Medicine Differentiation Analytics Process

Marketing Plan3/30/3/30

March 21, 2011

© Medicines Differentiation Analytics LLC 2011

Background

The Problem: while budget constraints continue to worsen, poor investment decisions are made today to advance compounds forward through development phases resulting in failed trials or commercial failures. Root causes are:

– Lack of rigorous Commercial assessment - Compounds are not rigorously evaluated against the unmet needs of the markets. Often the unmet needs of the market or how our asset will be differentiated compared to competing compounds are not even discussed.

– Lack of vision of required Critical Label Claims - The label is a basis of approval, reimbursement, and commercial claims – yet often it is not planned for until late in Phase III. Trials drive the label, rather then the other way around.

– True, accurate, data comparisons are manually intensive & time consuming. Historical data and prior decisions are forgotten as team members and governance boards change. Data residing on power point charts are lost.

The Solution: create an environment of innovation that captures the vast amount of scientific & commercial data available efficiently & effectively with processes that:

– Begin with the End in Mind – establish differentiated label claims to meet unmet needs and then design trials to achieve them

– Evaluate compounds based on their Commercial Differentiation Score– Use standard & automated decision making tools & processes at every development phase– Measure the strength of the alignment between customer needs, asset differentiation and label claims– Evaluate investments not only on technical probability, but the likelihood the medicine will be taken,

prescribed, approved and paid for over other alternatives– Compare how Real the medicine is, our capability to Win in the market and it’s Worth – to all other

medicines in our portfolio

© Medicines Differentiation Analytics LLC 2011

Intent of MDA

The Medicine Differentiation Analytics (MDA) process is a set of linked activities that effectively & efficiently ensure how likely a medicine will obtain strongly differentiated label claims which directly address critical unmet needs in the market. The MDA process:

– Reflects true Differentiation. How is this medicine uniquely differentiated in the market so that it will be Taken, Prescribed, Approved and Paid For over other alternatives?

– Is Customer-Driven. How strongly does this medicine address real unmet needs in the market from patients, prescribers, approvers, caregivers and/or payers?

– Monetizes Value. What is the likelihood our medicine will return the highest ROI over other alternatives?

The Resulting Outcomes: greater ROI of portfolio decision making - with a streamlined process for teams to prepare.

© Medicines Differentiation Analytics LLC 2011 4

Unmet Needs:•Patients•Prescribers•Payers•Approvers

Standard Parameters:•Efficacy•Safety•Tolerability•Convenience•Cost

Begin with the End in Mind:•Differentiated Label Sections,•Competitors Claims,•Ideal & •Fallback Claims

Probability this Asset will be:•Taken, •Prescribed, •Approved ,and •Paid For over all other alternatives.

Investment Decisions that

result in:

SignificantlyImproved

ROI

MDA Overall Process

MEDiff

Structured Application Of MDA MethodologyStructured Application Of MDA Methodology