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Future Pharmaceutical Trends - Patent & Pipeline –

Future Pharmaceutical Trends - Patent & Pipeline – . Chris Peterson, PharmD Aimee Tharaldson, PharmD. Objectives. Patent Expiration Overview: 2011-2013 Traditional Pipeline Highlights Specialty Pipeline Overview. Objectives. Patent Expiration Overview: 2011-2013

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Future Pharmaceutical Trends - Patent & Pipeline –

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  1. Future Pharmaceutical Trends- Patent & Pipeline – Chris Peterson, PharmD Aimee Tharaldson, PharmD

  2. Objectives • Patent Expiration Overview: 2011-2013 • Traditional Pipeline Highlights • Specialty Pipeline Overview

  3. Objectives • Patent Expiration Overview: 2011-2013 • Traditional Pipeline Highlights • Specialty Pipeline Overview

  4. Patent Expiration Landscape $ Billion 4

  5. Patent Expiration LandscapeNext 5 Years $ Billion 5

  6. Patent Expiration LandscapeNext 5 Years $ Billion Nexium Celebrex Actonel Abilify Gleevec Namenda Cymbalta OxyContin Niaspan 6

  7. Patent Expirations: 2011 * Settlement Agreement

  8. Patent Expirations: 2011 * Settlement Agreement

  9. Patent Expirations: 2012 * Settlement Agreements

  10. Patent Expirations: 2012 * Settlement Agreements

  11. Patent Expirations: 2012 * Settlement Agreements

  12. Patent Expirations: 2012 * Settlement Agreements

  13. Patent Expirations: 2012 * Settlement Agreements

  14. Patent Expirations: 2013 * Settlement Agreement

  15. Patent Expirations: 2013 * Settlement Agreement 15

  16. Objectives • Patent Expiration Overview: 2011-2013 • Traditional Pipeline Highlights • Specialty Pipeline Overview 16

  17. Cardiovascular Pipeline Xarelto(rivaroxaban – Bayer/J&J) Indication: Stroke/systemic embolism in a-fib. Route: Oral (once daily) Comments: Approved July 1, 2011. Also under FDA Review for a-fib indication (Nov. 5, 2011). Eliquis(apixaban – BMS/Pfizer) Indication: Stroke/systemic embolism in a-fib. Route: Oral (twice daily) Comments: Submission of NDA by the end of 2011 with FDA approval in 2012. 17

  18. FDA Action Dates: Cardiovascular 18

  19. Diabetes Pipeline Dapagliflozin(AstraZeneca/BMS) Indication: Type 2 diabetes Route: Oral (two times daily) Comments: FDA Ad Board held on July 19. FDA action date is October 28, 2011. Bydureon(exenatide LAR – Amylin/Lilly) Indication: Type 2 diabetes Route: subcutaneous injection (once weekly) Comments: “Complete response” received in March 2011. FDA action date is January 28, 2012. 19

  20. Diabetes Pipeline Insulin Degludec(Novo-Nordisk) Indication: Diabetes Route: Subcutaneous injection (three times weekly) Comments: Long-acting basil insulin. Submission planned by the end of 2011. 20

  21. FDA Action Dates: Diabetes 21

  22. Respiratory Pipeline Eklira (aclidinium – Forest) Indication: COPD Route: Inhalation (twice daily) Comments: FDA Action date is Apr 30, 2012. Glycopyrronium (NVA237 – Novartis) Indication: COPD Route: Inhalation (once daily) Comments: NDA submission planned by the end of 2011. 22

  23. FDA Action Dates: Respiratory 23

  24. CNS Pipeline Opana ER (oxymorphonee.r. – Endo) Indication: Chronic pain Route: Oral (Twice daily) Comments: “Tamper resistant” formulation. FDA Action date is Dec 13, 2011. Remoxy (oxycodonee.r. – Pfizer) Indication: Chronic pain Route: Oral (Twice daily) Comments: “Tamper resistant” formulation. Complete response issued in in June. 24

  25. CNS Pipeline Levomilnacipran (Forest) Indication: Depression Route: Oral (once daily) Comments: Isomer of milnacipran (Savella). NDA by expected “early 2012”. 25

  26. CNS Pipeline Levadex(dihydroergotamine - MAP) Indication: Acute migraine Route: Inhalation Comments: Asthma-sized inhaler device. FDA Action date is Mar 26, 2012. 26

  27. FDA Action Dates: CNS 27

  28. FDA Action Dates: Other 28

  29. Objectives • Patent Expiration Overview: 2011-2013 • Traditional Pipeline Highlights • Specialty Pipeline Overview 29

  30. FDA New Drug Approvals Traditional Specialty Source: U.S. Food and Drug Administration

  31. Specialty Trend Continues to Dwarf Traditional PMPY Annual Trend Source: Express Scripts’ Drug Trend Report data and Forecasting Specialty Traditional

  32. Top Specialty Therapy Classes $37 $30 $22 PMPY 2010 PMPY Source: Express Scripts’ Drug Trend Report data

  33. Therapy Class Review • Inflammatory Conditions • Multiple Sclerosis • Cancer • Hepatitis C • Cystic Fibrosis • Other Drugs to Watch

  34. Inflammatory ConditionsPipeline Trends • Oral biologics will compete with injectables • More therapies for gout? • “Biobetters” on the horizon

  35. Inflammatory ConditionsPipeline RA = Rheumatoid Arthritis; PA = Psoriatic Arthritis *Already on the market for another indication or different route

  36. Oral Biologics Apremilast (Celgene) Indication: Psoriasis, Psoriatic Arthritis Route: Oral (twice daily) Comments:Inhibits inflammatory cytokines; Approval in 2012 for psoriasis Tofacitinib (Pfizer) Indication: Rheumatoid Arthritis, Psoriasis Route: Oral (twice daily) Comments: Inhibits JAK; Approval in 2012 for RA RA = Rheumatoid Arthritis JAK = Janus Kinase

  37. Gout Ilaris (canakinumab - Novartis) Indication: Treatment and prevention of acute gout Route: SQ Injection Comments: Negative Ad Board, CRL in August Arcalyst (rilonacept - Regeneron) Indication: Treatment and prevention of acute gout Route: SQ Injection Comments: Approval in 2012? - Both already on market for CAPS - CRL = Complete Response Letter; CAPS = Cryopyrin-Associated Periodic Syndromes

  38. Multiple Sclerosis Pipeline Trends • More oral disease-modifying drugs • May see combination use of MS drugs • Expanded MS use for currently marketed drugs

  39. Multiple Sclerosis Pipeline *Already on the market for another indication

  40. Oral Disease-Modifying Drugs for MS DimethylFumarate(BG-12 – Biogen Idec) Indication: Relapsing Remitting Multiple Sclerosis Route: Oral (two times daily) Comments: Approval in 2012; G.I./flushing issues Laquinimod(Teva / Active Biotech) Indication: Relapsing Remitting Multiple Sclerosis Route: Oral (once daily) Comments: Approval in 2012; May liver enzymes

  41. Currently Marketed Drugs Expand into MS Lemtrada (alemtuzumab - Genzyme) Indication: Relapsing Remitting Multiple Sclerosis Route: IV Infusion (5 then 3 days per year) Comments: Approved for CLL; ITP and infection risk Zenapax (daclizumab – Biogen Idec/Abbott) Indication: Relapsing Remitting Multiple Sclerosis Route: SQ Injection (once monthly) Comments: Approved for transplant; Infection and liver toxicity risk CLL = Chronic Lymphocytic Leukemia; ITP = Immune Thrombocytopenic Purpura

  42. Cancer Pipeline Trends • Cancer treated as a chronic condition • Oral drugs • Targeted therapies • Niche or orphan cancer types • Pharmacogenomics plays a role

  43. 2011 Cancer Drug Approvals HL = Hodgkin’s Lymphoma; ALCL = Anaplastic Large Cell Lymphoma; NSCLC = Non-Small Cell Lung Cancer

  44. Pharmacogenomics Zalboraf(vemurafenib – Genentech) Indication: Malignant Melanoma Route: Oral (twice daily) Comments: For patients with BRAF mutation; Approved Aug. 17th Xalkori(crizotinib - Pfizer) Indication: Non-Small Cell Lung Cancer Route: Oral (twice daily) Comments: For patients with ALK mutation; Approved Aug. 26th

  45. Cancer Pipeline- 2011 – Erwinaze (crisantaspase – EUSA) Indication: Acute Lymphoblastic Leukemia Route: IM (every other day) Comments: Cell growth inhibitor; Approval in 2011 Ruxolitinib(Incyte) Indication: Myelofibrosis Route: Oral (twice daily) Comments: JAK inhibitor; FDA action: Dec 3rd JAK = Janus Kinase

  46. Cancer Pipeline- 2012 - NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

  47. Cancer Pipeline- 2012 - NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

  48. Cancer Pipeline- 2012 - NHL = Non-Hodgkin’s Lymphoma; CML = Chronic Myeloid Leukemia; NSCLC = Non-Small Cell Lung Cancer

  49. Oral Drugs for Cancer Axitinib (Pfizer) Indication: Renal Cell Carcinoma Route: Oral (twice daily) Comments: Angiogenesis inhibitor; FDA approval expected in April 2012 Ridaforolimus (Merck) Indication: Soft-Tissue and Bone Sarcomas Route: Oral (once daily x 5 days each week) Comments: mTOR inhibitor; Approval in April 2012

  50. Hepatitis C Pipeline Trends • Oral protease inhibitors hit the market • Watch for more direct acting antivirals • Novel interferons in 2-3 years

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