Main CoverGlobal Brand Manual for RotaTeq1 2 3G

lobal B

rand M

anual for RotaTeq

Welcome to the Global Brand Manual for RotaTeq™ (Rotavirus Vaccine, Live,

Oral, Pentavalent).

As fellow brand stewards for RotaTeq™, we must share a collective sense of

ownership for what the brand is today, and what it can become tomorrow. An

extensive amount of work has already been invested in the worldwide launch of

RotaTeq. Now, as countries around the world prepare to launch the brand, it is time to

share the knowledge and insight that have guided the strategy and creative to date.

The Global Brand Manual for RotaTeq is the vehicle that will house these learnings.

Additionally, it will serve as the “glue” that holds the brand together as hands around

the world begin touching the brand, preparing to bring it to market.

As you begin using the Global Brand Manual for RotaTeq, the Worldwide Marketing

Team would like you to be inspired by it. The information presented herein should be

thought of as guidelines, not restrictions, for creating consistent branded materials

for RotaTeq.

Introduction to Global Branding forRotaTeq™ (Rotavirus Vaccine, Live,Oral, Pentavalent)Rationale for Global BrandingIn order for a brand to flourish in today’s market, it must go beyond its features and

establish credible and sustainable differentiation versus its competition—occupying a

unique place in the customer’s heart and mind.

Through branding, the process of creating a brand, a product forges an emotional

relationship with its customers with the goal, ultimately, of forming an intimate

long-term relationship—one that can transcend barriers and cultural gaps.

This type of an approach can increase loyalty, usage, and brand equity. Most

importantly though, by establishing a unique place in customers’ hearts and minds,

a brand can prevail through the emergence of new competition, shifts in the market

place, and competitive noise.

Successful branding accomplishes this by communicating

the core values of the brand within the psychological,

emotional, and rational context of customers’ daily

lives. A successful brand must communicate its message

consistently—regardless of where, when, or how a

customer is exposed to it.

How to Use This ManualMerck is committed to developing brands with a truly global identity. This means that

regardless of where our customers come in contact with our brand, for example, at an

international congress, or what promotional materials they see, they recognize our

brands and our key messages. To help Merck Sharp & Dohme (MSD) achieve a global

identity for RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent), we have provided

the essential strategic, creative, and scientific materials for developing branded

communications specific to RotaTeq.

Ultimately, the brand created for RotaTeq is the sum of all its parts. That is why it is

critical that each individual country launch RotaTeq using the same set of brand

“blueprints,” the Global Brand Manual for RotaTeq. This type of approach ensures

that each market develops promotional materials that are consistent creatively and

strategically. To aid you and your vendors in the development of these materials, we

have enclosed CD-ROMs consisting of all approved artwork and logos for RotaTeq.

The Global Brand Manual for RotaTeq is the quintessential tool for anyone working

on the brand, regardless of media or specialty.

Adherence to the brand manual, coupled with the heritage of Merck Sharp & Dohme,

will position RotaTeq for a powerful entrance into vaccine markets around the world.

The Global Brand Manual for RotaTeq was specifically

developed for MSD with its worldwide affiliates in

mind. For ease of use, it is divided into three sections

representing mind, body, and soul.

The Worldwide Marketing Team for RotaTeq recognizes

the challenges that surround implementing and adhering

to the guidelines in a vacuum. For that reason, the team

has embraced the following philosophy:

Global branding for RotaTeq must strike a balance of

consistency and relevancy.

Body:Nurturing the brand through graphic standards

This section provides a detailed presentation of thephysical framework of the brand. Included is thephysical manifestation of the brand; that is, how itshould look and feel in a promotional setting.Categories in this section include typography, colorpalette, and artwork, among others.

This section outlines the intellectual framework that wentinto developing the brand for RotaTeq. Included is anoverview of the scientific support, product information,and background materials for RotaTeq and the rotavirusmarket.

Soul:Growing the brand through strategy

This section provides a top line overview of thestrategic thinking, product positioning, and targetaudience for RotaTeq. The qualities that comprise thesoul of the brand cannot necessarily be seen andtouched. But they are the foundation for developingmaterials that align strategically with the global visionfor RotaTeq. While section 2 provides examples formaking promotional materials consistent from a visualperspective, this section provides the marketing insightthat will help make the brand consistent from a strategicand messaging perspective.

Mind:Developing the brand through science1 2 3

By consistency we mean that the approved branding hallmarks—the message, logo

and icon, color palette, and font style—must remain intact and consistent around the

world. This will ensure that the brand is instantly recognizable, no matter the country

of origin.

By relevancy we mean that each market must use its discretion to tailor the

approved branding elements into a voice and style that is appropriate for their

market. For example, when using a patient photo, the patient should reflect the

characteristics and attributes of the country developing the materials—giving it

relevancy to that individual market. As the brand’s worldwide stewards, your judgment

will be required to ensure that cultural intricacies are addressed.

By aligning your materials strategically using Section 1

(Soul), following the visual examples put forth in

Section 2 (Body), and developing a firm understanding

of the science, Section 3 (Mind), you will be able to

create communications that are relevant at the local

level, while maintaining the power of a consistent

global brand.

This manual should be retained post launch for future reference.

Note: Section 3 to be added later

Table of ContentsWelcome to the Global Brand Manualfor RotaTeq™ (Rotavirus Vaccine, Live,Oral, Pentavalent)

Introduction

How to Use This Manual

1 Growing the brand through strategy

Brand Positioning. . . . . . . . . . . . . . . . 02Personality TraitsDisease and Product Positioning

Brand Outlook . . . . . . . . . . . . . . . . . . 05

Business Strategy . . . . . . . . . . . . . . . . 07Tactical Plan for RotaTeqPerceptions of Rotavirus Physicians’ Key Drivers and BarriersBenefit Ladder for RotaTeqPhysician Archetypes

2 Nurturing the brand throughgraphic standards

Branding Elements. . . . . . . . . . . . . . . 02The BrandmarkThe Brandmark-LockupColorTypographySecondary GraphicsImagery

Branding Guidelines. . . . . . . . . . . . . . 09Clear SpaceMinimum SizeColor ApplicationsIncorrect Use of the Brandmark

File Nomenclature . . . . . . . . . . . . . . . 15File Formats

Growing the brandthrough strategy1

Brand PositioningPersonality Traits

Life-Saving

Nurturing

02

This section is divided into two sub-sections. The

first outlines the most fundamental aspects of the

brand strategy (ie, personality, positioning, and

brand commitment). The second section reviews

the market dynamics as they pertain to rotavirus

immunization and RotaTeq™ (Rotavirus Vaccine,

Live, Oral, Pentavalent) (ie, physician segmentation,

drivers and barriers, and critical success factors).

01

A distinct Brand Personality is an integral component of a successful brand. The

personality attributes assign a unique set of human characteristics that are associated

with a given brand, in human terms. It describes who the brand is, what it feels like,

and how it acts. It should be evident in any branded communication, regardless of the

media, vehicle, or location in which it is exposed.

I am able to prevent a potentially fatal disease. Withoutme, infants are vulnerable to suffering and devastation.

I am helping to protect infants and the community againstdisease so that all can grow up healthy and strong.

Trustworthy

I inspire confidence that I will not only deliver on mypromise, but that I will do so safely.

Note: In ex-US markets the dominant personality trait is Nurturing followedby Trustworthy followed by Life-Saving. This differs from the US marketwhere the dominant trait is Trustworthy—followed by Nurturing and then Life-Saving.

Disease and Product Positioning

that can put any infant under your care at risk of rapiddeterioration leading to consequences such ashospitalization and death

that will enable you to safely and conveniently protect yourinfant patients against a serious and unpredictable disease

is a serious, highly contagious, and unpredictable diseasethat affects all infants

is the most complete [superior efficacy, broadestcoverage] protection against RGE

For healthcare professionals vaccinating infants, RotaTeq

For healthcare professionals vaccinating infants, RGE because...(country-specific)• Virtually all children will be infected with rotavirus before age 5• One out of every 40 who gets the disease develops a severe case • Severe dehydration can occur rapidly • RGE causes more than 2 million hospitalizations every year and XX in [local market]• RGE causes ~500,000 deaths in children worldwide every year and XX in [local market]

because...(country-specific)• Protects against 98% of severe RGE cases• Reduces 96% of hospitalizations• As a pentavalent vaccine, provides serotype-specific efficacy against

more than 90% of circulating rotavirus strains • Was proven safe in a clinical trial of 70,000 subjects, one of the largest clinical trials

in vaccine history• Is approved by the FDA• Is recommended by the AAP, ACIP, and local recommending body• Is an oral, ready-to-use, liquid vaccine given at 2, 4, and 6 months and approved for

concomitant use with other vaccines• Provides protection by 6 months of age

Positioning Statement forRotavirus Gastroenteritis (RGE)

Positioning Statementfor RotaTeq

0403

As is the case with all preventive medicine, disease perception plays a critical role in

determining product positioning. To that end, a positioning statement for rotavirus

gastroenteritis (RGE) was developed congruently with a positioning statement for

RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent). Both the Disease Positioning

Statement and the Product Positioning Statement are shown below and can be

identified by color. The Disease Positioning Statement appears in gray, while the

Product Positioning Statement appears in turquoise.

Note: These statements are for internal use only to help guide tacticaldevelopment. They should never be used, verbatim, in print or promotion.

Brand OutlookThe first step in determining the Brand Commitment for RotaTeq™ (Rotavirus

Vaccine, Live, Oral, Pentavalent)—the criteria used to evaluate every encounter the

customer has with the brand—is to determine the functional, practical, and emotional

benefits associated with the brand.

This three-pronged approach guided the development of acohesive and well-balanced Brand Commitment for RotaTeq.

The Functional BenefitsFeatures and attributes of RotaTeq

The Practical BenefitsActions RotaTeq enables the customer to take

The Emotional BenefitsEmotional need RotaTeq can meet

• 98% efficacy against severe RGE • Oral delivery• Fully liquid—ready to use• Human-bovine origination• Compatible with other vaccines• Administered as early as 6 weeks• Sweet-tasting

• Low viral shedding • From a trusted company• Broad(est) coverage against most

prevalent serotypes circulating• Proven safe in one of the biggest trials in

vaccine history• Decreased morbidity/mortality

Brand Commitment for RotaTeq

• Saves lives• Offers protection from:

- Disease- Disruption

• Allows maintenance of anormal schedule

• Fits existing vaccineschedule

• Relieves burden on:- Practice- Parent- Hospital- Society (costs)

• Peace of mind• Comfort• In control• Protective (nurturing)• Secure• Certain• Confident

• Inspired• Empowered• Liberated• Responsible• Validated• Smart

Only with RotaTeq am I empowered to liberate my practice/patient/childfrom the unpredictable nature, intimidating burden, and devastatingeffects of RGE, giving me the confidence and peace of mind that I amprotecting my patients/children against a pervasive disease.

05 06

Business StrategyTactical Plan for RotaTeq™ (RotavirusVaccine, Live, Oral, Pentavalent)

Relative to other childhood diseases, physicians do not consider rotavirus infections as

serious, feeling it can be easily managed. Many believe that there are certain “at risk”

groups, primarily those in daycare settings.

However, most physicians agree that RGE is unpredictable and that the potential

exists for rapid dehydration and deterioration. Since nearly all children get RGE,

and physicians cannot predict which child will contract a severe case, there is a need

to prevent RGE.

Overall there is little consumer awareness of rotavirus. Lack of testing means most

parents are unfamiliar with rotavirus, though some may refer to the condition using

general terms such as “stomach flu” or “winter diarrhea.”

To ensure the successful launch of RotaTeq, the Rotavirus Franchise Business Group

has the following global strategic and region-specific tactical plans in place:

Obtain universal recommendations from policy-makers and reimbursement from payers

by building cases for societal disease burden and health economics

Drive physicians to stock RotaTeq immediately; to strongly recommend the vaccine to parents;

and to select RotaTeq in competitive markets by shifting attitudes on the seriousness of RGE

Drive parents to accept vaccination for their children by overcoming lack of

disease awareness

• Sequenced targeting of thought leaders with diseaseeducation and health economics data

Leverage favorable product profile

• Differentiate on pentavalent composition- Broad serotype coverage- Strong serotype-specific efficacy

• Emphasize fully liquid and ready to use

• Shift physician attitudes on seriousness of disease throughchannels such as physician education, ad boards,publications, etc.

• Raise parental disease awareness through public affairs,targeted ad campaigns, new mother kits, etc.

07 08

• Diagnosis of rotavirus is frequently instinctive, based onexperience and prevalence, rather than scientific testing.Physicians tend to focus on symptom treatment rather thansource of infection. The actual infection is rarely diagnosed.

• The majority of physicians think that parents can easilymanage the disease with oral rehydration therapy.

• RGE has the potential to become a serious disease,causing dehydration leading to hospitalization and, inextreme cases, death. As it is a self-limiting disease, veryfew cases lead to death.

• Most doctors agree that RGE is unpredictable becausethey cannot predict the course of the disease or itsseverity. The unpredictability is compounded by thepotential for rapid deterioration into severe cases.

Perceptions of Rotavirus

Most physicians agree that rotavirus can be seriousand unpredictable.

“You can’t always predict how the disease will affecteach child—meaning we are unable to predictthe severity of each case or who will get it.”

– Warsaw

Physicians’ Key Drivers and Barriers

Behavioral ObjectivesDriversBarriers

1009

The Worldwide Marketing Team for RotaTeq™ (Rotavirus Vaccine, Live, Oral,

Pentavalent) conducted extensive market research to uncover physician drivers for

adopting a new rotavirus vaccine. This was a particularly critical step to gain a clear

and realistic view of the rotavirus vaccine market. The following table illustrates the

four key physician segments that were identified and outlines the potential Drivers and

Barriers associated with each segment.

Brand Choice (ex-US)Physicians choose RotaTeq over Rotarixb (Rotavirus Vaccine) manufactured by GlaxoSmithKline (for competitive markets)

Identification (EU)Physicians identify children for rotavirus vaccination

based on age

• Recommendation from local recommending body• Routine universal ACIP/AAP recommendation and FDA approval

• Belief that RotaTeq is efficacious (superior efficacy for brand choice)

• Belief in prevalence of disease• Belief in unpredictability of severe cases

• Broader serotype coverage• Fully liquid, ready to use

• Low incidence of side effects (eg, viral shedding)

• Potentially, lack of recommendation by recommending bodies

• Human-bovine vs human• 3 doses vs 2 doses• “Earlier” protection

• Low awareness of serotypes• Concomitant use

• Second to market: switching costs

• Belief in the ability to be able to identify children that are at risk

Early AdoptionPhysicians stock early

Strong RecommendationPhysicians strongly recommend

• Recommendation from local recommending body• Routine universal ACIP/AAP recommendation and FDA approval

• Belief that RotaTeq is efficacious (superior efficacy for brand choice)

• Belief in seriousness/need in practice• Strong preventive care mind-set

• See vaccination as important part of role

• Potentially, lack of recommendation by recommending bodies

• Lingering safety concerns in United States and some other markets

• Lack of understanding of trial design/appreciation of RESTa

• May want to wait for vaccine to be used in general population• Lack of clarity around reimbursement

• Some physicians do not perceive vaccination against rotavirus asnecessary due to parents’ ability to manage

bRotarix is not manufactured by Merck & Co., Inc.aREST: Rotavirus Efficacy and Safety Trial

Emotional and/or Self-ExpressiveBenefits/Outcomes

• Responsible• Compliant/Fulfilling my role in the healthcare community• Public health-minded• Effective, competent • Caring, nurturing• Protective

End-use Benefits/Outcomes

• I am protecting infant patients from a potentially serious disease• I am reducing suffering from RGE in my infant patients• I am contributing to the reduction of this disease in the community • I am providing the broadest protection possible to my patients • I am helping protect against a disease that almost all infants would otherwise experience• I save parents time and anxiety from caring for their children with RGE symptoms• I save parents the anxiety of caring for children with severe RGE symptoms

12

To develop effective marketing communications, it is

necessary to link product features with meaningful

physician and patient benefits. This approach ensures

that communications regarding RotaTeq appeal to

physicians on a rational and emotional level. By

focusing communications on these key features and

benefits, the marketing messages for RotaTeq will be

heard around the world with clarity and consistency.

Benefit Ladder for RotaTeq™ (Rotavirus

Vaccine, Live, Oral, Pentavalent)

End-use and Emotional Benefits

Functional Benefits/Outcomes

• Prevents 98% of cases of severe RGE• Decreases overall RGE morbidity and healthcare cost in the community • Reduces symptoms associated with RGE, eg, diarrhea, vomiting, and fever• Recognized as safe and efficacious by the FDA• Demonstrated no increased incidence in adverse effects, including intussusception • Prevents most cases of mild to moderate RGE• Ready to use, without injecting• Offers protection against a broad range of serotypes• Decreases parental anxiety and stress from managing a sick child

Product/Offer Attributes

• 98% efficacy against severe disease• Recommended by US ACIP and AAP• Approved by US FDA• Serotype-specific efficacy against 95% of circulating rotavirus strains• Adverse events comparable to placebo (eg, fever)• Concomitant use with vaccines recommended in the first 6 months (except influenza, OPV)• Oral (2-ml dose)• In 70,000-patient clinical trial, statistically, no evidence of safety risk related to intussusception• 74% efficacy against mild to moderate disease • Fully liquid, no reconstitution required, ready-to-use tube (ie, screw-off top) • Polyvalent (G1, G2, G3, G4, and P1)• Low rate of shedding of vaccine (8.9% after first dose)

11

Physician Archetypes

Seriousness of Disease and Speed of Uptake

Bold font = significantlygreater than the average at95% confidence

Italic font = significantlylower than the average at95% confidence

Weighted N = 900 Physicians*Seriousness measured by those who answered 8-10 on a 10-pt. scaleSource: MVI RotaTeq Study - July 04, Monitor Analysis

The likelihood that a physician will strongly recommend RotaTeq™ (Rotavirus

Vaccine, Live, Oral, Pentavalent) and adopt it within six months of launch can be

anticipated based on his/her past adoption behavior and perception of rotavirus.

Physicians who were early adopters of a previous rotavirus vaccine are more likely to

be early adopters of RotaTeq. Within this group, those who believe rotavirus is serious

are most likely, overall, to be early adopters and strong recommenders of RotaTeq.

13

Physicians who were late or non-adopters of the

previous vaccine are less likely to be early adopters of

RotaTeq. Within this group, those who believe

rotavirus is serious are much more likely to strongly

recommend RotaTeq.

Stocking Early Adopter of Previous Vaccine(Within 6 months)

Late or Non-Adopter of Previous Vaccine(More than 6 months)

Believerotavirus isserious*

Early Adoption of RotaTeq: 93%Strong Recommendation: 78%

Early Adoption of RotaTeq: 57%Strong Recommendation: 65%

Believerotavirus isNOT serious

Early Adoption of RotaTeq: 75%Strong Recommendation: 49%

Early Adoption of RotaTeq: 45%Strong Recommendation: 39%

Recommend

2 Nurturing the brandthrough graphic standards

02

A system of branding elements—brandmark, color, typography, secondary graphics,

and imagery—helps generate greater brand awareness and a strong association with a

clearly defined set of brand identification elements.

Branding ElementsThis basic graphic standards system has been

created to enable Merck Sharp & Dohme to

implement and maintain a cohesive and consistent

brand identity for RotaTeq.

No variations from these guidelines are permitted

without prior approval from a representative of the

FPG for RotaTeq.

01

* It is the local country’s responsibility to determine whether a registered(®) or trademark (™) symbol should be used with the product name.

†Trademark of MERCK & CO., Inc., Whitehouse Station, NJ, USA.

1X

1X

1/2X

The Brandmark Lock-up

The logotype appearing with the other two elements of the brandmark (the liquid

drop and the generic) forms the logo lock-up for RotaTeq.

Legal RequirementsIt is a legal requirement that the generic always appear with the RotaTeq name.

Under no circumstances should the logotype appear without the generic.

The text for the generic is scaled in specific proportion to the logotype so as to

comply with legal requirements.

Always use the appropriate reproduction digital art.

04

The Brandmark

The brandmark for RotaTeq is comprised of three elements: the logotype, the

“Rotavirus Vaccine, Live, Oral, Pentavalent” generic, and the ‘liquid drop’ symbol.

The logotype for RotaTeq has been created using a customized Myriad typeface.

The generic has been created using a Helvetica Condensed typeface.

Logotype

Generic

Symbol

RotaTeq Brandmark

03

Consistent use of typestyles will ensure that all visual communications

materials are distinct and recognizable.

Avenir is the primary typeface for RotaTeq. It is recommended that it

be used for all headlines, subheads, and primary running text.

Arial may be used as an alternative in electronic mediawhen Avenir is not available, eg, PowerPoint®.

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

Times New Roman may be used when a secondary

typeface is required for running text. It is not

recommended for headlines and subheads.

Typography

Avenir Roman

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

Avenir Oblique

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

Avenir Heavy

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

Avenir Heavy Oblique

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

Times New Roman

ABCDEFGHIJKLMNOPQRSTUVWXYZ

abcdefghijklmnopqrstuvwxyz

1234567890 !@#$%^&*(){}?

06

Color

PurplePMS 2607C85 M95 Y10 K0R79 G11 B123

GrayPMS 423C50 M37 Y35 K23R142 G144 B143

AquaC100 M0 Y44 K0R1 G149 B135

Light GreenC50 M0 Y100 K0R128 G195 B28

Medium GreenC65 M0 Y100 K0R89 G178 B36

YellowC10 M0 Y100 K0R230 G243 B6

Dark GreenC100 M0 Y100 K5R0 G129 B52

Color is an important element in ensuring brandmark recognition.

The primary brand colors for RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)

are PMS 2607 Purple and PMS 423 Gray.

A secondary color palette (Aqua, Dark Green, Medium Green, Light Green, and

Yellow) has been created to complement the primary palette and can be used for

digital media and four-color printing.

CMYK formulas apply when offset printing is not an option. RGB color formulas

are to be used only for broadcast, Web, and on-screen applications.

05

Imagery

08

Imagery can have a key impact in shaping peoples’

perceptions of a brand; therefore, it is important to use

images that provide positive reinforcement. All images

should convey one or more of the personality traits of

RotaTeq: nurturing, trustworthy, life-saving. All images must

be realistic, credible, and appropriate for their geographical

market. Images containing people should also be

appropriate in terms of age, distress level, and clothing.

Both color and black and white images may be used.

AppropriateBaby appears to be less than 18 months of age; baby

appears comfortable and engaged; nudity is not blatant.

InappropriateBaby might appear to be more than 18 months;

baby appears in distressing situation; absence of clothing has potential to offend.

Secondary Graphics

07

Full Color One Color Grayscale Outline Knockout Outline Positive

Full Color Grayscale

‹ Contour

Color Blocks ›

Pentavalent

Horizontal Vertical

AgeBabies should appear to beless than 18 months old.

Distress Level Babies should not appeardistressed or uncomfortable(unless specificallyreferencing rotavirus).

ClothingImages that do not includeclothing can be used providedthey are not likely to offend.

Three secondary graphics have been created for RotaTeq™ (Rotavirus Vaccine, Live,

Oral, Pentavalent). They are pentavalent, contour, and color blocks. Each can be

found on the file format CD.

An example of the pentavalent graphics can be seen

on the front cover of this manual, the contour is shown

on creative concept samples that appear later in this

section, and the use of color blocks is illustrated on

the front page of each section of this manual.

Minimum Size

These are examples of the brandmark at the approved minimum size for use in

print communications.

To ensure proper quality in print reproduction, it is preferred that the brandmark

appear no smaller than 3.28 cm (1.3") in width. In circumstances when a smaller size

is needed, the black and white outline version of the brandmark can be used to a

minimum size of 2 cm (0.79").

3.28 cm (1.3“) 2 cm (0.79“)3.28 cm (1.3“) 2 cm (0.79“)

Color B&W Outline

10

For use with a taglineFor use without a tagline

Branding GuidelinesClear SpaceClear space ensures the proper staging and maximum visibility of the brandmark.

Allowing for sufficient clear space keeps the brandmark free from distracting text,

imagery, or other graphic elements.

Providing more clear space than the minimum area is preferred, as it will preserve the

appearance and impact of the brandmark.

09

Full Color (Preferred)

Wherever possible, the full color format should be used.

12

One ColorA single color format should be used when the use of

full color is not an option.

Color Applications

11

The brandmark for RotaTeq exists in four different color formats. Each can be used

in its positive or negative form.

Do not rotate thebrandmark

Do not place any graphicinside the clear space areademonstrated on page 09

Do not place any rule inside the brand lock-updemonstrated on page 04

Do not place the brandmarkover graphics

Do not place thebrandmark over an image

Do not place the brandmarkover a textured background

Do not place the brandmarkover any color other thanthose approved on pages11 and 12

Do not box the brandmark

For Kids

14

Do not distort thebrandmark in any way

Do not change the colors ofthe brandmark

Do not set the brandmark in perspective

Do not use the logotypewithout the drop symbol

Do not use the brandmarkwith drop shadow

Do not change the font ofthe logotype

Incorrect Use

of the Brandmark

Maintaining visual consistency of the brandmark is vital in preserving recognition

of the brand. The brandmark should never be altered or redrawn in any way. The

examples on this and the next page illustrate just some of the many unacceptable

uses of the brandmark.

13

RT-E-N-6C-OL.eps

File Nomenclature File Formats

Application

RT: Brandmark forRotaTeq

Treatment

P: Positive

N: Negative

Language

E: English

S: Spanish

Description

KGen: Black Generic

WGen: White Generic

OL: Outline

Colors

1pms: 1 Pantone Color

CMYK: 4-Color Process

6C: 2pms + 4-Color Process

RGB: Screen Colors

GS: Grayscale

K: Black

W: White

Extension

eps: Vectorized

jpg: Rasterized

15 16

RT-E-P-6C.epsRT-E-N-6C.epsRT-E-P-CMYK.epsRT-E-N-CMYK.epsRT-E-P-RGB.epsRT-E-N-RGB.epsRT-E-P-RGB.jpgRT-E-N-RGB.jpg

RT-E-P-1pms.epsRT-E-N-1pms.eps

RT-E-P-GS.epsRT-E-N-GS.eps

RT-E-P-K-OL.epsRT-E-N-W-OL.eps

RT-E-N-6C-OL.eps

File Nomenclature File Formats

Application

RT: Brandmark forRotaTeq

Treatment

P: Positive

N: Negative

Language

E: English

S: Spanish

Description

BGen: Black Generic

WGen: White Generic

OL: Outline

Colors

1pms: 1 Pantone Color

CMYK: 4 Color Process

6C: 2pms + 4 Color Process

RGB: Screen Colors

B: Black

W: White

Extension

eps: Verctorized

jpg: Rasterized

15 16

RT-E-P-6C.epsRT-E-N-6C.epsRT-E-P-CMYK.epsRT-E-N-CMYK.epsRT-E-P-RGB.epsRT-E-N-RGB.epsRT-E-P-RGB.jpgRT-E-N-RGB.jpg

RT-E-P-1pms.epsRT-E-N-1pms.eps

RT-E-P-GS.epsRT-E-N-GS.eps

RT-E-P-B-OL.epsRT-E-N-W-OL.eps

Examples of Promotional Materials

17 18

The following materials were developed for the launch of RotaTeq™ (Rotavirus

Vaccine, Live, Oral, Pentavalent) in 2005 and are provided as an example of how the

brand can be represented in promotional materials.

Patient Education PosterJournal AdDetail Aid

3 Developing the brandthrough science

RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent),

a new, highly innovative rotavirus vaccine, offers

broad coverage that goes well beyond the current

standard of care. To develop effective marketing

messages, it is critical that we reinforce the solid

intellectual framework used to develop the brand

for RotaTeq. The following is an overview of the

scientific support, product information, and

background materials for RotaTeq and the rotavirus

market. Only by understanding the science can we

fortify global branding for RotaTeq with

consistency and relevancy.

01 02

Rotavirus is the most common diarrhea pathogen in infants and young children

worldwide. It causes approximately one third of diarrhea-associated hospitalizations and

half a million deaths each year in children under 5 years of age. While symptoms may

vary, the most common symptoms of rotavirus gastroenteritis (RGE) include vomiting,

fever, abdominal pain, and watery diarrhea and can persist for 3 to 9 days. Disease

severity ranges from asymptomatic to dehydrating gastroenteritis, which can be fatal.

Rotavirus Disease Background

Rotavirus Disease Overview

04

• Severity ranges from asymptomatic to dehydratinggastroenteritis, which can be fatal

• Worldwide, annually:– Approximately 440,000 deaths

• In the United States, annually:– 400,000 physician visits– 55,000 to 70,000 hospitalizations– 20 to 70 deaths

• In developing countries, annually:– Nearly 1 billion cases of diarrhea– Approximately 3 million deaths

• With no antiviral treatment, supportive care (such asrehydration) is the only available option

• In the United States, annually:– Nearly $300 million in medical care– More than $1 billion in costs to society

Morbidity/Mortality Treatment/Economic Impact

• Approximately 95% of children worldwide under5 years of age are affected– Peak infection rates occur between 4 and

36 months of age• Fecal-oral transmission dominates

– Spread through respiratory secretions and person-to-person contact; spread via contaminatedenvironmental surfaces has also been speculated

• Seasonal variations in temperate climates, with peakinfection rates in colder months

• Improving food, water, and sanitation does notreduce incidence

• In the United States, approximately 2.7 millionchildren under 5 years of age are affected annually

Mode of Transmission & Prevalence

• 18 serotypes cause human infection– 5 serotypes are responsible for more than 90% of

the disease globally• Unusual serotypes are common in developing countries• Serotype prevalence can vary by region and season

Infectious Agent

03

During the first few years of life, a child typically has several rotavirus infections.

The highest rates of gastroenteritis occur in children under 3 years of age, who are

also at the greatest risk for severe disease. Nearly all children will be infected with

rotavirus by age 5.

Rotavirus Mortality by Region

>10 Deaths/1,000 Births5–10 Deaths/1,000 Births1–5 Deaths/1,000 Births

<1 Death/1,000 Births

Latin America and the CaribbeanRotavirus deaths: 15,000

East & Southeast AsiaRotavirus deaths: 61,000

South AsiaRotavirus deaths: 155,000

Middle East & North AfricaRotavirus deaths: 23,000

North America, Europe,ex-USSR, Australia /New ZealandRotavirus deaths: 7,000

Sub-Saharan AfricaRotavirus deaths: 178,000

0605

Nearly every child will be infected with rotavirus at least once in the first 5 years of life.

It is the most common cause of severe, dehydrating gastroenteritis in infants and young

children worldwide and a leading cause of death among children under 5 years of

age. Each year, approximately half a million global deaths can be attributed to

rotavirus, of which 85% occur in low-income countries.

The incidence of rotavirus is similar in developed and developing countries, which

suggests that environmental variables (clean water, food, hygiene, and sanitation)

do not affect incidence. Approximately 95% of children worldwide are affected by

age 5. This results in 111 million home care episodes, 25 million physician visits,

and 2 million hospitalizations.

Globally, rotavirus is responsible for about 440,000 deaths each year or 1,205 deaths

each day. These numbers vary according to region:

• Low-income countries: 361,000 deaths• Low-middle-income countries: 69,000 deaths• High-middle-income countries: 10,000 deaths• High-income countries: <1,000 deaths

In the United States annually, direct costs from rotavirus amount to $264 million and

indirect costs amount to more than $1 billion. The disease burden resulting from

rotavirus infection has established an unmet need for a vaccine that will help improve

public health.

Rotavirus Global Disease Burden

07 08

Rotavirus–Treatment

There is no antiviral treatment available for rotavirus. Current treatment for

symptoms of RGE consists of supportive care. This includes rehydration to replace

fluid and electrolyte losses. Oral therapy is the preferred method of delivery;

however, in cases of severe gastroenteritis (eg, intractable vomiting) nasogastric or

intravenous treatment may be used.

Rotavirus is an icosahedral virus in the family Reoviridae with a distinct morphologic

appearance. The viral capsid is triple-layered: a double-layered outer shell surrounds

a single-layered inner core. This inner core contains the virus genome, composed of

11 segments of double-stranded RNA that each code for either structural viral proteins

(VP) or nonstructural proteins (NSP). The segmented genome readily reconfigures

during co-infection, a property that plays a role in virus evolution and has proven

useful in the development of vaccines.

The key antigenic properties of rotavirus (group, subgroup, and serotype) are

determined by the viral capsid proteins. Rotavirus has 7 major groups (A through G);

however, most human strains belong to group A. Group A rotavirus encodes VP6, the

most abundant viral protein, which is the major determinant of group reactivity and

which contains the antigen used to divide rotaviruses into subgroups I and II. The

outer capsid proteins include glycoprotein (or G-protein) VP7, which determines the

G serotype, and protease-cleaved protein (or P-protein) VP4, which determines the P

serotype. Both G and P proteins induce neutralizing antibodies that may be involved

in protective immunity.

Figure adapted from Knipe DM,Howley PM, Griffin DE, et al, eds.

Fields Virology. 4th ed.Philadelphia, Pa: Lippincott

Williams & Wilkins; 2001.

VP4(P serotype)

VP7(G serotype)

Rotavirus–Morphology

Important Notes:

Serotype prevalence varies byregion and can change from oneseason to the nextG2: More severe disease; linked tooutbreaks in adults and school-aged childrenG9: Emergent strains; may be afifth common serotype worldwide

10

The G serotypes of >80% of rotavirus strainsworldwide are G1, G2, G3, and G4.

G1

65.4

%

Oth

er 4

.2%

G4

12.2

%

G3

4.9%

G2

13.2

%

09

There are several different serotypes of rotavirus. Prevalence varies by geographic

region and season. Evidence indicates that immunity acquired from first infections

with rotavirus is serotype-specific and the likelihood of a second infection with

the same G serotype is significantly lower than infection with a different serotype.

Children develop immunity after early and repeated infections with different

rotavirus serotypes.

Four globally common G serotype rotavirus strains (G1, G2, G3, and G4) are

responsible for approximately 88.5% of rotavirus diarrhea among children

worldwide. In addition, other G serotypes are increasing in frequency. The prevalence

of G9 has increased dramatically in the past decade, establishing this emergent strain

as a globally common G serotype with clinical importance. Other emergent strains

include G5, G8, and G10 in Brazil; G8 in Malawi; G12 in India; and the novel G6 in

Hungary. The most common P serotype, responsible for more than 75% of rotavirus

strains worldwide, is P1.

Mechanism of ActionHuman-Bovine Reassortant Rotavirus VaccineAll rotavirus vaccines currently in late-stage development are live, orally administered

vaccines that aim to mimic the protection offered by naturally occurring rotavirus

infection. Naturally acquired infections provide protection upon reinfection, especially

against the most severe disease outcomes. The degree of protection increases with

successive rotavirus infections. Thus, multiple doses of an attenuated rotavirus strain

can stimulate immunity and induce protection from rotavirus disease without

producing diarrhea.Attenuation of rotaviruses for use in oral vaccines can

be achieved in a number of ways. The pentavalent

human-bovine reassortant is generated by co-infecting

cell cultures with bovine rotavirus and human rotavirus

strains G1, P1, G2, G3, and G4. The results are naturally

attenuated G1, G2, G3, and G4 rotaviruses that take their

G serotype from the human strain and their P serotype

from the bovine strain, as well as a P1 rotavirus that takes

its G serotype from the bovine strain and its P serotype

from the human strain. By combining these serotypes

into one vaccine, RotaTeq™ (Rotavirus Vaccine, Live,

Oral, Pentavalent) offers broad, polyvalent coverage

against all of the major circulating strains.

Human Rotavirus Bovine (WC3) Rotavirus

Human-Bovine Reassortant

P (Bovine)

G

G (Human)

P

G

P

Rotavirus–Worldwide Serotype Prevalence

Phase 3 Studies:

Rotavirus Efficacy and Safety Trial (REST)Research FindingsRotavirus Efficacy and Safety Trial (REST)The REST study was the largest double-blind, placebo-controlled trial in vaccine

history and involved nearly 70,000 patients in 11 countries on 4 continents. REST

was a Phase 3 study that utilized a comprehensive, active safety monitoring system to

record adverse events and assess the risk of intussusception.

Objectives:• Safety with respect to adverse events, including intussusception• Efficacy against RGE caused by vaccine and nonvaccine serotypes• Efficacy to reduce healthcare costs for RGE

Results:• Significantly reduced (74%) the incidence of RGE of any severity • 98% reduction of severe RGE • Significantly decreased hospitalizations, emergency department visits, office visits,

and work loss due to RGE• 94% reduction in hospitalizations and emergency department visits combined• RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent) was generally well tolerated,

with frequency of adverse events comparable to placebo• RotaTeq was not associated with any increased risk of intussusception

11 12

RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the prevention

of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2,

G3, G4, and G9, and potentially may provide protection against other emerging G

serotypes that contain P1.

The vaccination series consists of 3 ready-to-use liquid doses administered orally to

infants. The first dose should be administered at 6 to 12 weeks of age; the subsequent

doses should be administered at a minimum interval of 4 weeks. RotaTeq was evaluated

in infants who received the third dose as old as 32 weeks of age.

There are no restrictions on the infant’s consumption of food or liquid, including breast

milk, either before or after vaccination.

RotaTeq can be administered with diphtheria and

tetanus toxoids and acellular pertussis (DTaP) vaccine,

inactivated poliovirus vaccine (IPV), Haemophilus

influenzae type b conjugate vaccine (HIB), hepatitis B

vaccine, pneumococcal conjugate vaccine, and

hexavalent vaccine.

For serotypes found in the vaccine, the efficacy against

RGE in the REST trial was:

• 74.0% against any RGE• 98.2% against severe RGE

RotaTeq reduced the rate of hospitalization due to RGE

by 95.9%.

1413

RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent) is generally well tolerated. In

the large-scale REST trial, there was no difference in the frequency of adverse reactions

with infants who received RotaTeq compared with infants who received placebo.

• In concomitant-use studies of RotaTeq and other vaccines (DTaP, IPV, hepatitis B,HIB conjugates, pneumococcal conjugate), the frequency of adverse eventsobserved was similar to that seen when the concomitant vaccines wereadministered with placebo

There was no increased risk of intussusception observed in the REST trial.

• Intussusception was reported in 6 patients who received RotaTeq compared with5 patients who received placebo within 42 days after vaccination (one placebointussusception case wasn’t adjudicated by the Data Safety Monitoring Board)

• Intussusception occurred in 12 patients who received RotaTeq versus 15 patientswho received placebo within 1 year after vaccination.

There was minimal to no viral shedding detected in the stool.

RotaTeq–Indications RotaTeq–Safety and Tolerability

Ease-of-Use Advantage

16

Competition Review

Dosing Schedule

Type of Vaccine

Administration

Concomitant UseIndication

Serotypes Covered

% of Disease Relatedto Serotype

Efficacy Data

Safety Data

Viral Shedding

Room Temperature Stability

3 doses (2, 4, and 6 months)

Human-bovine (reassortant)

Oral–fully liquid; ready-to-use

HepB, HIB, DTaP, Prevnar, IPV, Hexavac (07), OPV (07)

G1, G2, G3, G4, and P1

> 80% of the serotypes covered in the vaccine

• Any Disease: 74%• Severe Disease: 100%

Comparable to placebo, including intussusception

8.9%

2 days at room temperature

2 doses (2 and 4 months)

Fully human

Oral–lyophilized; requires reconstitution

HepB, HIB, DTwP, DTaP, IPV, Prevnar, Hexavalent, OPV

G1, P1

~50% of the serotypes covered in the vaccine

• Any Disease: 70%• Severe Disease: 74%–90%

Comparable to placebo, including intussusception

40%–50% with transmission

1 week lyophilized; 1 day after reconstitution

RotaTeq Rotarix

15

RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent) is an oral vaccine that allows

for easy administration. It is fully liquid, requires no reconstitution, and comes in a

ready-to-use tube designed for oral delivery. Initial dosing is recommended at 6 to

12 weeks minimum, with 2 subsequent doses every 4 weeks minimum thereafter

(eg, 3 doses at 2, 4, and 6 months). RotaTeq is refrigerator stable (2ºC–8ºC) and can

be held at room temperature (≤25ºC) for up to 2 days. Its ease-of-use will provide a

clear advantage over competing products, such as Rotarix, that require reconstitution.

The most significant competitor to RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)

is Rotarix, manufactured by GlaxoSmithKline. Rotarix was first launched in Mexico in

January 2005 with subsequent launches planned for additional Latin American countries

and some Asia Pacific countries. Clinical studies for Rotarix have also been conducted in

the United States, Europe, and Africa.

+ +

Vial Connector Syringe

RotaTeqReady-to-use liquid in squeeze-tube

RotarixLyophilized powder with multistep administration process

Vaccine Company Vaccine Status Availabilitycomposition of vaccine

Phase 2: manufacturinglicense with Aridis (UnitedStates, Canada, EU) andBharat Biotech/BiologicalE Ltd (India)

Licensed by the FDA;potential BIOVIRxmanufacturing facility in theUnited States and China

2000, licensed in China

Phase 2

Phase 1

Launch in India in 2009;other MVI markets(primarily public sector)2010. Approved for usein the United States,Canada, and EU 1Q2011

Initially in developingworld public markets(1Q2009); moving intoselect private marketsbeginning 1Q2010

Limited to China

Not expected to bewidely commercialized

Not expected to bewidely commercialized

Other Potential Competition

UK human-bovinereassortant

Rhesus rotavirus (RRV-TV)

LLR

Australian RV3

Neonatal, 116E & 1321

NIH (USA)

NIH (USA); BIOVIRx (USA)

Lanzhou Institute ofBiological Products, China

University of Melbourne(Australia)

Bharat Biotech (India)

Human-bovine (UK)reassortant: G1, G2, G3,& G4

Tetravalent human-rhesusreassortant, G1–G4

Monovalent lamb G10P[12]

Neonatal human G3P[6]

Neonatal strains G9P[11]& G10P[11]

18

Rotarix—Key Marketing Messages

• Two natural rotavirus infections confer protection against moderate/severe gastroenteritisregardless of serotype. Two oral doses of Rotarix should mimic natural infection butwithout gastroenteritis.

• Rotarix presents more relevant antigens than animal or animal-human reassortedvaccines, thus should perform better than rhesus, bovine, or lamb vaccines (as well aseliciting cross-protection).

• The first dose is given at 2 months of age and the second at 4 months. Thus, children canbe protected against severe rotavirus diarrhea before the age of 6 months when theirvulnerability tends to increase.

Rotarix was launched in 2005 with the following key marketing messages:The table below provides a summary of other vaccines in addition to Rotarix that

may compete with RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent) in the

future.

17