`
`U '1 - I - I - I - I
`1!”
`1910
`1930
`1920
`
`r
`
`1945
`
`195U
`
`I i i I
`
`I
`
`I
`
`1H0
`
`1970
`
`I
`
`_
`
`- 1
`
`I
`
`I
`
`I
`
`1980
`
`1990
`
`ZOIII
`
`I
`
`2010
`
`I
`
`2020
`
`1
`
`2030
`
`I
`
`2040
`
`I
`
`2050
`
`flue
`ESJ4
`
`lfloe Elks:
`run
`05»
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 7
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 7
`
`

`
`OAB Market Prescriptions
`
`Oxybutynin 27.3%
`
`VESIcare 24.4%
`
`Oxybutynin ER 18.8%
`
`Detrol LA 12.7%
`
`Enable): 6.5%
`
`Toviaz 4.2%
`
`Source: IMS Health; Vector One: Nati0na1;januaI'y 2012
`
`' Toviaz‘
`E-E:¢§'~EErEr‘3»£1'inrh]£v{'l£1n:!-elves“
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 8
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 8
`
`

`
`OAB Market Promotional
`
`Spending
`
`VESIcare 44.8%
`
`Toviaz 37.7%
`
`Enable): 11.8%
`
`Sanctura XR 2%
`
`Others 3.7%
`
`Source: IMS Health; integrated Promotion a] Services; MAT 1 1/1 1
`
`.
`
`I.‘.'.§.'1E':‘.£°.E’,‘.'.I.‘E 59.9.19L1“
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 9
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 9
`
`

`
`Clinical Trials
`
`Testing the Efficacy of Toviaz in doses of 4mg and 8mg
`
`12 week Phase 3 randomized, double—blind placebo controlled study
`
`Mean age 58
`
`79% female
`
`21% male
`
`0
`
`__
`
`F
`Tovlaz
`fesolerodine fumarate
`emu-at-d vri-new mum Av-sq ml In;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 10
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 10
`
`

`
`Clinical Trial Findings..
`
`- Compared to the placebo Toviaz had statistically
`
`significant reductions in the number of urges per
`
`24 hours
`
`- Using 4-point scale ranging from “Improved” to
`
`“Greatly Improved”
`
`- Toviaz scored higher than placebo
`
`' Toviar
`fesoterodine fumarate
`um-Uni mmmmmml\ U-nqnd In-g
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 11
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 11
`
`

`
`Clinical Trial #2
`
`- Open label extension study
`
`- Phase 3 designed to assess long term safety,
`
`tolerability and maintenance of Toviaz therapy in
`
`adults with OAB
`
`- 12 Week, short term, double blind study
`
`- Started with 8 mg, lowered to 4mg after 1 month
`
`- Efficacy was measured up to 2 years,
`
`safety/tolerability up to 3 years
`
`- Study was never finished, it was terminated by
`
`Schwarz Pharma
`
`' Toviaz‘
`fesoterodine fumatate
`nmurc mun ullrh Mg an In
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 12
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 12
`
`

`
`SWOT Analysis
`
`I
`
`,
`
`I
`Toviaz
`fesoterod_i_r_1£ fumatate
`elm-vlnltl-Inn-e
`iim-gnllrlq
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 13
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 13
`
`

`
`Strengths
`
`- Pfizer offers patient assistant programs to
`
`help people who cant afford the medication
`
`- Toviaz taken only once per day; with or
`
`Without food
`
`- Toviaz 8mg has proven superiority VS. Detrol
`
`LA 4mg in reducing urge urinary
`
`incontinence
`
`1. Pfizer for professionals
`
`.
`
`fesoterodine fumarate
`um-lent Inn-so uum I-via‘ and I-13
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 14
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 14
`
`

`
`Weaknesses
`
`- Newest OAB drug on the market (there is
`
`limited research to date)
`
`- Cost
`
`- Does not offer any safety advantages over
`
`other treatment options
`
`- Compliance; patients taking it at the same
`
`time everyday
`
`May take up to 12 weeks to feel full benefits
`
`- Many harmful side effects. . .Why would
`
`someone switch?
`
`- Toyiar
`
`fesolerodine fumarate
`Nrafih
`nwhtl vrba
`In-q In-I IN;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 15
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 15
`
`

`
`Opportunities
`
`Gives physicians a new option to address
`
`challenges OAB patients face
`
`Threats
`
`Sanctura has proven less severe side effects
`
`including a lower rate of dry mouth among this
`
`patients
`
`Does not provide additional value in terms of
`
`efficacy, safety, convenience or cost
`
`° Toviar
`fesolerodine furnarale
`nun:-u n-tuuuum u-gnu.-q
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 16
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 16
`
`

`
`Target Market and Objectives
`
`' TOVICIZ‘
`fesoterodine fumarale
`emmti 1wneutIr11
`“'1-I009‘;
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 17
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 17
`
`

`
`Women ages 55-85
`
`Physicians
`
`Increase awareness of OAB through consumer
`
`marketing and promotional efforts
`
`Increase physician Visits to talk about OAB
`
`Increase amount of Toviaz prescriptions through
`
`professional marketing (e—detailing, detail aids)
`
`_
`
`_
`Tovlaz‘
`fesaterodine fumaiaie
`ubhh
`nerntdwhm
`Uhqubiiig
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 18
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 18
`
`

`
`Campaign Theme
`
`
`
`"Don't Let Overactive Bladder Stop You In
`Your Tracks"
`
`- OAB does not have to stop you from living
`
`life to the fullest.
`
`- Each ad, commercial and detail aid will portray
`
`an older couple enjoying the outdoors— Without
`
`having to Worry about where the nearest
`
`restroom is.
`
`' Toviaz‘
`fesoterodine iumarate
`amid what: mi-H Iraq at rig
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 19
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 19
`
`

`
`
`
`- Brand Colors
`
`- Positioning
`
`“Toviaz is the latest treatment option for patients
`
`suffering from overactive bladder and the 8mg dosage has
`
`proven superiority VS. Detrol LA 4mg in reducing urge
`urinary incontinence.”
`
`' T°V.iaZ'
`1s:2:".=:9i2.=.J.i.":.eL1‘°
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 20
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 20
`
`

`
`Advertising Plan: Creative
`
`0
`
`I
`
`__
`
`1 Toviaz
`rm:-u‘.e 1P74l$!|'}NPN1‘‘;I'|fl 11;
`fesoterodine fumaiate
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 21
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 21
`
`

`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 22
`
`

`
`i
`
`I I I i I
`
`TESTIMONIAL
`
`‘Wm?’ M09 3 day T0W¥'=’Z i V70 50099’
`have to worry about finding the next
`restroom. Ican finaiiy enjoy iife and
`do the things Hove without the
`constant need to go."
`
`Mary 5-11 1'}
`
`®P|an
`o
`Important Safety Information: Ifyou have
`
`Toe most common s de effects are dry mom and
`00%! 0=’~10"-
`
`Stop Worrying and Start Living!
`'
`
`certain stomach roblems or glaucoma you
`should not take oviaza.
`
`Copyright © 2012 Pfizer Inc. All rights reserved. Pfizer, PO Box 29387, Mission, KS 66201
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 23
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 23
`
`

`
`Home
`
`About OAB
`
`More
`
`
`
`The OAB Symptoms Quiz can help you better explain your symptoms to your doctor.
`
`Did You Know...
`
`Get Doctor Conversation
`
`Tips
`
`Talking with your doctor about your OAB symptoms
`isn‘t easy. But he or she is the only one who can make
`a diagnosis. Use this linkto download conversation
`tips and a guideline to initiating a discussion with your
`doctor. If your doctor says that you have OAB, you can
`ask if Toviaz may be right for you.
`
`Find a Doctor in your
`area
`
`The American Medical Association (AMA) offers a
`search tool 0 its Website. Search for doctors by name,
`or medical speciality along with city, state and zip.
`
`Keep a one—day bladder
`diary
`Keep a written diary of your daily bladder habits to
`help your doctor better understand your symptoms.
`Remember to bring it with you next time you visit your
`doctors otfioe.
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 24
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 24
`
`

`
`Don't Let Ovexactive Bladdet Stop You In Your Tracks...
`
`diuulinn & Cliaicnl Cu-
`JIn.'util inr Ihr I=l'I'.|HrlI4'rII an‘ f\II.Kl'Ib| hath -rvwoduuu i11w.lnl¢r
`ah n_\-nu;-Iunmn -:1‘ unwary lnqurmy. Ilfp."fl'BJV. 15!‘ um»
`.'u|IJ.u.-ulmr. <Ir any -fIlf!ha\t#L|IN|fl DI I11-rw nls HI [vb-.w|.-.-
`liifcrrni
`Dc '
`‘
`TPI-' i.uII-rniun -If TU'l'1n\.T an in J4.1':vr
`.m.—uI:u|m 5—l!MT in nu dcprr-am:
`um r_r:.n.- Eurnmr I‘-Gil lmr rm-._vm:
`
`"I
`
`It
`
`in H'I‘fl' Bil -
`tn‘
`lip In 3:. .1:-nun-r m urg,rnn_- ¢51i:adcJ1'rl lur-
`:
`".'u pl.-.1-Eu us Wnvk J2
`Malian ‘IL qlurigr Fmlri Eun-liar -
`15.15 lI'(YlL'L:\Z -1 mg Rlkl -ill -1 \.
`IUW-'IJ\.Z Fig.5 n. -.1.) I. pluvbn.
`Zmnnnn Sid: [finch
`by usual]: and ..-anal-.i;+-Imn
`
`Iain! 51:9 nlornilbinn
`lm‘I/L1 ublch .iuuJ.i L»: uunl wmh :. ulnzm an -puirmtn with
`Eli“-mil‘? ..,.;mJ;..m LL..1.an name ..L«.im.—hm—.. .1.-m-...\.1
`5.n|.n_-an-inuuul mnI.d'.;rt_\', .-nub-ullni um-nu-n Aflslt |g_Ilu|:I:I'.1J, an
`uu_\-nuhnu .5.---u.
`n..- m-on-m—n4-.1 -o.u-e.=.,; .i...r as I£‘A'h\I .. 1 mg. non-9 Jul}
`:rn'.IH-.~i-r=‘u'i Irrlmlc In-rd up-i.-1:1 imlm-Iiul rnpnmr anul
`Ia-In-nEuIat_v. Ih: in: may hr ilI(traIm\‘I In 5 mg cm.-r Liallj.
`I)mn- ,i_-_:1'.|kr that I. mg ;:-r Pm‘! ennnmsmrudnl ufl p.n1:'a-1-ilu will
`a-an-fir a-mat :Iuu£Ei..a-I\c_r, M an pal:r1-II» Liking a gmhnl
`C\“.|".'-J'I: mhilwihcr. T(1'|'L.'|u1 in rural n-ucouumu.-nth.-xi in In: m.
`,..m'mu n-II}: ..n-.—n— r~..;..n.— nr:1-pairnacnf iuqilct $'h5.+. C|.
`Tu Man Ida-.1301
`is:-e
`1.1-
`I'Ina-or no-nun I {lit pflhdlhl I.-ra.-mI5r.npi1.|: .. \. x'— l-
`.-.
`ampuehnl mlur||\.fl$u:n tn-fishing In b..iw-:rus- n-nslnm. |£I'1.%
`nflrrltturtn. Jnai dinning n which 31:1-it hnl but-n
`
`
`¢7@
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 25
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 25
`
`

`
`Don't Lat OAB Stapi fofi In YO..;l‘:|'I-‘_aCkS
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 26
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 26
`
`

`
`
`
`i
`4 --a._-
`CHIICIIYIIIII Erna-wanna: ‘in: :.11¢tvui‘ Tuna: was IN1I1||Ja2Bfli|'| Plum 1 and J -:|:rrtraIei::r.-I1:l: natnlzal
`or law D:.mc'I:s wlzn m.erai:t-2 uiwdtt. lat uhnr 225:!!! were treat‘.-6 with its-oue'u¢ne. Drtms u:vr.a.. F81
`"I!-EENIH1 1Tmi.:: -C mm‘-nah‘. .ra:- NS rectum: '-m-Ia: 3 i-I-aqlillw I1 F'|'1:s-I: 2 Ell J stung ii-arm tleuti-I'ci"-t pcnuds
`or Ii or 12 M:t‘iIi:i.J¢|Dr1:Il.-fl*am|I;' NIH: 91' time uterus mo 1-11: -nulu u:-cnoruuw: ho Tm.»-az Ir‘-trmsc tmis.
`In Frrasac '.' no 3 Dh‘hDt't1u-ta-*l.='fllb:1l at--ah oarvianncn. the nu: acme.-.5 at st.-i1:r.n adlrtifl‘: cunts Il'| Dabcnns
`Pu-ccmnn phccm. Inulari NR}, an-I: ‘mu: I! mm «mm 1.9%.. 1.59%, am! );5l'!h, n5pn.:1:rur.'!.|. NI sums
`acm.-rsieevmrs -um: iuoqndta be not -aimed nr unlkdif to be missed to mm Pnemcahon by tn»
`ln r. cncqnt int tour i:i.1m:nt:. rdevtio ‘--zmai who ncparzna one man amuse a-wen: mm: arlqina.
`chat pan, izastrnentcrem, and Q1’ nrninnnrmnn ur ECG.
`
`lIIIrodudn¢To\¢II!.
`Thu Illa-niastlaun at
`treatment Intonat-
`active Bladder
`Swnmnms
`
`l|Ipu'IInlSIl'atv IIIIIIIIIIIIJIIII. flnqmmam cf arc race. has. tnniaunl, aI'\¢.'i1r '.'In"cI Hus mm rcpar'.ei:i
`a-tn 'csn:¢::rndn::. in some cases :"!cI mu: rr: acne. Pat-uni: slim.-I: be sums-:1: bu IIf0f"CKHI 6:5-:|:II"KI"iuc'
`lui:n.I!I'CII‘hI1c n'I:raDb'an: siizdu. i|'I'IfI'iI!II-‘LDC rrH':\3c.Il .'m:.r_"'mnn I‘ (-15, eI.nI'_-'H:ri.:c Ibfl-I‘:‘-|'|.I o‘ trig-Innquc,
`aaryfiaunhawnh or dl|'i:ul: DrmI:1‘iI'I'l.
`“F-ZFUIAZ DDCB Ihnuld be uni‘. wD'I r::I..tI:vI"= |l'| :38.-cuts aim clntaiw 9qriI“t:nI'I‘t D'aI1cll:r -:v.I'L|a: ntbs1'1.C:I:r‘I..
`aeacasccl gash-antes: na? I'M-.'.i'.‘:IH.1, CD|'IT!|1lI!‘fl I‘?-3|‘-‘I1II\"3flfi|tn:|'u'3|.iC|'.I""-i. D‘ -"'||'H!i'|fl'I--1 df-IH I5.
`'-D‘u'|IA£ I5 asm-:uI:1-_-c um" .:ncr:rI::ImcTt:-i: ccrrnrai 1cru0.E svstian :|t_‘N'S: an.-ct: I-Izludro ‘|'Ja:d.}d"l!,
`01¢.-I nuns. MCI sornnuk-.-rv:-i:. Mum D-31N:I'I:s not to cm»: cr ecu.-nun: hc.‘:n' l1'Ia<J"l|'|¢fY I.rr,l trtr know ruaw
`ELN Mu’. aifccls '.rJ1c111.
`
` I.guI.'
`
`«-9; n III’; m..-In-u. niucu pa- ism .1.-5, -|
`flout
`
`0
`
`5--- .
`' -- _
`
`' ‘ -
`—
`_
`
`_
`-
`— _ __
`
`0
`
`. .
`I
`
`_
`
`_
`
`g
`
`.
`"
`
`_
`
`I.
`
`‘.
`
`‘.
`
`".
`
`.5
`
`‘
`
`5
`ti
`1.
`2!
`.'i
`I‘
`ul
`.
`Ii
`
`.3O
`
`I
`
`O
`
`I
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 27
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 27
`
`

`
`' Toviaz
`
`fesoterodin fumarat
`
`Powerful efficacy in
`reducing urge
`urinary incontinence
`
` “
`In-mwmu-mum
`soilimuaumuuauuun
`Iflinnndlnnducflonhwountiulv
`%II%lIdIIUI'IDVI.IZI@flW§I.I." up-1-yjnfifjg
`II-unotluuzauululllluu
`Insane
`on-III}
`u-In
`i--ma
`I-11--lw
`3.1
`as 1%
`42
`
`I-uqiuu
`....:'.:.'.'-:~..:
`
`I;
`I
`ii
`'1 _
`I
`
`
`
`Iuui
`-:....-..:.-i
`
`'
`i-
`
`,
`
`I"
`‘-I
`all‘
`I
`
`'
`
`
`
`I
`-
`
`"
`5"“
`-;m 2.5
`
`.
`
`La
`
`.
`
`1.4
`
`Inlnqum "
`.m........
`
`1.3
`
`‘I'sII'llnfl:Ih'
`...................
`
`I
`
`‘unmet-n::qnuu¢uI:-A
`=Mmmonno-nnuun-
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 28
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 28
`
`

`
`Toviaz Mobile App
`
`Cancei New Reminder
`
`EIEIEIBIBIIEIE
`
`EBEIIBBIIIIJIII
`
`i BEIIEEIEIEIID «=1
`
`' Toviaz"
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 29
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 29
`
`

`
`Toviaz Mobile App
`
`. Kegelmaster Home
`
`M Page
`
`BLADDER D|ARY
`
`Day
`TIME
`
`FLUIDS
`
`What
`kind’?
`
`How
`much?
`
`How
`How
`many much?
`times?
`[S.M,L}
`
`Date:
`UHINATION
`Did you
`feel a
`strong
`urge to
`urinate?
`
`What
`activity
`did this
`intermpt?
`
`Did you
`have an
`accident?
`
`S=Sma|| M=Medium L=Large
`ACCIDENTS
`]
`How
`What
`much
`were you
`did you
`doing at
`Leak?
`the time?
`(S.M,L)
`
` Regu:‘ai'Gs'ass
`Sample
`
`6-9am —flZ
`9-W00"— 1
`12-3 pm
`
`mi,’/h'r:giJ{1'dog
`
`
`
`3-6 pm
`
`6-9 pm
`9-12 mid
`
`
`
`123 am — Z
`3-6 am
`Yes No
`
`Day
`
`Date:
`
`S=Sma|| M=Medium L=Large
`
`" Toviaz‘
`fesoterodine furnarale
`llbllldld Nbmmmo-gun-q
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 30
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 30
`
`

`
`Conclusion
`
`- Toviaz 8mg has proven superiority VS. Detrol LA
`
`4rng in reducing urge urinary incontinence
`
`- This campaign aims to show how Toviaz is the
`
`preferred treatment option for overactive bladder
`
`and allows patients to enjoy life’s activities Without
`
`being hindered by the need to go.
`
`With Toviaz, Don't Let Overactive
`
`Bladder Stop You In Your Tracks...
`' Toviaz‘
`fesoterodtne fumaiate
`nun!!! ivluu PJIIHI Uhq IIC I-I:
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 31
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 31
`
`

`
`Works Cited
`
`"Aging Statistics." Administration on Aging. Department of Health and Human Services, 1 Sept.
`
`2001. Web. 15 Apr. 2013. <http://WWW.aoa.govKAging_Statistics/>.
`
`"Evaluating Prescription Drugs Used to Treat: Overactive Bladder Comparing Effectiveness, Safety,
`
`and Price." Health.-org. Consumer Reports, n.d. Web.
`
`<bttp:Uwww.consurnerreportsaorg/bealtb/resources./pdf/best—buy— drugs/Overactix.-'e_Blad(ler—
`
`FlNAL.pdf:~.
`
`"Global Overactive Bladder (OABJ Therapeutics Market to Exceed $4.0 Billion by 2017, According to
`
`a New Report by Global Industry Analysts, inc." PRWeb. N.p., n.d. Web. 21 Apr, 2013.
`
`<:bttp:f/wwwprweb.corn/releases/overactive_bladder./O AB_tl'1erapeuticsXprweb858524I .htrn>.
`
`Leonhauser, Melissa. "Overactive Bladder Market: Managing the Future." PM36(JOr1lir1e. IMS Health,
`
`Apr. 2012. Web. 15 Apr. 2013.
`
`<l1ttp:f/WWW.irnshealth.cornKirns/GlobaUCor1tent/Corporate/Press%20Roorn/lMS%20in%20the%2O
`
`NewsXDo-:umentsXOveractive_Bladder_l\/larket1.pdt'>.
`
`"Overactive Bladder Treatment & Management." Medscape Reference. N.p., n.d. Web. 18 Apr. 2013.
`
`<l1ttp:./Xen‘1eclicine.n‘1edscape.con‘1/article/459340—treatInent:>.
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 32
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 32
`
`

`
`Works Cited Continued
`
`Pfizer For Professionals. Pfizer, n.d. Web. 21 Apr. 2013.
`
`<http://Wwwtpfizerpro.com/hcp/toviaz/efficac)[>.
`
`"Superiority." Pfizer for Professionals. Pfizer, n.d. Web. 21 Apr. 2013.
`
`<http://WWw.pfizerpro.Com/hcpftoviazfsuperiority>.
`
`"The OAB Therapeutics Market Is Forecast to Decline up to 2019." ASDReports.
`
`N.p., n.d. Web. 2 Apr. 2013. <11ttps://Wwwasdreports.com/news.asp?pr_id=255>.
`
`"Therapeutic Class ReviewSM Urology: Overactive Bladder — Fesoterodine
`
`(ToViaz®)." ReGenceRx Pharmacy Benefit Management, Apr. 2009. Web.
`
`<http://www.1"egen cerx.com/docs/physicianRx/ urology—toviaz—O4—2009.p df>.
`
`"TOVIAZ 4 Mg Prolonged—release Tablets 8: TOVIAZ 8 Mg Prolonged—release
`
`Tablets." EMC. N.p., 19 Oct. 2012. Web. 10 Apr. 2013.
`
`<http://www.rnedicir1es.org.uk/emc/medicine/20928/SPC/TOVlAZ+4+rI1g+prolo11
`
`ged—re1ease+tab1ets+%26+TOVIAZ+8+mg+prolonged—
`
`release+tablets/#CLlNICAL_PARTS>.
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. — Exhibit 1035 — Page 33
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1035 - Page 33