LAN11--JS So!oSTAR
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`•'",:,1::,rv,,,•~
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`Sanofi et al. v. Merck
`1 :16-cv-812-RGA
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`PTX-0705
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`US Lantus SoloSTAR Launch Book, 2007
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`US Launch Book
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`FOR TNTRRNAT, USR 0,VT,Y
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`1 of 37
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`HIGHLY CONFIDENTIAL
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`SANOFI 00232909
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`PTX-0705.0001
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`Sanofi Exhibit 2145.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`LAN11--JS So!oSTAR
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`1
`2
`3
`4
`
`5
`
`6
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`7
`
`8
`
`5.1
`5 .2
`
`7.1
`7.2
`7.3
`
`8 .1
`8 .2
`8.3
`
`Lantus SoloS TAR is ............................................................................................................... 3
`Vision and strategy ................................................................................................................. 4
`Features ofLantus SoloSTAR ................................................................................................ 6
`Positioning ............................................................................................................................. 8
`4 .1
`SoloS TAR positioning .................................................................................................... 8
`Placing SoloSTAR within the portfolio .......................................................................... 8
`4.2
`Questions and example answers on the pen portfolio: ............................................. 9
`4.2.1
`Pen portfolio positioning ......................................................................................... 9
`4.2.2
`Importance of a portfolio approach .......................................................................... 9
`4.2.3
`Critical success factors in a pen portfolio approach ................................................ 9
`4.2.4
`Targeting SoloSTAR ............................................................................................................ 11
`Patient focus/ targeting ................................................................................................. 11
`Healthcare professional focus / targeting ...................................................................... 12
`CreativeNisual campaign ..................................................................................................... 13
`Logo .............................................................................................................................. 14
`6.1
`Writing "SoloSTAR" or "SoloStar" ...................................................................... 14
`6.1.l
`Lantus SoloS TAR messaging ............................................................................................... 15
`SoloSTARmessaging ................................................................................................... 15
`Core sales aid inclusion pages ....................................................................................... 16
`Lantus SoloSTAR Leave Behind .................................................................................. 17
`Selling approach, Q&As and traps to avoid ......................................................................... 20
`Communicating sales messages about SoloS TAR before showing the actual pen ....... 20
`Preference and superiority versus other pens is not absolute ........................................ 20
`Examples where individual features on other pens may be preferred by some customers
`...................................................................................................................................... W
`Avoid wasting time over-analysing pen comparisons ................................................... 21
`8.4
`8.5
`Objection handler/ Questions and answers .................................................................. 21
`Other traps to avoid ....................................................................................................... 22
`8.6
`Pen demonstration ......................................................................................................... 22
`8.7
`Head to head comparisons .......................................................................................................... 22
`Versus Flex Pen ..................................................................................................................... 22
`Versus Lilly disposable pen ................................................................................................... 23
`Important things to know ....................................................................................................... 24
`Publications .......................................................................................................................... 25
`Haak et al ...................................................................................................................... 25
`9.1
`9 .1. l
`Patients and methods ............................................................................................. 25
`Usability assessment .............................................................................................. 26
`9 .1.2
`Preference assessment.. .......................................................................................... 26
`9 .1. 3
`9.2
`Clarke, SpolleL
`............................................ 27
`9.2. l
`Design process/ thoroughness ............................................................................... 27
`Dose accuracy ........................................................................................................ 27
`9.2.2
`9.2.3
`Ii~ection force comparison data ............................................................................. 28
`9.2.4
`Expert opinion ...................................................................................................... 29
`l O Training and materials .......................................................................................................... 30
`10.1
`HCP Leave Behind ........................................................................................................ 31
`10.2 Quick reference guide ................................................................................................... 31
`10.3
`Consumer Material..
`............................................ 32
`10.4
`Launch Training for Sales Professionals ....................................................................... 34
`11 Needle compatibility ............................................................................................................. 35
`11.1 Needle card .................................................................................................................... 36
`12 Waste disposal / environmental impact statement ............................................................... 37
`
`9
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`US Launch Book
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`Sanofi Exhibit 2145.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`LAN11--JS So!oSTAR
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`1 Lantus SoloSTAR is
`• The new disposable pen for Lantus
`• The product of over 5 years of design, development and industrialization
`• An easy to use device, with every feature optimised through interviews and testing
`with over 1,000 doctors and nurses and over 2,000 patients
`
`SoloST AR offers the best combination of user-preferred features available on the market
`( currently this is only supported by data versus FlexPen and Lillypen).
`
`<••• <<>< c > insulin glargine {rDNA origin) injection
`100 units/ml (U-100)
`1==,==1======:1=======1:=:=:=::1==::==:,■[::,:■[':':,,:■
`,<1!.V!i0N_lllR liliJECTION IN•\ DISP05i\BLE1NSULl~l DEllVERY DEVICE
`Oo Nol MIK with Other Insulins
`h:,: ~:i;J~Y :.:tmrDus tnjt:(iion-Onl)'
`II)[ oi:,',; :r- ~.na:TION IS CllAR AND(OLGR!.ESS WITH NO PMU!UES VISIBLE
`~i~tW,'~~:_n,~!:~~J;~:;opening *Needles not included{see back panel)
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`US Launch Book
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`PTX-0705.0003
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`Sanofi Exhibit 2145.003
`Mylan v. Sanofi
`IPR2018-01676
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`

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`2 Vision and strategy
`
`Lantus vision: Establish Lantus as the cornerstone for achieving AlC goals
`in diabetes patients
`
`Lantus® Strategy
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`PTX-0705.0004
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`Sanofi Exhibit 2145.004
`Mylan v. Sanofi
`IPR2018-01676
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`

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`SoloSTAR is a key lever to help us realize our visions for Lantus
`
`SoloSTAR vision: Establish SoloSTAR as the preferred pen, supporting the
`Lantus & Apidra leadership position in the diabetes market
`
`Lantus® SoloSTAR® Strategy
`
`ci·:i·:·~·················1
`L__j
`
`Opportunities
`Business
`
`Lantus: Capture non(cid:173)
`Lantus insulinised
`T1&T2 patients, and
`new T1 patients
`
`Maximize value of each patient
`
`Timely insulinization
`of uncontrolled OAD
`patients
`(Lanius opportunity)
`
`········································ 1
`
`Establish SoloStar as the preferred disposable pen
`(establish core ease of use plus advantages vs Flexpen/Lillypen)
`
`Strategic
`Levers
`
`:===============================================================~
`
`Use Lantus SoloStar to expand the number of HCPs writing Lantus
`( destroy the 'Flexpen/LiUypen barrier, increase the number of GPs initiating insulin, ... )
`
`Use SoloStar as a key addition to, and lever for, programs supporting capture of
`uncontrolled patients and maximise
`the value of each patient
`(doseoptimisation, screening & initiation, persistence, training, etc.)
`
`Make the 'same, differentiated pen' {SoloStar) a compelling reason to add
`Apidra SoloStarto Lantus SoloStar for adding or switching rapid insulin
`
`Leverage pen portfolio: SoloStar as a part of a portfolio (disposable + reusable
`choice of solutions) for the patient
`Leverage diabetes portfolio: SoloStar as the driver to establish portfolio of
`........................................ ~--------b_e_st_b_a_s_al_. _be_s_t_ra~p_id_, _be_s_t~pe_n_s_, _be_st_se_rv_i_ce_s ________ ~
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`US Launch Book
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`Sanofi Exhibit 2145.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`LAN11--JS So!oSTAR
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`3 Features of Lantus SoloSTAR
`
`Core
`• Easy to use
`• Simple intuitive pen with a minimum of steps
`• Each step and feature optimized
`• Disposable. Disposable pens are easier than reusable pens because of fewer steps
`required to operate ( e.g no cartridge exchange), ease of having spares available, better
`insulin identification (insulin name marked on the outside for SoloS TAR) and keeping
`pens in multiple locations for convenient use on everyday life.
`• Small and discrete
`•
`3 00 units of insulin per pen
`
`Dose setting
`• Dial forward and back (up and down)
`1 unit dose steps
`•
`•
`\1:aximum dose 80 units
`• Easy to dial - low force to tum the dosage selector
`• Ease to read display: large dose numbers, black text on white background for
`maximum contrast and brightness
`• Tactile click feedback for security in setting the dose
`• Audible click feedback for security in setting the dose
`• Physical 'stop' at O and 80 prevents users from dialing outside the limits - stops are
`extremely robust and hard to break
`• Physical 'stop' prevents users from dialing a dose higher than the amount of available
`insulin remaining in the cartridge - this stop is robust and hard to break
`
`injection
`• Shorter dial extension vs FlexPen
`• Easy to push injection:
`o >30% less force than FlexPen
`o >50% less force than Lillypen
`• Low injection force means that the injection can be easily delivered using thumb or
`finger, for added Jlexibility
`• Soft/ smooth injection: low variation in the force needed to press for injecting (versus
`FlexPen and Lillypen), which may help lead to a more secure injection feeling without
`accidental interruption or stop
`• Soft clicking for tactile and audible feedback during the injection stroke
`• The dose display returns to O indicating completion of the injection stroke
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`Sanofi Exhibit 2145.006
`Mylan v. Sanofi
`IPR2018-01676
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`

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`Appearance
`•
`\1:odem design, comfortable everyday non-medical appearance
`• Appealing colors
`
`Insulin identification
`• The only disposable pen with completely different pen color for each insulin
`• Colors are chosen to be both appealing and easy to differentiate, even in dim lighting
`conditions or for people with color blindness
`• The Lantus SoloSTAR and Apidra SoloSTAR (currently under FDA review) also have
`different label shapes and label and print color for added visual cues
`• Raised ring on the Apidra SoloST AR ( currently under FDA review) injection button
`for tactile differentiation from the smooth injection button on the Lantus SoloST AR
`
`Other
`• Accommodates all standard (non-safety) needles under the cap, even up to 12.7mm
`with the inner needle cap on. This allows temporary storage of a used needle in a
`secure place until it can be disposed of safely. US Labelling currently states ONLY
`BD needle tips.
`\1:arkings on cartridge holder to indicate amount of insulin remaining
`
`•
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`Sanofi Exhibit 2145.007
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`4 Positioning
`The injection pens are enablers of insulin treatment and deliver the benefits Lantus and
`Apidra. Adding new disposable pens to the current pen portfolio gives Healthcare
`Professionals (HCPs) and patients a wider choice of options to support Lantus use:
`• Gives HCPs and patients choices to support individual patient needs
`• Facilitates individualisation of therapy by the HCP
`
`For all pens, the positioning includes that the pen is an enabler of the use of Lantus and
`Apidra to achieve treatment targets through the benefits of Lantus and Apidra.
`
`4.1 SoloSTAR positioning
`
`'i
`
`?
`
`•ai~~~;i,::ieve their
`
`. To help all patients with Type 1
`
`JKB
`
`4.2 Placing SoloSTAR within the portfolio
`The promotional effort for pens will focus on Lantus SoloST AR, patient new starts, to
`generate maximum energy and benefit from the launch phase. After the initial launch, pen
`promotion efforts will expand to include a conversion strategy, switching patients over time
`from Lantus OptiClik to Lantus SoloST AR.
`
`The brand will continue to support the existing full portfolio of pens and vial (e.g.
`OptiClik and vial) so that satisfied users and HCPs can continue with their existing
`delivery systems.
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`Sanofi Exhibit 2145.008
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`4.2.1 Questions and example answers on the pen portfolio:
`• Q: Should I switch my existing Lantus patients from their current device to Lantus
`SoloSTAR?
`A. This is entirely up to you, doctor/nurse. Our advice is that if a patient is satisfied
`with their existing method and you are also satisfied for that patient then there is no
`need to change. If there are patients you think would benefit from changing device,
`then obviously you can do so.
`• Q: Should I put all my new Lantus patients on Lantus SoloSTAR?
`A. As the easiest option, you could start all your new patients with Lantus Solo ST AR.
`However, sanofi-aventis also offers OptiChk for your patients where a reusable pen
`might be preferred, or a vial for those who do not want a pen.
`• Q: Are you discontinuing the other devices?
`A. Sanofi-aventis will continue to support the current devices as long as there is
`interest from customers, so your existing patients can continue to use these and any
`new patients you so choose.
`
`4.2.2 Pen portfolio positioning
`Both the disposable Lantus SoloST AR and the reusable Lantus OptiClik will remain available
`for patients and providers.
`
`4.2.3 Importance of a portfolio approach
`After the launch ofLantus SoloSTAR, Lantus OptiClik will not be actively promoted by the
`field sales teams. Current inventories ofOptiClik pens and Lantus Cartridge samples will be
`offered to customer prior to Lantus SoloSTAR launch; post launch, samples will no longer be
`distributed to HCPs.
`
`This requires that the brand communicate a clear understanding of the role of each product,
`following these guidelines:
`• Limit competition between portfolio entities
`• A void marketing one product in a way that damages another product
`
`4.2.4 Critical success factors in a pen portfolio approach
`The US Lantus Marketing team will follow the global strategy: communicate where and how
`new pens fit alongside the existing pens and what this means for the overall product offering.
`• What this means for the overall portfolio offering, e.g. increasing choice
`• The positioning of the new pen
`• An order of preference, or a rationale/structure for choosing bet.veen the different pen
`options. For example, HCPs and patients make device choices based on:
`o Hard features like dose range, increments, reusable or disposable, which are
`drivers of suitability for the patient's likely regimen
`o Soft features, like size, weight, injection force, etc. which are drivers of user
`preference
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`Sanofi Exhibit 2145.009
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`LAN11--JS So!oSTAR
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`Avoid positioning the existing pens in a negative light (e.g. actively promoting switching
`except in specific allowed cases.)
`
`Many patients will continue to use the already marketed sanofi-aventis pens (OptiClik) even
`after new launches. Also, from a risk management point of view, it will be important to have
`multiple viable pen options in the market, until the development portfolio is fully established.
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`Mylan v. Sanofi
`IPR2018-01676
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`

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`5 Targeting SoloSTAR
`
`5. 1 Patient focus I targeting
`Patient targeting for Lantus SoloST AR is consistent with the targeting for Lantus today. The
`first target is to capture a greater share of new insulin patients. The second target is to switch
`patients on specific competitor insulins to Lantus.
`
`Lantus Solo ST AR, the first target is Type 2 patients starting insulin. The second targets to
`capture uncontrolled or unsatisfied T2 patients on competitor insulins, NPH and Premix.
`
`The figure below shows the target patients groups mapped against the core business
`opportunities for Lantus SoloST AR and Apidra SoloSTAR (when available in the US,
`projected in 2008.)
`
`Maximise value of
`each patient
`
`and/or unsatisfied
`T2DM patients on
`competitor insulin
`NPH*
`Premix*
`Levemir*
`
`New T1 DM basal
`bolus
`I
`
`.........................................
`
`I For all. .. e.g. titration message I
`'1'1~T?l>Nl6Mii6~••••
`starling basa1< · · · · · ·
`l:lij!Qs(Apic:1.-i:t)< >••••
`
`..................................
`
`l•t,,, .. ,..,,.
`
`* Uncontrolled patients on optimal basal dose
`
`Uncontrolled
`and/or unsatisfied
`T2DM patients on
`competitor S/RAI
`
`Secondary targets
`
`Avoid promoting pen switch of existing
`Lantus or Apidra users - HCPs will
`make this decision
`
`*Importance/ priority of NPH/Premix/Levemir
`patient pool depends on each market conditions
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`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`LAN11--JS So!oSTAR
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`5.2 Healthcare professional focus I targeting
`The key to healthcare professional targeting for Lantus SoloST AR is identification of
`healthcare professionals for whom pens are thought to have affected their prescribing habits.
`The brand team will provide direction at launch regarding markets with pen potential and the
`field sales team will utilize prescriber data to uncover the barriers of assigned targets.
`
`For Lantus, key targets are those doctors who have objections to OptiClik or Lantus pen
`options: this is where differences versus competitor pens arc said or thought to impact
`prescribing behaviour.
`
`Additional targets are providers who are starting new patients who want the convenience of
`the pen and also doctors who have high OAD populations that are ready for a Basal insulin.
`
`Obviously SoloST AR will still be an appealing and useful tool for HCPs who either are not
`swayed by the pen or who prescribe a high proportion of Lantus regardless of pens, but for
`these targets there is less value in SoloST AR as a lever.
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`Mylan v. Sanofi
`IPR2018-01676
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`

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`6 CreativeNisual campaign
`
`The visual campaign has been developed to accurately translate SoloSTAR brand value and is
`based on global research. The chosen concept has been extensively tested during its evolution
`within physicians, nurses and patients (pens users and naive patients) in France, Germany, the
`United Kingdom, and the United States.
`
`The core of the visual campaign is the continuation of the core visual elements for Lantus
`(since the insulin is key), overlaid and linked with a star visual and star sub-elements. This
`campaign tested very positively. The central star visual is eye catching, the star is seen as a
`positive symbol, and it links with the brand name. Furthermore the star provides a clear link
`across different visuals without altering the core identity for the Lantus visuals.
`
`For the Lantus SoloSTAR HCP Leave Behind, the integration of the STAR concept with the
`insulin was also well received. The concept was perceived as adding something distinctive,
`different and new to the existing/ recognisable concepts for the insulin. Again, there is a clear
`patient visual and focus within each concept In each case the concept promotes that the
`combination ofLantus with SoloSTAR helps our customers to go further (to start insulin
`more easily, to go further towards their goals, towards a better life, etc.).
`
`Global Lantus SoloSTAR
`
`US Lantus SoloSTAR
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`Sanofi Exhibit 2145.013
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`6.1 Logo
`The key elements of the Lantus SoloSTAR part of the logo are:
`•
`the lead-in line of three stars, in black, Lantus purple/violet
`•
`the capitalisation as SoloSTAR, to highlight the word STAR
`
`For the Lantus SoloSTAR logo, the words are ½Titten in the Lantus logo font.
`For the SoloSTAR alone logo, the letters Solo are written in an italic version of the Lantus
`font
`
`LANTlJS·,1:SoloSTAR"
`
`*':f·
`
`insu!ln gbrginc
`
`6.1.1 Writing "SoloSTAR" or "SoloStar"
`Whenever SoloSTAR is referred to in a promotional material, e.g. a sales aid, this Solo STAR
`form is to be used. For training material the usage is the form SoloStar (as it appears on the
`pen itself) is used.
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`Mylan v. Sanofi
`IPR2018-01676
`
`

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`7 Lantus SoloSTAR messaging
`The focus of selling communications, and real value for the patient, is Lantus itself. It is
`important to keep SoloSTAR firmly placed within the context of the Lantus brand.
`
`7.1 SoloSTAR messaging
`The core Lant us Solo ST AR messages are:
`• Easy to teach
`• Easy to use
`• Easy to inject*
`*Reference to the injection force Clarke study and Data on File from the second
`injection study that was initiated and completed in May 2007
`
`*'Easier to inject' was not supported by two studies showing data versus FlexPen and
`Lillypen. Therefore, the Haak data will be used by Medical Education, RMLs, and other non(cid:173)
`promotional groups at this time.
`
`Further detail on the studies supporting these claims can be found in the section on
`publications.
`
`Core features ofLantus SoloSTAR to be included in the messaging are:
`1 to 80 units in 1 unit steps
`•
`• Easy to set the dose - can dial up and down
`• Easy to read dose numbers
`• Easy to differentiate Lantus SoloSTAR and Apidra SoloSTAR
`
`The presentation of the core messages and additional messaging around Lantus is
`demonstrated in our Lantus SoloST AR HCP leave behind and Lantus core sales aid.
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`Sanofi Exhibit 2145.015
`Mylan v. Sanofi
`IPR2018-01676
`
`

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`LAN11--JS So!oSTAR
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`7.2 Core sales aid inclusion pages
`
`One page is dedicated to Lantus Solo ST AR in the 2007 H2 Lantus Sales Aid. This page shares the
`"Easy" message and provides a visual of the pen. A separate detail piece, the Lantus SoloSTAR
`HCP Leave Behind, contains the details of the pen and provides differentiating data on pen force
`injection versus competitors.
`
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`US Launch Book
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`FOR TNTRRNAT, USR 0,VT,Y
`
`16 of 37
`
`HIGHLY CONFIDENTIAL
`
`SANOFI 00232924
`
`PTX-0705.0016
`
`Sanofi Exhibit 2145.016
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`LAN11--JS So!oSTAR
`
`•'",:,1::,rv,,,•~
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`7.3 Lantus SoloSTAR Leave Behind
`
`A Lantus SoloST AR leave behind has been developed for launch in order to create added
`value and messaging to differentiate the pens in the US marketplace. The core objective is to
`transform the launch of Lantus SoloST AR into an opportunity for Lantus and to avoid the trap
`of positioning this simply as a day-to-day line extension. The Lantus SoloST AR HCP Leave
`behind will be used in conjunction with the existing Lantus sales aid in the launch phase and
`throughH2.
`
`Lantus SoloST AR HCP Leave Behind is a tri-fold, cardstock sales aid using the global
`star concept with the running man, pen image, and core messaging.
`
`Front cover
`
`Back cover
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`
`US Launch Book
`
`FOR TNTRRNAT, USR 0,VT,Y
`
`17 of 37
`
`HIGHLY CONFIDENTIAL
`
`SANOFI 00232925
`
`PTX-0705.0017
`
`Sanofi Exhibit 2145.017
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`LAN11--JS So!oSTAR
`
`•'",:,1::,rv,,,•~
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`Tri-fold interior opened up to show pages 2-3 (the middle and right hand panel of leave behind).
`Required fair balance language is place on a pocket that will hold the Quick Reference Guide Tear
`Pad.
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`
`US Launch Book
`
`FOR TNTRRNAT, USR 0,VT,Y
`
`18 of 37
`
`HIGHLY CONFIDENTIAL
`
`SANOFI 00232926
`
`PTX-0705.0018
`
`Sanofi Exhibit 2145.018
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`LAN11--JS So!oSTAR
`
`•'",:,1::,rv,,,•~
`
`The Quick Reference Guide is an integral part of the HCP Leave Behind. The guide will be a 25-
`page tear pad that inserts into the right hand pocket of the HCP and each page can be pulled off and
`left behind with providers, nurses, pharmacists, and the doctor's office can also use it as a reference
`for their patients. NDC numbers for pharmacy selling and the customer service line will be placed
`on the guide for reference by customers.
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`
`US Launch Book
`
`FOR TNTRRNAT, USR 0,VT,Y
`
`19 of 37
`
`HIGHLY CONFIDENTIAL
`
`SANOFI 00232927
`
`PTX-0705.0019
`
`Sanofi Exhibit 2145.019
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`LAN11--JS So!oSTAR
`
`•'",:,1::,rv,,,•~
`
`8 Selling approach, Q&As and traps to avoid
`There are several important items detailed here to ensure that you make acceptable claims,
`that your selling approach is effective, and to help you maximise the value for SoloSTAR as a
`lever for Lanius.
`
`8.1 Communicating sales messages about SoloSTAR before
`showing the actual pen
`The brand will train sales professionals to detail from the HCP Leave Behind prior to showing
`the pen. This allows the associate to fully control the detail and pen training.
`
`Sequence for the first detail ofLantus SoloSTAR:
`• Start with the insulin, Lantus
`• Then, without showing the pen, introduce Lantus SoloST AR and go through the
`message flow using the Lantus SoloST AR Leave Behind as support
`• Then produce the pen and demonstrate how it works
`• Only then, handing it over the HCP to try
`
`8.2 Preference and superiority versus other pens is not absolute
`
`The US will promote 'less injection force' as the differentiating factor in pens along with the
`consistent use of "Easy" language; this does not include the Haak preference data, which
`could not be used at this time for promotion in the US. Global marketing suggests promoting
`that Lantus Solo ST AR is preferred versus FlexPen and Lillypen because it offers the best
`combination of achievement in the multiple important features that are important to a user.
`This makes it appealing to the mass market, and suitable for almost every patient. It is not,
`and does not need to be, best on every individual feature. Focusing too much on individual
`features, even for example the injection force, is easier to challenge and risks creating a niche
`for the pen.
`
`Note that for the core messaging versus Flexpen and Lillypen, there is some supporting data
`from a study (Haak et al.) showing that Solo ST AR was preferred by patients versus FlexPen
`and Lillypen. This was a handling study, without clinical use, so while the data is powerful it
`does have some limitations. This is discussed further in the section on publications and
`additional supporting studies are necessary for inclusion in US sales material.
`
`•
`
`8.3 Examples where individual features on other pens may be
`preferred by some customers
`Injection force:
`o SoloSTAR has one of the