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Marketing of Protein and Peptide Pharmaceuticals

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Presented to Ph.D. students of Faculty of Pharmacy of Tehran University

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Marketing of Protein and Peptide Pharmaceuticals

  1. 1. Marketing of Peptide, Proteins, Author: Sasan Nasoohi Function : Sales Manager Schering Plough Date : Nov 08 Presented to Ph.D. students of Faculty of Pharmacy of Tehran University
  2. 2. Proteins, eventually !! <ul><li>Our genetic material speaks the tale of proteins </li></ul>
  3. 3. Proteins: disease and remedy <ul><li>Loss in protein production or functionality might lead to serious diseases </li></ul><ul><ul><li>Diabetes Mellitus </li></ul></ul><ul><li>Proteins might mediates diseases as well </li></ul><ul><ul><li>C-reactive protein mediates cardiovascular disorders. </li></ul></ul><ul><li>Exogenous proteins might mediate serious reactions </li></ul><ul><ul><li>Hypersensitivity reactions. </li></ul></ul>
  4. 4. Proteins are drugs ! <ul><li>Serving or mimicking an endogenous function: </li></ul><ul><ul><li>Hormonal therapy (Insulin,) </li></ul></ul><ul><li>Exploiting an endogenous reaction: </li></ul><ul><ul><li>Vaccines </li></ul></ul><ul><li>Antagonizing an endogenous function: </li></ul><ul><ul><li>(infliximab) </li></ul></ul>
  5. 5. From cells to patients
  6. 6. Peptide Pros and Cons <ul><li>Advantages: </li></ul><ul><li>High Activity, High Specifity, Little unspecific binding to molecular structure other that desired target, Minimization of drug-drug interactions, Less accumulation in tissues, Lower toxicity, Often very potent, Biological diversity </li></ul><ul><li>Disadvantages </li></ul><ul><li>Low oral bioavailability, injection required, Less stable, Difficult delivery and challenge to transport across membranes, Challenging and costly synthesis, Solubility challenges, Risk of immunogenic effects, Cleared from body quickly </li></ul>
  7. 7. Origin of peptide products <ul><li>Synthetic peptides </li></ul><ul><li>Naturally-derived peptides </li></ul><ul><li>Natural, non-blood derived proteins </li></ul><ul><li>Natural, blood derived proteins </li></ul><ul><li>Recombinant proteins </li></ul>
  8. 8. Peptide Pharmaceuticals <ul><li>Annual market value: $ 35 Bln </li></ul><ul><li>Aprox. 40 marketed peptides worldwide </li></ul><ul><li>270 in clinical phase </li></ul><ul><li>400 in preclinical phase </li></ul><ul><li>Growth rate double the rate all APIs </li></ul><ul><li>(Estimated : 10%) </li></ul><ul><li>Expanding interest in peptides for drug discovery </li></ul>
  9. 9. Protein Therapeutics <ul><li>Market size: 60 bln </li></ul><ul><li>Growth rate: 13% </li></ul><ul><li>Aprox. 130 marketed protein therapeutics worldwide </li></ul>
  10. 10. Major Brands > $ 1 Mln <ul><li>Procrit (Johnson & Johnson) – epoetin alpha, treatment of anemia </li></ul><ul><li>Epogen (Amgen)- Epoetin , increase of red blood cells </li></ul><ul><li>Rituxan (Genentech)- Rituximab, treatment of rheumatoid arthritis </li></ul><ul><li>Enbrel (Amgen)- Etanercept, treatment of rheumatoid arthritis </li></ul><ul><li>Remicade (Schering Plough) – infliximab, anti-inflammatory </li></ul><ul><li>Herceptin (Chugai)- Trastuzumab – breast cancer treatment </li></ul><ul><li>Humalog ( Eli Lilly)- Insulin - Diabetes </li></ul>
  11. 11. Major Brands > $ 1 Mln <ul><li>Procrit > $2bln $35/ml </li></ul><ul><li>Epogen $37/ml </li></ul><ul><li>Rituxan $70/ml </li></ul><ul><li>Enbrel $160/vial </li></ul><ul><li>Remicade $700/vial </li></ul><ul><li>Herceptin $1200/vial </li></ul><ul><li>Humalog $ 100/vial </li></ul>
  12. 12. Iran Sales 4 month <ul><li>Procrit > $2bln $35/ml </li></ul><ul><li>Epogen $37/ml </li></ul><ul><li>Rituxan $70/ml </li></ul><ul><li>Enbrel $160/vial 1875 vials / 920,000 Rials </li></ul><ul><li>Remicade $700/vial 659 vials / 6,500,000 Rials </li></ul><ul><li>Herceptin $1200/vial 499vials / 8,000,000 Rials </li></ul><ul><li>Humalog $ 100/vial </li></ul>
  13. 13. Cost-effectiveness <ul><li>Follitorpin Urine collection/Recombinant </li></ul><ul><li>Price </li></ul><ul><li>Batch to batch consistency </li></ul><ul><li>Novel new product </li></ul><ul><li>Less risk of contaminations </li></ul>
  14. 14. Production Costs <ul><li>$300-$500 per g for 300-500 g </li></ul><ul><li>$100-$200 per g for 1-2 Kg </li></ul><ul><li>$25-$ per g for 50-100 Kg </li></ul><ul><li><$10 per g for high ranges </li></ul>
  15. 15. What is PharmacoEconomics (PE)? Inputs Costs Health Care Outcomes
  16. 16. Pharmacoeconomics (PE) <ul><li>Compares the costs and consequences (outcomes) of drug therapies and medical interventions </li></ul><ul><li>PE analysis </li></ul><ul><ul><li>efficient allocation of limited resources among competing alternative medications and services </li></ul></ul>
  17. 17. Costs <ul><li>What is cost? </li></ul><ul><li>How is cost different from price? </li></ul><ul><li>Do we know the cost of drugs? </li></ul>
  18. 18. Costs <ul><li>Direct costs : costs to deliver services to patient; both medical and non-medical </li></ul><ul><li>Indirect costs : cost of treatment to patient or society </li></ul><ul><li>Intangible costs : quality of life </li></ul>Advantages: High Activity, High Specifity, Little unspecific binding to molecular structure other that desired target, Minimization of drug-drug interactions, Less accumulation in tissues, Lower toxicity, Often very potent, Biological diversity
  19. 19. Costs can be described in many ways <ul><li>Cost / unit (cost/tab, cost/vial) </li></ul><ul><li>Cost / treatment </li></ul><ul><li>Cost / person </li></ul><ul><li>Cost / person / year </li></ul><ul><li>Cost / case prevented </li></ul><ul><li>Cost / life saved </li></ul><ul><li>Cost / DALY (disability-adjusted life year) </li></ul>
  20. 20. Outcomes <ul><li>Both positive and negative outcomes should be addressed </li></ul><ul><li>Positive outcomes: drug’s efficacy measure </li></ul><ul><li>Negative outcomes: ADR and treatment failure </li></ul>
  21. 21. Most Active Developments <ul><li>Types: Cytokines , Monoclonal Antibodies, Vaccines </li></ul><ul><li>Segments: Oncology, Cardiovascular, Infection </li></ul>
  22. 22. The top 10 biotechnology companies
  23. 23. Challenges <ul><li>80’s : Technological challenges for peptide delivery </li></ul><ul><li>High R&D and marketing costs </li></ul><ul><li>Large scale manufacturing </li></ul><ul><li>Competitive environment </li></ul><ul><li>Formulation of stable product </li></ul><ul><li>Delivery of the product to body </li></ul><ul><li>Overcoming short bioavailability </li></ul><ul><li>Peptide production still maturing </li></ul><ul><li>Conventional pharmaceutical formulations would destroy most proteins and eliminate their activities: </li></ul><ul><ul><li>Pharmaceutical manufacturing includes harsh processing steps that would be harmful for proteins e.g. heating, high shear force, granulation, compression, etc. </li></ul></ul><ul><li>Short shelf life of protein preparations: </li></ul><ul><ul><li>If kept in correct conditions, must not be used after 4 weeks post opining </li></ul></ul>
  24. 24. Challenges <ul><li>Chance of commercialization from Phase I = 10-20% </li></ul><ul><li>Chance of commercialization from phase III = 60-80% </li></ul><ul><li>90% of drugs entering clinical trials fail to make it to market </li></ul><ul><li>The average cost to bring a new drug to market is estimated at $770 million </li></ul>
  25. 25. Current FDA Policy for approval of rDNA-derived Products <ul><li>FR Notice (51 FR 23309), June 26, 1986 </li></ul><ul><li>Points to Consider in the Production Testing of New Drugs and Biologicals Produced by Recombinant DNA Technology (April 10, 1986) </li></ul><ul><ul><li>Protein drug substances produced by rDNA technology cannot be assumed to be the same. </li></ul></ul><ul><ul><li>IND and Full NDA (505(b)(1)) required. </li></ul></ul>
  26. 26. Determining the Degree of Similarity of Proteins <ul><li>Past : Limited ability to characterize the identity, structure, activity of the active components </li></ul><ul><li>Scientific advances: sensitive and validated assays </li></ul><ul><li>Accumulated agency’s experience in making determinations of the similarity and sameness of peptides and proteins </li></ul><ul><li>FDA published recommendations on comparability/evaluations in 1996. </li></ul>
  27. 27. Product Comparability Testing <ul><li>Analytical Testing </li></ul><ul><li>Bioassays </li></ul><ul><li>Pre-clinical Animal Studies </li></ul><ul><li>Clinical Studies </li></ul>
  28. 28. Pharmaceutical Equivalence (PE) <ul><li>Identical active drug ingredients </li></ul><ul><li>Identical amounts of active ingredients </li></ul><ul><li>Identical dosage forms </li></ul><ul><li>Identical compendia or other applicable standard of identity , strength, quality, and purity </li></ul>
  29. 29. The ICH S6 Document <ul><ul><li>usage of relevant vs. non-relevant species </li></ul></ul><ul><ul><li>usage of animal models of disease </li></ul></ul><ul><ul><li>immunogenicity testing and its implications </li></ul></ul><ul><ul><li>genotoxicity testing </li></ul></ul><ul><ul><li>chronic toxicity testing </li></ul></ul><ul><ul><li>carcinogenicity testing </li></ul></ul><ul><ul><li>preclinical study design </li></ul></ul>
  30. 30. Toxicology Testing of Biotech-Derived Agents: ICH-S6 <ul><li>General Principles </li></ul><ul><ul><li>sufficiently well-characterized products </li></ul></ul><ul><ul><li>rely on purification processes to remove impurities/contaminants </li></ul></ul><ul><ul><li>comparability of test material demonstrated throughout development </li></ul></ul><ul><ul><li>conventional approaches to toxicity studies often NOT appropriate to address unique issues </li></ul></ul><ul><ul><li>GLP compliance </li></ul></ul>
  31. 34. We sell benefits
  32. 35. Feature of Benefit? <ul><li>Advantages: </li></ul><ul><li>High Activity, High Specifity, Little unspecific binding to molecular structure other that desired target, Minimization of drug-drug interactions, Less accumulation in tissues, Lower toxicity, Often very potent, Biological diversity </li></ul>
  33. 36. <ul><li>Protein pharmaceuticals </li></ul>
  34. 37. <ul><li>[email_address] </li></ul>

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