Medicines Differentiation Analysis

Multiple Sclerosis

18 January 2011

Mary Perkins

Expected Launch Date: 3/31/2013

© Medicines Differentiation Analytics 2010

As a Patient, As a PATIENT, MS is a debilitating disease. The treatments available are only to slow down the progression. When will there be a cure or at least a treatment that significantly slows MS progression? The only oral solution has major side effects. Most of the time, I don’t take the treatments prescribed but hope that diet and exercise will help. The treatments (IV, intramuscularly or subcutaneously) are uncomfortable

As a Payer, "We need a more cost effective solution without the side effects." As a PAYER, MS is a very expensive disease effecting many of our patients. The recently approved oral solution by Novartis costs $4000 a month and has significant side effects.

As a Provider, As a PROVIDER, my MS patients have very little treatment options. MS is very debilitating –" a cure or more effective solution is needed for my many patients.” Often my patients don’t take my prescriptions due to the significant side effects.

Multiple sclerosis Unmet Needs -Customer Value Statements

As a Approver, As a REGULATOR, we recently approved an MS oral treatment because it is generally effective in slowing MS progression, but comes with significant risks. A treatment just as effective without the side effects would be approved quickly

As a Caregiver,

© Medicines Differentiation Analytics 2010

Multiple sclerosis Competitive Positioning

In-Line

3

1. NovartisFingold Gilenya2. BiogenAvonex3. Merck SeronaRebiff4. TevaCopaxone5. BiogenTysabri

1. BiogenBG-122. TevaLaquinimod3. Genzyme-SanofiLemtrada

InlineInlineInlineInlineInline

23412

Pipeline-Phase 3Pipeline-Phase 2Pipeline-Phase 2

111

Company/Drug Stage Rigor Score

Company/Drug Stage Rigor Score

Pipe-Line

© Medicines Differentiation Analytics 2010 4

Multiple Sclerosis Healthcare Differentiation Instrument

Target Perf.

Observed

SOC

Competitors

KEY

Reduction in Relapse Rate

SOC50000 40000 30000 10000 120000

reduction in Progression of Disability rate

SOC0 30 60 3

Adverse EventsSOC

Severe&Often

1 2Mild&Infr

eq. 33 4 5

Ability to Stay on Treatment

SOC

Freq Disc.

1 2Cont.

treat. 33 4 5

© Medicines Differentiation Analytics 2010 5

Multiple Sclerosis Healthcare Differentiation Instrument

Target Perf.

Observed

SOC

Competitors

KEY

AdministrationSOC

Daily IV 1 Wkly IVOral

(1/Day) 32Oral(2+d

ay)

Annual Cost SOC50000 40000 30000 10000 120000

© Medicines Differentiation Analytics 2010 6

Multiple Sclerosis Real Analysis

Is the Market & Opportunity REAL? Is the asset real? Are we addressing a truly unmet medical need? Is there strong justification for moving forward?

Real Questions

1) Will Pateints take Multiple Sclerosis over other alternatives? 5 1 3.66666666666667

1

2) Will Multiple Sclerosis gain Access over other alternatives? 3 1 2.5 1

3) Will Multiple Sclerosis be Prescribed over other alternatives? 3 1 3.5 1

4) Will Multiple Sclerosis gain Approval over other alternatives? 3 1 3 1

5) Will Caregivers give Multiple Sclerosis over other alternatives? 1 1 1 1

ValueSys Value Sys Rigor

Rigor

3 1 2.73 1Real Scores

© Medicines Differentiation Analytics 2010 7

Multiple Sclerosis Win AnalysisHow capable are we internally to execute & win, timely? How competitive is the marketplace? How differentiated will we be in the market?

Win QuestionsSys Value Sys Rigor

Rigor

1 1Win Scores

1) Are we differentiated on Efficacy? 3 1 1.8 1

2) Are we differentiated on Safety? 3 1 1.8 1

3) Are we differentiated on Tolerability? 5 1 1.7 1

4) Are we differentiated on Convenience? 9 1 2.4 1

5) Are we differentiated on Cost? 1 1 2.3 1

6) Is this Disease Area on of our internal areas of strength? Or is it a brand new area that will require new resources and capabilities (marketing, sales & manufacturing)?

1 1

7) Do we have the cycle times in drug development and product launches to be able to get to the market timely to win? 1 1

8) How likely are we to become 1st in Class or Best in Class or SOC? 1 1

9) Do we understand and can execute the full health care solution required (diagnostics, devices, education materials, other)? 1 1

10) Do our trials align with the required patient populations? 1 1

11) How likely is the possibility of Comparator Effectiveness Research (CER) (in new health care bill & in Europe)? 1 1

12) Are we prepared to mitigate CER risks? 1 1

13) How competitive is this Disease Area? What is the likelihood we can out perform the competition? 1 1

14) Can we engage with the right key opinion leaders to support our opinion? 1 1

15) Can we engage with the Payer community to support our opinion? 1 1

Value

© Medicines Differentiation Analytics 2010 8

Multiple Sclerosis Worth Analysis

Is the opportunity WORTH the required investment? Can we make it worth it? Where can we make it worth it? Is this the right investment? Is the right strategic fit?

Worth Questions

1) How large will our market share be?

2) How attractive is the Net Present Value of this asset?

3) How much development budget remains?

4) How quickly will we get reimbursed?

5) What is the life cycle potential for this drug (new indications, new markets, etc)?

Worth Scores

6) Is there a strategic fit beyond financials (reputation, etc)?

1

1

1

1

1

Value

1

1

1

1

1

1

1

Rigor

1

1

© Medicines Differentiation Analytics 2010

Multiple Sclerosis Real, Win, Worth Summary

Is the Market & Opportunity REAL? What is the unmet medical need? What is the

likelihood that Stakeholders will: Take, Prescribe, Approve, & Pay For. What are the hurdles that must be overcome for stakeholders to actually take action?

9

Can we WIN? Is our Asset Differentiated, safe and effective to meet the Customer Need? Can we leverage our differentiated position? How strong is our competitive position? Are our internal capabilities well aligned with asset?

Is the Opportunity WORTH the investment? Are the Sales & Profit attractive?How high is the Cost of entry?

• Pharm Sci, Sales force, etc.Is there Strategic Fit?

• Reputation, Tie to Strategy, etc.Can we leverage multiple indications?

Value Score Rigor Score

1

1

1

1

1

1

1 1Average

© Medicines Differentiation Analytics 2010

Understand needs and desired outcomes of this Asset/Project

Finalize competitive landscape & parameters

Build differentiation instrument & competitive label position statements

Prepare Differentiated Commercialization Package

Next Steps