DCA
`
`sanoFi aventis
`
`DBA Design Effectiveness Awards 2009
`
`SoloSTAR®
`
`A disposable pen injector for insulin
`
`Category:
`
`Sub category:
`
`Product
`
`Consumer
`
`Client company:
`
`Sanofi Aventis GmbH
`
`Design consultancy:
`
`DCA Design International Ltd
`
`Current date:
`
`2nd June 2009
`
`Sanofi Exhibit 2121.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`sanoFi aventis
`
`DBA Design Effectiveness Awards 2009
`
`SoloSTAR®
`
`A disposable pen injector for insulin
`
`Category:
`
`Sub category:
`
`Product
`
`Consumer
`
`Client company:
`
`Sanofi Aventis GmbH
`
`Design consultancy:
`
`DCA Design International Ltd
`
`Current date:
`
`2nd June 2009
`
`Sanofi Exhibit 2121.001
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`Executive summary
`
`sanoFi aventis
`
`Pen injectors were introduced over 20 years ago to deliver liquid medication . They allow
`users to select a dose of medication and inject this via a needle connected to a small
`reservoir within the pen.
`
`In Europe, Japan and the US, pen injectors are commonly used to deliver insulin for the
`treatment of diabetes mellitus. In many countries they have largely replaced the
`traditional vial and syringe because they benefit patients by allowing accurate and easy
`dosage, whilst being convenient and discrete.
`
`Lantus®, a new once a day basal insulin, was originally offered in a licensed injector
`device but in order to sustain the development of the new insulin, Sanofi Aventis decided
`to begin developing its own pen in 2003. The new device could not be a 'me too'
`product; it had to offer significant improvements over all other disposable insulin devices
`on the market.
`
`The design brief was suitably ambitious. In order to satisfy the needs of patients
`requiring high dose volumes of insulin, the new pen injector had to be capable of
`delivering a single dose of 80 insulin units (over 30% larger than all comparable devices
`on the market) with no penalty for comfort and convenience. In addition to being
`extremely robust, the device also had to satisfy the very high accuracy standards
`outlined in 150-11608.
`
`The solution is SoloSTAR®. SoloSTAR® meets all of these requirements and exhibits
`significant advantages over previous devices in terms of comfort, safety and ease of
`use1
`. Since its launch in 2007, SoloSTAR® has rapidly established itself as a leading
`disposable pen injector for insulin, accounting for 41% of all growth in the global
`injectable insulin market in 20082
`•
`
`(277 words)
`
`Lantus® SoloSta
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 2 of 10
`
`Sanofi Exhibit 2121.002
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`Project overview
`
`Outline of project brief
`
`sanoFi aventis
`
`To develop a 'best-in-class' disposable pen injector with the following key features:
`
`Maximum selectable dose up to 80 units in 1 unit increments.
`
`Dose correction without penalty, i.e. the possibility to dial back without expelling
`liquid.
`
`The lowest injection force in its class.
`
`User interface design based on good ergonomic principles.
`
`Simple, obvious operation with no additional steps beyond selecting and dispensing a
`dose.
`
`Suitable for extremely high volume manufacture at low cost.
`
`Safe, robust and reliable.
`
`Maximum differentiation for devices containing different insulins.
`
`Description
`
`SoloSTAR® contains 3ml of insulin, dispensable in single unit increments (0.01ml). The
`user selects a dose by rotating a dial and injects this volume by simply depressing the
`dose button.
`
`Improvements over predecessor devices have been achieved in all key areas (from initial
`learning through to daily usage) and together they provide genuinely important
`advantages for users. SoloSTAR® is the first disposable insulin pen to combine very low
`injection force (which provides a smooth injection experience for patients) with 80 units
`maximum dose capability, an important breakthrough.
`
`Overview of market
`
`Measured by the number of insulin units (IU) prescribed worldwide, the total market for
`injectable insulin grew from 217 Billion IU in 2003 to 302 Billion in 2008.
`
`Of the different methods of injecting insulin available, disposable pen injectors form the
`fastest growing sector, up from approximately 20% of the market in 2003 to 31 % in
`20083
`•
`
`In 2003, Sanofi Aventis held just 6.1% of the total disposable insulin pen market, well
`behind its two main rivals Novo Nordisk (60.2%) and Eli Lilly (29.2%) 4
`•
`
`Project launch date
`
`April 2007 in Germany.
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 3 of 10
`
`Sanofi Exhibit 2121.003
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`sanoFi aventis
`
`DCA
`
`Size of design budget
`
`Not available
`
`Outline of design solution
`
`The key technical challenges faced in developing SoloSTAR® resulted from worldwide
`research, which indicated that users strongly desire low injection force together with a
`large selectable dose range.
`
`A fundamentally new operating mechanism was needed to resolve this problem. The
`highly efficient mechanism at the heart of SoloSTAR® is the product of a rigorous,
`evidence-based engineering design process. This innovative mechanism gives
`SoloSTAR® the lowest injection force in its class (over 30% less than key competitor
`devices) 5
`•
`
`Averag force to del iver a 40 unit dose in 4 second
`
`24.4
`
`16.3
`
`11.3
`
`- - - -
`
`25
`
`20
`
`-
`5
`
`0
`
`Competitor
`Pen 1
`
`Competitor
`Pen 2
`
`Lantus1i
`SOloSTAR
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 4 of 10
`
`Sanofi Exhibit 2121.004
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`sanoFi aventis
`
`During the development of SoloSTAR®, the design team held the needs of users in
`primary focus and careful consideration was given to visual design. SoloSTAR® has a
`discretely appealing form that helps to neutralise any stigma that may be attached to its
`use in public.
`
`Colour is used to enhance safety by minimising the risk of a misidentification. In fact
`SoloSTAR® Lantus and Apidra have a total of five differentiation features for improved
`safety: body colour, dial colour, button colour, label design and a tactile feature on the
`injection button of the Apidra pen.
`
`As many diabetic sufferers experience vision deficiencies, a very clear, high-contrast dial
`number display with magnification was also developed.
`
`(480 words)
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 5 of 10
`
`Sanofi Exhibit 2121.005
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`Summary of results
`
`Increase in sales
`
`sanoFi aventis
`
`Analysis of the market growth during 2008 shows that SoloSTAR® is highly successful.
`Around the world, SoloSTAR® has become the engine for growth in sales of Lantus®.
`Between October 2007 and October 2008, the Lantus® SoloSTAR® device alone captured:
`
`41 % of the total growth in the injectable insulin market6,
`
`and accounted for 89% of Sanofi Aventis' annual consumption growth in the
`injectable insulin market6
`•
`
`Reductions in manufacturing costs
`
`SoloSTAR® has few components and is designed to facilitate very high speed automated
`manufacture and assembly. Careful attention to these aspects means that greatly
`improved functional performance is gained with no cost penalty over previous devices.
`
`Increases in market distribution
`
`Before the launch of SoloSTAR®, Sanofi Aventis did not market disposable insulin pen
`injectors in the US and Japan. The disposable devices available at the time simply did not
`meet the particular needs and expectations of these important markets.
`
`SoloSTAR® has been launched into both of these markets and is proving very successful,
`as can be seen in the sales evolution graphs shown on the previous page.
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 6 of 10
`
`Sanofi Exhibit 2121.006
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`sanoFi aventis
`
`Increases in market share
`
`The worldwide sales evolution in the first 15 months after launch clearly shows that
`Lantus® SoloSTAR® has overtaken the closest basal insulin competitor7
`• In fact, in the
`last quarter of 2008 Lantus® SoloSTAR® achieved almost 45% more sales (by volume)
`than this competitor. This success demonstrates the markets' preference for a device
`designed with the patient's needs at the heart of its development.
`
`In 2008, Sanofi Aventis' share (volume share) of the total disposable insulin pen market
`grew to 22.7%, with Novo Nordisk taking 61.8% and Eli Lilly 14%8 • This represents a
`significant improvement on the position in 2003, when Sanofi held just 6.1% of this key
`market, indicating just how successful SoloSTAR® has been.
`
`Improvements in staff morale
`
`DCA have been working alongside a dedicated device department set up at Sanofi
`Aventis to develop injection devices. All members of the team involved in the project are
`very proud to have helped create such a globally successful product.
`
`A great deal of positive feedback has also been given by the Sanofi Aventis global sales
`teams who are delighted that they are now able to offer their best-in-class insulin
`(Lantus®) within a best-in-class device.
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 7 of 10
`
`Sanofi Exhibit 2121.007
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`sanoFi aventis
`
`Improvements in consumer attitudes or behaviour
`
`In September 2008, Sanofi Aventis commissioned market research agency Ipsos Health
`to undertake interviews with over 2000 health-care professionals, who are involved in the
`initiation of treatment for patients with diabetes in eight major countries around the
`world 9
`•
`
`One of the questions that this group were asked was whether SoloSTAR® has changed
`attitudes towards prescribing Lantus@. 69% of physicians responded that the availability
`of the SoloSTAR® pen increases their likelihood of prescribing Lantus® to patients.
`
`Within the same study 422 specialist Diabetologists were asked how they would rate the
`SoloSTAR® device overall, on a scale from 1 to 10. The chart below shows the average
`ratings given by Diabetologists from the six largest markets, as well as the result for all
`responses globally.
`
`Average ratings for SoloSTAR given by Diabetologists
`
`10
`
`8
`
`7
`
`6
`
`5
`4
`
`3
`
`2
`
`1
`
`o~~~- ~~- - ~- - ~-- - -~~- ~
`
`ease
`
`France Gem1any
`so
`so
`
`Sp 111
`60
`
`UK
`~o
`
`USA
`60
`
`Jap.1n
`71.
`
`Global
`411
`
`"SoloSTAR takes very little time
`to teach ... we can teach more
`patients and teach them more
`quickly. And that is a huge
`advance."
`
`Maureen Bancroft (Diabetes Nurse, UK)
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 8 of 10
`
`Sanofi Exhibit 2121.008
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`sanoFi aventi,s
`
`Market studies10 undertaken by Sanofi Aventis have also shown high acceptance of
`SoloSTAR® by patients. The graph below illustrates one key element of this.
`
`Patient preference fo the lower injection
`force oi SoloSTAR
`
`100
`
`90
`
`69%
`
`16%
`
`13%
`
`10
`2%
`o...L-.L...--L-__JL----l_---1_~-L-....c:======i...-
`Solos AR
`Comp titor
`Comp titor Competitor
`Pen 1
`P n 2
`Pen
`
`"I have got rheumatoid arthritis
`and my fingers are buckled, but
`I can manage the pen. I think
`it's fantastic, the Lantus
`SoloSTAR . ... If I can do it,
`anyone can do it!"
`
`Wendy Tait (Diabetic patient, Australia)
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 9 of 10
`
`Sanofi Exhibit 2121.009
`Mylan v. Sanofi
`IPR2018-01676
`
`
`
`DCA
`
`sanoFi aventis
`
`Research sources
`
`1 - Clinical Therapeutics 2007. Haak T, et al.
`
`2 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`3 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`4 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`5 - Expert Opinion on Drug Delivery (2007) 4(2) pages 165-174, Clarke and Spollet.
`Comparison is made for the mean force of the total dose between SoloSTAR®, Novo
`Nordisk Flexpen® and Eli Lilly Humalin®/Humalog®.
`
`6 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`7 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`8 - IMS Health 2008. The world's leading provider of market intelligence to the
`pharmaceutical and healthcare industries.
`
`9 - Ipsos Health. Help pharmaceutical, biotech and medical device businesses around the
`world understand patients, prescribers and influencers.
`
`10 - Clinical Therapeutics 2007. Haak T, et al.
`
`Other influencing factors
`
`A number of PR events for press/ doctors/ nurses where held to increase awareness of
`the new product; a number of publications have also featured articles which challenge
`the competition on dispense force, importance of dose accuracy for the therapy, etc.
`
`SoloStar_DBA_2009_for_publication.doc
`
`Page 10 of 10
`
`Sanofi Exhibit 2121.010
`Mylan v. Sanofi
`IPR2018-01676
`
`
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