`Ler161:t.ot
`ttl~t~il·······
`tm1nu1es>
`
`...............................
`
`... ........ .................. .
`
`'tJ ~~ir111119
`<iiiith~ii••
`
`·.·.·.· .. ·.·.·.··.·.·.· .. ·.·.·.··.·.·.· .. ·.· .. ··.·.·.· .. ·.·.·.··.·.·.· .. ··.·.··.·.·.· .. ·.·.·.··.·.·.· .. ·.·.·.··.·.·.·.
`
`t till ~jirninD$ t t
`/ (~k~Pf MP~!~~rnfr~g\\
`II ij9Ql~t61rl••v@i)}I
`
`7o/c
`
`=
`
`:
`
`=
`
`j
`
`}ff•• f !R~nf if
`I RiUit,qriitUi
`I i)••?tv~~~Ji It
`
`3.0
`
`.
`I
`
`2 ,4PCP
`!
`L
`!~i
`I
`... ........ ........ ........ ........ ........ ... .
`···.·.······· .. ·······.·. ·····.·.·.· ·····.··· ···.·····
`;
`
`<••miscussions u
`···········~····P,i!ii.ii••····••·•
`~! 48% Personal office
`II
`! 24% Lunch/Break room L ........................................ •:<-. __ ____ ____ ____ __ __ _ . ,
`I 16% Hallway
`: f !15% Formulary update
`j
`~! 40% Lunch/Break room!!
`!25% New needles
`I 28% Hallway
`I
`16%
`70%
`7 .8
`1.9
`113% Less variability
`·
`\ 20% Personal office
`\ 13% Dosing / Titration
`==rnm· .. ····· .. ········· .. ····· .. ··· ............... · ............................................. · .............................................. · ............................................................... · ........................................... · ............................................................ .
`L
`)
`)
`i\ 30% Lunch/Break room \
`\38% New long-acting
`i
`: : . .:.::.: :.::.:. ,:.:.:.: : .. :,: .. :,:,:,: :.:.:.:. :.:.:.::.:.:.: ,:,:,:.: :,:.: .. ~
`:
`product out soon
`:::::::::::::•a·· AOI •.•. •.•.•.•.•.•.•.•.•.•.•.•.•.•.•·•·•••·•••·•••·••)• 23°1/o Hallway
`::<<>><:.: .ft\/()
`U I d 21% Personal office
`l13% Formulary update
`j ................................ ······· 1 32% Hallway
`jso% Lily interested in
`
`.·.· .. ··.·.·.· .. ·.·.·.··.·.·.· .. ··.·.··.·.·.· .. ·.·.·.··.·.·.· .. ·.·.·.··.·.·.· .. ·.·.··
`:-:-::--:-:-:-::-:.:-:--:-:-:-::--:-:--:-:-:-::-:-:-:-.:-:-:-::-:-:-:.-:-:-:-::-:-:--
`
`..........................................
`
`72%
`
`.
`~
`
`7.1
`
`8.6
`
`9 .4
`
`,
`;
`
`2.6
`
`1.8
`
`4.7
`
`.
`.
`l
`t !
`! H ij,~
`I
`F •• ••••• •••••••• •••••••• •••••••• ••• •••• H
`r :.: . .::.:c.:,.:,·.:.::.:.:.:..::.:.:::.:.:..:.:.:.:·.:.:.:..:.:.:.:.:.:.: . .:.:.:;
`
`50%
`
`45%
`
`66%
`
`! 29% Personal office
`!
`I 25% Lunch/Break room I
`; 34% Hallway
`;
`! 24% Personal office
`I 21 % Lunch/Break room I
`~ 34% Personal office
`~
`! 31 % Hallway
`!
`\ 17% Lunch/Break room \
`
`:
`
`:
`
`New Learnings percentages not mutually exclusive. Other footnotes shown in appendix
`
`CONYlUJ<.;N'l'lAL
`
`19%
`
`7%
`
`17%
`
`inhaled insulin
`!SO% Education opport.
`lso% Starter Kit/
`
`Coupons
`!SO% Pen device
`~40% Formulary update
`!20% Vouchers
`\20% Indication update
`
`:
`
`Yellow shading indicates category leader
`111
`
`SANOFl3 90330917
`
`PTX-0739.0111
`Sanofi Exhibit 2146.111
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Resources Sales Rep Used in Last Discussion: Total
`
`% of Physicians 0%
`
`20%
`
`40%
`
`60%
`
`80%
`
`100%
`
`Detail piece
`
`Clinical reprint
`
`>4- [ID
`
`Hand-held/ Electronic media
`
`::~_:![>@
`
`Clinical speaker
`
`Educational video
`
`Medical information request ., ....
`
`Patient education materials
`
`. ◊ G >·$>
`
`Package insert
`
`l>♦MP<>
`
`Non-product related material {value-added) ¾ti
`
`Patient starter kit
`
`Sample box
`
`Did not use any materials
`
`..... L
`
`!llllllantus .J Humalog Mix * Januvia ◊ Levemir ❖ Novolog 70/30
`
`;;. Byetta
`
`Source: COMPASS Sales Force Tracking Study
`Note: Data are weighted by reach. L=Statistically different at 95% between Lantus and other products. TRK6: During the last
`detail for [Product] what did the sales rep use to aid the discussion?
`
`CONYlUJ<.;N'l'lAL
`
`Levemir
`Byetta
`Hum Mix
`Nov 70/30
`Januvia
`
`118
`103
`105 12
`104
`
`SANOFl3 90330918
`
`PTX-0739.0112
`Sanofi Exhibit 2146.112
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Activities Sales Rep Performed During Last Discussion: Total
`
`% of Physicians 0%
`
`20%
`
`40%
`
`60%
`
`80%
`
`100%
`
`Left samples
`
`Identified patients appropriate for therapy
`
`Discussed treatment procedures and guidelines
`
`Invited you to a promotional program
`
`I> D<~f,
`
`Followed up with further product information
`
`·· ··· ···· )>-8
`
`Specifically asked me to prescribe this product
`
`.. L
`
`®
`
`lilll Lantus .A Humalog Mix @ Januvia ◊ Levemir ❖ Novo log 70/30
`
`, Byetta
`
`Source: COMPASS Sales Force Tracking Study
`Note: Data are weighted by reach. L=Statistically different at 95% between Lantus and other products. SFACT3: During the
`most recent detai for [Product], which of the following activities did the representative do?
`
`CONYlUJ<.;N'l'lAL
`
`Levemir
`Byetta
`Hum Mix
`Nov 70/30
`Januvia
`
`118
`103
`105 13
`104
`
`SANOFl3 90330919
`
`PTX-0739.0113
`Sanofi Exhibit 2146.113
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`.·.· ............................... ....... ·.··.·.·.· .. ·.·.·.·.·.·.· .. ·.·.·.··.·.·· .. ·.·.·.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·: ..
`
`.............. ....... ........ ............................... ........ ........ ........................ ....... ........ ............................... ........ ....... ........................ ....... ........ ................................ ........ ....... ........................ ....... ........ ................................ ........ ....... ...................... .
`
`.............. ....... ........ ............................... ........ ........ ........................ ....... ........ ............................... ........ ....... ........................ ....... ........ ................................ ........ ....... ........................ ....... ........ ................................ ....... .
`
`Physicians Specifically Asked to Prescribe: by Specialty
`
`100%
`
`80%
`
`VI
`
`C ca ·u so%
`i ..s:::
`0.
`0 40%
`'$.
`
`20%
`
`Trend break due to
`
`100%
`
`80°k
`
`60%
`
`20%
`
`64o/o
`55o/o
`,52%
`49%
`47%
`
`Trend break due to
`survey change
`Endos
`\ /----
`........................................................... ················································y··············;
`
`69%
`
`·······:
`
`480/4,
`460/4
`43%
`42%
`35%
`31%
`
`0%-'----'-----'----'----'----L.---L---'----'
`Jan-
`Jun-
`Aug-
`Jan-
`May-
`Mar-
`Sep-
`Nov-
`Apr ·os Jul •05 Oct '05 Dec '05 Apr '06 Jul '06 Apr '07 Oct '07
`
`0% ......_ __ _._ __ _._ __ _._ __ __,__ __ _. ___ ....._ __ .__ _ __,
`
`Sep-
`Mar-
`May-
`Jan-
`Nov-
`Aug-
`Jun-
`Jan-
`Apr '05 Jul ·os Oct '05 Dec '05 Apr '06 Jul '06 Apr '07 Oct '07
`
`~ Lantus
`.. ,.,.,.,.,.,,,., .. ,., .. Byetta
`
`~Levemir
`««<&= Ja nuvi a
`
`~ Novo Nordisk
`.,.,.,l;:-•:•>:• Humalog 75/25 or 50/50
`~ NovoLog 70/30
`
`Source: COMPASS Sales Force Tracking Study
`Note: Data are weighted by reach. Dotted red line Indicates trend break due to survey revisions for Sep-Oct '07. Green line
`formerly Eli Lilly Insulins. Not statistically different at between specialties. Statistical testing between product shown in
`appendix. Statistical testing not performed between Mar-Apr '07 and Sep-Oct '07 due surey revisions in Sep-Oct '07. LAN8:
`During your last visit from your [company] sales representative for [product]. did the representative specifically ask you to
`prescribe the product?
`
`Lantus
`Levemir
`Betta
`Hum Mix
`Nov 70/30
`Januvia
`
`76
`76
`75
`75
`76
`75
`
`50
`50
`43
`28
`29 14
`29
`
`SANOFl3 90330920
`
`CONJ<'lUJ<.;N'l'lAL
`
`PTX-0739.0114
`Sanofi Exhibit 2146.114
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Introduction
`•
`♦ Key Findings
`• Awareness and Trial
`♦ Special Topics
`• Product Perceptions
`♦ Product Usage
`♦ Sales Force
`- Messaging
`- Resources & Activities
`
`♦ Appendix
`
`CONYlUJ<.;N'l'lAL
`
`115
`
`SANOFl3 90330921
`
`PTX-0739.0115
`Sanofi Exhibit 2146.115
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Best in Class Diabetes Sales Force: by Specialty
`Endos
`PCPs ·············································································100%
`
`80%
`
`60%
`
`100%
`
`80%
`
`U)
`C
`.!!! 60%
`(.) -~
`.c
`~40%
`0
`?F-
`
`20%
`
`Jan-Apr Jun..Jul Aug-Oct Nov-Dec Jan-Apr May-Jul Mar-Apr Sep-Oct
`Jan-Apr Jun..Jul Aug-Oct Nov-Dec Jan-Apr May..Jul Mar-Apr Sep-Oct
`'05
`'05
`'05
`'05
`'06
`'06
`'07
`'07
`'05
`'05
`'05
`'05
`'06
`'06
`'07
`'07
`, - - - - - - - - - - - - - - - - - - - - - - - ,
`....... ·,;;.•:•:••Eli Lilly
`-C-Novo Nordisk
`,,,....,. sa nofi-a ve ntis
`.w.-,,,,,,, .. w, Amyl in
`=4:=·Merck
`Pfizer
`
`Sales Force Relative Ratings
`(best in class= 100%)
`
`PCP
`
`Endo
`
`.. ,,,.,s-a
`
`._s-a U
`
`Source: COMPASS Sales Force Tracking Study
`Note: Data are weighted by reach. Statistical testing between companies shown in appendix. s-a = statistically different at 95%
`between sanofi-aventis and other companies as noted. VL2: In this exercise, we would like to understand you overall impression
`of the sales force for each company that details you for diabetes products. Considering these companies, which one would you
`define as the "best" in terms of meeting your needs?
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330922
`
`PTX-0739.0116
`Sanofi Exhibit 2146.116
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Introduction
`•
`♦ Key Findings
`• Awareness and Trial
`♦ Special Topics
`• Product Perceptions
`♦ Product Usage
`♦ Sales Force
`♦ A
`
`-
`-
`
`Appendix 2: Additional Sales Force Slides
`Appendix 3: Stat Testing Appendix & New Question List
`
`CONYlUJ<.;N'l'lAL
`
`117
`
`SANOFl3 90330923
`
`PTX-0739.0117
`Sanofi Exhibit 2146.117
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Delivery Method of Insulins to Type 2 Patients: by Specialty
`
`PCPs
`
`Endos
`
`80% ·
`
`60% ·
`
`40%
`
`20% ·
`
`0%
`
`51%
`
`48%
`
`2,4
`
`m Inhaler (4)
`□ Vial/ Syringe (3)
`!ill Pump (2)
`111111 Pen (1)
`
`Mar-Apr '07
`
`Sep-Oct '07
`
`J!}
`C
`(I)
`i
`
`a. -
`
`0
`~ 0
`
`80%
`
`60%
`
`40%
`
`20%
`
`0%
`
`40%
`
`36%
`
`2.,.4··
`
`Mar-Apr '07
`
`Sep-Oct '07
`
`J!}
`C
`(I)
`
`i a. -0
`
`~ 0
`
`CONYlUJ<.;N'l'lAL
`
`Source COMPASS Physician ATU Tracking Study
`Note; Data are weighted by physician population and patient base. INS3: Please consider your Type 2 diabetes patients using
`insulin. What percent did you personally initiate with each of the following methods of delivery?
`
`~-.',/~ ~a~ •=~•w
`125
`PCP
`76 18
`Endo
`
`SANOFl3 90330924
`
`PTX-0739.0118
`Sanofi Exhibit 2146.118
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`HbA1 c Goals & Achievement: by Specialty
`
`HbA1c Goal for Type 2 Patients
`
`10
`
`9
`
`% of Patients Who Have
`Achieved This HbA1c Goal
`100% . . . . . - - - - - - - - - - - - - - - - - - - - - - ,
`
`8
`
`ADA
`TARGET
`~ 7
`
`- ~ ~
`:::' AACE 6
`_i TARGET 5
`c.>
`.....
`<(
`.0
`J:
`
`4
`
`3
`
`2
`
`1
`
`0
`
`CONJ<'lUJ<.;N'l'lAL
`
`6.6
`
`6.6
`
`......... ,,. fjw'}"w,, ~j
`
`_L.
`
`........ ::: .... :::::y:::::: .....
`
`ti) -C:
`CII i Q. -0
`
`80%
`
`60%
`
`40%
`
`20%
`
`... 57%
`
`PCP
`
`Endo
`
`PCP
`
`Endo
`
`0%-+----
`
`Source COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. HBA1: Please consider your Type 2 patients. What is your HbA 1 c goal, on average,
`for these patients? HBA2 What percentage of your Type 2 patients have achieved this HbA 1 c goal?
`
`SANOFl3 90330925
`
`PTX-0739.0119
`Sanofi Exhibit 2146.119
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`.·.· ............................... ....... ·.··.·.·.· .. ·.·.·.·.·.·.· .. ·.·.·.··.·.·· .. ·.·.·.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·: ..
`
`............. ....... ........ ............................... ........ ........ ........................ ....... ........ ............................... ........ ....... ........................ ....... ........ ................................ ........ ....... ............... .
`
`Cardiovascular Effects of Exogenous Insulin: by Specialty
`PCP
`Endo
`Mean
`
`Causes poor cardiovascular
`outcomes
`
`Has a neutral effect on
`cardiovascular outcomes
`
`Lowers glucose, which
`is cardioprotective
`
`Is cardioprotective
`beyond glucose lowering
`
`710foPCP
`
`28%
`
`Mean
`
`2.0
`
`3.5
`
`5.3
`
`4.4
`
`20%
`0%
`40%
`[I Bottom Box (1-2) [IT] Middle Box (3-5) Ill Top Box (6-7)
`
`!
`
`60%
`
`80o/1./
`/
`
`\ 100%
`
`';
`
`Reasons for Agreement
`(% of those rating 6-7)
`
`................................................ ,
`: Because exogenous insulin ... :
`·
`: 71 % Reduces lipids
`! 68% Reduces inflammation
`I 55% Reduces free fatty acid
`:0% 0!~=~·-···••«•···
`
`Source; COMPASS Physician ATU Tracking Study
`CV1: For each of the statements below, on a scale of 1 to 7, Qlease md1cate how much you agree or disagree with each
`statement (Please select one response for each statement). CV2: Why do you strongly agree that "the use of exogenous
`insulin is cardioprotectlve beyond glucose lowering"" Please select all that apply.
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330926
`
`PTX-0739.0120
`Sanofi Exhibit 2146.120
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`HbA1c Level at Which Insulin Is Introduced
`
`Patients on Two Orals (2)
`...................................................................................................................................................................... .
`
`:;:;·:==.-:; J~ ·········································&:2·i
`
`3 0
`
`""•
`
`Patients on Three Orals (3)
`
`9.5
`
`9.0
`
`8.5
`
`8.0
`
`.....................................................................................................................................................................
`
`9.5
`
`_9.0
`
`~ 0 -a; 8.5
`
`> Q)
`...J
`u 8.0
`~ .c
`:::c 7.5
`
`7.5
`. ADA 7 0
`: TARGET·
`AACE 6.5
`TARGET
`
`7.0
`
`6.5
`
`Jan-
`Apr
`'05
`
`Jun- Aug- Nov-
`Jul
`Oct Dec
`'05
`'05
`'05
`
`Jan- May- Sep- Mar- Sep-
`Apr
`Jul
`Oct Apr Oct
`'07
`'06
`'06
`'06
`'07
`
`Jan-
`Apr
`'05
`
`Jan- May- Sep- Mar- Sep-
`Jun- Aug- Nov-
`Jul
`Oct Dec Apr
`Jul
`Oct Apr Oct
`'05
`'06
`'06
`'05
`'05
`'06
`'07
`'07
`
`Addressing barriers to insulinization and emphasizing Lantus' efficacy at helping
`patients achieve HbA1c goals remains an opportunity for Lantus
`
`-::'
`
`. ,~, , ;:,\. ·I'! ·,: ..... ,i• ;;:· .,,.
`
`:~:::·=;=,;::;-:. ,...;_1;" \. t t;;:(;=;~:::: .::~.
`-~:==-=(•::.:~.
`:~=:•:;=·~•:::.·
`-
`-
`-
`•::; . .,, ..... ,, ....... ,.. Source: COMPASS PhysIc1an ATU Tracking Study
`\,",,cf \~3".' j V j r··,···'f=·«·=\<~J: ,,,;;::J= Note: Data are weighted by physician population LAN2B: For each patient type described below, what level of HbA1 c would compel
`you to introduce insulin into the treatment regimen?
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330927
`
`PTX-0739.0121
`Sanofi Exhibit 2146.121
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Type 2 Patients Treated with Insulin per Month: by Specialty
`
`PCP
`--r----------------------------r-60%
`
`100
`
`Endo
`
`32%
`31%
`30%
`29%
`30%
`·-1>❖•""'········· •••• ·<'··· ....... .. . . ... -.. ·· <,•·❖.-❖,«❖.-,. ,_ ., ··-q,;,-. ··"'··"'··'··'·"""', .. ,;;,",,"·"···"·'·'·· • .-, •.... -,.,':",.·········•.-c-· ., •.. ,,,,,fo
`
`........
`
`33%
`
`33%
`
`80
`
`(/) -C
`cu a. .... 0
`
`<I)
`
`:.:; 60
`
`ll: 40
`
`20
`
`0
`
`Aug-Oct Nov-Dec Jan-Apr May-Jul Sep-Oct Mar-Apr Sep-Oct
`'06
`'06
`'06
`'06
`'06
`'07
`'07
`
`40%
`
`30%
`
`20%
`
`10%
`
`0%
`
`80
`
`60
`
`40
`
`20
`
`0
`
`40%
`
`(I) -C
`30%i
`ca a. ....
`20%~
`
`0
`
`Aug-Oct Nov-Dec Jan-Apr May-Jul Sep-Oct Mar-Apr Sep-Oct
`'05
`'05
`'06
`'06
`'06
`'07
`'07
`
`10%
`
`0%
`
`m # of Type 2 patients on insulin
`
`,.-.,-:_:p- % of Type 2 patients on insulin
`
`Source COMPASS Physidan ATU Tracking Study
`Note: Data are weighted by physician population. BS2A: In the past month, how many total patients did you treat for each of the following
`conditions? (If the past month was not a typical month, please answer based on a "typical month"). TP1A: In the past month, what percent
`of your Type 2 diabetes patients did you treat with the following? Please consider a fixed combination oral pill as one therapy.
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330928
`
`PTX-0739.0122
`Sanofi Exhibit 2146.122
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Aided Therapy Experience: Total
`
`100%
`
`80%
`
`60%
`
`40%
`
`.... u
`::J
`"C
`0 ....
`c..
`.... 0
`I!
`"' ;:
`"' en
`"' ·o
`en
`>,
`.c: a. .... 0
`
`C:
`
`~ 0
`
`20%
`
`0%
`
`W1'07 W2'07
`Lantus +
`Orals
`
`W1'07 W2'07
`Lantus
`Intensive
`
`W1'07 W2'07
`Levemir+
`Orals
`
`W1'07 W2'07
`Levemir
`Intensive
`
`W1'07 W2'07
`Premix BID
`
`W1'07 W2'07
`Byetta +
`Insulin
`
`W1'07 W2'07
`Byetta +
`Orals
`
`rn Never Tried
`□ Tried but Discontinued
`11111 Currently Use
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. Stat testing across products for current wave shown in appendix. TP11: Please
`indicate your experience with each of the following therapies by checking the appropriate box for each therapy listed below.
`
`LEV
`PRE
`BYT
`
`201 23
`200
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330929
`
`PTX-0739.0123
`Sanofi Exhibit 2146.123
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Therapies for Treatment of Type 2 Patients: Total
`
`11111 Orals+ Byetta + Insulin
`□ Insulin+ Byetta
`m Ora Is+ Byetta
`□ Insulin only
`11!1 Orals+ insulin
`m 3 orals only
`□ 2 orals only
`rn Mono oral therapy only
`111111 No medication (diet and exercise only)
`
`24%
`
`25%
`
`27%
`
`23%
`
`22%
`
`21%
`
`51%
`
`II> 60% -C:
`.... 0
`
`a>
`:;:
`cu
`CL
`
`40%
`
`~ 0
`
`20%
`
`0%
`
`Nov-Dec '05 Jan-Apr '06 May..Jul '06 Sep-Oct '06 Mar-Apr '07 Sep-Oct '07
`
`Source COMPASS Physician ATU Tracking Study
`Note: Data are weighted by patient base and physician population. TP1A: In the past month, what percent of your Type 2 diabetes
`patients did you treat with the following types of therapy?
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330930
`
`PTX-0739.0124
`Sanofi Exhibit 2146.124
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`PCP
`
`100%
`
`80% ·
`
`Ill
`+-'
`C:
`Q.)
`:i:;
`
`ri:J a. .... 0
`
`'#,
`
`60%
`
`40%
`
`20% ·
`
`100%
`
`80%
`
`60%
`
`40%
`
`20%
`
`:;:;:;e;c;:;:";""
`
`·.,· ... ¥._;_,_,·, .. :,,.,.·.· .. ·.•··.
`
`1- W//.
`........ ~ ....... , ............... ~{\/ ..
`~
`~
`... -·-
`·--
`,J)Ltl
`.......... ::'Tl ..
`.ft
`K
`
`1.l:!··_··_
`
`-
`
`Lantus Usage for Type 2 Patients: by Specialty
`
`Endo
`
`0%
`
`Aug-Oct Nov-Dec Jan-Apr May-Jul Sep-Oct Mar-Apr Sep-Oct
`·os
`•05
`•05
`'06
`·06
`·01
`·01
`
`Aug-Oct Nov-Dec Jan-Apr May-Jul Sep-Oct Mar-Apr Sep-Oct
`'05
`'05
`'06
`'06
`'06
`'07
`'07
`
`rn Lantus + Byetta
`11!11 Lantus + inhaled insulin
`11!11 Lantus + insulins
`□ Lantus + orals+ insulins
`rn Lantus + orals
`111111 Lantus monotherapy
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by patient base and physician population. Statistical testing beDNeen therapies shown in appendix. LAN48:
`Please think about all of the times that you have used Lantus with Type 2 patients. What percentage of the time would you say that
`you use the following?
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330931
`
`PTX-0739.0125
`Sanofi Exhibit 2146.125
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Sample NRx Share of Basal Insulins (Lantus and Levemir only): by Specialty
`
`3-month NRx Share (Jun -Aug '07)
`
`17%
`
`18%
`
`~
`C'II"
`..r::.
`Ch
`
`~ z
`
`75%
`
`50%
`
`25%
`
`0%+---
`
`Total
`
`PCP
`
`□ Levemir
`1111 Lantus
`
`Endo
`
`CONJ<'lUJ<.;N'l'lAL
`
`Source: COMPASS Physician ATU Tracking Study, IMS Health Confidential Proprietary: Source IMS Health Incorporated Xponent NRx
`share Jun-Aug '07. Data are not weighted, Note: Basal market includes Lantus and Levemir only,
`
`126
`
`SANOFl3 90330932
`
`PTX-0739.0126
`Sanofi Exhibit 2146.126
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`.·.· ............................... ....... ·.··.·.·.· .. ·.·.·.·.·.·.· .. ·.·.·.··.·.·· .. ·.·.·.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·: ..
`
`••••••••••••••••••• 21~tte 21~tin 11a1 timerrame t••••••• t t+••> ///••·······.···
`
`...........................................................................................................................................
`
`Sample Physician Levemir Users and Basal NRx Share: Total
`
`-
`0
`I\
`
`E
`a,
`> a,
`
`~ z -...
`..J .;
`
`~Levemir Share Among Users
`45% ~ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -~ 30%
`
`c::::::::J # Leve mi r Users
`
`40%
`
`35%
`
`30%
`
`25%
`
`20%
`
`15%
`
`10%
`
`5%
`
`25%
`
`20%
`
`15%
`
`10%
`
`5%
`
`0%
`
`CD
`QI
`U)
`~
`z
`;:a
`><
`t/1
`:::;
`QI
`cil
`QI
`3
`0
`:::::5
`(0
`r-
`CD
`
`< CD ~-.,
`
`C:
`U)
`CD
`al
`
`Sep '06 Oct '06 Nov '06 Dec '06
`
`Jan '07 Feb '07 Mar '07 Apr '07 May '07 Jun '07
`
`Jul '07 Aug '07
`
`Source: Lantus COMPASS Physician ATU Tracking Study, IMS Lantus NRx Data Jun-Aug '07
`
`CONYlUJ<.;N'l'lAL
`
`127
`
`SANOFl3 90330933
`
`PTX-0739.0127
`Sanofi Exhibit 2146.127
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`.·.· ............................... ....... ·.··.·.·.· .. ·.·.·.·.·.·.· .. ·.·.·.··.·.·· .. ·.·.·.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·: ..
`
`.............. ....... ........ ............................... ........ ........ ........................ ....... ........ ............................... ........ ....... ........................ ....... ........ ................................ ........ ....... ........................ ....... ........ ................................ ........ ....... ...................... .
`
`. ·.··.·:.·.·.·.·:·.·: ... ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.··· .............................................................................. .
`
`..........................................................................................................................................................................
`
`••••••••••• ••••••••••••••11•1•111•1•1•s•••••1••••n•111•g•11•••111•••11•1•~•1••••••1•11•1•1•~11••••••••••••••••••••••••••••••••••••••••••••••••••••••·•·•··•·•·•·••···············································
`~~:~~l::~L~AfM.iE~~:~: ~:!!
`Attribute Stated Importance Means: Total
`::::: :,:::.w.:tw.t:::::: :,:
`
`Glucose control (HbA1c levels <7)
`High degree of long-term patient compliance
`Provides 24-hour glucose control
`Is well tolerated in a majority of patients
`Controls patients no longer controlled on orals
`l ...........
`Low incidence of nocturnal hypoglycemia
`Achieving target fasting glucose control
`Low incidence of symptomatic hypoglycemia
`Easy to titrate
`Effective in lowering post-prandial glucose
`Low insulin release variability (individual patient)
`Mimics normal basal insulin release
`Provides once daily dosing
`Provides 24-hour control with one daily injection
`Has no unwanted peak
`Appropriate for first-time insulin users
`Promotes weight loss
`Low degree of weight gain
`Weight-neutral effect
`Preserves beta-cells/slows disease progression
`
`I:•:•:•:•:•:•:
`
`IL
`......
`
`1••··········
`
`..
`
`••·•·•
`·.·.·.
`
`. .
`
`••:•:•:•
`
`••·•·•·•
`
`................ :·::::::-:·:·:·:·::·:·:·:-:·:·:
`
`..........
`
`:
`
`:
`
`.
`
`•
`
`:
`
`••·•·•
`·.·.· .........
`
`6.0
`6.0
`5.9
`5.9
`5.9
`5.8
`5.8
`5.8
`5.8
`5.8
`5.8
`5.7
`5.7
`5.7
`5.7
`.. •:•:•::::•: 5.6
`5.6
`5.6
`5.5
`5.5 '1t5.8
`
`••:•:•:•
`
`••·•·•·•
`
`CONYlUJ<.;N'l'lAL
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`Source: COMPASS Physician Study
`Note: Data are weighted by physician population. PR3A: For each of the factors listed below, please indicate how important each
`factor is in your selection of a particular diabetes product for Type 2 patients.
`
`128
`
`SANOFl3 90330934
`
`PTX-0739.0128
`Sanofi Exhibit 2146.128
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Far
`Superior
`7 . . . - - - - - - - - - - - - - - - - - - - , - - - - - - - - - - - - - - - , - - - - - - - - - - - - - - - - - - , - - - - - - - - - - - - - - - - ,
`
`Safety Attributes: Performance vs. 12 Month Range: Total
`
`Ll,,LV, P, B
`L, LI, LV, J ~ '
`
`L, LI, Lv, P, B, J
`L, LI, Lv, P ~
`
`:
`
`....... XLl;P
`
`ll,I, p
`I I
`
`1,2,3,4,5
`
`J.,2,3,4@
`-.::;:.
`
`,u, pl,=,=.=,=.=,.. 1Ll,P
`!
`
`LI, P, B
`
`LI, P, B
`
`....
`
`I X
`
`L, Ll,.Lv, P, B
`$
`
`i LI, p
`. ................... Xu, p
`
`I !LI
`
`6
`
`5
`
`i
`
`Cl)
`(,)
`
`C: cu
`E 4
`.g
`Cl) a.
`
`3
`
`2
`
`1
`Far
`Inferior
`
`=~-==-·/'..;::~??r~~mssf,,,,r="""'====~======
`. . . . . . . ae.br.~as~lc~~tu$. ,;~M;.;;e;ti6(ls ma, be aug to~
`i i ...
`Mt. mhe.revi~edfohl!)a.t &tttie. svt¥~v whitH e.n.~outa.ge.s /
`==·=·=·=·•••••••••••w~~~=r~;~~T:~~~':~~··•~~···~·1
`··•·•·lZ~· T~~ij9att1P~ Bf ~~o~v,~ t9 to~ ~~tv~?~ ~hi~b ~~ ~tf HJ H
`~~~~···~~~~~::·•·~~~~~·~·~~·~~···•·•··
`J I §tlm!iijlJ.P.b.~t'.@Dt jivi(U~sti!!l ~ffifl:ij itt!iP:9J@~ I t
`
`,·,•,•,•, .. ,•,•,•,,•,•,•,·•,•,•,•,:,.,•,•,••,•,•'•,:,.,•,•,••N,•,:,.,•,•,••,·,•,•,:,.,•,•,••,•,•,•,::•,•,•, .. .._.N,•,•,•,••,•,•,•,·,•,•,•,••,•,:,.,·,•,::,,••,•,•,•,·,••,•,••·•,•,•,·,•,•,•, .. ,•,•,•,,•,•,•,:•,•,•,•,:,.,•,•,••,•,•'•,:,.,•,•,••N,•,:,.,•••••••••·••
`
`Is well tolerated in a
`majority of patients
`
`High degree of long-term
`patient compliance
`
`Low incidence of
`symptomatic
`hypoglycemia
`
`Low incidence of
`nocturnal
`hypoglycemia
`
`Im Lantus + Orals (L) ED Lantus Intensive (LI) X Levemir + Orals (Lv) 'tl- Premix BID (P) .;'} Byetta + Orals (B) ® Januvia (J) I
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. PR3B: On a scale of 1 to 7, please rate how well you feel each therapy performs on
`these attributes/functions for Type 2 patients. Please consider all other therapies that you currently use with your Type 2 diabetes
`patients (not only the therapies listed below). Not all attributes applicable for all therapies.
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330935
`
`PTX-0739.0129
`Sanofi Exhibit 2146.129
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Far
`Superior
`?~----------------------------------------------------~
`
`Dosing Attributes: Performance vs. 12 Month Range: Total
`
`6
`
`5
`
`Cl)
`(,)
`C:
`cu
`E 4
`.g
`Cl) a.
`
`3
`
`2
`
`1
`Far
`Inferior
`
`Lv P;
`'
`l
`
`L
`
`Lv,:P +·
`Lv,P
`1111
`
`p
`
`IT]
`
`Lv, P
`
`!
`
`i LI, p
`,...., LI, p
`~PX
`
`! . .
`
`LI, Lv, P
`II
`
`TP
`E}
`
`LI, p z
`
`.............. f.
`
`Easy to titrate
`
`Provides once
`daily dosing
`
`Mimics normal basal
`insulin release
`
`Low variability in
`insulin release from
`day to day in an
`individual patient
`
`Appropriate for
`first-time insulin
`users
`
`Has no
`unwanted peak
`
`Im Lantus + Orals (L) ED Lantus Intensive (LI) X Levemir + Orals (Lv) 'tl- Premix BID (P) .;'} Byetta + Orals (B) ® Januvia (J) I
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. PR3B: On a scale of 1 to 7, please rate how well you feel each therapy performs on
`these attributes/functions for Type 2 patients. Please consider all other therapies that you currently use with your Type 2 diabetes
`patients (not only the therapies listed below). Not all attributes applicable for all therapies.
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330936
`
`PTX-0739.0130
`Sanofi Exhibit 2146.130
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`.·.· ............................... ....... ·.··.·.·.· .. ·.·.·.·.·.·.· .. ·.·.·.··.·.·· .. ·.·.·.··.·:.· .. ·:.·.··::.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.·.·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.·.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·:: .. ·.· .. ··.·:.· .. ·.·.·.··.·:.· .. ··.·.··::.·.:.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:· .. ·.·:.··.·:.· .. ·:.·.··.:.· .. ·.·.·.··.·:.· .. ·.·.·.··.·:.· .. ·.·.·:·.·: ..
`
`............. ....... ........ ............................... ........ ........ ........................ ....... ........ ............................... ........ ....... .............. .
`
`••••••••••• •••••••••••••••11111•1•••11,1•••••t•n•1•••••••■tll'll•l+Mleftl•~•••11111•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••··•·•······································· .
`Weight Attributes: Performance vs. 12 Month Range: Total
`
`Far
`Superior
`7 - . - - - - - - - - - - - - - - - - - - - , - - - - - - - - - - - - - - - - - - -~ - - - - - - - - - - - - - - - - ,
`
`,..;.;:,, L, Lv, P, J
`
`•
`
`··· ···· ········ ········ ····· L; LV)P
`
`!
`
`. ,Ll,P I IL, LI, p
`
`....
`
`T L, LI, Lv, P, J
`'=::·;::.i
`
`m:
`
`L, Ll,,LV, P
`i
`
`L, Lv, P,J
`~ L, Lv, P
`a;
`
`1:
`
`6
`
`5
`
`Cl)
`(,)
`C:
`cu
`E 4
`.g
`Cl) a.
`
`3
`
`2
`
`f
`
`1~ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -~
`Promotes weight loss
`Low degree of weight gain
`Weight-neutral effect
`Far
`Inferior
`
`Im Lantus + Orals (L) ED Lantus Intensive (LI) X Levemir + Orals (Lv) 'tl- Premix BID (P) .;'} Byetta + Orals (B) ® Januvia (J) I
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. PR3B: On a scale of 1 to 7, please rate how well you feel each therapy performs on
`these attributes/functions for Type 2 patients. Please consider all other therapies that you currently use with your Type 2 diabetes
`patients (not only the therapies listed below). Not all attributes applicable for all therapies.
`
`CONYlUJ<.;N'l'lAL
`
`SANOFl3 90330937
`
`PTX-0739.0131
`Sanofi Exhibit 2146.131
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`Lantus vs. Competitors Performance Ratings - Selected Attributes: Total
`
`Lantus
`Advantage
`
`Glucose control, as defined by HbA 1 c levels <7
`1.75
`................................................................................................................................ .
`
`1.50
`
`1.25
`
`0.50
`
`0.25
`
`-0.25
`
`Lantus
`Disadvantage
`
`CONYlUJ<.;N'l'lAL
`
`1.75
`
`1.50
`
`1.25
`
`1.00
`
`0.75
`
`0.50
`
`0.25
`
`-0.25
`
`Effective at achieving
`target fasting glucose control
`
`L
`
`Jan- Jun- Aug- Nov- Jan- May- Sep- Mar- Sep-
`Apr
`Jul Oct Dec Apr
`Jul Oct Apr Oct
`'05
`'05
`'05
`'05
`'06
`'06
`'06
`'07
`'07
`
`·:~ ..... '.~······~····················
`
`·l::e'·.
`
`L
`
`............................................................................................... ................................................... •
`Jun- Aug- Nov- Jan-
`May- Sep- Mar- Sep-
`Jul Oct Dec Apr
`Jul
`Oct Apr Oct
`'05
`'07
`'05
`'05
`'06
`'06
`'06
`'07
`
`Jan-
`Apr
`'05
`
`❖,❖@,-,.,.,-,-Lantus with Orals versus Premix twice per day
`........ ,, .. ,.,,.·Lantus with Orals versus Byetta with Orals
`~Lantus with Orals versus Levemir with Orals
`
`Source: COMPASS Physician ATU Tracking Study
`Note: Data are weighted by physician population. L = statistically different between Lantus and [Product]. Stat testing performed with
`paired data points, using data only from physicians who answered for both regimens, PR3B: On a scale of 1 to 7, where 1 means
`"Far inferior to all other products" and 7 means "Far superior to all other products," please rate how well you feel each product
`perfo