Spotlight on Drug Pipeline: 2019 and Beyond
Michele Yoon, Pharm.D.
5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 1
Ventegra Overview
Formed in 2004 “Veritas” (Truth) + “Integritas” (Integrity)
Company of Healthcare Professionals! A family-owned California Corporation Based in Glendale, CA Certified Small Business Certified B-Corp. (by B-Lab) Certified Member of MSDC
Ventegra, Inc., a California Benefit Corporation
Servicing 107 Clients; 9,805,193 lives (4Q 2015) Being recognized as a “new Class of Trade”
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1 Overview
• Key trends • Pipeline targets most impactful to physician groups • Specialty drugs • Significant pipeline therapeutic areas • Management strategies
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Market Trends
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2 2018 FDA approvals: All-time Record • 61 new molecular entities approved • 1996 was previous record @ 50
https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d
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Rare Diseases = 51% of Approvals
https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d
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3 Trends
https://www.forbes.com/sites/bernardmunos/2019/01/14/2018-new-drugs-approvals-an-all-time-record-and-a-watershed/#4fbcb80a332d
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• An orphan drug is a product intended for the treatment, diagnosis, or prevention of a rare disease. A rare disease also affects fewer than 200,000 people in the United States
2017-2018 Pharmaceutical Marketplace Trends: Douglas Long, V.P. Industry Relations, IQVIA. Market Trends and Pricing
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4 2017-2018 Pharmaceutical Marketplace Trends: Douglas Long, V.P. Industry Relations, IQVIA. Market Trends and Pricing
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Trends 2019 • Specialty drugs will continue to dominate the new drug approvals • Specialty drugs will attribute to approx. 50% of the prescription spend by 2020 • 2024: Orphan drug pipeline will contribute $188bn in sales (35% of combined pipeline forecast) • Increased competition • Some specialty blockbusters are coming to end of their exclusivity • Potential for generic and biosimilar competition • Caner drug development • Orphan drug development • Top therapeutic areas : Blood, CNS and respiratory
AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 www.evaluate.com/orphandrug2019. Accessed 5/9/19
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5 Therapy Classes Impacted by Specialty
Significant Disease Impacted by Specialty Drugs Cancer* HIV/AIDS* Crohn’s Disease Immune disorders* Gaucher’s Disease Infertility Growth Hormone Deficiency Multiple Sclerosis* Hemophilia* Pulmonary hypertension Hepatitis C* Rheumatoid Arthritis*
*Indicates therapeutic class with maturing products
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Increased Competition
AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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6 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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Biosimilar* Opportunity
*FDA BIOSIMILAR definition: Biologic product that is “highly similar to” an approved biologic product (the “reference,” “originator,” or “bio- originator” product) and that has “no clinically meaningful differences” in safety or effectiveness as compared to the reference product
AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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7 FDA-Approved Biosimilars Approval Biosimilar Originator Launch Biologic Date 9/23/16 Amjevita – Amgen/Adalimumab-atto Humira® 2023 8/25/17 Cyltezo - Boehringer/Adalimumab-adbm 2023 10/31/18 Hyrimoz – Sandoz/Adalimumab-adaz 2023 9/14/17 Mvasi – Amgen/Allergan/Bevacizumab-awwb Avastin® ? 5/15/18 Retacrit – Pfizer/Epoetin alpha-epbx Procrit®/Epogen® Available 3/6/15 Erelzi – Sandoz/Etanercept-szzs Enbrel® 2019 or 2029 4/26/19 Enticovo – Samsung Bioepis/etanercept-ykro Enbrel® 2019 or 2029 3/6/15 Zarxio – Sandoz/Filgrastim-sndz Neupogen® available 7/23/18 Nivestym – Pfizer/Filgrastim-aafi available 4/5/16 Inflectra – Pfizer/Infliximab-dyyb Remicade® available 4/21/17 Renflexis – Merck/Infliximab-abda available 12/13/17 Ixifi – Pfizer/Infliximab-qbtx Not launching 6/5/18 Fulphila – Mylan/Pegfilgrastim-jmbd Neulasta® Available 11/2/18 Udenyca – Coherus/Pegfilgrastim-cbqv Available 11/28/18 Truxima – Celltrion/rituximab-abbs Rituxan ? 12/1/17 Ogivri - Mylan/trastuzumab-dkst Herceptin TBD 12/18/19 Herzuma – Celltrion/trastuzumab-pkub) 1/18/19 Ontruzant – Samsung/trastuzumab-dttb 3/12/19 Tranzimera – Pfizer/trastuzumab-qyyp
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Biosimilars Pending FDA Approval as of February 2019 Biosimilar Biosimilar applicant Reference Status/Anticipated Approval Manufacturer Adalimumab Samsung Humira® – AbbVie July 2019 (Imraldi™) Bioepis/Merck Adalimumab-ADBM Pfizer Humira® - Abbvie 4Qtr2019 Bevacizumab Pfizer Avastin® - Genentech June 2019 Infliximab Amgen Remicade® – Janssen Oct. 17, 2019
Filgrastim Tanvex BioPharma Neupogen® (Amgen) Aug. 1, 2019 Filgrastim Adello Biologic Neupogen® (Amgen) 2019 - pending
Filgrastim Grastoil/Apotex Neupogen® (Amgen) 2019 Pegfilgrastim Sandoz Neulasta® (pegfilgrastim) Oct. 3, 2019 Amgen
Pegfilgrastim Apotex/Intas Neulasta® (pegfilgrastim) Pending (Lapelga™) Amgen
Rituximab Pfizer Rituxan® (Genentech) July 2019
Trastuzumab Amgen, Allergan Herceptin® (Genentech) June 2019 (kanjinti™) Trastuzumab Pfizer Herceptin® (Genentech) 1Q:2019 (Trazimera™) Teriparatide Pfenex Forteo® (Eli Lilly) Oct. 7, 2019
https://www.jdsupra.com/legalnews/biosimilars-2018-year-in-review-72247/. accessed 2/4/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 16
8 Biosimilars Phase 3/Pre-BLA Biosimilar Biosimilar Reference Status/Anticipated Approval applicant Manufacturer
Adalimumab Coherus Humira® – AbbVie TBD Adalimumab Fresenius Humira® - Abbvie TBD Adalimumab Kyowa Hakko Kirin Humira® - Abbvie TBD Adalimumab Momenta Humira® - Abbvie TBD Adalimumab Mylan Humira® - Abbvie TBD Aflibercept (CHS- Coherus Eyelea® – Regeneron Phase 3/BLA end of 2019. Abbvie 1420) agreement – launch 2023 Aflibercept (M710) Momenta/Mylan Eyelea® – Regeneron Phase 3
Bevacizumab Samsung Bioepis Avastin® – Genentech Phase 3 Ranibizumab Coherus Lucentis® - Genentech Phase 3 Ranibizumab Samsung Lucentis® - Genentech Phase 3
Ranibizumab Xbrane Lucentis® -Genentech Phase 3
https://www.jdsupra.com/legalnews/biosimilars-2018-year-in-review-72247/. accessed 2/4/19 5/15/19 CONFIDENTIAL & PROPRIETARY, Ventegra, Inc. 17
Specialty Pipeline: Inflammatory/Immune Conditions Drug Manufacturer MOA Indication Route Approval (PDUFA) Risankizumab Abbvie IL-23 inhibitor Psoriasis SC Q12 wks Approved (Skyrizi®) Upadacitinib Abbvie JAK1 inhibitor RA, Crohn’s, Oral 8/20/2019 Atopic Once daily dermatitis Filgotinib Gilead JAK1 inhibitor RA Oral 2020 Once daily Bimekizumab UCB IL-17A and IL-17F Psoriasis SC Q 4wks 2020 Inhibitor Viaskin Peanut DBV Tech Allergy peanut allergy Patch TBD immunotherapy AR101 Aimmune Immunotherapy Peanut Allergy Oral 2020
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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9 Specialty Pipeline: Multiple Sclerosis Drug Manuf. MOA Indication Route Approval (PDUFA) Cladribine EMD Serono DNA synthesis RMS Oral Approved (Mavenclad®) inhibitor
Siponimod Novartis SP1 receptor RMS, SPMS Oral Approved (Mayzent®)
Diroximel Biogen/Alkermes NrF2 activator RMS Oral 10/17/19 fumarate (Vumerity™) Ozanimod Celgene SP1 – 1/5 receptors RMS Oral 3/25/20
Monomethyl Banner Life Sciences NrF2 activator RMS Oral 6/20/20 fumarate*
RMS = Relapsing multiple sclerosis; SPMS = Secondary progressive multiple sclerosis *Novel fumarate bioequivalent to Tecfidera SIP = Sphingosine-1-phosphate receptor
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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Specialty pipeline: Cancer 2019 Drug Manuf. MOA Indication Route Approval (PDUFA) Erdafitinib Janssen Fibroblast growth Urothelial Cancer Oral Approved factor receptor(FGFR) inhibitor Quizartinib Daiichi Sankyo FMS-like tyrosine Acute myeloid Oral 5/25/19 kinase 3 (FTL3) leukemia inhibitor Selinexor Karyopharm Selective inhibitor Penta-refractory Oral 7/6/19 nuclear export (SINE) multiple myeloma after 3 prior txs Pexidartinib Daiichi Sankyo Colony stimulating Tenosynovial giant cell Oral 8/3/19 factor-1 receptor tumor (TGCT) (CSF1R) inhibitor Entrectinib Genentech TrKA, TrKB, TrKC, ROS1, NTRK-fusion+ solid Oral 8/18/19 and ALK inhibitor tumors Polatuzumab Genentech Cytotoxic agent Large B-cell lymphoma IV 8/19/19 vedotin Fedratinib Celgene Selective JAK2 Myelofibrosis Oral 9/3/19
Darolutamide Bayer Prostate cancer Oral 10/27/19
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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10 Specialty pipeline: Cancer 2019 Drug Manuf. MOA Indication Route Approval (PDUFA) Erdafitinib Janssen Fibroblast growth Urothelial Cancer Oral Approved factor receptor(FGFR) inhibitor Quizartinib Daiichi Sankyo FMS-like tyrosine Acute myeloid Oral 5/25/19 kinase 3 (FTL3) leukemia inhibitor Selinexor Karyopharm Selective inhibitor Penta-refractory Oral 7/6/19 nuclear export (SINE) multiple myeloma after 3 prior txs Pexidartinib Daiichi Sankyo Colony stimulating Tenosynovial giant cell Oral 8/3/19 factor-1 receptor tumor (TGCT) (CSF1R) inhibitor Entrectinib Genentech TrKA, TrKB, TrKC, ROS1, NTRK-fusion+ solid Oral 8/18/19 and ALK inhibitor tumors Polatuzumab Genentech Cytotoxic agent Large B-cell lymphoma IV 8/19/19 vedotin Fedratinib Celgene Selective JAK2 Myelofibrosis Oral 9/3/19
Darolutamide Bayer Prostate cancer Oral 10/27/19
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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Alzheimer’s Pipeline
AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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11 Hemophilia Pipeline
AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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Specialty Pipeline: Orphan Drugs Drug Manuf. MOA Indication Route Approval (PDUFA) Tafamidis Pfizer transthyretin amyloid Transthyretin amyloid Oral Approved meglumine fibril inhibitors cardiomyopathy (ATTR- (Vyndaqel/. CM) Vyndamax) Amifampridine Jacobus Potassium channel Lambert-Eaton myasthenic Oral Approved (Ruzurgi) blocker syndrome` Onasemnogene Novartis CART Spinal muscular atrophy Single June 2018 abeparvovec (SMA) type 1 infusion (Zolgensma)* Mannitol Pharmaxis Cystic fibrosis in Inhaled 6/20/19 (Bronchitol) conjunction with standard powder tx Celiprolol Acer Tx Selective B-blocker Vascular Ehlers-Danlos Oral 6/25/19
(Edsivo) Partial B2 agonist syndrome (vEDS)
Pitolisant Harmony Narcolepsy Oral Jul/Aug 2019
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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12 Specialty Pipeline: Orphan Drugs (Cont.) Drug Manuf. MOA Indication Route Approval (PDUFA) Luspatercept Acceleron TGF-β inhibitor Myelodysplastic SC 4/3/20 syndrome Afamelanotide Clinuvel α-melanocyte Erythropoietic Intradermal 7/18/19 (Scenesse) stimulating hormone porphyria Golodirsen Sarepta Tx Anti-sense Duchenne MD Infusion 8/19/2019 Pretomanid TBAlliance Nitroimidozooxazines Tx resistant TB Oral Aug/Sept. 19 Rivipansel Glycomimetics Pan-selectin antagonist Sickle cell Injection Phase 3* Givosiran Alnylam Gene silencing Porphyria Injection Phase 3* Saritozan Newron 5-HT1a agonist/D2-like Rett syndrome Oral Phase 3* (Merck KGaA) agonist Zuretinol Noveliou Retinoid Retinitis pigmentosa Oral Phase 3* Elivaldogene BlueBirdBio Gene transference Other metabolic Injection Phase 3* Tavalentivec indications (Lenti-D) Trihepatnoin Ultragenyx Triglyceride Other metabolic Injection Phase 3* indications
*Estimated PDUFA date: 12/31/19 https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 Specialty Pharmacy Summit 2019. www.asembia.com
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Specialty Pipeline: Orphan Drugs (Cont.) Drug Manuf. MOA Indication Route Phase 3 (PDUFA)* VTS-270 `Malinckrodt Binding agent- Niemann-Pick disease Inj. 11/19 (Vteese) cholesterol modifier Rintatolimod Hemispherx Immunostimulant Chronic fatigue syndrome Inj. 6/20 (Ampligen) Biopharma Nomacopan Akari LTB4 inhibitor Paroxysmal nocturnal Inj. 12/20 (Coversin) hemoglobinuria (PNH) Crizanlizumab Novartis P-selectin blockade Sickle cell anemia Inj. 12/20 Inclisiran Medicines Company siRNA PCSK-9 target Hyperlipidemia Inj. 12/20 Risdiplam Genentech Increases SMN protein Spinal muscular atrophy Oral 12/20 Terlipressin Malinckrodt Vasopressin analogue General liver disorders Inj. 12/20 (Lucassin) Bardoxolone Reata Selective estrogen Pulmonary hypertension Oral 12/20 Pharmaceuticals receptor modulator Efgartigimod Argenx Neonatal Fc receptor Myasthenia Gravis Inj. 12/20 antagonist
*Estimated PDUFA date
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19 AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19 Specialty Pharmacy Summit 2019. www.asembia.com
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13 Specialty Pipeline: Misc. Drug Manuf. MOA Indication Route Approval (PDUFA) Triamcinolone Clearside Steroid Macular edema assoc. Suprachoroidal 4/6/19 suspension with uveitis (alone or injection (Xipere™) in combo with anti- VEGF) Lefamulin Nabriva Pleuromutin Community-acquired Oral/IV 4/30/19 Tx antibiotic pneumonia (CABP) Tiopronin Retrophin New formulation Cystinuria Oral 6/30/19 of Thiola (time-release?) Istradefylline Kyowa Selective Parkinson’s Oral 8/27/19
adenosine A2A (off episodes) receptor antagonist Teriparatide – PF708 Pfenex Bone density Osteoporosis S.C. 10/19 (Forteo® follow- regulator (high fracture risk) on)*
Lasmiditan Lilly Serotonin 5-HT1f Acute migraine Oral 11/14/19 receptor agonist Ubrogepant Allergan CGRP inhibitor Acute migraine Oral 12/19
Eptinezumab Alder Bio CGRP inhibitor Migraine prevention IV 2/21/20
CGRP = Calcitonin gene-related peptide https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19
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Specialty Pipeline: Misc. (Cont.) Drug Manuf. MOA Indication Route Approval (PDUFA) Cabotegravir GSK Integrase strand HIV-1 infection IM 2/28/20 transfer inhibitor (INSTI)
Lonafarnib Eiger Prenylation inhibitor Hutchinson-Gilford Oral TBD BioPharm Progeria Syndrome (HGPS) and progenoid laminopathies Leronlimab Moleculin Viral re-entry HIV Inj TBD inhibitor Brolucizumab Novartis Anti-VEGF Age-related Macular Inj TBD degeneration (AMD)
https://biopharmcatalyst.com/calendars/fda-calendar. Accessed 3/15/19
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14 NASH Pipeline
NASH = Non-alcoholic steatohepatitis AMCP Annual Meeting March 26, 2019. [P1] Specialty Pharmaceuticals in Development. Aimee Theraldson, Pharm.D. Accessed 5/9/19
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Rising to the Challenge
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15 2019 Managing Specialty Trends • Value-based contracting (VBC) • Contracting linking price of product to its clinical and economic value • Outcome-based payments • Administrative Blueprint to lower drug prices • Remove some of the gaming of the regulatory and patent process of brands • Include drug prices in advertising • Reserve Part-D incentives only for manufacturers without price increases • Prohibition of gag rules which prevent pharmacist from telling patient when lower cost drug available vs. insurance • FDA guidance to address pharma using REMs program to delay/block competition • Review imbalance of reimbursement based on site-of-care • Allow providers to be reimbursed appropriately with care provided in the least expensive setting • Biosimilars • Slow uptake, growing and potential impact significant • Megamergers
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Conclusion
• Evaluate often ► Pricing, pipeline, market drivers • Understand your financial risk landscape by ► Having a clear definition of the DOFR lines of services • Understand what control levers you have or need to develop by evaluating your: ► UM intake process ► Prescriber relationship ► Sites of administration ► Clinical Committee (e.g. Pharmacy and Therapeutics) ► Clinical guidelines that drives appropriate use and product selection
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16 References for Pipeline
• Manufacturer websites/press releases • Biopharmcatalyst.com/calendars/FDA-calendar • AMCP 2019 annual meetings presentation • AMCP website • Asembia Specialty Pharmacy Summit 2019 • FiercePharma/fiercebiotech.com • www.centerforbiosimilars.com • Clinicaltrials.gov • Subscription required ► Pharmacist’s Letter – pending generics
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Thank you
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