Mercer Short Duration Fixed Income Fund Class Y-3 · NASDAQ:MSDYX
Mercer Short Duration Fixed Income Fund Class Y-3 — Mercer Government — EMPAA (August 2023)
46 slides from Mercer Short Duration Fixed Income Fund Class Y-3's conference presentation, Aug 16, 2023
Slide 1: New Drug Update August 2023
welcome to brighter New Drug Update August 2023 EMPAA August 16, 2023 Bethany Holderread, Principal, Pharm.D. Boston, Massachusetts 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 approved by the FDA Identify novel
Slide 4: Learning Assessment Questions
Learning Assessment Questions True or False? Roctavian (valoctocogene roxaparvovec) is indicated for Duchenne muscular dystrophy (DMD). Which of the following are important considerations for Leqembi (lecanemab) regarding patient selection? 1. Severity of dementia 2. Presence of amyloid beta 3. Qual
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. Other Conditions Bethany Holderread, Pharm.D. 8. Immunomodulators A Principal and pharmacist in the 9. Biosimilars Merce
Slide 6: Overview of FDA New Drug Approval Patterns
1 Overview of FDA New Drug Approval Patterns Random State Fact 1: In Alabama, it's illegal to put an ice cream cone in your back pocket. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 7: FDA Approval Trends: New Molecular Entities
FDA Approval Trends: New Molecular Entities 70 59 60 53 51 50 46 48 45 39 41 40 37 30 27 26 22 20 10 0 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023* FDA. New Drug Therapy Approvals. https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities
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 Priority Review Therapy Approval 57% 35% 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 Approval Timeline Elevidys (delandistrogene moxeparvovec) Abecma (idecabtagene vicleucel) Lantidra (donislecel) Zolgensma (onasemnogene Breyanzi (lisocabtagene maraleucel) Omisirge (omidubicel) abeparvovec) Rethymic (allogeneic processed thymus tissue) Roctavi
Slide 10: Biosimilar Approvals
Biosimilar Approvals FDA has approved a total of 41 biosimilar products for 11 different reference products since 2015 12 10 10 8 7 7 6 5 4 4 3 3 2 1 1 0 2015 2016 2017 2018 2019 2020 2021 2022 2023* FDA. FDA-Approved Biosimilar Products. https://www.fda.gov/drugs/biosimilars/biosimilar-product-info
Slide 11: Gene and Cell Therapy Products
2 Gene and Cell Therapy Products Random State Food Fact 2: In Gainesville, Georgia, it's illegal to eat a chicken sandwich with a fork. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 12: 2nd Half 2022-2023 Gene and Cell Therapy Products
2nd Half 2022-2023 Gene and Cell Therapy Products Drug Name Approval Date Indication Elevidys (delandistrogene moxeparvovec) June 2023 Duchenne muscular dystrophy (DMD) Lantidra (donislecel) June 2023 Type 1 diabetes Roctavian (valoctocogene roxaparvovec) June 2023 Hemophilia A Vyjuvek (beremagene g
Slide 13: Roctavian (valoctocogene roxaparvovec)
Roctavian (valoctocogene roxaparvovec) Indication Adult males with severe Hemophilia A • Estimated 30,000 to 33,000 people with hemophilia in the U.S. with the majority having hemophilia A Market • Estimated 2,500 patients eligible to receive Roctavian Landscape • Patients currently use high-cost pr
Slide 14: Lantidra (donislecel)
Lantidra (donislecel) Indication Type 1 diabetes (T1D) Market Target population: patients unable to achieve target blood glucose levels Landscape because of frequent episodes of severe hypoglycemia despite intervention • 30 patients with T1D and hypoglycemia unawareness • Patients received 1 to 3 in
Slide 15: Elevidys (delandistrogene moxeparvovec)
Elevidys (delandistrogene moxeparvovec) Indication Duchenne muscular dystrophy (DMD) • Estimated U.S. prevalence ranges between 10,000 and 15,000 males Market • First gene therapy for ambulatory DMD patients 4-5 years of age Landscape • Current treatment consists of exon skipping therapies and gluco
Slide 16: Oncology
3 Oncology Random State Food Fact 3: Kansas really is flatter than a pancake: Scientists proved it when they compared the topography of Kansas against that of a pancake from IHOP. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 17: Novel 2023 Oncology Approvals
Novel 2023 Oncology Approvals 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 DLBCL
Slide 18: Novel 2nd Half 2022 Oncology Approvals
Novel 2nd Half 2022 Oncology Approvals Drug Name Approval Date Indication Lunsumio (mosunetuzumab) Dec 2022 Relapsed or refractory follicular lymphoma Krazati (adagrasib) Dec 2022 Non-small cell lung cancer Rezlidhia (olutasidenib) Dec 2022 Relapsed or refractory acute myeloid leukemia Elahere (mirv
Slide 19: Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib) Relapsed or refractory mantle cell lymphoma (MCL) after at least 2 lines of therapy, Indication including a Bruton’s tyrosine kinase inhibitor (BTKi) • MCL is a form of non-Hodgkin lymphoma (NHL), comprising 3 to 10% of NHL cases in the United States (estimated 80,550 new ca
Slide 20: Neurology
4 Neurology Random State Food Fact 4: Up until the late 1990s, in Lehigh, Nebraska, it was illegal to sell donut holes. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 21: Novel 2nd Half 2022-2023 Neurology Approvals
Novel 2nd Half 2022-2023 Neurology Approvals Drug Name Approval Date Indication April 2023 Amyotrophic lateral sclerosis (ALS) with SOD1 Qalsody (tofersen) gene mutation Daybue (trofinetide) Mar 2023 Rett syndrome Zavzpret (zavegepant) Mar 2023 Migraine Skyclarys (omaveloxolone) Feb 2023 Friedrich’s
Slide 22: Leqembi (lecanemab)
Leqembi (lecanemab) Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia Indication stage of disease • About 5 million Americans 65 years of age and older have mild cognitive impairment due to AD Market • Second FDA-approved anti-amyloid monoclonal antibody for AD fol
Slide 23: Skyclarys (omaveloxolone)
Skyclarys (omaveloxolone) Indication Friedrich’s ataxia (FA) • Estimated 5,000 patients with diagnosed FA in the United States Market • Only available treatments for FA prior to Skyclarys were supportive therapies that Landscape address specific symptoms • MOXIe Part 2 study: Skyclarys demonstrated
Slide 24: Diabetes/Cardiology/Nephrology
5 Diabetes/ Cardiology/ Nephrology Random State Food Fact 5: There is more shrimp consumed in Las Vegas every day (60,000 lbs!) than the rest of the country combined. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 25: Novel 2nd Half 2022-2023 Diabetes/Cardiology/Nephrology Approvals
Novel 2nd Half 2022-2023 Diabetes/ Cardiology/ Nephrology Approvals Drug Name Approval Date Indication Inpefa (sotagliflozin) May 2023 Heart failure Filspari (sparsentan) Proteinuria in adults with primary immunoglobulin Feb 2023 A nephropathy Jesduvroq (daprodustat) Anemia caused by chronic kidney
Slide 26: Jesduvroq (daprodustat)
Jesduvroq (daprodustat) Indication Anemia caused by chronic kidney disease (CKD) in adults on dialysis • More than 500,000 patients in the United States receiving dialysis Market • Will likely compete with erythropoiesis-stimulating agents (ESAs) Landscape • Two other oral hypoxia-inducible factor p
Slide 27: Rare Diseases
6 Rare Diseases Random State Food Fact 6: When Teddy Roosevelt visited Tennessee in 1907, he was served Maxwell House coffee and came up with the phrase, "good 'til the last drop." Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 28: Novel 2nd Half 2022-2023 Rare Disease Approvals
Novel 2nd Half 2022-2023 Rare Disease Approvals Drug Name Approval Date Indication Ngenla (somatrogon) Growth failure due to inadequate secretion of June 2023 endogenous growth hormone Elfabrio (pegunigalsidase alfa) May 2023 Fabry disease (FD) Joenja (leniolisib) Activated phosphoinositide 3-kinase
Slide 29: Elfabrio (pegunigalsidase alfa)
Elfabrio (pegunigalsidase alfa) Indication Adults with confirmed Fabry disease (FD) • Type 1 affects approximately 1 in 40,000 to 60,000 males; Type 2, the most Market common phenotype by 3- to 10-fold, may affect up to 1 in 1,500 to 4,000 males Landscape • Current treatments are IV enzyme replaceme
Slide 30: Other Conditions
7 Other Conditions Random State Food Fact 7: Vermont loves syrup so much that when McDonald's debuted their Fruit and Maple Oatmeal (not made with real maple syrup), Vermont's Agency of Agriculture took official action to have McDonald's change the item for all 28 Vermont locations to add a tablespo
Slide 31: Novel 2023 Other Approvals
Novel 2023 Other Approvals Drug Name Approval Indication Date Litfulo (ritlecitinib) June 2023 Severely patchy hair loss Paxlovid (nirmatrelvir, ritonavir) May 2023 COVID-19 Xacduro (sulbactam, durlobactam) Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused Ma
Slide 32: Novel 2nd Half 2022 Other Approvals
Novel 2nd Half 2022 Other Approvals Drug Name Approval Indication Date NexoBrid (anacaulase) Dec 2022 Eschar in adults with thermal burns Xenoview (hyperpolarized Xe-129) Dec 2022 To evaluate pulmonary function and imaging Sunlenca (lenacapavir) Dec 2022 HIV infections that cannot be treated with ot
Slide 33: Rebyota (fecal microbiota, live)
Rebyota (fecal microbiota, live) Indication Recurrent CDI • 500,000 patients with CDI in the U.S. each year; 15% to 30% experience reoccurrence with 40% of those experiencing a 2nd recurrence Market • Guidelines suggest Zinplava (bezlotoxumab) for 1st recurrence of CDI Landscape • Fecal microbiota t
Slide 34: Miebo (perfluorhexyloctane)
Miebo (perfluorhexyloctane) Indication Signs and symptoms of dry eye disease (DED) • DED diagnosed in about 16.4 million adults in the United States Market • Will compete with other topical DED products including Restasis and generics, Landscape Xiidra (lifitegrast), and Tyrvaya (varenicline solutio
Slide 35: Veozah (fezolinetant)
Veozah (fezolinetant) Moderate-to-severe vasomotor symptoms (VMS), or hot flashes, caused by Indication menopause • 64% of females 40 to 65 years of age in the United States were menopausal with Market VMS occurring in approximately 75% to 80% of menopausal women Landscape • Menopausal hormone thera
Slide 36: Immunomodulators
8 Immunomodulators Random State Food Fact 8: Wisconsin is the only state that offers a Master Cheesemaker program, which takes three years to complete. Oh, and you need 10 years of cheese making experience before you can even apply. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by
Slide 37: Novel 2nd Half 2022 Immunomodulator Approvals
Novel 2nd Half 2022 Immunomodulator Approvals Drug Name Approval Date Indication Rystiggo (rozanolixizumab) June 2023 Generalized myasthenia gravis Sotyktu (deucravacitinib) Sept 2022 Moderate-to-severe plaque psoriasis Spevigo (spesolimab) Sept 2022 Generalized pustular psoriasis flares FDA. Novel
Slide 38: Rystiggo (rozanolixizumab)
Rystiggo (rozanolixizumab) Generalized myasthenia gravis (gMG) in adults who are positive for anti-acetylcholine Indication receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies • Prevalence of gMG is 100–350 patients per 1 million individuals. Market • AChR-positive ~85% of pati
Slide 39: Biosimilars
9 Biosimilars Random State Food Fact 9: South Carolina is actually the birthplace of BBQ. Livermore. https://www.delish.com/food/g3802/weirdest-food-facts-by-state/.
Slide 40: Biosimilar Approvals in 2nd Half 2022-2023
Biosimilar Approvals in 2nd Half 2022-2023 Drug Name Approval Date Reference Product Yuflyma (adalimumab-aaty) May 2023 Humira Idacio (adalimumab-aacf) Dec 2022 Humira Releuko (filgrastim-ayow) Feb 2022 Neupogen Fylnetra (pegfilgrastim-pbbk) May 2022 Neulasta Stimufend (pegfilgrastim-fpgk) Sept 2022
Slide 41: Number of Approvals
Biosimilar Approvals FDA has approved a total of 41 biosimilar products for 11 different reference products since 2015 10 9 8 7 Number of Approvals 6 5 4 3 2 1 0 Humira Neulasta Herceptin Remicade Avastin Rituxan Neupogen Enbrel Lantus Lucentis Epogen FDA. New Drug Therapy. https://www.fda.gov/drugs
Slide 42: Conclusions
Conclusions Oncology continues to grow at a 26 rapid pace with the Novel FDA drug most novel approvals approvals in in 2023 thus far 2023 thus far Cell and Gene therapy 5 approvals are accelerating Gene and cell Specialty therapy therapy approvals continue to approvals in increase, including 2023 th
Slide 43: Learning Assessment Questions
Learning Assessment Questions True or False? Roctavian (valoctocogene roxaparvovec) is indicated for Duchenne muscular dystrophy (DMD). Which of the following are important considerations for Leqembi (lecanemab) regarding patient selection? 1. Severity of dementia 2. Presence of amyloid beta 3. Qual
Slide 44: Questions
Questions Bethany Holderread, Pharm.D. Acknowledgements: Payal Kotadiya, April Lindquist 44
Slide 45: Abbreviations
Abbreviations AChR Anti-acetylcholine receptor FDA United States Food and Drug Administration AD Alzheimer’s disease FMT Fecal microbiota transplantation ALS Amyotrophic lateral sclerosis gMG Generalized myasthenia gravis ARIA Amyloid-related imaging abnormalities HIF-PH Hypoxia-inducible factor pro
Slide 46: A business of Marsh McLennan
A business of Marsh McLennan Copyright © 2022 Mercer (US) Inc. All rights reserved.