Dymista briefing document
`
`The product: Dymista is a novel formulation of azelastine and fluticasone propionate in an advanced
`delivery system. The product has been positioned as a new allergic rhinitis product and not as a fixed
`dose combination . There is evidence that the formulation/device contribute to product characteristics as
`well as the 2 active principles. The product has been shown to be twice as effective as current 1 st line
`therapy e.g. intranasal corticosteroids in reducing nasal and ocular symptoms. The most bothersome
`symptoms of AR are nasal congestion and ocular itching. Dymista is twice or even three times more
`effective than intranasal corticosteroids in reducing those symptoms. Furthermore Dymista is superior
`regardless season, symptom, and severity. Leading experts including the editor of JACI (the most
`prestigious allergy journal) consider Dymista the drug of choice for moderate to severe AR. Publications
`will be made available via the brand portal.
`
`Label of the product: The label of the product is different. Dymista has a SAR label in the US, a SAR/PAR
`label for moderate to severe AR patients in Europe, a SAR/rhino conjunctivitis label in Switzerland and a
`SAR/PAR/rhino conjunctivitis label in Australia. Meda will send agency an overview of the label in the
`various countries. Various country labeling will dictate what product attributes mentioned above may be
`utilized (e.g. the US label does not include ocular symptoms, regardless season, or litwice as effective").
`
`Positioning of Dymista: There is an unmet medical need for a faster and more effective allergic rhinitis
`(AR) therapy in moderate to severe patients. Up to 90% of patients already use combinations of existing
`mono therapy in an attempt to control their AR symptoms. Dymista shall be positioned as the first line
`therapy for those patients. This is the vast majority of AR patients who are seeking medical help. Dymista
`shall be positioned as a new AR therapy and not as a fixed dose combination .
`
`Launch positioning and physician perception of the product in the US: Meda US did not follow the
`global strategy and reinforced physician perception of Dymista as a fixed dose combination. The graphics
`did also emphasize the existing physician perception by using a 2 color Trademark and a two color design
`in the overall branding. As a result Dymista was reserved for late in the treatment algorithm. This
`positioning turned out to be overly restricted and, in turn adversely affected patient access through
`managed care payers. As stated by investors: lithe cost/benefit profile of Dymista versus cheap generic
`standard-of-care (fluticasone) is simply not good enough for a commercial success and that lack of payer
`support will continue to hamper the uptake". Several payers did not grant Dymista unrestricted access
`(Tier 2 and Tier 3) arguing that the premium price is not justified (approx. 2.5 times higher than the lose
`combination generic equivalent). Experts consider to use the lose combination of Fluticasone propionate
`and Azelastine nasal spray which are commercially available, claiming lithe superiority of Dymista does
`not offset the additional hassle a higher price and less favorable formulary status implies".
`
`Importance of Dymista for Meda AB: Meda is the leading Swedish company with overall sales of approx.
`2 billion US$. Dymista has to be the growth driver for the next 5 years must reach approx. 1 billion US$
`in the rest of
`net sales in the US, more than 250 million € net sales in Europe and approx. 200 million €
`the world. Dymista and especially Dymista in the US are in the focus of financial investors after the
`placed on improving the current growth trajectory of Meda US in spite of declining branded AR markets.
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`PLAINTIFFS'
`TRIAL EXHIBIT
`PTX1654
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`MEDA_APTX02483660
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`PTX1654-00001
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`1
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`CIP2073
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`

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`Current sales development: Dymista was launched in September 2012 in the US and in some European
`countries 2013. Dymista sales are clearly behind expectations in the US with an approx. 1.5% market
`share in units of the intranasal corticosteroid market (which is used as benchmark) and 4% market share
`in US$. The launch has been successful in some European markets e.g. Ireland, Germany, Austria,
`Finland, Sweden where a market share of 4-12% in units (8-25% in Euro) has been achieved. This
`provides some proof that the positioning of Dymista is predicated on the right combination of market
`pricing and clinical advantages.
`
`Branding: The branding has been developed by the marketing center within Meda, which is located in
`Germany. An overview of the branding elements will be provided.
`
`• Meda US used an own branding which was not in line with Meda Germany. One task of the
`agency is to advise Meda AB how to achieve global alignment and strengthen the branding.
`
`Marketing materials: The marketing materials for Dymista have been developed by the marketing center
`and are located on the brand portal. The agency will have access to the brand portal. Agency has to
`review these materials and, if necessary, make proposals how to improve those.
`
`• Meda US has, as mentioned above, used marketing materials developed in the US, e.g. sales
`folder, patient brochure. The quality is not acceptable for Meda AB. The most urgent priority of
`the agency is to adapt the existing US marketing materials. Agency must have a good track
`record in navigating US legislation in order to generate marketing materials, which are both
`compliant and assertive in their positioning. Meda needs the agency to advise Meda AB and
`Meda US how to achieve that position.
`
`Pre-marketing and launch activities: Agency will review pre-marketing and launch activities of countries
`which will launch the product in the near future e.g. Australia, Canada, Mexico, Middle East, South
`Africa, Russia and make suggestions (if needed).
`
`Publications: A global publication plan has been developed and key publications have been written.
`Previously, alignment between Meda US and Meda AB regarding publication planning and content has
`not existed. While some progress has been made, these conflicts have not been entirely solved. The
`agency must review the publication plan and make suggestions for alignment, if needed. The overall aim
`of the publication plan is to maximize the competitive profile of Dymista.
`
`Life cycle studies: Life cycle studies have been discussed with leading experts and the l't wave has been
`initiated. Agency has to review if the current life cycle plan will provide Dymista with further growth.
`Dymista must become a block buster product.
`
`• Agency has to assess if the current US indication (SAR) is sufficient to provide product with
`approx. 1 billion net sales.
`
`Dymista web site: The Dymista web site is fully developed. The agency will have to review the Dymista
`web site and if necessary make proposals how to improve those. Agency will also provide suggestions
`how to generate traffic to the web site.
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`• Again, quality of digital materials differs between Meda AB and Meda US and should be aligned
`as regulation allows. One priority of the agency is to update and improve the US web site.
`
`Meda as a global AR player: Meda is not known as a company nor recognized yet as a major player in
`allergy. The presence at international as well as local congresses is therefore very important. Meda AB
`has by far the biggest booth (twice as large as other companies) at the EAACI and ERS congress and by
`far the highest number of poster/oral presentations (approx .. 20) and symposia among all companies (4).
`
`•
`
`In the US, Meda also has a dominant presence at congresses. However, certain activities differ
`from that of the European congresses. The agency has to review the congress activities and
`assess if the current presence is appropriate, and if needed, improve and increase that presence.
`
`Meda is lacking adequate pre-marketing activities to attract participants and lacks also follow up
`activities of these participants on a global level.
`
`International KOL management: Meda AB has established productive relationships with leading
`European AR experts including the chairmen of ARIA. Challenges have arisen when attempting to
`manage the activities of US thought leaders and principal investigators of Dymista trials when engaged in
`ex-US activities. The agency has to assess the perception of Meda AB and Meda US with regard to US
`experts to understand the perception of Meda, and if the internal conflict has been recognized and
`negatively impacted the relationship.
`
`Meda AB does not fully understand the extent in which local and international experts are integrated in
`the promotion of Dymista or the effectiveness of those activities. Agency has to assess the role of
`experts in the promotion of Dymista.
`
`Sales force related activities: Market research on sales force effectiveness has been done in some
`countries. The agency has to assist Meda in the roll out of a sales force effectiveness program in close
`cooperation with market research. Meda will provide agency with market research and its results.
`
`Non-sales force related activities: Meda is too focused on sales force related activities as a stand-alone
`growth driver and has not fully developed effective non-personal promotional campaigns. There is a
`clear gap in the understanding of how to run for example PR activities: press/broadcasting/TV and DTC
`activities.
`
`Meda has a digital marketing department in Sweden and is initiating e-mail marketing activities for
`Dymista. Additionally, we are establishing a digital tool called Meda connect which links doctors to an
`interactive multiproduct web page. The agency has to review the non-sales force related activities and, if
`needed, improve those. The agency has to come up with a global PR plan .
`
`Interplay of all marketing tools: Meda has no systematic approach how to link personal, non-personal,
`congress activities and experts to one unified communication strategy. The agency has to provide
`guidance as well as tools.
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`Global tasks of the agency:
`
`Agency must review all Meda activities as well as current positioning and communication strategy.
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`Agency must identify all gaps and must provide a global communication/marketing plan including,
`congresses, key opinion leader management, sales force and non-sales force related activities. Agency
`must provide content and tools for activities where Meda lacks knowledge and infrastructure e.g. non(cid:173)
`sales force related activities/interplay of all marketing tools.
`
`US tasks of the agency:
`
`Agency must provide Meda AB and Meda US asap with a plan how to change/improve positioning and
`branding of Dymista. Agency must adapt marketing materials/web site asap to the corporate guidelines.
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`Agency:
`
`Agency must be global and must have an unbeatable track record in generating global blockbusters in
`the pharmaceutical industry. Agency must also have a track record how to deal especially with the US
`legislation and how to manage US compliance issues. Agency must have the capability to advice Meda
`how to overcome potential compliance issues with their suggested marketing campaign/materials.
`Agency must have a track record not only to generate the content/activities but also to implement
`measures to all Meda affiliates (US, Canada, Mexico, Europe, Australia, Russia, South Africa, Middle East
`Turkey)
`
`Agency must present their entire team to Meda. Members of the team must have a certain seniority
`level and have successfully managed blockbusters. Members of this team shall exclusively work on this
`project.
`
`Reporting:
`
`Agency will report defined milestones and deliverables to a Steering Committee consisting of:
`
`Jorg-Thomas Dierks (CEO)
`•
`• Hans Tritschler (Executive Vice President Marketing Rx)
`• Dirk Groen (Executive Vice President Marketing OTC who is also responsible for digital
`marketing)
`• Maria Carell (EVP North America & Australia)
`• Ton van't Hullenaar (EVP Europe & Latin America)
`• Esfandiar Faghfouri (EVP Europe, Asia & Africa)
`•
`Joachim Maus (EVP Scientific Affairs)
`
`The Dymista Marketing Group, which will be the agency's primary point of contact, is consisting of:
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`HIGHLY CONFIDENTIAL-
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`• Hans Tritschler
`• Stuart Loesch (VP Marketing Meda US)
`• The European Dymista marketing team
`• The US Dymista marketing team
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`MEDA_APTX02483664
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`PTX 1654-00005
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`5
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