BRAND BOOK

BRAND BOOK F. Hoffmann-La Roche Ltd 4070 Basel, Switzerland MIRCERA Brand Book 1. Building MIRCERA Into a Global Brand . . . . . . . . . . . . . . . . . 1 The Promise of MIRCERA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Building MIRCERA Into a Successful Global Brand . . . . . . . . . . . . . . . . 2 Using These Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 What Makes a Successful Brand? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 What Makes a Successful Pharmaceutical Brand? . . . . . . . . . . . . . . . . .5 The Value of a Brand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 Brand Positioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Branding Personality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 Core Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Crystalised Product Promise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 4. Applications of Global Branding . . . . . . . . . . . . . . . . . . . . . . 45 Launch Advertisements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Launch Detail Aid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Letterhead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Branded Clinical Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Branded Training Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Giveaways . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Panels and Signage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 5. Electronic Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 PowerPoint Slide Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Use of Colour in PowerPoint Presentations . . . . . . . . . . . . . . . . . . . . . . 63 Slide Format Colour Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Slide Format White Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 E-mail Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 2. Branding Hallmarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Name . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 Colours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16 Competitive Colour Palette . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 Typography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18 Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20 Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28 Symbol as a Graphic Element . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30 Droplets as a Graphic Element . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34 6. Messages and Brand Vocabulary . . . . . . . . . . . . . . . . . . . . . 71 7. ROCHE Logo Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 8. Examples of Unacceptable Usage . . . . . . . . . . . . . . . . . . . . . 89 3. Illustrative Style . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Photography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Correction and Maintenance Line as a Graphic Element . . . . . . . . . 41 Applications of the Illustrative Style of MIRCERA . . . . . . . . . . . . . . . . 42 9. About These Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95 These branding guidelines are only for use by MIRCERA team members throughout the world. Adherence to these branding guidelines will ensure branding consistency with the global marketing strategy. MIRCERA is a registered trademark of Roche Pharmaceuticals. Do not duplicate, distribute, or use in detailing. PowerPoint is a registered trademark of Microsoft Corporation. Section 1: Building MIRCERA Into a Global Brand Building MIRCERA Into a Global Brand Section 1: BUILDING MIRCERA INTO A GLOBAL BRAND The Promise of MIRCERA MIRCERA is an innovative treatment for anaemia that offers stable and sustained haemoglobin (Hb) levels with the added benefit of once-monthly dosing for all patients with chronic kidney disease (CKD). Anaemia—a consequence of CKD—normally develops early in the disease process, but it is commonly diagnosed and treated much later. Anaemia is considered a “risk-multiplier” that leads to other serious, sometimes fatal, complications. Thus, it is vital that physicians and other healthcare providers view MIRCERA in terms of its promise—an effective anaemia therapy for patients with CKD with the added benefit of once-monthly dosing. Using These Guidelines This manual is intended to standardise the elements of the MIRCERA brand in order to bring the brand to life in the most informative, differentiating and unique way possible. The following pages detail each of the components of the MIRCERA brand and how they should be used. These guidelines should serve as your constant reference for establishing and maintaining a consistent brand identity for MIRCERA. Successful branding of MIRCERA ensures that its image and messages reach targeted prescribers. Successful branding can be achieved when affiliates adopt a uniform approach across all markets. Building MIRCERA Into a Successful Global Brand The path to success for MIRCERA as a global brand lies in maintaining a consistency regardless of where the brand appears globally. The target audiences for MIRCERA are nephrologists, nephrology nurses, patients, caregivers, advocacy groups, and other members of the international nephrology community. To attract the attention of treating physicians and healthcare providers, the MIRCERA brand must be constructed to reach them both emotionally and rationally. This is accomplished by developing a guiding structure for the brand that differentiates it from its competitors in a meaningful and compelling manner. For MIRCERA, as with any successful brand, the most essential structural guidance comes from brand positioning, brand personality and core value. 2 Do not duplicate, distribute, or use in detailing. BUILDING MIRCERA INTO A GLOBAL BRAND What Makes a Successful Brand? A brand is a concise yet thorough distillation of a product’s identity. This identity is communicated via the product’s name, visual hallmarks, and the language used to describe the product. A brand functions as the thread connecting all internal and external impressions; it also links together all perceived emotional and functional benefits. By design, a brand is successful when it establishes and continually reinforces a familiarity that is distinctive, differentiating, informative and enduring over time. There are many successful brands in the consumer world. Two notable examples are represented by the following icons: What Makes a Successful Pharmaceutical Brand A successful pharmaceutical brand must be flexible, yet sustainable, to address product challenges, changes in the marketplace and indication expansions. Establishing brand identity ensures success as the brand evolves to include new indications for new target audiences. In the case of global brands, it is even more critical to ensure that a brand speaks with a common voice to all audiences and in all languages. The Value of a Brand Each of these icons is simply designed and executed. Each has been successfully used for cultivating recognition and mass appeal of the brands. Because the icons convey the feeling and spirit of the brand, their consistent application across a variety of messages has led to a global brand identity. As consumer brands, the brands represented by the icons speak to a vast audience with diverse needs and desires. In contrast, a pharmaceutical brand addresses a restricted target audience that demands a more specific brand presence. While the MIRCERA brand is an intangible asset, it is potentially the truest and most accessible representation of the value of MIRCERA to patients and healthcare providers. It is more valuable than traditional assets such as inventory, infrastructure, and equipment; more valuable than intellectual property such as ideas and patents; even more valuable than the human component of the product that includes the intelligence, skill, integrity, motivation, collaboration and goodwill of all the people who have partnered together to develop and launch MIRCERA. In brief, the MIRCERA brand is greater than the sum of all the parts that were essential in its development. 4 Do not duplicate, distribute, or use in detailing. BUILDING MIRCERA INTO A GLOBAL BRAND Brand Positioning Positioning refers to the place the brand should occupy in the physician’s mind, ie, how our audience is intended to perceive MIRCERA. Brand positioning characterises the brand in rational terms. While physicians may not be consciously aware of the brand positioning as they become familiar with MIRCERA, the positioning will inform, provide context and serve as the standard for presentation of all visible elements, including visual hallmarks and language. While providing the same therapeutic benefit as previous agents, the greater efficiency of MIRCERA—as defined by its unique molecular structure and mechanism of action that extends dosing intervals up to once-monthly maintenance—sets it apart in the marketplace. This scientific approach is also less burdensome for those being treated, and allows physicians to extend optimal care to all of their CKD anaemia patients. The positioning statement for MIRCERA is: In chronic kidney disease, MIRCERA, with its unique receptor interaction and long half-life, is the first continuous erythropoietin receptor activator. MIRCERA is the preferred treatment for anaemia because, unlike with epoetin and darbepoetin alfa, physicians can treat all patients in maintenance on a monthly regimen, providing once-monthly Hb control. This elegant approach to anaemia management gives patients the energy for healthier everyday lifestyles while freeing healthcare providers to focus on the other medical challenges of CKD. The positioning focus of MIRCERA is: Improved anaemia care, simplified—through innovative high science. This simple approach to anaemia management gives patients the energy for healthier everyday lifestyles while freeing healthcare providers to focus on the other medical challenges of CKD. 6 Do not duplicate, distribute, or use in detailing. BUILDING MIRCERA INTO A GLOBAL BRAND Brand Personality While positioning sets an ideal for what the brand aspires to be in rational terms, brand personality reflects the brand in terms of personality attributes used to describe a person. The brand personality provides the audience feeling about the brand. MIRCERA is Provocative because it dares to be different. It offers physicians and other healthcare providers a unique clinical solution to an existing problem that will forever change the practice of anaemia management. The provocative aspect of the brand is reflected through our 4-droplet symbol that features one droplet in a contrasting color, highlighting the fact that MIRCERA can be dosed once monthly. MIRCERA is Visionary because it redefines anaemia management for patients, physicians and other healthcare providers. The visionary aspect of the brand is reflected through the use of strong colors and a clean, sans serif typeface. MIRCERA is Catalytic because it is an agent that sets many positive MIRCERA is Ingenious because it is the first in a new class of agents called continuous erythropoietin receptor activators with a distinct and unique interaction at the receptor that sets it apart from its competitors. It binds, and dissociates from one receptor; then repeats the process continuously on multiple receptors without immediate degradation. MIRCERA is Compassionate because its once-monthly administration affords physicians and other healthcare providers more time to devote to the many needs of their patients with CKD-related anaemia, and it frees patients from the burden of frequent dosing, which is necessary due to Hb instability such as cycling and fluctuation. The compassionate aspect of the brand is reflected through the organic, symmetrical shape of the symbol. reactions into motion. These reactions take place in nephrology offices, in healthcare organisations and in patients’ bodies. The catalytic aspect of the brand personality is realised through the perpetual motion depicted in the 4-droplet symbol of MIRCERA. By combining these unique attributes, MIRCERA becomes the LIBERATOR—the one and only agent that releases physicians, healthcare providers and patients from the burden of traditional therapies, freeing them to improve care and embrace life. The MIRCERA brand personality consists of 5 personality traits. MIRCERA is: • • • • • Ingenious Compassionate Provocative Visionary Catalytic 8 Do not duplicate, distribute, or use in detailing. BUILDING MIRCERA INTO A GLOBAL BRAND Core Value The core value is the brand’s ultimate promise capturing what the brand will be remembered for long after its time. The core value relates back to what is of value to the customer. Like the brand positioning and brand personality, the core value is not intended to be stated. Instead, it should inform all promotional and creative work that is done for MIRCERA. Crystalised Product Promise A product’s crystalised product promise is the most condensed written statement of what that product means for those who will use it. The crystalised product promise for MIRCERA is: Continuous Activity. Targeted Stability. This crystalised product promise appears in executions of the MIRCERA logo lockup. As with any other brand element, the crystalised product promise for MIRCERA should not be modified, since consistent usage serves to reinforce the brand’s identity over time. For this reason, the crystalised product promise should always appear as it does above, in English, without being edited or translated for regional markets. (Please see Examples of Unacceptable Name Usage on page 89 of this manual for more information.) The core value of MIRCERA is: A partnership to achieve more for optimal management and care of CKD patients with anaemia. 10 Do not duplicate, distribute, or use in detailing. Section 2: Branding Hallmarks Branding Hallmarks Section 2: BRANDING HALLMARKS Branding Hallmarks: Name The name MIRCERA is an acronym for Monthly Injections Realized (“MIR-“) and Continuous Erythropoietin Receptor Activator (“-CERA”). MIRCERA is a registered tradename. It is crucial that the name MIRCERA only refers to MIRCERA itself and not to any similar or associated product. A name can be protected from becoming a generic and kept out of the public domain only if the trademark owner consistently maintains exclusive rights over that name in relation to the product. To preserve the relationship to the product itself, the name MIRCERA should always appear in a way that is distinctive from surrounding type, and the following rules for usage should be maintained: • In text, the name MIRCERA should always appear in all-capital letters • In written communications, the name MIRCERA should be uniquely associated with the product itself, and not with closely associated products such as self-injection devices or other delivery systems • Use of pronouns such as “it” should be avoided to refer to the product • The name MIRCERA should never be part of a hyphenated or compound word construction • The name MIRCERA should never appear as a plural • The name MIRCERA should never appear as a possessive The brand name MIRCERA should always appear in a non-italic, all-capital letter format. This allows the use of italics for words that act as descriptors for MIRCERA, such as once-monthly or NEW, as in the following: • Once-monthly MIRCERA • once-monthly MIRCERA • NEW MIRCERA For examples of unacceptable brand usage, see pages 89–93 of this manual. Registered symbol In graphic treatments, including the logo cluster, MIRCERA should always appear with the registered ® symbol. As long as the logo cluster appears on the page with the registered symbol, the registered symbol should not appear with the name MIRCERA in non-logo text, since its status as a trademark is communicated by consistent, all-capital letter usage. Generic name and generic descriptor usage The generic name for MIRCERA is methoxy polyethylene glycol-epoetin beta. Examples of the logo lockup with the generic name appear on page 20 of this manual. Regulations regarding the use of the generic name with the brand name MIRCERA vary from country to country. Please check local regulatory guidelines for correct use of the generic name in your country. 14 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Branding Hallmarks: Colours To maintain uniformity in the global branding of MIRCERA, the Pantone Matching System® (PMS), an internationally recognised standard for colour matching and printing, should be used. The appearance of the MIRCERA colours may vary somewhat depending on the paper stock or background. However, to ensure global uniformity, please use the following Pantone® colours. The colours for MIRCERA are avant-garde purple (PMS 260) and courageous orange (PMS 1665), which synergistically communicate a provocative, visionary, yet compassionate entrant into anaemia management. Branding Hallmarks: Competitive Colour Palette The colours below are recommended when representing competitors and other comparators in bar graphs, pie charts and other graphics. C:0 M: 20 Y : 60 K : 20 Aranesp® (darbepoetin alfa) R : 202 G: 165 B : 83 C : 10 M: 80 Y : 50 K : 10 Procrit®/Epogen® (epoetin alfa) R : 186 G: 59 B : 70 MIRCERA Purple C: 66 M: 100 Y: 6 K: 28 R: 98 G: 37 B: 103 HTML: 622567 Eprex® (epoetin alfa) C : 60 M: 0 Y : 30 K : 20 R : 74 G: 147 B : 145 NeoRecormon® (epoetin beta) C :0 M : 40 Y :0 K : 10 R : 222 G: 150 B : 173 PMS 260 MIRCERA Orange C: 0 M: 76 Y: 100 K: 0 R: 221 G: 72 B: 20 HTML: DD4814 C :0 M: 0 Y:0 K : 45 Placebo R : 143 G: 143 B : 143 ESAs C : 30 M: 0 Y : 55 K : 25 R : 131 G: 160 B : 98 PMS 1665 C : 50 M : 15 Y :0 K : 10 General information R : 114 G : 154 B : 198 Pantone and Pantone Matching System are registered trademarks of Pantone, Inc. The colours shown throughout this document, except for actual PANTONE colour swatch sheets, are not intended to match the Pantone colour standards. For accurate Pantone colour standards, refer to the most current Pantone formula guide. Aranesp is a registered trademark of Amgen Inc. Eprex is a registered trademark of Johnson & Johnson. NeoRecormon is a registered trademark of F. Hoffmann-La Roche Ltd. 16 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Branding Hallmarks: Typography A typeface reflects the brand’s character and tone. The typeface family for materials in support of MIRCERA is Myriad Pro. As an alternative, the corresponding font weights found in Myriad may also be used. Headlines/Subheads Myriad Pro Black Body Copy Myriad Pro Roman ABCDEFGHIJKLMNOPQRSTUVWXYZ123 4567890abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? Myriad Pro Black Italic ABCDEFGHIJKLMNOPQRSTUVWXYZ1234567890 abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? Myriad Pro Italic ABCDEFGHIJKLMNOPQRSTUVWXYZ1234 567890abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? Myriad Pro Bold ABCDEFGHIJKLMNOPQRSTUVWXYZ1234567890 abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? Please see section 5: Electronic Communication for the alternative typeface to be used in Microsoft® Office programs, including PowerPoint® presentations, Excel®, Word® and Outlook®. ABCDEFGHIJKLMNOPQRSTUVWXYZ1234 567890abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? Myriad Pro Bold Italic ABCDEFGHIJKLMNOPQRSTUVWXYZ12345 67890abcdefghijklmnopqrstuvwxyz ~!@#$%^&*()_+{}|:”<>? 18 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Branding Hallmarks: Logo The MIRCERA logo should be considered artwork and is not to be typeset under any circumstances. This logo has been thoughtfully crafted, reviewed and validated through market research to communicate key elements of the MIRCERA brand. As such, the MIRCERA logo should only be reproduced from the electronic files provided. This logo may not be “set in” and is not interchangeable with any standard typeface. Launch Logo Cluster The logo cluster for MIRCERA consists of the following elements: • Typographical art of the brand MIRCERA followed by the registered symbol ® • The MIRCERA symbol, which consists of 4 droplets arranged in a circular, clockwise pattern • The typographical art of the generic name • The MIRCERA crystalised product promise, “Continuous activity. Targeted stability.” At launch and after launch, a white background is preferred for the logo cluster. See “Special Logo Usage” section on page 26 for guidelines on using colour backgrounds. • MIRCERA Purple is used for the “MIR” portion of the trade name and MIRCERA Orange is used for the “CERA” portion of the trade name • The left droplet in the symbol always follows the colour treatment of “CERA” in the trade name • The registered symbol ® always follows the colour treatment of “CERA” in the trade name According to local regulatory requirements, at 6 or 12 months after launch, the word “NEW” must be removed from the logo cluster as shown here. Please follow local regulatory guidelines for use of NEW at the time of launch and post-launch. In addition, local Roche affiliates should determine best use of the logo lockup with or without CPP and generic name based on requirements for their particular market. The first and third logos above appear with the MIRCERA crystalised product promise: Continuous activity. Targeted stability. In promotional print material pieces, such as the detail aid, the logo cluster with the crystalised product promise should appear on each spread. Post-Launch Logo Cluster 20 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Logo Usage: PMS This represents the preferred usage of the MIRCERA logo, on a white background. Consistent use of this logo will help ensure global uniformity. Logo Usage: Grayscale The MIRCERA logo is never used in black or white type. If the logo is to be used in a black and white printed piece, use the grayscale version shown below. The logo may be reproduced in grayscale if the background is less than 25% tonality and where contrast and legibility permit. Logo Usage: 4-colour (CMYK) When PMS colours cannot be used, due to printing or production limitations, this 4-colour MIRCERA in CMYK logo may be used. Logo Usage: Reversed Grayscale The MIRCERA logo may be reproduced in reversed grayscale if the background is over 50% tonality and where contrast and legibility permit. Logo Usage: RGB In PowerPoint® presentations, electronic use and Web use, this MIRCERA logo in RGB may be used. Note that colours are not consistent from one monitor to another. To show colours with the greatest accuracy, monitors should be set to their maximum brightness. The use of the sRGB colour space on monitors is also recommended. 22 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Clear Zone The clear zone refers to the minimum amount of space around the logo that must remain free of any other text or visual element. A clear space equal to the width of the “E” in the trade name of the logo is required on all 4 sides of the logo cluster. To maintain visual balance, the clear zone spacing at the top and right sides of the clear zone are slightly adjusted from that of the bottom and left-side spacing. The same clear zone should be applied with all logos including logos with the generic name and CPP. Minimum Logo Size The minimum size at which the MIRCERA logo lockup can be reproduced in print with good quality has been determined and is shown below. These dimensions are specified only for use where a smaller version of the MIRCERA logo is required— for example, on promotional items such as pens and small notepads—and should not be used anywhere else. Launch Logo The minimum size of the MIRCERA trade name, when scaled down proportionally within the logo cluster, may not appear any smaller than 28 mm. For applications of minimum logo size usage, please see the “Giveaways” section of this manual on page 58. For access to this and other logos shown in this brand book, go to the “Brand Room” in PIP on the Roche Intranet at: http://cera.intranet.roche.com. Post-launch logo 24 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Special Logo Usage In addition to white backgrounds, the MIRCERA logo may be used on a MIRCERA Purple background or a MIRCERA Orange background. On coloured backgrounds, the “CERA” portion of the logo and the corresponding left droplet always appear in white. Examples below provide approved logo use with these coloured backgrounds: On MIRCERA Purple background Logo Usage In order to maintain the integrity of the brand through consistent logo usage, please adhere to the following guidelines: • Do not use the logo in text. Instead, set the brand name in capital letters in the same font as surrounding copy and include the generic name and registered symbol ® the first time the brand name is used on every document • Do not alter the proportions, character spacing, typestyle, or character placement of the logo • The logo should only appear on a background that is white or MIRCERA purple or MIRCERA orange • Do not combine the logo with a box, circle, triangle or other graphic element. Use of the logo with such embellishment alters the logo’s image and character and should therefore be avoided • Do not crowd or violate the live area around the logo • Do not use the trade name in the possessive form For examples of unacceptable brand usage, see pages 89–93 of this manual. On MIRCERA Orange background 26 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Branding Hallmarks: Symbol As the visual element of the MIRCERA logo, the graphic MIRCERA symbol depicting 4 rotating droplets is the most immediate communication of the promise of the MIRCERA brand. Every aspect of this symbol has been carefully thought out and extensively tested in international market research to ensure that it is an accurate and compelling representation of the MIRCERA promise. In international research, the MIRCERA symbol proved to be a successful visual counterpart to the story of MIRCERA on levels that were both scientific and emotional. For physicians across cultures, the perpetual movement of the droplets conveyed energy and spoke to the erythropoietic process and the body’s potential for regeneration. Others interpreted the symbol’s motion and logical symmetry as representing the process of scientific discovery and innovation. Overall, it reflects attributes that are essential parts of the MIRCERA brand. The following pages include guidelines on the appropriate uses of the symbol and the droplets that make up the symbol. Symbol Attributes: The MIRCERA symbol consists of 4 droplets arranged so as to convey perpetual movement and activity. The left droplet is a different colour to depict once-monthly dosing, which is a differentiating attribute of MIRCERA. The colour of the left droplet always matches the colour of the “CERA” in the MIRCERA logo, to connect once-monthly dosing to the meaning of “CERA”: continuous erythropoietin receptor activator. 28 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Symbol as a Graphic Element The MIRCERA symbol is an integral part of the MIRCERA logo, but can also be used independently as a graphic element to supplement the logo in successful branding. On white backgrounds, the symbol is either given a solid-colour treatment, or it is outlined with MIRCERA Orange (left droplet) and MIRCERA Purple (3 remaining droplets). This graphic element may be used individually or in conjunction with the MIRCERA trade name graphic element. The Symbol On printed communications with coloured backgrounds, the left droplet of the symbol always appears in white with the 3 remaining droplets appearing in: • MIRCERA Purple (on MIRCERA Orange backgrounds) • MIRCERA Orange (on MIRCERA Purple backgrounds) Special use of a tinted symbol is recommended for use in certain electronic formats, including PowerPoint® Internet and intranet presentations templates. For optimal display, the tinted symbol is not recommended for printed communications. Please see pages 89–93 of this manual for examples of unacceptable usage. On white (outlined) On white (tinted) For PowerPoint® Only MIRCERA Orange at 20% opacity MIRCERA Purple at 15% opacity On MIRCERA Purple (outlined) On MIRCERA Orange (outlined) 30 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Symbol as a Graphic Element To properly highlight the left droplet, usage of the symbol graphic element is limited to: “bleeding off” the right side of the page, “bleeding off” the lower-right corner of a page or showing the symbol in full. The symbol should never bleed off the left or top edge of a page, nor should the bottom droplet ever bleed off the bottom of the page without having the right droplet bleed off the side of the page as well. Y Y SYMBOL SPACE X X Y Edge alignment for box “X” Trim area Y = 25% of X X Y 32 Do not duplicate, distribute, or use in detailing. BRANDING HALLMARKS Droplets as a Graphic Element Each of the 4 droplets that make up the MIRCERA symbol may be used separately as graphic elements. When using the droplets as a graphic element, they should be used according to the visual guidelines given on pages 28–35 herein, and adherence to the following guidelines should be maintained: • Droplet size(s) may be increased or decreased proportionately and cropped as they are on the borders of these pages, but they may not be stretched or distorted, flipped, reversed, or used in colours other than MIRCERA brand colours • Colour guidelines restricting the application of tints (given on page 16 of this manual) should be maintained when using droplets as graphic elements • An isolated droplet must always appear as positioned in the symbol—for example, the orange droplet must always have the rounded edge on the left and the point on the right • To feature one droplet alone, use the activation droplet (left droplet in symbol orange or reversed out in white) 1st droplet a unique molecule 2nd droplet unique receptor interaction Droplets The droplets were developed from the MIRCERA symbol and are used in the detail aid and other core launch campaign art as a way to show the benefits that result from continuous erythropoietin receptor activation. Each droplet is devoted to a particular brand benefit: Activation Droplet For examples of unacceptable brand usage, see pages 89–93 of this manual. 3rd droplet Hb stability maintained in tight target range 4th droplet patient benefit 34 Do not duplicate, distribute, or use in detailing. Section 3: Illustrative Style Illustrative Style Section 3: ILLUSTRATIVE STYLE Photography The role of photography in the launch campaign is to communicate the end benefit of MIRCERA for patients, giving them the energy for everyday lifestyles. Photography should be positive and depict patients in daily activities, with an emphasis on personality and brand colour. In the MIRCERA launch campaign, patient-focused photography appears only within the frame of the final droplet as the end benefit resulting from the MIRCERA story. Patient photography should never appear alone or as the singular focus of promotional materials for launch. Instead, it should play a supportive role to science-focused illustrative art, which is the dominant visual element in all promotional materials at launch. Mailbox Woman picking up daily mail Market Woman enjoying a trip to the market Photography library Photos feature MIRCERA brand colours and depict subjects engaged in positive daily activities. Subjects were chosen to represent a diverse range of patients who typify the global markets where MIRCERA is launching. Park bench Woman outside on a park bench enjoying conversation and company with her husband At home Woman taking care of household chores Soccer Grandfather spending quality time with his son and grandson Birdhouse Man engaged in a household project Travel agent Man in a positive work environment 38 Do not duplicate, distribute, or use in detailing. ILLUSTRATIVE STYLE Illustration In addition to the activity photographs in the previous page, the following portraits may be cropped if needed and used in promotional and patient education pieces. Correction and Maintenance Line as a Graphic Element An essential benefit offered by MIRCERA is a smooth and steady rise in Hb (“correction”), followed by stable Hb levels maintained in a tight target range (“maintenance”). This correction and maintenance line is such an important part of the story of MIRCERA that it has been integrated as an ongoing motif in the detail aid and other core launch campaign art. Portrait: Female Patient Portrait: Male Patient Usage rights Images in the photography library above may be used without permission, since Roche has unlimited global usage rights. Stock photography may be purchased on a market-need basis. However, Roche headquarters is not responsible for purchasing of or reimbursement for stock photography purchases. Please follow guidelines given in MIRCERA Global Approval Process on page 96 of this manual for review and approval of any material using purchased photography or images. 40 Do not duplicate, distribute, or use in detailing. ILLUSTRATIVE STYLE Applications of the Illustrative Style of MIRCERA 1st droplet—A continuous activation The unique MIRCERA molecule is the essential element in the science of MIRCERA, so it is displayed prominently in core launch campaign art. Market research revealed that, as an unfamiliar image, the molecule can be misunderstood if it is not labeled, so the first appearance of the molecule should be accompanied by the words “continuous activation” in a title or caption. 3rd droplet—Hb stability As the visual counterpart to “stable and sustained Hb levels,” this third droplet features a maintenance graph. Hb is shown within a desired target range that is familiar to physicians who treat patients with anaemia. This graphic is a key element in explanations of efficacy. 4th droplet—Patient benefit 2nd droplet—Unique receptor interaction The molecule is shown within the context of a cell wall with receptor proteins. Continuous receptor activation is depicted through use of light where the molecule interacts with the receptor. The fourth droplet features a patient enjoying an everyday activity to visually communicate the end benefit offered by MIRCERA—the benefit to patients who may resume daily activities as a result of treatment with MIRCERA. 42 Do not duplicate, distribute, or use in detailing. Section 4: Applications of Global Branding Applications of Global Branding Section 4: APPLICATIONS OF GLOBAL BRANDING Launch Advertisements The launch advertisements bring together all elements of the core launch campaign—the correction and maintenance line, MIRCERA droplets and core imagery. They were developed and tested extensively to tell the story of MIRCERA at a single glance. These executions feature the MIRCERA molecule framed by an illuminated droplet, leading along a correction and maintenance line to droplets featuring continuous erythropoietin receptor activation, Hb stability and patient benefit. Single page A horizontal, single-page version of this advertisement is also available. See art files. NOW AVAILABLE FOR CKD-RELATED ANAEMIA Spread ONCE-MONTHLY MAINTENANCE FOR ALL PATIENTS 1–3 NOW AVA I L A B L E FOR CKD-RELATED ANAEMIA ONCE-MONTHLY MAINTENANCE FOR ALL PATIENTS 1-3 Introducing a new molecule for continuous activation1,4,5 Brief Prescribing Information Introducing a new molecule for continuous activation1,4,5 Brief Prescribing Information Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi.vel accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi.dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatuat vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatudolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum. References: 1. MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007. 2. Levin NW, Fishbane S, Valdés Cañedo F, et al. Once-monthly intravenous C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease receiving dialysis. Kidney Int. [In press]. 3. Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous C.E.R.A. maintains stable control in patients with chronic kidney disease on dialysis directly converted from epoetin one to three times weekly. Clin J Amer Soc Nephrol. [In press]. 4. Jarsch M, Brandt M, Haselbeck A. Consumption of C.E.R.A. and epoetin beta in cellular assay: UT-7 consumption model. Presented at American Society of Hematology (ASH) 48th Meeting, December 9–12, 2006; Orlando, FL. 5. Jarsch M, Lanzendörfer M, Brandt M, Haselbeck A. Different receptor binding kinetics of C.E.R.A. compared with epoetin beta determined by surface plasmon resonance and competition binding assay in cultured UT-7 cells. Am J Nephrol. [In press]. F. Hoffmann-La Roche Ltd 4070 Basel, Switzerland Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipminim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipeuismod ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim quivel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissimqui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Lorem ipsum dolor sit amet, consectetuer blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipminim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipeuismod blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipminim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquipeuismod ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim quit. References: 1. MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007. 2. Levin NW, Fishbane S, Valdés Cañedo F, et al. Once-monthly intravenous C.E.R.A. maintains stable control of hemoglobin in patients with chronic kidney disease receiving dialysis. Kidney Int. [In press]. 3. Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous C.E.R.A. maintains stable Hb control in patients with chronic kidney disease on dialysis directly converted from epoetin one to three times weekly. Clin J Amer Soc Nephrol. [In press]. 4. Jarsch M, Brandt M, Haselbeck A. Consumption of C.E.R.A. and epoetin beta in cellular assay: UT-7 consumption model. Presented at American Society of Hematology (ASH) 48th Meeting, December 9–12, 2006; Orlando, FL. 5. Jarsch M, Lanzendörfer M, Brandt M, Haselbeck A. Different receptor binding kinetics of C.E.R.A. compared with epoetin beta determined by surface plasmon resonance and competition binding assay in cultured UT-7 cells. Am J Nephrol. [In press]. F. Hoffmann-La Roche Ltd 4070 Basel, Switzerland These images are intended as visual guidance only— Please do not use as final content. These images are intended as visual guidance only— Please do not use as final content. 46 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Launch Detail Aid The Launch Detail Aid was developed for use by Roche representatives who will be calling on physicians to introduce them to the benefits of MIRCERA. The Launch Detail Aid is intended to support representatives’ verbal presentations. It contains market-tested messages, charts, graphs, data, efficacy and safety information. The recommended template for the Global Launch Detail Aid shown here is given with a MIRCERA purple background. White-background options of scientific spreads of the Launch Detail Aid are also available for use in certain markets if legal, regulatory, and cultural issues arise. Please see page 53 for examples and guidelines on using white-background executions of these spreads. Cover The cover announces NEW MIRCERA for patients with CKD-related anaemia. The cover features the MIRCERA molecule inside a droplet. The droplet is illuminated, and the molecule is surrounded by orbitals of energy to convey an innovative mechanism of action (MOA)—continuous erythropoietin receptor activation. NOW AVAILABLE FOR CKD-RELATED ANAEMIA, THE INNOVATION OF… These images are intended as visual guidance only— Please do not use as final content. 48 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Inside spread Bringing together all launch elements including the Hb correction and maintenance line and the MIRCERA droplets, the inside spread features the molecule in a state of continuous activation, followed by an Hb stability line, and a patient with an improved quality of life. Each of these images appears along a stylised correction and stability line, and each is framed by 1 of the 4 droplets that makes up the MIRCERA symbol. Captions appear under each droplet to add clarity about the benefit shown. ONCE-MONTHLY MAINTENANCE FOR ALL PATIENTS1-4 CONTINUOUS RECEPTOR ACTIVATION 1,5,6 Hb STABILITY 2,3 HELPS IMPROVE PATIENT CARE 2,3 These images are intended as visual guidance only— Please do not use as final content. 50 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Recommended Spreads (Purple Background) The standard template for the Global Launch Detail Aid, recommended where permitted in markets worldwide, is the purple-background version shown below. Spreads (White Background) If local rules, regulations or cultural associations hinder the use of a purple background, the white-background version shown below is available. MIRCERA—unique receptor interaction and longer half-life allows for sustained predictable anaemia management1,3,5,6 The first and only continuous erythropoietin receptor activator1,5 First approved chemically synthesised erythropoiesis-stimulating agent (ESA)1,6 Treats anaemia by continuously activating the erythropoietin receptor1,5 Yields predictable and stable Hb levels in target range3 MIRCERA has the longest half-life of all ESAs ...Up to 6 times longer than darbepoetin alfa1,6 IV half-life of ESAs1,7-9 134 MIRCERA—unique receptor interaction and longer half-life allows for sustained predictable anaemia management1,3,5,6 The first and only continuous erythropoietin receptor activator1,5 First approved chemically synthesised erythropoiesis-stimulating agent (ESA) 1,6 MIRCERA has the longest half-life of all ESAs ...Up to 6 times longer than darbepoetin alfa1,6 IV half-life of ESAs1,7-9 134 MOA/PK MOA/PK MIRCERA Treats anaemia by continuously activating the erythropoietin receptor1,5 Yields predictable and stable Hb levels in target range3 MIRCERA darbepoetin alfa 21 darbepoetin alfa 21 MIRCERA acts differently at the receptor level 6,* epoetin beta MIRCERA acts differently at the receptor level 12 6,* epoetin beta 12 epoetin alfa 5 epoetin alfa 5 0 24 48 72 96 120 144 0 24 48 72 96 120 144 IV half-life in hours IV half-life in hours The half-life of MIRCERA is equivalent following IV or SC administration1 The half-life of MIRCERA is equivalent following IV or SC administration1 Reduced affinity for the receptor allows continuous stimulation5,6 Continuous activation more closely mimics the body’s physiologic processes6 Please see Summary of Product Characteristics. * Compared to epoetin. Reduced affinity for the receptor allows continuous stimulation5,6 Continuous activation more closely mimics the body’s physiologic processes6 Please see Summary of Product Characteristics. * Compared to epoetin. 2 3 2 3 Proven high success rate in correction MIRCERA achieved target Hb levels in up to 97.5% of patients1,10 MIRCERA response rate in correction9,* MIRCERA delivers the confidence of a smooth and steady rise in Hb levels10 Mean Hb during correction phase 15 14 13 Proven high success rate in correction MIRCERA achieved target Hb levels in up to 97.5% of patients1,10 MIRCERA response rate in correction9,* MIRCERA delivers the confidence of a smooth and steady rise in Hb levels10 Mean Hb during correction phase10 15 10 n= 162 n= 324 n= 162 n= 324 14 13 12 12 11 11 10 10 n=162 9 8 BL 4 8 12 16 darbepoetin alfa MIRCERA 20 24 97.5% Comparable results achieved in dialysis patients treated with IV MIRCERA (n=181) —response rate 93.3%11 In correction studies, MIRCERA was dosed every 2 weeks10,11 n=162 9 8 BL 4 8 12 16 darbepoetin alfa MIRCERA 20 24 CORRECTION CORRECTION Weeks 97.5% Comparable results achieved in dialysis patients treated with IV MIRCERA (n=181) Weeks Fewer patients exceeded Hb level of 13 g/dL during correction with MIRCERA10 Patients with at least 1 Hb excursion >13 g/dL during first 8 weeks of treatment10 P<0.0001 Patients in first 8 weeks (%) 30 Fewer patients exceeded Hb level of 13 g/dL during correction with MIRCERA10 Patients with at least 1 Hb excursion >13 g/dL during first 8 weeks of treatment10 P<0.0001 Patients in first 8 weeks (%) —response rate 93.3%11 In correction studies, MIRCERA was dosed every 2 weeks10,11 34% 20 30 34% 20 10 10 12% 0 12% 0 1x/2 wks (n=162) MIRCERA† darbepoetin alfa† 1x/wk (n=162) 1x/2 wks (n=162) MIRCERA† darbepoetin alfa† 1x/wk (n=162) Please see Summary of Product Characteristics. * Hb response defined as increase ≥1.0 g/dL vs baseline and concentration ≥11 g/dL without blood transfusion and during first 24 weeks.10,11 † Please see Summary of Product Characteristics. Dosed as per label. 4 5 * Hb response defined as increase ≥1.0 g/dL vs baseline and concentration ≥11 g/dL without blood transfusion and during first 24 weeks.10,11 † Dosed as per label. 4 5 MIRCERA—safety comparable to shorter-acting ESAs2,3,10,11,13 In clinical trials with nearly 1800 patients, MIRCERA was generally well tolerated Most frequent adverse events12,* Adverse events Patients treated with MIRCERA (n=1789) Patients treated with darbepoetin alfa, epoetin alfa, or epoetin beta (n=948) Reduces risk for you and your staff No refrigeration necessary for 1 month1 Room temperature shelf life1,7-9 MIRCERA darbepoetin alfa epoetin beta† epoetin alfa 0 MIRCERA—safety comparable to shorter-acting ESAs2,3,10,11,13 In clinical trials with nearly 1800 patients, MIRCERA was generally well tolerated Reduces risk for you and your staff No refrigeration necessary for 1 month1 Room temperature shelf life1,7-9 MIRCERA 31 7 5 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 Most frequent adverse events12,* Adverse events Patients treated with MIRCERA (n=1789) Patients treated with darbepoetin alfa, epoetin alfa, or epoetin beta (n=948) 31 7 5 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 darbepoetin alfa epoetin beta† epoetin alfa Hypertension 14% 14% Hypertension 14% 14% Days Days Diarrhoea 11% 11% Reduced risk of spoiled product due to interruption of cold chain Once removed from refrigeration, the product must be used within 1 month or discarded Diarrhoea 11% 11% Reduced risk of spoiled product due to interruption of cold chain Once removed from refrigeration, the product must be used within 1 month or discarded Nasopharyngitis 11% 10% Nasopharyngitis 11% 10% Upper respiratory tract infection Fewer injections 9% 8% Upper respiratory tract infection Fewer injections 9% 8% Injections per year with MIRCERA vs shorter-acting ESAs1,7,9 Headache 9% 9% Epoetin 3x/wk Darbepoetin alfa or epoetin 1x/wk Once-monthly MIRCERA Injections per year with MIRCERA vs shorter-acting ESAs1,7,9 Headache 9% 9% Epoetin 3x/wk Darbepoetin alfa or epoetin 1x/wk Once-monthly MIRCERA Adverse events were typical for this patient population2,3,10,11 No cases of pure red blood cell aplasia (PRCA) have been reported in patients treated with MIRCERA12 156 52 12 Adverse events were typical for this patient population2,3,10,11 No cases of pure red blood cell aplasia (PRCA) have been reported in patients treated with MIRCERA12 156 52 12 Reduced risk of needlestick injuries Please see Summary of Product Characteristics. * Pooled data from 6 phase 3 studies of patients on dialysis and not on dialysis. † Reduced risk of needlestick injuries Please see Summary of Product Characteristics. Shelf life of epoetin beta multi-dose vials. Shelf life of prefilled syringes is 3 days. * Pooled data from 6 phase 3 studies of patients on dialysis and not on dialysis. † Shelf life of epoetin beta multi-dose vials. Shelf life of prefilled syringes is 3 days. 8 9 8 9 These images are intended as visual guidance only— Please do not use as final content. These images are intended as visual guidance only— Please do not use as final content. 52 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Letterhead The MIRCERA letterhead includes MIRCERA branding and the Roche logo. Branded Clinical Materials For branded clinical materials, colours and other elements are minimised and understated in order to establish an objective, unbiased approach. Scientific Poster Template Mr. Peter Taylor Director Sample Department Sample Company Ltd Sample Street 00 P.O. Box 0000 Capital City Samplecountry TITLE OF POSTER GOES HERE First Name, Second Name, Third Name, Fourth Name, Fifth Name ABSTRACT Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna ali quam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcor per suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna ali quam erat volutpat. facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut blandit praesent luptatum zzril delenit augue duis dolore te feugai. dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna ali quam erat volutpat. CONCLUSION Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option congue nihil imperdiet doming id quod mazim placerat facer possim assum. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamc. RESULTS Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, DISCUSSION Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna ali quam erat volutpat. Autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie con sequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugai.feugait nulla facilisi. Lorem ipsum dolor sit amet, con sectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulp utate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend odio dignissim qui blandit praesassum. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna ali quam erat volutpat. Autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie con sequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugai. Basel, 00. January 2000 Vaniente autem Tharsia Dear Mr Taylor I refer to sunnt consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue. Minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option. Vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Nam liber tempor cum soluta nobis eleifend option. Sincerely yours REFERENCES 1. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non 2. Ummy nibh euismod tincidunt ut laoreet dolom erat volut 3. Pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper 4. Suscipit lobortis nisl ut aliquip ex ea commodo consequa 5. Eum iriure dolor in hendrerit in vulputate velit esse molestie 6. Illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulpu tate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tin cidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper susciit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie conseet iusto odio dignisim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla sed diam nonummy nibh euismod eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscip it lobortis nisl ut aliquip ex ea commodo consequat. Quisque non ipsum a mi varius scelerisque. Nam at quam. Aliquam posuere purus eget risus. Etiam Lorem Quisque non ipsum a mi varius 00-ng n+332 Etiam Aliquam erat volutpat. Cras placerat Aliquam Nam METHODS Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscip it lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iri ure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignis sim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscip it lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum irure dolor in hendrerit in vulputate velit esse molestie cnsequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut pat. Ut wisi enim ad minim veniam, quis nostrud modo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie con sequat, vel illum dolore eu feugiat nulla facilisis at. Vero eros et accumsan et iusto odio dignissim qui blandit praesent lup tatum zzril delenit augue duis dolore te feugait nulla facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euis mod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper suscipit lobortis nisl ut aliquip ex ea commodo consequat. Autem vel iusto odio dignissim qui Etiam tin cidunt Aliquam posuere Class aptent taciti purus eget risus. sociosqu ad litora Etiam dui lorem torquent Aliquam posuere Class aptent taciti purus eget risus. sociosqu ad litora Etiam dui lorem torquent Aliquam posuere Class aptent taciti purus eget risus. sociosqu ad litora Etiam dui lorem torquent Aliquam posuere Class aptent taciti purus eget risus. sociosqu ad litora Etiam dui lorem torquent Aliquam posuere Class aptent taciti purus eget risus. sociosqu ad litora Etiam dui lorem torquent Etiam tin cidunt Etiam tin cidunt Etiam tin cidunt Etiam tin cidunt Etiam tin cidunt 00-ng n+332 Etiam tin cidunt Etiam tin cidunt Etiam tin cidunt Etiam tin cidunt facilisi. Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam nonummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volutpat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcor per suscipit lobortis nisl ut aliquip ex ea commodo consequat. Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio Lorem ipsum dolor sit amet, consectetuer adipiscing elit. Quisque non ipsum a mivarius scelerisque. dignissim qui blandit praesent luptatum zzril delenit augue duis dolore te Nam at quam. Aliquam posuere purus eget risus. Etiam dui lorem, fermentum mattis, consectetuer ac, feugait nulla facilisi. molestie quis, enim. Nam ultrices, enim sed adipiscing dictum, neque lorem interdum tortor, id vehicula Lorem ipsum dolor sit amet, consectetuer adipiscing elit, sed diam non Duis autem vel eum iriure dolor in hendrerit in vulputate velit esse molestie ummy nibh euismod tincidunt ut laoreet dolore magna aliquam erat volut consequat, vel illum dolore eu feugiat nulla facilisis at vero eros et accumsan pat. Ut wisi enim ad minim veniam, quis nostrud exerci tation ullamcorper et iusto odio dignissim qui blandit praesent luptatum zzril delenit augue duis illum dolore eu feugiat nulla facilisis at vero eros et accumsan et iusto odio 00-ng n+332 00-ng n+332 00-ng n+332 M. Sample c.c. AB/CD F. Hoffman La-Roche Ltd Street 000 X Y-0000 City Country Pharma Business Development & Strategic Marketing Bldg. 000 / 000 Tel. +00 - 000 00 00 Fax +00 - 000 00 00 m.sample.pharma.busines s development@roche.com 54 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Branded Training Materials Monograph Sales Training Landscape MONOGRAPH INTRODUCTION TO RENAL ANAEMIA Proprietary and confidential. For internal use only. Not to be distributed outside Roche or used in discussions with healthcare providers. INTRODUCTION TO CKD LOREM: IPSUM DOLOR SIT AMET Excepteur sint occaecat cupidatat Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisiut aliquip ex ea commodo consequat. Excepteur sint occaecat cupidatat non proident, sunt in culpaqui officia deserunt mollit anim id est laborum:Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum: LOREM: IPSUM DOLOR SIT AMET Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit laborum… Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur,labore et dolore magnam aliquam quaerat voluptatem. LOREM IPSUM DOLOR: Sed ut perspiciatis unde omis SINT™ (eiusmod tempor) Empor Sed ut perspiciatis unde omis iste natus error sit4,5 EXCEPTEUR™ ab/illo Quis nostrud exercitation ullamco laboris FG-2216 Fibro/Ast Sed ut perspiciatis unde omis iste natus error sit4,5 Anaemia Risk in CKD Anaemia is an important complication and a risk multiplier in patients with CKD. It is most commonly diagnosed in Stage 3 and later, but may develop in earlier stages. Anaemia may develop early in the course of CKD and worsens as CKD progresses. Anaemia is a shortage of red blood cells and haemoglobin in the body. It results in reduced oxygen-carrying capacity of the blood The primary cause of anaemia in CKD is the inability of diseased kidneys to secrete a sufficient amount of erythropoietin, a hormone that regulates red blood cell production Among other symptoms, anaemia causes debilitating weakness and fatigue, affects cognitive function, and negatively impacts quality of life. It also contributes to the development of cardiovascular disease Current practice guidelines emphasize early detection and correction of anaemia as the standard of care for patients with CKD CKD-related anaemia can usually be corrected with administration of synthetic forms of erythropoietin called erythropoiesis-stimulating agents Internal Structure of the Kidney The kidney has 3 distinct regions: The outer cortex consists of blood vessels and tubules of nephrons, which form urine The inner medulla consists of renal pyramids, which contain urine-collecting ducts. Renal papilla at the tip of each pyramid drain urine The renal pelvis is an extension of the ureter that branches into calyces, which collect urine from nephrons Structure of the Kidney (A) and Nephron (B) Renal Pyramid Glomerulus Bowman’s Capsule • Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed • Lorem ipsum dolor sit amet, consectetur adipisicing elit — Dolore eu fugiat nulla pariatur Major Calyx Minor Calyx Renal Pelvis Collecting Duct Renal Tubule do eiusmod tempor incididunt ut labore et dolore magna aliqua. Sed ut perspiciatis Nisi ut aliquip ex ea commodo Sed do eiusmod tempor incididunt ut labore4,5 Lorem ipusum dolor sit amet consectetur adipisicing elit Quis nostrud exercitation ullamco laboris Kidney Structure and Function General Description The kidneys are organs of the urinary (renal) system whose functions include: Removal of waste and fluid for excretion in the urine Regulation of body fluids, blood pressure, RBCs (Red Blood Cells) and of vitamin D activation Urine produced by the kidneys is eliminated from the body via the ureters, bladder, and urethra. Renal Papilla Medulla • Excepteur sint occaecat cupidatat non proident • Lorem ipsum dolor sit amets sunt in culpa qui officia Consequat duis aute irure Lorem ipusum dolor sit amet consectetur adipisicing elit4 Quis nostrud exercitation ullamco laboris Sed ut perspiciatis unde omis iste natus error sit4,5 A Cortex B Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. et dolore magna aliqua. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Nephrons Nephrons are the functional units of the kidney that form urine. Each kidney contains approximately 1 million nephrons The number of functioning nephrons does not increase after birth and declines gradually with advancing age Due to the large reserve capacity of the kidneys, individuals can survive with one healthy kidney In the process of forming urine, nephrons remove waste from the blood and adjust the volume, composition, and acidity of the fluid in the body. Renal Blood Vessels The kidneys are highly vascular organs that receive approximately 20% of the cardiac output: A renal artery supplies blood to each kidney. The renal artery divides into branches that supply blood to different areas of the kidney Blood leaves the kidney via the renal vein Maintenance of blood pressure and blood flow within normal limits is necessary for the kidneys to effectively filter waste from the blood and regulate the volume and composition of body fluids. Excepteur sint occaecat cupidatat non proident! Proprietary and confidential. For internal use only. Not to be distributed outside Roche or used in discussions with healthcare providers. Proprietary and confidential. For internal use only. Not to be distributed outside Roche or used in discussions with healthcare providers. 2 FOR INTERNAL REVIEW ONLY. NOT TO BE USED IN DISCUSSIONS WITH PHYSICIANS. FOR INTERNAL REVIEW ONLY. NOT TO BE USED IN DISCUSSIONS WITH PHYSICIANS. 3 4 5 These images are intended as visual guidance only— Please do not use as final content. These images are intended as visual guidance only— Please do not use as final content. 56 Do not duplicate, distribute, or use in detailing. APPLICATIONS OF GLOBAL BRANDING Giveaways Branded premiums should feature the logo cluster or symbol, along with the Roche hexagon, according to the sections 2 and 7 of this manual: Branding Hallmarks and Roche Logo Guidelines. Panels and Signage New signage with the launch concept integrated is currently in development. Until launch, please refer to guidance in the Phase 1 Brand book. 58 Do not duplicate, distribute, or use in detailing. Section 5: Electronic Communication Section 5: Electronic Communication All electronic communication including PowerPoint® presentations and e-mail messages should be consistent with branding guidelines contained herein Section 1: Building a Global ELECTRONIC COMMUNICATION PowerPoint® Slide Templates There are 2 branded slide formats for presentations, with colour or white background. The Arial typeface family is recommended for use in all MIRCERA PowerPoint presentations. If Arial is not available on your computer, the Imago font may also be used. Presentations for external use should be submitted for approval by Medical-Legal-Regulatory. For information and approvals, please contact the appropriate international product manager or business leader at Roche Headquarters. Use of Colour in PowerPoint® Presentations The RGB equivalents of PMS 260 and PMS 1665 for PowerPoint® presentations are illustrated below. MIRCERA Purple for PC MIRCERA Purple for Mac Title Area To maintain consistency, all titles and subtitles should be set within the the text area specified by the dotted magenta area below and should never run over the MIRCERA symbol graphic element. 38 mm 212.7 PMS 260 R : 98 G: 37 B : 103 MIRCERA Orange for PC MIRCERA Orange for Mac 76 SAMPLE HEADLINE SET HERE IN ARIAL BOLD AT 32 PT. Subtitle set here in Arial Italic at 28 pt. PMS 1665 R : 221 G: 72 B : 20 155.5 PowerPoint is a registered trademark of Microsoft Corporation. PowerPoint is a registered trademark of Microsoft Corporation. 62 Do not duplicate, distribute, or use in detailing. ELECTRONIC COMMUNICATION Slide Format Colour Background This is the template for presentations in which the MIRCERA brand name, symbol and logo will be used in conjunction with a colour background. Content slide: • Headline is set in Arial Bold at 28 pt white type within the MIRCERA Orange bar at top of page • Subhead (if needed) is set in Arial Italic at 26 pt white type • First level of text is set in Arial at 24 pt white type, with each subsequent level set in smaller sizes at 2 pt intervals (22 pt, 20 pt, 18 pt, etc) • Pagination is centred at the bottom of the slide and is set in Arial 8 pt white type HEADLINE IN ARIAL BOLD AT 28 PT. Subtitle is set here in Arial Italic at 26 pt. First level of text is set in Arial at 24 pt. • Second level of text is set in Arial at 22 pt. – Third level of text is set in Arial at 20 pt. Title slide: • The title and a second line (if needed) are set in Arial Bold at 32 pt white type • Subtitles (if needed) are set in Arial Italic at 28 pt white type • MIRCERA name (vertical treatment) and symbol are used as graphic elements SAMPLE HEADLINE SET HERE IN ARIAL BOLD AT 32 PT. Subtitle set here in Arial Italic at 28 pt. Title slide Content slide with logo HEADLINE IN ARIAL BOLD AT 28 PT. Subtitle is set here in Arial Italic at 26 pt. First level of text is set in Arial at 24 pt. • Second level of text is set in Arial at 22 pt. – Third level of text is set in Arial at 20 pt. SAMPLE HEADLINE SET HERE IN ARIAL BOLD AT 32 PT. Subtitle set here in Arial Italic at 28 pt. Title slide with CPP Content slide with symbol 64 Do not duplicate, distribute, or use in detailing. ELECTRONIC COMMUNICATION Slide Format White Background This is the template for presentations in which the MIRCERA brand name and logo will be used in conjunction with a white background. Content slide: • Headline is set in Arial Bold at 28 pt MIRCERA Purple type • Subhead (if needed) is set in Arial Italic at 26 pt MIRCERA Purple type • Thin 4.5-pt rule separates headline from body copy • First level of text is set in Arial at 24 pt black type, with each subsequent level set in smaller sizes at 2 pt intervals (22 pt, 20 pt, 18 pt, etc) • Pagination is centred at the bottom of the slide and is set in Arial 8 pt MIRCERA Orange type HEADLINE IN ARIAL BOLD AT 28 PT. Subtitle is set here in Arial Italic at 26 pt. First level of text is set in Arial at 24 pt. • Second level of text is set in Arial at 22 pt. – Third level of text is set in Arial at 20 pt. Title slide: • The title and a second line (if needed) are set in Arial Bold at 32 pt MIRCERA Purple type • Subtitles (if needed) are set in Arial Italic at 28 pt MIRCERA Purple type • MIRCERA name (vertical treatment) is used as a graphic element SAMPLE HEADLINE SET HERE IN ARIAL BOLD AT 32 PT. Subtitle set here in Arial Italic at 28 pt. Title slide Content slide with logo HEADLINE IN ARIAL BOLD AT 28 PT. Subtitle is set here in Arial Italic at 26 pt. First level of text is set in Arial at 24 pt. • Second level of text is set in Arial at 22 pt. – Third level of text is set in Arial at 20 pt. SAMPLE HEADLINE SET HERE IN ARIAL BOLD AT 32 PT. Subtitle set here in Arial Italic at 28 pt. 66 Title slide with CPP Do not duplicate, distribute, or use in detailing. Content slide with symbol ELECTRONIC COMMUNICATION E-mail Template This is an internal template intended for MIRCERA news about new publications materials, direction and updates. 68 Do not duplicate, distribute, or use in detailing. Section 6: Messages and Brand Vocabulary Messages and Brand Vocabulary Section 6: MESSAGES AND BRAND VOCABULARY MIRCERA Messages The core promotional messages of MIRCERA inform physicians about its key brand attributes, create a common language between Roche and physicians and convince physicians to prescribe MIRCERA. Message rationale and intended use A single “umbrella” message encapsulates the overall benefit offered by MIRCERA within each of the 4 key and 3 supportive categories. Also, each category includes several ancillary messages. Umbrella messages should guide the development of headlines in most cases. Ancillary messages should fit within subheads and body copy. Overall message The core of MIRCERA is encompassed in the following 4 key message categories: Reason to believe MOA/ Pharmacokinetics Conversion 4 Targeted Hb stability Once-monthly dosing for all patients 1 Safety 3 2 Efficacy The message of what MIRCERA offers is simple, direct and concise. Further, the key messages of MIRCERA are supported by messages from the following 3 categories: • Dosing • Patient outcomes • Value 72 Do not duplicate, distribute, or use in detailing. MESSAGES AND BRAND VOCABULARY Messages from the 4 key categories MOA/Pharmacokinetics Umbrella: MIRCERA—through its unique receptor interaction and longer half-life—delivers sustained, predictable anaemia management Ancillary messages: • MIRCERA acts differently at the receptor level • Due to its unique receptor interaction, once-monthly MIRCERA provides stable haemoglobin levels • MIRCERA has the longest half-life of all anti-anaemia agents— up to 6 times longer than darbepoetin alfa • Introducing a new class of anti-anaemia agents Safety Umbrella: MIRCERA demonstrated safety comparable to shorter-acting ESAs Ancillary messages: • In clinical trials with nearly 1800 patients MIRCERA was generally well-tolerated • MIRCERA protects patients with a smooth and steady rise in Hb levels • Adverse events were comparable to other ESAs and typical for this patient population Efficacy Umbrella: MIRCERA provides stable and sustained Hb levels with once-monthly dosing in all patient types Ancillary messages (correction): • MIRCERA achieved target Hb levels in up to 97.5% of patients • MIRCERA protects patients with a smooth and steady rise in Hb levels • 34% of patients receiving darbepoetin alfa exceeded Hb target (>13 g/dL) in the first 8 weeks of treatment, versus only 12% of patients receiving MIRCERA Ancillary message (maintenance): • Stable and sustained Hb levels with once-monthly MIRCERA in all patients Conversion Umbrella: Successful conversion to once-monthly MIRCERA with consistent Hb stability Ancillary messages: • Patients previously maintained on shorter-acting ESAs were successfully converted to once-monthly MIRCERA • Stable Hb in target range achieved regardless of previous ESA dosing frequency 74 Do not duplicate, distribute, or use in detailing. MESSAGES AND BRAND VOCABULARY Messages from the 3 supportive categories Dosing Umbrella: MIRCERA provides predictable Hb stability with once-monthly dosing Ancillary message: • Once-monthly MIRCERA is effective in maintaining haemoglobin levels regardless of route of administration—at the same IV or SC dose Value Umbrella: Once-monthly MIRCERA provides efficiencies to you, your renal care settings and your patients Ancillary messages: • No refrigeration necessary for 1 month • Remarkably fewer injections vs shorter-acting ESAs • For your nurses and administrators, once-monthly MIRCERA allows more time to devote to other patient needs Patient outcomes Umbrella: Effective anaemia management improves long-term patient outcomes Ancillary messages: • Stable Hb levels in target range are associated with a decreased risk for hospitalisation, mortality and cardiovascular disease • Patients treated with MIRCERA showed significantly greater improvement in patient energy and functional capacity • MIRCERA maintains stable Hb levels with as few as 12 injections per year These messages are intended to cover the key benefits MIRCERA offers physicians and patients, but these messages are not meant to be an exhaustive resource. 76 Do not duplicate, distribute, or use in detailing. MESSAGES AND BRAND VOCABULARY MIRCERA Brand Vocabulary The objective of the MIRCERA Brand Vocabulary is to create a proprietary language that is consistent across all forms of communication and that is uniquely and immediately associated with the name MIRCERA. Through use of highly standardised and consistent language, the brand vocabulary also continually confirms a connection between MIRCERA and a certain set of positive product attributes. Topic Name Brand Name (chemical name) MIRCERA®* Global Brand Vocabulary Recommended Language MIRCERA® (methoxy polyethylene glycol-epoetin beta) MIRCERA, a continuous erythropoietin receptor activator Non-recommended Language Use of MIRCERA and C.E.R.A. together in same context is not allowed: MIRCERA (C.E.R.A.) Neither C.E.R.A. nor spelled out version may be placed in parentheses or brackets: MIRCERA (Continuous Erythropoietin Receptor Activator) In publications: If the name ‘MIRCERA’ cannot be used in a publication, then use ‘C.E.R.A.’ In the title, use only ‘C.E.R.A.’, without ‘continuous erythropoietin receptor activator.’ The 1st time C.E.R.A. is used in the body text, C.E.R.A. must be accompanied by “is a continuous erythropoietin receptor activator” or “a continuous erythropoietin receptor activator”. Continuous Activity. Targeted Stability. Traditional ESAs/short-acting Shorter-acting ESAs Frequently dosed ESAs Biosimilars Biogenerics No translation of CPP allowed Anti-anaemia agents MIRCERA CPP Competitive Agents Note: When describing a competitive agent, use its full generic name. Never use competitive brand names or shortcuts (eg, EPO). Conversion dose categories Direct conversion Successful conversion Conversion factor Conversion Note: The word “switch” should be limited to use for journalists and should always be accompanied by the word “conversion” Correction Achieved predictable Hb levels Smooth and steady rise of haemoglobin ESA-naïve patients Epoetin-naïve patients Once every 2 weeks correction in all CKD patients q2w Treatment Correction Disease CKD-related anaemia Patients with CKD on dialysis (Stage 5) Patients with CKD not on dialysis (Stages 1-4) Dosing Regimen Once-monthly dosing Q4W, Q2W (only to describe study design/methodology) As few as 12 injections per year Half-life Longest half-life of all ESAs Up to 6 times longer half-life than darbepoetin alfa Equivalent half-life following IV or SC administration (~130 h) *Name approved by EMEA; pending approval from USAN. Chronic renal failure (CRF) Pre-dialysis, not yet on dialysis Once every 4 weeks Extended half-life, prolonged half-life 1 CONFIDENTIAL — FOR INTERNAL USE ONLY 78 Do not duplicate, distribute, or use in detailing. MESSAGES AND BRAND VOCABULARY MIRCERA®* Global Brand Vocabulary Topic Maintenance Maintains stable Hb levels within target range with once-monthly dosing Maintains stable Hb levels with the same IV or SC dose Maintains stable Hb levels regardless of patient age, gender, race, CKD stage or comorbidities Mechanism of Action (MOA) Continuous receptor activation Acts differently at the receptor level Closely mimics the body’s control of red blood cell production Molecule C.E.R.A., a continuous erythropoietin receptor activator First chemically synthesised ESA First of a new class Methoxy polyethylene glycol-epoetin beta Functionally and structurally unique Follow-on product Next-generation epoetin/NeoRecormon Non-inferiority At least as effective as Patient Outcomes Improves energy and functional capacity Safety Safety comparable to shorter-acting ESAs Adverse events typical for this patient population Smooth and steady rise of haemoglobin (in correction) Stability Hb stability Targeted stability Value Allows more time to focus on other patient needs Less risk of needlestick injury As few as 12 injections per year Fewer dose adjustments per year than traditional ESAs No refrigeration up to 1 month. Once removed from refrigeration, MIRCERA must be used within 30 days or discarded. Variability Hb cycling Hb fluctuations Hb variability Overshoots Energy to make a difference (CPP NeoRecormon) Capitalisation of first letter is not allowed: Continuous Erythropoietin Receptor Activator C.E.R.A. in parentheses or brackets is not allowed: (C.E.R.A.) CERA (without periods) is not allowed Unique interaction at receptor level Phase III Trials MIRCERA®* Global Brand Vocabulary Correction trial with C.E.R.A. given IV 1X every 2 weeks and 1X every 4 weeks in dialysis patients vs epoetin Correction trial with C.E.R.A. given SC 1X every 2 weeks and 1X every 4 weeks vs darbepoetin alfa “AMICUS (friend, comrade) for AnaeMIa Correction and sUStained maintenance in dialysis” “ARCTOS (northern; at the top) Administration of C.E.R.A. in CKD patients to treat anaemia with a Twice-mOnthly Schedule” “MAXIMA (excels; exceeding to the highest degree) Maintenance of hAemoglobin eXcels with IV adMinistration of C.E.R.A.” “PROTOS (first) Patients Receiving C.E.R.A. Once a month for the mainTenance Of Stable haemoglobin” “STRIATA (striped lines such as guideline ranges) Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment of Anaemia” “RUBRA (red, energy colour) TaRgeting sUstained haemogloBin in dialysis with IV and SC C.E.R.A. Administration” “PATRONUS (benefactor and a protector) comPArator sTudy of C.E.R.A. and darbepOetin alfa in patieNts Undergoing dialysiS” Recommended Language Non-recommended Language BA16736 BA16738 BA16739 Maintenance trial with C.E.R.A. given IV 1X every 2 weeks and 1X every 4 weeks in dialysis patients vs epoetin Maintenance trial with C.E.R.A. given SC 1X every 2 weeks and 1X every 4 weeks in dialysis patients vs epoetin Maintenance trial with C.E.R.A. given IV 1X every 2 weeks in dialysis patients vs darbepoetin alfa BA16740 BA17283 BA17284 Maintenance trial with C.E.R.A. given by prefilled syringe (PFS) 1X every 2 weeks in dialysis patients vs epoetin IV C.E.R.A. vs darbepoetin alfa administered at extended dosing intervals for Hb maintenance in dialysis patients BH17847 Glossary of Key Terms Correction Conversion Maintenance “Non-inferiority” Hb Stability Once-monthly Treatment phase in which an ESA is administered to bring Hb levels to within target range Ability to convert previously treated patients directly to once-monthly MIRCERA from a more frequent dosing schedule while maintaining stable Hb levels Phase of ESA treatment after correction in which the goal is to maintain stable Hb levels within target range A non-inferiority clinical trial shows that a new treatment is at least as effective as the standard treatment in terms of the end point measured, such as efficacy, when the new agent differs fundamentally from the comparator Hb levels stay within a defined target range 1. Effective in all patients with CKD-related anaemia (patients on dialysis and not on dialysis regardless of age, gender or comorbidities) 2. Ability to convert directly and successfully to a once-monthly regimen regardless of previous ESA dosing frequency 3. All patients can use once-monthly administration without stepwise progression of dosing interval or loss of Hb stability *Name approved by EMEA; pending approval from USAN. 2 CONFIDENTIAL — FOR INTERNAL USE ONLY *Name approved by EMEA; pending approval from USAN. 3 CONFIDENTIAL — FOR INTERNAL USE ONLY 80 Do not duplicate, distribute, or use in detailing. Section 7: ROCHE Logo Guidelines ROCHE Logo Guidelines Section 7: ROCHE LOGO GUIDELINES Roche Logo The Roche logo is the most important and visually prominent element of the company’s corporate identity. As a design element, the Roche logo must never be altered. Use the Roche logo exactly as it appears in this guide and as it appears in the Roche Design Guidelines sections on logo usage. When reproducing the Roche logo, it is important to maintain the proportions and spacing of the characters. Any deviation would weaken the global graphic image and therefore should be avoided. Roche logo is art—it is not to be typeset. The Roche logo is uniquely designed typographical art and should be reproduced only from the electronic artwork as provided. This logo cannot be “set in” and is not interchangeable with any standard typeface. Roche Hexagon Guidelines The hexagon and logotype within form an integral whole and must never be used separately or in combination with other elements. • The Roche hexagon should be used in the upper right corner of the page, or the bottom right corner when it appears with an address (eg, stationery), and never centred on the page — Please refer to the Roche Design Guidelines for exceptions to this guideline • Scale artwork proportionately • Minimum height of the Roche hexagon is 6.4 mm or 1⁄4" • The Roche logo should not be altered or recreated 84 Do not duplicate, distribute, or use in detailing. ROCHE LOGO GUIDELINES Roche Logo Colour Specifications There are 3 colour options for use with the Roche logo. The Roche name and hexagon can be used independently in Roche Blue (PMS 300), black or white on a dark background. For comprehensive guidelines on appropriate use of the Roche logo, refer to the Roche Design Guidelines. Area of Isolation The minimum clear space that must be maintained between the logo and any surrounding elements is “X” (equal to the height of logo). On stationery, the distance is “Z” (equal to 1.3 times the height of the logo). X X X X X Z Z = 1 1/3 X Z Z Comprehensive guidelines on appropriate use of the Roche logo and Roche corporate design appear in Roche Design Guidelines, which may be accessed at http://corporate-design.roche.com 86 Do not duplicate, distribute, or use in detailing. Section 8: Examples of Unacceptable Usage Examples of Unacceptable Usage Section 8: EXAMPLES OF UNACCEPTABLE USAGE Examples of unacceptable name usage Examples of unacceptable logo usage: Incorrect capitalization MIRCERA name not to appear as possessive The logo can never be distorted in any fashion that changes its shape. Do not rearrange the position of the symbol from its approved placement in relation to the trade name. MIRCERA name not to appear as plural MIRCERA name not to appear in compound or hyphenated construction In the symbol, the left droplet that is closest to “CERA” must always follow the same colour treatment as “CERA” within the trade name. Never put a circle, box or other graphic element around the logo that cuts into the clear zone. The logo can never appear in colours other than those specified in this manual. Do not try to replicate the logo with other fonts. 90 Do not duplicate, distribute, or use in detailing. EXAMPLES OF UNACCEPTABLE USAGE Examples of unacceptable logo-lockup usage NEW Continuous activity. Targeted stability. Examples of incorrect droplet design: Incorrect clear space Incorrect placement of CPP and generic name Distorted Droplet flipped NEW NEW Continuous activity. Targeted stability. methoxy polyethylene glycol-epoetin beta Activité continue. Stabillité bien ciblé. Colours reversed Reversed CPP and generic name CPP should not be translated from English for the logo lockup Incorrect brand colours Droplets flipped 92 Do not duplicate, distribute, or use in detailing. Section 9: About These Guidelines About These Guidelines Section 9: ABOUT THESE GUIDELINES About These Guidelines Images and graphics presented herein are available electronically. To download, go to the Brand Room on the MIRCERA intranet: http://cera.intranet.roche.com. Situations may arise that necessitate deviations from these guidelines. Please contact the international product manager or business leader at Roche Headquarters for approval. 96 Do not duplicate, distribute, or use in detailing.