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Taking a Commercial Approach to
       Drug Development

     Target Product Profile Development
                     And
New Product Strategic Planning For Early Stage
    Pharmas and Drug Development Cos.
Pharma/Biotech New Product Strategic Planning
           Understand the market environment
           Develop therapies to meet unmet medical and realized market needs
           Start with the end in mind
             – Develop target product profile (TPP) to realize unique value proposition
             – Understand financial valuations of TPP over product life cycle
             – Factor in risk
             – Build plan for Exit strategy
           Create a drug development plan to reach TPP
           Effectively utilize advisory board and primary research to
           develop/support assumptions
           Estimate risks and outlicensing valuations
           Demonstrate investment value opportunities to support strategic
           decision making and fund raising support

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        2
Goal: Develop Target Product Profile
                Hypothesis
                Blueprint for valuations and future planning
                Frequently “gut-checked” throughout drug development
                            Indication



                            Efficacy




                            Safety/Tolerability




                            Convenience




Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        3
Strategic Planning Approach – How TPP Fits In
                                    Market Mapping/Prioritization

                                                       Define Success

                                     Develop Target Product Profile
        Clinical                                                             Manufacturing &
      Development                                                              formulation
        Strategy                                                                 Strategy
                                                                             (not covered in this presentation)
                                                  Financial Projections



                                                             Exit strategy
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                    4
Example
                  Market Mapping – Define market and map out market landscape
           8 0 0 ,0 0 0

                                                                                                  Acute
                                                                                                  59,633

           70 0 ,0 0 0

                                                                    Un-
                                                                 diagnosed




                                                                                                                              Undiagnosed
           6 0 0 ,0 0 0                                           Patients
                                 Target                                                           Chronic
                               Condition(s)                                                       332,936

           50 0 ,0 0 0            Patient
Patients




                                Prevalence

           4 0 0 ,0 0 0
                                                                                                 Chronic
                                                                                                  61,147

           3 0 0 ,0 0 0
                                                                                                Symptomatic

                                                                  Patients        “High Risk”




                                                                                                                          Diagnosed
                                                                 Diagnosed         Patients
           2 0 0 ,0 0 0
                                                                    and
                                                                                                Asymptomatic
                                                                  In Health
           1 0 ,0 0 0
            0                                                       Care
                                                                                                                Symptomatic
                                                                                   “Low Risk”
                                                                                    Patients    Asymptomatic

                     0



    Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
    info@pharmacision.com                                                     5
Example
           Evaluate SOC* and unmet needs – Determine Target segments

                                                                                           “Satisfied”
                                                                      “Unsatisfied”        with therapy
                                                                       with therapy


                                         High Risk,
                                        Symptomatic
                                                                     “Unsatisfied”
                                                                      with therapy
                                                                                            “Satisfied”
Patients




                                                                                            with therapy


                                          High Risk,                                      “Satisfied”
                                         Asym ptom ati                                    with therapy
                                              c
                                                                         “Unsatisfied”
                                                                          with therapy
                                          Low Risk,
                                         Sym ptom atic


                                          Low Risk,
                                                                    “Unsatisfied”
                                         Asym ptom ati                                         “Satisfied”
                                                                     with therapy
                                              c                                                with therapy



                                         Diagnosed Pts          *SOC= standards of care
   Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
   info@pharmacision.com                                        6
Example
Understand Key Market Drivers and Barriers to Prescribing For Each Segment
                           Primary Drivers
                           Primary Drivers                            Primary Barriers
                                                                      Primary Barriers

         Stricter guidelines calling for lower               Concern over cost/managed care
         BP in high risk patients                            reimbursement challenges
         Want greater ability to control HBP                 Push to use generics
         No longer acceptable for high risk                  Prior authorizations and insurance
         patients to have “borderline” HTN                   claim rejections for use of newer high
         Want greater reduction in the rate of               priced antihypertensive drug as initial
         end organ failure (brain, kidney,                   therapy
         heart, eyes) in all patients                        Skeptical of data showing differences in
         Want easy to take, well-tolerated                   efficacy within RI class
         therapy                                             Entrenched prescribing habits
         Need to see compelling clinical data                Comfortable with existing
         before switching to any new                         antihypertensive products and
         products                                            regimens




Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        7
Evaluate Current and Future Competitor Landscape

                                                                          Strengths/                 Exp.     Launch Date/
                                                                                       Weaknesses/   Future   Anticipated
                                              Class          Indication   Compelling   Unmet Needs   Impact   date of generic
                                                                          Advantage                  on Mkt   entry
                            Product
                            1
                            Product
                            2
     Current                Product
   Competitors              3
                            Product
                            4
                            Product
                            5
                            Product
                            6
                            Product
  Compounds in              7
   Dev. (Future
   Competitors              Product
                            8
                            Product
                            9


Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                           8
Define your unique value proposition for each target market segment
   • Identify Imp/Diff features and benefits that are sustainable and can drive
     behavioral change leading to initial product trial and usage
   • Postulate unique value proposition for product based on hypothesized
     Imp/Diff features and benefits
   • Create target product profile to highlight important differences
   • Target product profile (TPP) should drive clinical development plan to
     demonstrate unique value proposition
                                                             Not Different          Different
                                                               Convenience
                                                                 Efficacy         Greater target
                    Important                                    Oral Rx
                                                                                 organ protection



            Unimportant
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                        9
Prioritize Segments For Clinical and Commercial Development

                                                             Evaluate and prioritize individual segments
                                                                 using the following eligibility tests:
                                                                Does the segment have adequate size to reach
                                                                financial targets with modest product market
                                Total Addressable               penetration?
                                      market
                                                                Can patients be easily identified and targeted?

                                                                Can high volume treaters be easily targeted?
                                      In care for
                                       condition
                                                                Will your product meet patient unmet needs?

                                                                Is unique value proposition in this patient segment
                                Not satisfied with              sustainable given current and future competition?
                                 current therapy
                                                                Will unique value proposition convince physicians to
                                                                use your product?
                                 Have symptoms
                                 compound can
                                      treat                     Can clinical trials be easily designed with end points
                                                                to demonstrate unique value proposition ?
TPP needs to
be compelling                         Willing to
                                                                Can clinical trials be designed, approved, enrolled
for this group                         switch
                                                                and completed in a timely manner?

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                            10
Example
             Develop Unique Value Proposition Hypothesis
      Antihypertensive market is huge
         –     65 million American adults have high blood pressure
         –     $55 billion spent annually in direct expenditures to treat HBP
         –     Antihypertensives are #1 prescribed class of drugs for Medicare Part D enrollees with 122 million
               prescriptions in 2006
         –     6 different classes of drugs and over 70 individual drugs on the market to treat hypertension

      Yet still largely uncontrolled
         –     60% of patients require 2 or more drugs to treat their hypertension
         –     Poor compliance remains a major factor exacerbating poor HTN control with existing therapies
         –     70% of patients on therapy still do not have their BP under control (<140/90 mm Hg)
         –     Hospitalization rates for congestive heart failure continue to increase – 69% of CHF patients are
               hypertensive
         –     Increasing trend in end stage renal disease – hypertension second only to diabetes as most
               common antecedent for this condition
         –     Higher blood pressures lead to higher risk of death from heart disease or stroke – 77% of first
               stroke patients have high blood pressure


      For patients with uncontrolled HTN on initial antihypertensive regimens,
      Product X provides an excellent “first switch” agent to add to a second
      antihypertensive regimen to lower blood pressure while providing proven
      protection against target organ damage that can cause heart failure, kidney
      damage and strokes.
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                           11
Define Commercial Success
                Efficacy, safety and convenience performance levels required to drive
                target segment behavioral change to generate product adoption

                Market environmental changes required to capitalize on market drivers
                and overcome barriers to adoption

                Pricing levels needed to meet NPV goals

                Adoption and target patient penetration levels needed to meet NPV goals

                Make assumptions on all the above

                Need Market research and/or medical advisory board feedback to
                validate assumptions!!

                TPP needs to deliver on commercial success drivers!

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        12
Historical Case Study
       Prod X to prevent infections after Bone Marrow Transplantation

          Problem: Allogeneic BMT patients, and in particular unrelated donor
          BMT patients are at increased risk for life-threatening airborne
          infections due to:
            – Immunosuppression for 6 months with calcineurin inhibitors
            – Treatment of acute Graft vs. Host Disease (aGvHD) with increased
              immunosuppression (high dose steroids)
            – Subsequent extended immunosuppression for more than 2 years



          Solution: Prod X aerosol new product concept:
            – Coats upper respiratory tract (trachea, big bronchi)
            – Blocks and physically expels viruses / fungi
            – Potential for use as prophylaxis against fungal and viral infections,
              which have high mortality rate in this patient population

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        13
Historical Case Study
                Bone Marrow Transplantation Market Landscape

          1998:                         Est. WW procedures       52,000
                                        10-40% infection rate    5,200 - 20,800
                                        mortality 2-8%           1,040 - 4,160

          Overall mortality is about 40% (GVHD, Infection, Relapse)

          Primary viral and fungal species implicated in morbidity and mortality
          are:
            –     Virus: CMV, RSV, rhinovirus, Influenza, parainfluenza
            –     Fungi: Aspergillus fumigatus (mainly pulmonary); Candida sp.



          Risk factors for post BMT infectious complications
            –     GVH Disease, Toxicity of chemotherapy, Steroid therapy for immuno-suppression, Antibiotics
                  (overgrowth of opportunistic fungi), Ganciclovir therapy (late stage CMV and/or fungal
                  infections), donor age, underlying disease morbidity



Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                           14
Historical Case Study
               Target Market and Commercial Success Criteria
         Target market – Preventing Aspergillus fumigatus fungal infections in
         allogeneic post BMT patients
           – Biggest post BMT infection concern
           – Incidence: 5-10% in allogeneic BMT patients, 30% in unrelated allogeneic
             BMT patients
           – mortality: 70-90%
           – Current Competition:
              • Amphotericin B, Itraconazole - modest efficacy against Aspergillus
              • issues: nephrotoxicity, Cyt.P450 3A4 inhibition
           – Future Competitive Landscape:
              • New class of antifungals on the rise: echinocandins (e.g. Cancidas
                 [Merck]) effective and less toxic.
              • Will be strongest competition, but resistance can develop with
                 overuse as prophylaxis.

         Commercial Success Criteria - Activity against Aspergillus with
          lower levels of resistance development than new antifungal class of
          antibiotics
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                             15
Historical Case Study
             Product X Product Profiling/ Gap Analysis
      • Key unmet need and physician concern: Aspergillus infection
        prevention in unrelated allogeneic post-BMT patients
      • Need to demonstrate activity against Aspergillus for commercial
        success
      • Clinical development efforts need to focus on prevention of
        Aspergillus infections and seek Aspergillus prophylaxis as a labeled
        indication
                                                    Not Different    Different

                                                                    Aspergillus
             Important                                              prevention


      Unimportant
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                          16
Historical Case Study
                           Prod X Aerosol Target Product Profile (TPP)
               Indication                               Prevention of life-threatening Aspergillus and
                                                        Respiratory Virus Infections in allogeneic Bone
                                                        Marrow Transplant Recipients

               Efficacy                                 1. Reduction of Aspergillus infections within the first 3
                                                           12 months after transplantation in unrelated donor graft
                                                           recipients by 50%
                                                        2. Reduction of Respiratory Virus infections in allogeneic
                                                           BMT patients with an aGvHD history requiring
                                                           continued high dose immunosuppression or cGvHD by
                                                           50% between month 3 and month 9 12 months after
                                                           Transplantation
               Safety/Tolerability                      Acceptable tolerability. No additional inflammatory
                                                        activity within the Upper Respiratory Tract and lungs.
                                                        No increased coughing
                                                        Enveloped viruses and prion safety comparable to present
                                                        hyperimmunes. Non-enveloped viruses safety according
                                                        to PEI standard
               Convenience                              Aerosol administration.
                                                        Low: 50 mg x 2 per day
                                                        Base: 50 mg x 3 per day
                                                        High: 50 mg x 5 per day

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                         17
Historical Case Study
TPP Drives Commercially Focused Clinical Development Strategy
       Clinical phase
       Phase I                                        Primary: Safety
                                                      Secondary: Effect on Respiratory Virus Infections; Respiratory Bacterial
                                                      Infections, Effect on Aspergillus Infections
                                                      Timing: 1.1 yr      Cost: $0.9 MM         Patients: 30

       Phase II                                       Primary: Safety and Dose Finding
                                                      Secondary: Effect on Respiratory Virus Infections; Respiratory Bacterial
                                                      Infections, Effect on Aspergillus Infections
                                                      Timing: 1.1 yr      Cost: $3.1 MM         Patients: 60

       Phase III                                      Primary: reduction of aspergillus lung infections within 12 months post-
                                                      transplant from 30% to 15% (50% reduction) (unrelated allogeneic pts)
                                                      Secondary: Reduction of Respiratory Virus Infections; Reduction of Bacterial
                                                      Infections, Mortality Reduction
                                                      Timing: 3.25 yr       Cost: $10.5 MM Patients: 240

       Phase III                                      Primary: reduction of RSV/parainfluenza/influenza lung infections 12 months
                                                      after transplant from 15% to 7.5% (50% reduction) (all allogeneic patients)
                                                      Secondary: Reduction of other respiratory virus infections (rhino, adeno),
                                                      reduction of aspergillus infections, reduction of bacterial (pneumococci,
                                                      hemophilus) infections, Mortality Reduction
                                                      Timing: 2.25 yr     Cost: $26 MM       Patients: 600


 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
 info@pharmacision.com                                                           18
Estimate Costs and Timelines for Clinical Trials

                                        Drug Development Timeline and Risks
                                            IND submission                                                    File NDA

                               Pre-Clinical
                               Testing                        Phase I          Phase II           Phase III         NDA Review   Total
Years                                 1.5                       1.5               2                 3.5                1.5        8.5

Expected Costs
($ millions) in 2007$                    $2                    $13.5            $28.3              $81.2                 $2.5    $127

                                                           20 to 100          100 to 500       1,000 to 5,000
Test Population                                         healthy subjects       patients            patients              n/a      n/a
                                                                                                   Confirm
                                                                                Evaluate        effectiveness,
                                                             Determine     efficacy, optimal   monitor adverse
                                                             safety and      dosing, side      reactions from
Purpose                                                       dosage             effects        long-term use
                                                                                                    n/a           n/a
Sources:
Risks in new drug development: Approval success rates for investigational drugs ; Clin Pharmacol Ther 2001;69:297-307.
The Drug Discovery, Development and Approval Process , PHRMA website
R&D Costs and Returns by Therapeutic Category ; Drug Information Journal, Vol 38, 2004.



Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                               19
Understand Risks and Exit Strategy Considerations
              Licensing most feasible exit strategy
              Probability of FDA approval ≠ Expected Probability of commercial
              success in all cases
              High risk business – platform strategies and compounds with multiple
              indication potential much more attractive to investors

              In most cases, plan for outlicensing at early human proof of concept
              stage
                                                                                    Prob of
                                              Stage                   Time (Yrs)   Success*
                                         Pre-Clinical                     2          40%
                                         Phase I/IIa                      2          65%
                                           Phase IIb                      2          44%
                                           Phase III                      3          65%
                                           Approval                       1          80%
                                         Cum Total                       10           6%

*Sources: DiMasi 2001, Kola 2004, Avance
* For Immunology drugs in development


Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        20
Construct Financial Projections

                          “You did a great job with your
                          forecast. The only thing I can
                             say about it with absolute
                            certainty is that it’s wrong.”
                                     -- Words of wisdom I received early in my career




                 Do the best you can without the benefits of having
                        perfect information and a crystal ball!
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                              21
Example
   Start by Tying Market Assumptions to Financial Assumptions
        Use US Census population projections
                                                              6%
        NHANES data used to estimate % population             5%
        with HTN                                              4%
                                                              3%
        85% of patients with HTN are on therapy               2%
                                                              1%
        63% to 75% of patients >20 have uncontrolled          0%
        HTN




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        Only Pts with uncontrolled HTN are candidates
        for NewProd X
                                                                           % Uncontrolled HTN Pts on PH-RI
        5% Peak patient shares estimated for % of
        uncontrolled pts on NewProd X
                                                             $2,000
        3% Peak patient shares estimated for % of total
        HTN treated patients on NewProd X
                                                             $1,000
        80% Compliance rate

        Pricing estimates based on current Tekturna             $0
        revenue/Rx + 10%
                                                                  18

                                                                  19

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        4% annual price inflation



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                                                                20
        Launch 2018 with 10 yrs of revenues                                 US Revenue Forecast ($MM)


Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                           22
Example
    Create Pre and Post-Launch Financial CF Projections
         Factor in probabilities of success and risk adjustments at each
         milestone
         Make financial projections for company and for any anticipated future
         alliance or licensing partners who complete development and launch
         product
                                              2018             2020      2022       2024       2026       2028       2030       2032
                                               Yr1              Yr3       Yr5        Yr7        Yr9       Yr11       Yr13       Yr15
  Phase                                      Launch           Market    Market     Market     Market     Market     Market     Market
  Revenues ($000s)                           $7,872          $97,444   $199,370   $244,342   $263,558   $259,352   $228,576   $185,988

  G&A and R&D Expenses                      $5,376             $0        $0         $0         $0         $0         $0         $0
  COGS                                      $1,120           $13,870   $28,377    $34,778    $37,513    $36,914    $32,534    $26,472
  Marketing and Sales                       $50,656          $53,741   $57,014    $60,486    $60,432    $56,860    $53,500    $50,338
  Milestones                                $10,000
  Royalties                                  $472            $5,847    $11,962    $14,661     $15,814   $15,561    $13,715    $11,159
  Expenses (for Licensee)                   $67,625          $73,457   $97,353    $109,925   $113,758   $109,336   $99,748    $87,970

  PHARMA LICENSEE
  Effective Tax Rate                            0%            26%        26%        26%        26%        26%        26%        26%
  Risk adjusted CF                          ($13,671)        $5,488    $23,341    $30,755    $34,274    $34,324    $29,476    $22,427
  Discount                                     53%            43%        35%        29%        23%        19%        15%        12%
  Risk adjusted net DCF                      ($7,309)        $1,762    $6,083      $6,505    $5,884      $4,783    $3,333     $2,058

  rNPV

  BIO-TEC
  Effective Tax Rate                          26%             26%        26%        26%        26%        26%        26%        26%
  Risk Adjusted CF                           $2,396          $1,338     $2,737     $3,354     $3,618     $3,560     $3,138     $2,553
  Discount                                    53%             43%        35%        29%        23%        19%        15%        12%
  Risk Adjusted DCF                           $948            $430       $713       $710       $621       $496       $355       $234
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                                              23
Example
 Cash flow projections provide early estimate of licensing value
                  License deal at start of phase IIb                   Milestones/Upfronts
                                                                        Phase I       Phase II     Phase III     NDA       Approval                Royalties
                  DCF                                                                 $5,000       $5,000      $8,000 $10,000                       6.0%
                                                  2010        2011        2012          2013        2014        2015        2016         2017       2018
                                                  Year3       Year4      Year5         Year6        Year7       Year8       Year9       Year10       Yr1
                  Phase                         Phase I/IIa Phase I/IIa Phase IIb     Phase IIb    Phase III   Phase III   Phase III     NDA       Launch
                  Transition probability                                 100%           44%         100%        100%         65%         80%        100%
                  Probability                                            100%          100%          44%         44%         44%         29%        23%
                  Revenues ($000s)                                         $0            $0           $0          $0          $0          $0       $7,872

                  G&A and R&D Expenses                                  $4,386         $4,386      $12,200     $12,200     $12,200     $2,000      $5,376
                  COGS                                                    $0             $0           $0         $0          $0          $0        $1,120
                  Marketing and Sales                                     $0             $0           $0         $0          $0        $25,328     $50,656
                  Milestones                                            $5,000                      $5,000                             $8,000      $10,000
                  Royalties                                                                                                                         $472
                  Expenses (for Licensee)                               $9,386         $4,386      $17,200     $12,200     $12,200     $35,328     $67,625

                  PHARMA LICENSEE
                  Effective Tax Rate                                      0%             0%           0%          0%          0%           0%          0%
                  Risk adjusted CF                                      ($9,386)      ($4,386)     ($7,568)    ($5,368)    ($5,368)    ($10,104)   ($13,671)
                  Discount                                               100%           90%          81%         73%         66%          59%         53%
                  Risk adjusted net DCF                                 ($9,386)      ($3,952)     ($6,142)    ($3,925)    ($3,536)     ($5,996)    ($7,309)
                  (11% discount rate used)
                  rNPV                                                  $17,460

                  BIO-TEC
                  Effective Tax Rate                                      26%            0%         26%           0%         0%         26%         26%
                  Risk Adjusted CF                                      $5,000          $0         $2,200        $0          $0        $2,288      $2,396
                  Discount                                               100%           90%         81%          73%         66%        59%         53%
                  Risk Adjusted DCF                                     $3,700           $0        $1,321         $0          $0       $1,005       $948
                  (18% discount rate used)


                                                                                                                             Construct business
                  rNPV in 2012                                          $14,071     Value of license for US rights

                  Value share                     45%
                  Total Milestone and Royalty
                  Payments ($000s):             $202,029

                  Initial Valuation Assuming Outlicensing at start of Phase I/Iia
                                                                                         $4
                                                                                                                             plans and financial
                  Cash Flows
                  Prob
                                                  2008

                                                   100%
                                                              2009

                                                             100%
                                                                          2010

                                                                          40%
                                                                                        2011

                                                                                        40%
                                                                                                     2012

                                                                                                    26%
                                                                                                                             projections with
                  rCFs
                  Discount Rate:
                  PV Cash Flows
                                                  ($775)
                                                  100%
                                                  ($775)
                                                             ($775)
                                                              85%
                                                             ($657)
                                                                         ($340)
                                                                          72%
                                                                         ($244)
                                                                                       ($340)
                                                                                        61%
                                                                                       ($207)
                                                                                                   $3,658
                                                                                                    52%
                                                                                                   $1,887
                                                                                                                             potential licensing
                  Total Value rNPV ($000s)         $4
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
                                                                                                                             valuations in mind.
info@pharmacision.com                                                                               24
Exit Strategy Considerations – “Typical” Deal Terms
             Look for comparable deal terms to draw from
             Develop strategic target outlicensing partner “short list”




Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        25
Summary
           Understand your market environment
           Develop therapies to meet unmet medical and realized
           market needs
           Start with the end in mind
             –     Develop target product profile to realize unique value proposition
             –     Understand financial valuations
             –     Factor in risk
             –     Anticipate exit strategy
           Create a drug development plan to reach TPP
           Estimate risks
           Construct financial projections linking market assumptions
           to financial assumptions
           Develop partnering strategy and demonstrate investment
           value opportunities to potential investors

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                            26
Pharmacision LLC Service Offerings
           Strategic Planning
             –     Business strategy and plan development
             –     In/out-licensing commercial due diligence assessments/preparation
             –     Business partnering support
             –     New product planning
             –     New market and competitive landscape assessments
             –     Qualitative Market Research
             –     Market modeling
             –     Demand forecasting and financial NPV analyses


           Marketing Initiatives
             –     Brand strategy and marketing plan development
             –     Positioning and message development
             –     Targeting strategy development
             –     Professional and patient advertising campaign development

Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        27
Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                        28
Contact Information
                                                      Pharmacision LLC
                                                  Thomas Marten
                                                      President
                                                   (734)895-3670
                                            tmarten@pharmacision.com
                                              www.pharmacision.com




Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com,
info@pharmacision.com                                          29

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Taking a Commercial Approach To Drug Development

  • 1. Taking a Commercial Approach to Drug Development Target Product Profile Development And New Product Strategic Planning For Early Stage Pharmas and Drug Development Cos.
  • 2. Pharma/Biotech New Product Strategic Planning Understand the market environment Develop therapies to meet unmet medical and realized market needs Start with the end in mind – Develop target product profile (TPP) to realize unique value proposition – Understand financial valuations of TPP over product life cycle – Factor in risk – Build plan for Exit strategy Create a drug development plan to reach TPP Effectively utilize advisory board and primary research to develop/support assumptions Estimate risks and outlicensing valuations Demonstrate investment value opportunities to support strategic decision making and fund raising support Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 2
  • 3. Goal: Develop Target Product Profile Hypothesis Blueprint for valuations and future planning Frequently “gut-checked” throughout drug development Indication Efficacy Safety/Tolerability Convenience Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 3
  • 4. Strategic Planning Approach – How TPP Fits In Market Mapping/Prioritization Define Success Develop Target Product Profile Clinical Manufacturing & Development formulation Strategy Strategy (not covered in this presentation) Financial Projections Exit strategy Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 4
  • 5. Example Market Mapping – Define market and map out market landscape 8 0 0 ,0 0 0 Acute 59,633 70 0 ,0 0 0 Un- diagnosed Undiagnosed 6 0 0 ,0 0 0 Patients Target Chronic Condition(s) 332,936 50 0 ,0 0 0 Patient Patients Prevalence 4 0 0 ,0 0 0 Chronic 61,147 3 0 0 ,0 0 0 Symptomatic Patients “High Risk” Diagnosed Diagnosed Patients 2 0 0 ,0 0 0 and Asymptomatic In Health 1 0 ,0 0 0 0 Care Symptomatic “Low Risk” Patients Asymptomatic 0 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 5
  • 6. Example Evaluate SOC* and unmet needs – Determine Target segments “Satisfied” “Unsatisfied” with therapy with therapy High Risk, Symptomatic “Unsatisfied” with therapy “Satisfied” Patients with therapy High Risk, “Satisfied” Asym ptom ati with therapy c “Unsatisfied” with therapy Low Risk, Sym ptom atic Low Risk, “Unsatisfied” Asym ptom ati “Satisfied” with therapy c with therapy Diagnosed Pts *SOC= standards of care Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 6
  • 7. Example Understand Key Market Drivers and Barriers to Prescribing For Each Segment Primary Drivers Primary Drivers Primary Barriers Primary Barriers Stricter guidelines calling for lower Concern over cost/managed care BP in high risk patients reimbursement challenges Want greater ability to control HBP Push to use generics No longer acceptable for high risk Prior authorizations and insurance patients to have “borderline” HTN claim rejections for use of newer high Want greater reduction in the rate of priced antihypertensive drug as initial end organ failure (brain, kidney, therapy heart, eyes) in all patients Skeptical of data showing differences in Want easy to take, well-tolerated efficacy within RI class therapy Entrenched prescribing habits Need to see compelling clinical data Comfortable with existing before switching to any new antihypertensive products and products regimens Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 7
  • 8. Evaluate Current and Future Competitor Landscape Strengths/ Exp. Launch Date/ Weaknesses/ Future Anticipated Class Indication Compelling Unmet Needs Impact date of generic Advantage on Mkt entry Product 1 Product 2 Current Product Competitors 3 Product 4 Product 5 Product 6 Product Compounds in 7 Dev. (Future Competitors Product 8 Product 9 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 8
  • 9. Define your unique value proposition for each target market segment • Identify Imp/Diff features and benefits that are sustainable and can drive behavioral change leading to initial product trial and usage • Postulate unique value proposition for product based on hypothesized Imp/Diff features and benefits • Create target product profile to highlight important differences • Target product profile (TPP) should drive clinical development plan to demonstrate unique value proposition Not Different Different Convenience Efficacy Greater target Important Oral Rx organ protection Unimportant Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 9
  • 10. Prioritize Segments For Clinical and Commercial Development Evaluate and prioritize individual segments using the following eligibility tests: Does the segment have adequate size to reach financial targets with modest product market Total Addressable penetration? market Can patients be easily identified and targeted? Can high volume treaters be easily targeted? In care for condition Will your product meet patient unmet needs? Is unique value proposition in this patient segment Not satisfied with sustainable given current and future competition? current therapy Will unique value proposition convince physicians to use your product? Have symptoms compound can treat Can clinical trials be easily designed with end points to demonstrate unique value proposition ? TPP needs to be compelling Willing to Can clinical trials be designed, approved, enrolled for this group switch and completed in a timely manner? Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 10
  • 11. Example Develop Unique Value Proposition Hypothesis Antihypertensive market is huge – 65 million American adults have high blood pressure – $55 billion spent annually in direct expenditures to treat HBP – Antihypertensives are #1 prescribed class of drugs for Medicare Part D enrollees with 122 million prescriptions in 2006 – 6 different classes of drugs and over 70 individual drugs on the market to treat hypertension Yet still largely uncontrolled – 60% of patients require 2 or more drugs to treat their hypertension – Poor compliance remains a major factor exacerbating poor HTN control with existing therapies – 70% of patients on therapy still do not have their BP under control (<140/90 mm Hg) – Hospitalization rates for congestive heart failure continue to increase – 69% of CHF patients are hypertensive – Increasing trend in end stage renal disease – hypertension second only to diabetes as most common antecedent for this condition – Higher blood pressures lead to higher risk of death from heart disease or stroke – 77% of first stroke patients have high blood pressure For patients with uncontrolled HTN on initial antihypertensive regimens, Product X provides an excellent “first switch” agent to add to a second antihypertensive regimen to lower blood pressure while providing proven protection against target organ damage that can cause heart failure, kidney damage and strokes. Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 11
  • 12. Define Commercial Success Efficacy, safety and convenience performance levels required to drive target segment behavioral change to generate product adoption Market environmental changes required to capitalize on market drivers and overcome barriers to adoption Pricing levels needed to meet NPV goals Adoption and target patient penetration levels needed to meet NPV goals Make assumptions on all the above Need Market research and/or medical advisory board feedback to validate assumptions!! TPP needs to deliver on commercial success drivers! Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 12
  • 13. Historical Case Study Prod X to prevent infections after Bone Marrow Transplantation Problem: Allogeneic BMT patients, and in particular unrelated donor BMT patients are at increased risk for life-threatening airborne infections due to: – Immunosuppression for 6 months with calcineurin inhibitors – Treatment of acute Graft vs. Host Disease (aGvHD) with increased immunosuppression (high dose steroids) – Subsequent extended immunosuppression for more than 2 years Solution: Prod X aerosol new product concept: – Coats upper respiratory tract (trachea, big bronchi) – Blocks and physically expels viruses / fungi – Potential for use as prophylaxis against fungal and viral infections, which have high mortality rate in this patient population Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 13
  • 14. Historical Case Study Bone Marrow Transplantation Market Landscape 1998: Est. WW procedures 52,000 10-40% infection rate 5,200 - 20,800 mortality 2-8% 1,040 - 4,160 Overall mortality is about 40% (GVHD, Infection, Relapse) Primary viral and fungal species implicated in morbidity and mortality are: – Virus: CMV, RSV, rhinovirus, Influenza, parainfluenza – Fungi: Aspergillus fumigatus (mainly pulmonary); Candida sp. Risk factors for post BMT infectious complications – GVH Disease, Toxicity of chemotherapy, Steroid therapy for immuno-suppression, Antibiotics (overgrowth of opportunistic fungi), Ganciclovir therapy (late stage CMV and/or fungal infections), donor age, underlying disease morbidity Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 14
  • 15. Historical Case Study Target Market and Commercial Success Criteria Target market – Preventing Aspergillus fumigatus fungal infections in allogeneic post BMT patients – Biggest post BMT infection concern – Incidence: 5-10% in allogeneic BMT patients, 30% in unrelated allogeneic BMT patients – mortality: 70-90% – Current Competition: • Amphotericin B, Itraconazole - modest efficacy against Aspergillus • issues: nephrotoxicity, Cyt.P450 3A4 inhibition – Future Competitive Landscape: • New class of antifungals on the rise: echinocandins (e.g. Cancidas [Merck]) effective and less toxic. • Will be strongest competition, but resistance can develop with overuse as prophylaxis. Commercial Success Criteria - Activity against Aspergillus with lower levels of resistance development than new antifungal class of antibiotics Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 15
  • 16. Historical Case Study Product X Product Profiling/ Gap Analysis • Key unmet need and physician concern: Aspergillus infection prevention in unrelated allogeneic post-BMT patients • Need to demonstrate activity against Aspergillus for commercial success • Clinical development efforts need to focus on prevention of Aspergillus infections and seek Aspergillus prophylaxis as a labeled indication Not Different Different Aspergillus Important prevention Unimportant Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 16
  • 17. Historical Case Study Prod X Aerosol Target Product Profile (TPP) Indication Prevention of life-threatening Aspergillus and Respiratory Virus Infections in allogeneic Bone Marrow Transplant Recipients Efficacy 1. Reduction of Aspergillus infections within the first 3 12 months after transplantation in unrelated donor graft recipients by 50% 2. Reduction of Respiratory Virus infections in allogeneic BMT patients with an aGvHD history requiring continued high dose immunosuppression or cGvHD by 50% between month 3 and month 9 12 months after Transplantation Safety/Tolerability Acceptable tolerability. No additional inflammatory activity within the Upper Respiratory Tract and lungs. No increased coughing Enveloped viruses and prion safety comparable to present hyperimmunes. Non-enveloped viruses safety according to PEI standard Convenience Aerosol administration. Low: 50 mg x 2 per day Base: 50 mg x 3 per day High: 50 mg x 5 per day Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 17
  • 18. Historical Case Study TPP Drives Commercially Focused Clinical Development Strategy Clinical phase Phase I Primary: Safety Secondary: Effect on Respiratory Virus Infections; Respiratory Bacterial Infections, Effect on Aspergillus Infections Timing: 1.1 yr Cost: $0.9 MM Patients: 30 Phase II Primary: Safety and Dose Finding Secondary: Effect on Respiratory Virus Infections; Respiratory Bacterial Infections, Effect on Aspergillus Infections Timing: 1.1 yr Cost: $3.1 MM Patients: 60 Phase III Primary: reduction of aspergillus lung infections within 12 months post- transplant from 30% to 15% (50% reduction) (unrelated allogeneic pts) Secondary: Reduction of Respiratory Virus Infections; Reduction of Bacterial Infections, Mortality Reduction Timing: 3.25 yr Cost: $10.5 MM Patients: 240 Phase III Primary: reduction of RSV/parainfluenza/influenza lung infections 12 months after transplant from 15% to 7.5% (50% reduction) (all allogeneic patients) Secondary: Reduction of other respiratory virus infections (rhino, adeno), reduction of aspergillus infections, reduction of bacterial (pneumococci, hemophilus) infections, Mortality Reduction Timing: 2.25 yr Cost: $26 MM Patients: 600 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 18
  • 19. Estimate Costs and Timelines for Clinical Trials Drug Development Timeline and Risks IND submission File NDA Pre-Clinical Testing Phase I Phase II Phase III NDA Review Total Years 1.5 1.5 2 3.5 1.5 8.5 Expected Costs ($ millions) in 2007$ $2 $13.5 $28.3 $81.2 $2.5 $127 20 to 100 100 to 500 1,000 to 5,000 Test Population healthy subjects patients patients n/a n/a Confirm Evaluate effectiveness, Determine efficacy, optimal monitor adverse safety and dosing, side reactions from Purpose dosage effects long-term use n/a n/a Sources: Risks in new drug development: Approval success rates for investigational drugs ; Clin Pharmacol Ther 2001;69:297-307. The Drug Discovery, Development and Approval Process , PHRMA website R&D Costs and Returns by Therapeutic Category ; Drug Information Journal, Vol 38, 2004. Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 19
  • 20. Understand Risks and Exit Strategy Considerations Licensing most feasible exit strategy Probability of FDA approval ≠ Expected Probability of commercial success in all cases High risk business – platform strategies and compounds with multiple indication potential much more attractive to investors In most cases, plan for outlicensing at early human proof of concept stage Prob of Stage Time (Yrs) Success* Pre-Clinical 2 40% Phase I/IIa 2 65% Phase IIb 2 44% Phase III 3 65% Approval 1 80% Cum Total 10 6% *Sources: DiMasi 2001, Kola 2004, Avance * For Immunology drugs in development Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 20
  • 21. Construct Financial Projections “You did a great job with your forecast. The only thing I can say about it with absolute certainty is that it’s wrong.” -- Words of wisdom I received early in my career Do the best you can without the benefits of having perfect information and a crystal ball! Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 21
  • 22. Example Start by Tying Market Assumptions to Financial Assumptions Use US Census population projections 6% NHANES data used to estimate % population 5% with HTN 4% 3% 85% of patients with HTN are on therapy 2% 1% 63% to 75% of patients >20 have uncontrolled 0% HTN 18 19 20 21 22 23 24 25 26 27 20 20 20 20 20 20 20 20 20 20 Only Pts with uncontrolled HTN are candidates for NewProd X % Uncontrolled HTN Pts on PH-RI 5% Peak patient shares estimated for % of uncontrolled pts on NewProd X $2,000 3% Peak patient shares estimated for % of total HTN treated patients on NewProd X $1,000 80% Compliance rate Pricing estimates based on current Tekturna $0 revenue/Rx + 10% 18 19 20 21 22 23 24 25 26 27 4% annual price inflation 20 20 20 20 20 20 20 20 20 20 Launch 2018 with 10 yrs of revenues US Revenue Forecast ($MM) Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 22
  • 23. Example Create Pre and Post-Launch Financial CF Projections Factor in probabilities of success and risk adjustments at each milestone Make financial projections for company and for any anticipated future alliance or licensing partners who complete development and launch product 2018 2020 2022 2024 2026 2028 2030 2032 Yr1 Yr3 Yr5 Yr7 Yr9 Yr11 Yr13 Yr15 Phase Launch Market Market Market Market Market Market Market Revenues ($000s) $7,872 $97,444 $199,370 $244,342 $263,558 $259,352 $228,576 $185,988 G&A and R&D Expenses $5,376 $0 $0 $0 $0 $0 $0 $0 COGS $1,120 $13,870 $28,377 $34,778 $37,513 $36,914 $32,534 $26,472 Marketing and Sales $50,656 $53,741 $57,014 $60,486 $60,432 $56,860 $53,500 $50,338 Milestones $10,000 Royalties $472 $5,847 $11,962 $14,661 $15,814 $15,561 $13,715 $11,159 Expenses (for Licensee) $67,625 $73,457 $97,353 $109,925 $113,758 $109,336 $99,748 $87,970 PHARMA LICENSEE Effective Tax Rate 0% 26% 26% 26% 26% 26% 26% 26% Risk adjusted CF ($13,671) $5,488 $23,341 $30,755 $34,274 $34,324 $29,476 $22,427 Discount 53% 43% 35% 29% 23% 19% 15% 12% Risk adjusted net DCF ($7,309) $1,762 $6,083 $6,505 $5,884 $4,783 $3,333 $2,058 rNPV BIO-TEC Effective Tax Rate 26% 26% 26% 26% 26% 26% 26% 26% Risk Adjusted CF $2,396 $1,338 $2,737 $3,354 $3,618 $3,560 $3,138 $2,553 Discount 53% 43% 35% 29% 23% 19% 15% 12% Risk Adjusted DCF $948 $430 $713 $710 $621 $496 $355 $234 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 23
  • 24. Example Cash flow projections provide early estimate of licensing value License deal at start of phase IIb Milestones/Upfronts Phase I Phase II Phase III NDA Approval Royalties DCF $5,000 $5,000 $8,000 $10,000 6.0% 2010 2011 2012 2013 2014 2015 2016 2017 2018 Year3 Year4 Year5 Year6 Year7 Year8 Year9 Year10 Yr1 Phase Phase I/IIa Phase I/IIa Phase IIb Phase IIb Phase III Phase III Phase III NDA Launch Transition probability 100% 44% 100% 100% 65% 80% 100% Probability 100% 100% 44% 44% 44% 29% 23% Revenues ($000s) $0 $0 $0 $0 $0 $0 $7,872 G&A and R&D Expenses $4,386 $4,386 $12,200 $12,200 $12,200 $2,000 $5,376 COGS $0 $0 $0 $0 $0 $0 $1,120 Marketing and Sales $0 $0 $0 $0 $0 $25,328 $50,656 Milestones $5,000 $5,000 $8,000 $10,000 Royalties $472 Expenses (for Licensee) $9,386 $4,386 $17,200 $12,200 $12,200 $35,328 $67,625 PHARMA LICENSEE Effective Tax Rate 0% 0% 0% 0% 0% 0% 0% Risk adjusted CF ($9,386) ($4,386) ($7,568) ($5,368) ($5,368) ($10,104) ($13,671) Discount 100% 90% 81% 73% 66% 59% 53% Risk adjusted net DCF ($9,386) ($3,952) ($6,142) ($3,925) ($3,536) ($5,996) ($7,309) (11% discount rate used) rNPV $17,460 BIO-TEC Effective Tax Rate 26% 0% 26% 0% 0% 26% 26% Risk Adjusted CF $5,000 $0 $2,200 $0 $0 $2,288 $2,396 Discount 100% 90% 81% 73% 66% 59% 53% Risk Adjusted DCF $3,700 $0 $1,321 $0 $0 $1,005 $948 (18% discount rate used) Construct business rNPV in 2012 $14,071 Value of license for US rights Value share 45% Total Milestone and Royalty Payments ($000s): $202,029 Initial Valuation Assuming Outlicensing at start of Phase I/Iia $4 plans and financial Cash Flows Prob 2008 100% 2009 100% 2010 40% 2011 40% 2012 26% projections with rCFs Discount Rate: PV Cash Flows ($775) 100% ($775) ($775) 85% ($657) ($340) 72% ($244) ($340) 61% ($207) $3,658 52% $1,887 potential licensing Total Value rNPV ($000s) $4 Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, valuations in mind. info@pharmacision.com 24
  • 25. Exit Strategy Considerations – “Typical” Deal Terms Look for comparable deal terms to draw from Develop strategic target outlicensing partner “short list” Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 25
  • 26. Summary Understand your market environment Develop therapies to meet unmet medical and realized market needs Start with the end in mind – Develop target product profile to realize unique value proposition – Understand financial valuations – Factor in risk – Anticipate exit strategy Create a drug development plan to reach TPP Estimate risks Construct financial projections linking market assumptions to financial assumptions Develop partnering strategy and demonstrate investment value opportunities to potential investors Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 26
  • 27. Pharmacision LLC Service Offerings Strategic Planning – Business strategy and plan development – In/out-licensing commercial due diligence assessments/preparation – Business partnering support – New product planning – New market and competitive landscape assessments – Qualitative Market Research – Market modeling – Demand forecasting and financial NPV analyses Marketing Initiatives – Brand strategy and marketing plan development – Positioning and message development – Targeting strategy development – Professional and patient advertising campaign development Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 27
  • 28. Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 28
  • 29. Contact Information Pharmacision LLC Thomas Marten President (734)895-3670 tmarten@pharmacision.com www.pharmacision.com Copyright © 2009 Pharmacision LLC, www.Rapid-Insights.com, info@pharmacision.com 29