Medicine Differentiation Analytics Process

Marketing Plan3/30/3/30

April 4, 2011

© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

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.

– Little focus on End in Mind – 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.

– Competitive 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

Needed straightforward & standard ways to more effectively evaluate compounds using the vast scientific and commercial data that exists today

© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

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 – PATENT PENDING 4

MDA Overall Process

Unmet Needs:PatientsPrescribersPayersApprovers

Standard Parameters:Efficacy

SafetyTolerability

ConvenienceCost

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

Predicting Behavior:Based on prior actions

© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

Structured Application Of MDA ProcessStructured Application Of MDA ProcessStructured Application Of MDA ProcessStructured Application Of MDA Process

MEDiff – Brings the MDA Process to Life

© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

Draft Brochure next pages:

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© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

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The Environment:

The pharmaceutical industry has transitioned from the Growth Stage to the Competitive Stage of its lifecycle.  With fewer new products, stagnant markets, price ceilings, and increasing brand and generic competition, pharmaceutical companies are fighting an increasingly intense battle for stakeholder mindshare, product sales, and corporate survival.   In the meantime, nearly every country in the world is reducing health care programs due to budget constraints. These pressures for innovation at significantly reduced costs come at a time when there is a vast amount of scientific data available.  The question is how to harness that vast amount of scientific data in ways that spurs innovation, while providing more standard analyses and data to speed the time required to prepare for and evaluate individual and portfolio level investment decisions.

 How will your potential medicine compete in this new environment? Do you have the tools to get there?

The Challenge:

How will your medicine be differentiated against

competing products so that it gets approved, reimbursed,

prescribed and taken above all other treatments?

How will you measure your medicines differentiation on

measurable terms for efficacy, safety, tolerability,

convenience and cost against the competition?

How will your label claims assist you in achieving

differentiation?

How differentiated is your entire portfolio? Which assets

have a higher probability of success in the market

2 Calais Road Mendham, New Jersey 07945Phone: 973-570-4784  Fax: [Fax]

[Web Address]

MEDICINE DIFFERENTIATION ANALYTICS, LLC

MEDiff

© Medicines Differentiation Analytics LLC 2011 – PATENT PENDING

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The Solution…..

Business Intelligence:

Automatically Pre-populate Parameters & Unmet

needs within Disease Area

Automatically pre-populate competitor parameter

data

Knowledge Creation (ie: Differentiation Score &

Real/Win/Worth Scoring)

Data Quality – internal edit checks –

Tracking History of Asset:

Monitor Multiple Differentiation Parameters -

Highlight Changes - from one period to another

Provide Rigor Trends

Ease of Use by Teams:

Direct flow of Unmet Need to Differentiation

Parameters to Real/Win/Worth Scoring

Access information globally

Automatic updating data from various

data bases

Eliminate/reduce redundancy between

analyses – data entered once

Help System – instructions/manual, drop

down choices, tutorial and examples.

Ease of Use by Governance Bodies:

Executive Reporting System

A Customer Driven Differentiation Process

“Quote from Diffusion Pharmaceuticals”- David Kalergis, JD/MBA, CEO, Diffusion Pharmaceuticals, LLC.

The System…..