Mercer Short Duration Fixed Income Fund Class Y-3 · NASDAQ:MSDYX
Mercer Short Duration Fixed Income Fund Class Y-3 — Mercer Government — ADURS Drug February2024
46 slides from Mercer Short Duration Fixed Income Fund Class Y-3's investor presentation, Feb 23, 2024
Slide 1: New Drug Update February 2024
welcome to brighter New Drug Update February 2024 ADURS February 23, 2024 Bethany Holderread, Principal, Pharm.D. San Diego, California A business of Marsh McLennan
Slide 2: Statement of Disclosure
Statement of Disclosure ✓ I have no relevant conflicts of interest to report ✓ This presentation will include a discussion of unlabeled or investigational use of therapies that have not yet been approved by the FDA ✓ This presentation will focus on therapies approved by the FDA within the last year;
Slide 3: Learning Objectives
Learning Objectives At the conclusion of this educational activity, participants will be able to: Describe important considerations for therapies approved by the FDA within the last year regarding patient selection, dose, and administration. List notable therapies Identify novel approved by the FDA
Slide 4: Learning Assessment Questions
Learning Assessment Questions True or False? (exagamglogene autotemcel) is indicated for Hemophilia A. Which of the following are important considerations for Zurzuvae (zuranolone)? 1. Faster onset of action compared to traditional antidepressant therapy 2. Use alone or as an adjunct to oral antidep
Slide 5: Our Discussion Today
Our Discussion Today 1. Overview of FDA New Drug Approval Patterns 2. Gene and Cell Therapy Products 3. Oncology 4. Neurology 5. Diabetes/Cardiology/Nephrology 6. Rare Diseases 7. Infectious Disease Bethany Holderread, Pharm.D. 8. Immunomodulators A Principal and pharmacist in the 9. Other Condition
Slide 6: Overview of FDA New Drug Approval Patterns
1 Overview of FDA New Drug Approval Patterns Random Food Fact 1: There are 40 billion Oreo cookies made each year. If you stacked them all together, the cookies would encircle the earth five times. Sanchez. https://www.thedailymeal.com/eat/weird-food-facts/
Slide 7: FDA Approval Trends: New Molecular Entities
FDA Approval Trends: New Molecular Entities FDA. New Drug Therapy Approvals. https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic- biological-products. Accessed 01/03/2024.
Slide 8: Summary of 2022 Novel Approvals
Summary of 2022 Novel Approvals At Least One Expedited Development or Review Method: 65% First-in-Class Orphan Fast Track 54% 54% 32% Breakthrough Accelerated Therapy Priority Review Approval 35% 57% 16% FDA. New Drug Therapy Approvals. https://www.fda.gov/drugs/development-approval-process-drugs/ne
Slide 9: Approved Gene and Cell Therapy Products
Approved Gene and Cell Therapy Products Casgevy Abecma (exagamglogene autotemcel) (idecabtagene vicleucel) Elevidys Breyanzi (delandistrogene moxeparvovec) Zolgensma (lisocabtagene maraleucel) Lantidra (onasemnogene abeparvovec) Rethymic (donislecel) (allogeneic processed thymus tissue) Lyfgenia 201
Slide 10: Biosimilar Approvals
Biosimilar Approvals FDA has approved a total of 45 biosimilar products for 14 different reference products since 2015 12 10 10 8 7 7 6 5 5 4 4 3 3 2 1 0 2015 2016 2017 2018 2019 2020 2021 2022 2023 FDA. FDA-Approved Biosimilar Products. https://www.fda.gov/drugs/biosimilars/biosimilar-product-infor
Slide 11: Gene and Cell Therapy Products
2 Gene and Cell Therapy Products Random Food Fact 2: Many people don't know that Cheetos' signature orange cheese "dust" that gets left behind on your fingers actually has a name. That powdery substance is called "cheetle." Sanchez. https://www.thedailymeal.com/eat/weird-food-facts/
Slide 12: 2023 Gene and Cell Therapy Products
2023 Gene and Cell Therapy Products Drug Name Approval Date Indication Casgevy (exagamglogene autotemcel) Dec 2023 Sickle cell disease (SCD) Lyfgenia (lovotibeglogene autotemcel) Dec 2023 SCD Elevidys (delandistrogene moxeparvovec) June 2023 Duchenne muscular dystrophy (DMD) Lantidra (donislecel) Ju
Slide 13: Elevidys (delandistrogene moxeparvovec)
Elevidys (delandistrogene moxeparvovec) Indication Duchenne muscular dystrophy (DMD) • Estimated U.S. prevalence ranges between 10,000 and 15,000 males Market Landscape • First gene therapy for ambulatory DMD patients 4-5 years of age • Current treatment consists of exon skipping therapies and gluco
Slide 14: Casgevy (exagamglogene autotemcel)
Casgevy (exagamglogene autotemcel) Indication SCD in patients ≥ 12 with recurrent vaso-occlusive crises (VOCs) • Estimated 100,000 patients with SCD in the United States Market • Manufacturer estimates 32,000 patients with SCD or TDT eligible Landscape • Current treatments consist of stem cell trans
Slide 15: Lyfgenia (lovotibeglogene autotemcel)
Lyfgenia (lovotibeglogene autotemcel) Indication Patients ≥ 12 years with SCD & history of vaso-occlusive events (VOEs) Market • Similar to Casgevy Landscape • Manufacturer estimates 20,000 patients eligible SCD patients 12 to 50 years of age: 28 of 32 patients (88%) experienced a complete Clinical
Slide 16: Oncology
3 Oncology Random Food Fact 3: Illinois is home to the world’s largest bottle of ketchup. It even has its own festival in the summer. Blee. https://spoonuniversity.com/lifestyle/51-state-food-facts
Slide 17: Novel 2023 Oncology Approvals
Novel 2023 Oncology Approvals Drug Name Approval Date Indication Ogsiveo (nirogacestat) Nov 2023 Desmoid tumors Truqap (capivasertib) Nov 2023 Breast cancer Ryzneuta (efbemalenograstim alfa) Nov 2023 Neutropenia Augtyro (repotrectinib) Nov 2023 Non-small cell lung cancer Fruzaqla (fruquintinib) Nov
Slide 18: Novel 2023 Oncology Approvals (2)
Novel 2023 Oncology Approvals (2) Drug Name Approval Date Indication Columvi (glofitamab) June 2023 Diffuse large B-cell lymphoma (DLBCL) To use with positron emission tomography imaging Posluma (flotufolastat F 18) May 2023 in prostate cancer Epkinly (epcoritamab) May 2023 Relapsed or refractory DL
Slide 19: Aphexda (motixafortide)
Aphexda (motixafortide) For use combination with filgrastim for mobilization of hematopoietic stem cells Indication (HSCs) to the peripheral blood circulation to facilitate collection for subsequent autologous stem cell transplantation (ASCT) in patients with multiple myeloma (MM) • Up to 8,000 tran
Slide 20: Neurology
4 Neurology Random Food Fact 4: The most expensive pizza in the world costs $12,000 dollars. Gabriel. https://www.thefactsite.com/100-random-food-facts/
Slide 21: Novel 2023 Neurology Approvals
Novel 2023 Neurology Approvals Drug Name Approval Date Indication polyneuropathy of hereditary transthyretin- Wainua (eplontersen) Dec 2023 mediated amyloidosis Agamree (vamorolone) Oct 2023 Duchenne muscular dystrophy Zilbrysq (zilucoplan) Oct 2023 Generalized myasthenia gravis Exxua (gepirone) Sep
Slide 22: Zurzuvae (zuranolone)
Zurzuvae (zuranolone) Indication Postpartum depression (PPD) in adults • ~1 in 8 women in the U.S. develop PPD; ~500,000 PPD diagnoses per year Market • First oral FDA-approved treatment for PPD Landscape • Prior to approval, only FDA-approved treatment was Zulresso (brexanolone) which requires a le
Slide 23: Exxua (gepirone)
Exxua (gepirone) Indication Major depressive disorder (MDD) in adults • ~21 million adults in the U.S. (8.3% of all U.S. adults) had at least one depressive Market Landscape episode in 2021 • Numerous generic options for MDD treatment • Mixed efficacy results across clinical trials • Approval suppor
Slide 24: Agamree (vamorolone)
Agamree (vamorolone) Indication Duchenne muscular dystrophy (DMD) • Estimated prevalence ranges between 10,000 and 15,000 males Market Landscape • First-in-class dissociative steroid • Current treatment consists of exon skipping therapies and glucocorticoids • Studied in 121 boys with DMD, 4-6 years
Slide 25: Diabetes/ Cardiology/ Nephrology
5 Diabetes/ Cardiology/ Nephrology Random Food Fact 5: While you likely lost count after five, academic debate rages on over how many licks it takes to get to the center of one of America's favorite Halloween candies. A machine modeled after the human tongue, developed by engineering students at Pur
Slide 26: Novel 2023 Diabetes/ Cardiology/ Nephrology Approvals
Novel 2023 Diabetes/ Cardiology/ Nephrology Approvals Drug Name Approval Date Indication Rivfloza (nedosiran) Sept 2023 Primary hyperoxaluria type 1 Inpefa (sotagliflozin) May 2023 Heart failure Proteinuria in adults with primary immunoglobulin Filspari (sparsentan) Feb 2023 A nephropathy Anemia ca
Slide 27: Jesduvroq (daprodustat)
Jesduvroq (daprodustat) Indication Anemia caused by chronic kidney disease (CKD) in adults on dialysis • More than 500,000 patients in the U.S. receiving dialysis • Will likely compete with erythropoiesis-stimulating agents (ESAs) Market Landscape • Two other oral hypoxia-inducible factor prolyl hyd
Slide 28: Rare Diseases
6 Rare Diseases Random Food Fact 6: Microwaves are for popcorn, not grapes. Place a grape, almost entirely split down the middle, in a microwave, heat it and watch it flame. Sanchez. https://www.thedailymeal.com/eat/weird-food-facts/
Slide 29: Novel 2023 Rare Disease Approvals
Novel 2023 Rare Disease Approvals Drug Name Approval Date Indication Fabhalta (iptacopan) Dec 2023 Paroxysmal nocturnal hemoglobinuria Pombiliti (cipaglucosidase) Sept 2023 Late-onset Pompe disease Veopoz (pozelimab-bbfg) Aug 2023 CD55-deficient protein-losing enteropathy (PLE) Sohonos (palovarotene
Slide 30: Pombiliti (cipaglucosidase)
Pombiliti (cipaglucosidase) In combination with Opfolda (miglustat) for adults with late-onset Pompe disease Indication (LOPD) who are not improving on their current enzyme replacement therapy (ERT) • Pompe disease is a rare lysosomal storage disorder that causes deficiency of the enzyme acid alpha-
Slide 31: Infectious Disease
7 Infectious Disease Random Food Fact 7: In 1885, while working as a pharmacist in Waco, Texas, Charles Alderton created a new drink — a unique blend of flavors we know as Dr. Pepper. Sanchez. https://www.thedailymeal.com/eat/weird-food-facts/
Slide 32: Novel 2023 Infectious Disease Approvals
Novel 2023 Infectious Disease Approvals Drug Name Approval Indication Date To reduce catheter-related bloodstream infections in Defencath (taurolidine, heparin) Nov 2023 adults receiving hemodialysis through a central venous catheter Prevention of respiratory syncytial virus (RSV) lower Beyfortus (n
Slide 33: Beyfortus (nirsevimab)
Beyfortus (nirsevimab) Prevention of RSV LRTD in newborns and infants their first RSV season and for Indication children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season • 1% to 3% of children < 12 months of age are hospitalized each year due to RSV
Slide 34: Immunomodulators
8 Immunomodulators Random Food Fact 8: Indiana produces more than 20% of the United States’ popcorn supply. Blee. https://spoonuniversity.com/lifestyle/51-state-food-facts
Slide 35: Novel 2023 Immunomodulator Approvals
Novel 2023 Immunomodulator Approvals Drug Name Approval Date Indication Omvoh (mirikizumab) Oct 2023 Ulcerative colitis Bimzelx (bimekizumab) Oct 2023 Plaque psoriasis Velsipity (etrasimod) Oct 2023 Ulcerative colitis FDA. Novel Drug Approvals for 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-
Slide 36: Bimzelx (bimekizumab)
Bimzelx (bimekizumab) Indication Moderate to severe plaque psoriasis in adults • 7.5 million people in the U.S. have psoriasis Market Landscape • Crowded treatment landscape including topical therapies, phototherapy, conventional oral agents, and targeted immunomodulators • Bimzelx demonstrated supe
Slide 37: Other Conditions
9 Other Conditions Random Food Fact 9: M&M's plain chocolate candies were introduced to the U.S. in 1941 and soon became the decade's most popular Halloween candy. By 1950, several imitation products flooded the candy-coated chocolate market. M&M's solution — stamp a black "m" onto each candy. Sanch
Slide 38: Novel 2023 Other Approvals
Novel 2023 Other Approvals Drug Name Approval Indication Date Wounds associated with dystrophic and junctional Filsuvez (birch triterpenes) Dec 2023 epidermolysis bullosa Geographic atrophy secondary to age-related Izervay (avacincaptad pegol) August 2023 macular degeneration Xdemvy (lotilaner) July
Slide 39: Biosimilars
10 Biosimilars Random Food Fact 10: Kansas once outlawed serving ice cream on cherry pie. Simon. https://www.usatoday.com/list/news/nation-now/weirdest-laws-every-state.
Slide 40: Biosimilar Approvals in 2023
Biosimilar Approvals in 2023 Drug Name Approval Date Reference Product Avzivi (bevacizumab-tnjn) Dec 2023 Avastin (bevacizumab) Wezlana (ustekinumab-auub) Oct 2023 Stelara (ustekinumab) Tofidence (tocilizumab-bavi) Sept 2023 Actemra (tocilizumab) Tyruko (natalizumab-sztn) Aug 2023 Tysabri (natalizum
Slide 41: Number of Approvals
Biosimilar Approvals FDA has approved a total of 44 biosimilar products for 14 different reference products since 2015 10 9 8 7 Number of Approvals 6 5 4 3 2 1 0 Humira Neulasta Herceptin Avastin Remicade Rituxan Neupogen Enbrel Lantus Lucentis Epogen Tysabri Actemra Stelara FDA. New Drug Therapy. h
Slide 42: Conclusions
Conclusions 55 Oncology continues to grow at a novel FDA drug rapid pace with the approvals in 2023 most novel approvals in 2023 7 Neurology and gene and cell therapy approvals Infectious Disease in 2023 with an approvals saw acceleration in innovative therapies approvals in recent in 2023 years 42
Slide 43: Learning Assessment Questions
Learning Assessment Questions True or False? (exagamglogene autotemcel) is indicated for Hemophilia A. Which of the following are important considerations for Zurzuvae (zuranolone)? 1. Faster onset of action compared to traditional antidepressant therapy 2. Use alone or as an adjunct to oral antidep
Slide 44: Questions
Questions Bethany Holderread, Pharm.D. Acknowledgements: Payal Kotadiya, April Lindquist 44
Slide 45: Abbreviations
Abbreviations 5-HT1A Selective serotonin 1A FDA Food and Drug Administration MM Multiple myeloma AAV Adeno-associated virus GAA Acid-alpha glucosidase NDD Non-dialysis dependent ABR Annualized bleed rate G-CSF Granulocyte colony stimulating factor NF-κB Nuclear factor kappa-light-chain AD Alzheimer’
Slide 46: A business of Marsh McLennan
A business of Marsh McLennan Copyright © 2022 Mercer (US) Inc. All rights reserved.