Aerie Pharmaceuticals is a company that focuses on discovering, developing, and marketing treatments for various eye diseases such as open-angle glaucoma and retinal disorders. The company offers products like Rhopressa, Roclatan, AR-13503, and AR-1105. It was established in 2005 by David L. Epstein, Casey C. Kopczynski, Thomas J. van Haarlem, and Eric J. Toone and is headquartered in Durham, NC and North Worth, TX.

Tags

Eye Diseases

Congenital Disorders

Endocrinology and Metabolic Disease

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Endocrinology and Metabolic Disease	1

Top 5 Drug Type	Count

Small molecule drug	4
Unknown	1

Top 5 Target	Count

ROCK(Rho-associated kinases)	1
JAK x PDGFRβ x ROCK	1
TRPM8(Transient receptor potential cation channel subfamily M member 8)	1
PKC x ROCK	1

Drugs associated with Aerie Pharmaceuticals, Inc.

Latanoprost/Netarsudil dimesylate

Target

NET x PTGFR x ROCK

Mechanism

PTGFR agonists [+2]

Active Org.

Santen Oy [+1]

Originator Org.

Aerie Pharmaceuticals, Inc.

Active Indication

Glaucoma, Open-Angle [+1]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date12 Mar 2019

Netarsudil Mesylate

Target

ROCK

Mechanism

ROCK inhibitors

Active Org.

Alcon Laboratories, Inc. [+2]

Originator Org.

Aerie Pharmaceuticals, Inc.

Active Indication

Glaucoma, Open-Angle [+1]

Inactive Indication

Corneal Edema [+2]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date18 Dec 2017

Acoltremon

Target

TRPM8

Mechanism

TRPM8 agonists

Active Org.

Alcon Research Ltd. [+1]

Originator Org.

Aerie Pharmaceuticals, Inc.

Active Indication

Dry Eye Syndromes

Inactive Indication-

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Aerie Pharmaceuticals, Inc.

NCT05769153 / RecruitingPhase 1/2

A Phase 1/2 Two-Stage Dose Escalation and Randomized Parallel-Group Study to Evaluate the Safety, Preliminary Treatment Effects, and Durability of AR-14034 Sustained Release Implant Compared to Intravitreal Anti-Vascular Endothelial Growth Factor Treatment in Participants With Neovascular Age-Related Macular Degeneration

The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).

Start Date06 Dec 2023

Sponsor / Collaborator

Aerie Pharmaceuticals, Inc.

[+1]

NCT05493111 / CompletedPhase 3

A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)

This will be a 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline (Day 1) visit as well as visits at Day 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit).

Start Date01 Nov 2022

Sponsor / Collaborator

Aerie Pharmaceuticals, Inc.

NCT05360966 / CompletedPhase 3

A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit).

Start Date18 Jul 2022

Sponsor / Collaborator

Aerie Pharmaceuticals, Inc.

100 Clinical Results associated with Aerie Pharmaceuticals, Inc.

0 Patents (Medical) associated with Aerie Pharmaceuticals, Inc.

Literatures (Medical) associated with Aerie Pharmaceuticals, Inc.

01 Oct 2023·Advances in therapy

Phase 3 Clinical Trial Comparing the Safety and Efficacy of Netarsudil to Ripasudil in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Japan Rho Kinase Elevated Intraocular Pressure Treatment Trial (J-ROCKET).

Article

Author: Sugiyama, Kazuhisa ; Araie, Makoto ; Kanemoto, Koji ; Iwata, Ryo ; Hollander, David A ; Senchyna, Michelle ; Kopczynski, Casey C ; Aso, Kenji

INTRODUCTIONA clinical trial evaluated ocular hypotensive efficacy and safety of netarsudil 0.02% once daily (QD) relative to ripasudil 0.4% twice daily (BID).METHODSThis was a single-masked, randomized, phase 3, superiority study. Japanese patients were randomized to either the netarsudil 0.02% group or the ripasudil 0.4% group in a 1:1 ratio and treated for 4 weeks. The primary efficacy variable was mean diurnal intraocular pressure (IOP) (average of diurnal time points at 09:00, 11:00, and 16:00) at Week 4.RESULTSA total of 245 patients were included in the primary analysis. At Week 4, least squares (LS) mean of diurnal IOP adjusted for baseline was 15.96 and 17.71 mmHg in the netarsudil 0.02% and ripasudil 0.4% groups, respectively, demonstrating the superiority of netarsudil 0.02% QD over ripasudil 0.4% BID by a margin of - 1.74 mmHg (p < 0.0001). Mean reduction from baseline in mean diurnal IOP at Week 4 was 4.65 and 2.98 mmHg, respectively. Adverse events (AEs) occurred less frequently in netarsudil 0.02% than in ripasudil 0.4%, with the incidence of ocular AEs being 59.8% and 66.7%, respectively. The most frequently reported AE was conjunctival hyperemia in both groups, with an incidence of 54.9% and 62.6%, respectively. No serious eye-related AEs were reported.CONCLUSIONNetarsudil ophthalmic solution 0.02% dosed QD (p.m.) was well tolerated and more effective in reducing IOP than ripasudil ophthalmic solution 0.4% dosed BID. Netarsudil 0.02% QD may become an important option for the treatment of Japanese patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).TRIAL REGISTRATIONClinicalTrials.gov identifier, NCT04620135.

03 Feb 2023·Investigative Opthalmology & Visual Science

Rho Kinase Inhibitor AR-12286 Reverses Steroid-Induced Changes in Intraocular Pressure, Effective Filtration Areas, and Morphology in Mouse Eyes

Article

Author: Ren, Ruiyi ; Kopczynski, Casey ; Gong, Haiyan ; Humphrey, Anne A.

PurposeWe investigated mechanisms of reduction of intraocular pressure (IOP) by Rho kinase inhibitor AR-12286 in steroid-induced ocular hypertension (SIOH).MethodsC57BL/6 mice (N = 56) were randomly divided into Saline, dexamethasone (DEX), DEX + AR-12286, and DEX-discontinuation (DEX-DC) groups. IOP was measured weekly during the first four weeks in all groups. Beginning at week 5, the DEX-DC group was followed without treatment until IOP returned to normal, and the other groups were treated as assigned with IOP measured every other day for another week. Fluorescent tracer was injected into the anterior chamber to visualize the outflow pattern in the trabecular meshwork (TM) and TM effective filtration area (EFA) was determined. Radial sections from both high- and low-tracer regions were processed for electron microscopy.ResultsAR-12286 reduced IOP in SIOH mouse eyes in one day (P < 0.01). At the end of week 5, mean IOP in the DEX + AR-12286 group was ∼4 mm Hg lower than DEX group (P < 0.001) and ∼2 mm Hg lower than DEX-DC group (P < 0.05). After one-week AR-12286 treatment (P < 0.05) or five-week DC of DEX (P < 0.01), DEX-induced reduction of EFA was rescued and DEX-induced morphological changes in the TM were partially reversed.ConclusionsAR-12286 reversed steroid-induced morphological changes in the TM and reduced EFA, which correlated with reduced IOP in SIOH eyes. AR-12286 reduced IOP elevation in SIOH eyes more effectively than discontinuing DEX treatment even when accompanied by continuous DEX treatment. Therefore Rho kinase inhibitors may lower SIOH in patients who rely on steroid treatment.

01 Jan 2023·Retina

PHASE 2 RANDOMIZED STUDY (ORION-1) OF A NOVEL, BIODEGRADABLE DEXAMETHASONE IMPLANT (AR-1105) FOR THE TREATMENT OF MACULAR EDEMA DUE TO CENTRAL OR BRANCH RETINAL VEIN OCCLUSION

Article

Author: Boyer, David S ; Williams, Stuart ; Hollander, David A ; Singer, Michael A ; Kopczynski, Casey C ; Kerr, Kevin ; Trevino, Leo ; Pegoraro, Tyler ; McKee, Hayley

Purpose:AR-1105 is a novel biodegradable sustained-release dexamethasone implant designed to deliver 6-month durability. This Phase 2 study evaluated two AR-1105 formulations with different release profiles in patients with macular edema due to retinal vein occlusion.Methods:Patients received a single intravitreal injection with 340 µg dexamethasone. In the initial phase, five patients received clinical formulation (CF) 1. In the randomized phase, 44 patients were randomized 1:1 to CF1 or CF2. The follow-up was 6 months. Patients had vision loss due to macular edema diagnosed ≥9 (central retinal vein occlusion) or ≥12 months (branch retinal vein occlusion) before screening, and could be treatment-naive or -experienced (if received prior steroids, must have demonstrated response).Results:Both formulations improved vision and reduced retinal thickening from baseline across all visits. At Month 6, mean changes in best-corrected visual acuity were +4.3 and +8.0 letters, and mean changes in central subfield thickness were −93 µm and −211 µm in CF1 and CF2 randomized patients, respectively. Most common adverse events were reduced visual acuity, worsening macular edema, conjunctival hemorrhage, and increased intraocular pressure. No patients required surgery or laser for intraocular pressure control.Conclusion:Both formulations were well tolerated and demonstrated clinically meaningful and sustained improvements in vision and retinal thickening in patients with retinal vein occlusion with longstanding edema.

News (Medical) associated with Aerie Pharmaceuticals, Inc.

14 Mar 2024

·www.prnewswire.com

Pharmaceutical and Biotechnology Royalty Rates Report 2024: Essential Benchmark Data for Dealmakers - Royalty Rates, Deal Financials, Contract Documents, Royalty Rate Trends

DUBLIN, March 13, 2024 /PRNewswire/ -- The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs Halozyme Therapeutics Hansen Medical Health Canada Healthcare Royalty Partners Health Discovery Heartseed Heat Biologics Hefei Life Science Hefei Tianhui Incubation of Technologies HekaBio Helsinn Therapeutics HemoCleanse Hemogenyx HemPup Henlius Biotech Hetero Labs HIBM Research Group Hikma Pharmaceuticals Hoffmann La Roche Hollister Biosciences Hookipa Pharma Horizon Pharma Inc Huadong Medicine HyperGenomics I-mab Icahn School of Medicine at Mount Sinai Ice + Jam Iconovo IDC-GP Pharm IDEAYA Biosciences Idera Pharmaceuticals Idorsia Idun Pharmaceuticals IGM Biosciences iMetabolic Biopharma Immugenyx Immunic ImmunityBio Immunomedics Immunomic Therapeutics Immunovative Therapies ImmVira Impax Laboratories Imprimis Pharmaceuticals In4Derm iNAP Incannex Healthcare Incuron Incyte Indiana University Infinity Pharmaceuticals InflaRx Inhibitor Therapeutics Innate Pharma Innocoll Innovate Biopharmaceuticals Innovation Pharmaceuticals Innovent Biologics Innovet Innovus Pharmaceuticals INO Therapeutics Inspiration Biopharmaceuticals Instrumentation Laboratory IntelGenx Intellia Therapeutics IntelliCell BioSciences Intellikine Internet Marketing Consortium Intrexon Intuitive Surgical Invekra Inverness Medical Innovations Ionis Pharmaceuticals Ipsen Iroko Pharmaceuticals Ironwood Pharmaceuticals Israeli National Authority for Technological Innovation Itrom Pharmaceutical Group Ivantis Jaguar Health Janssen Biotech Janssen Pharmaceuticals Jazz Pharmaceuticals JFC Technologies Jiangsu Alphamab Jiangsu Lianhuan Pharmaceuticals Jiangsu NHWA Pharmaceutical Ji Xing Pharmaceuticals John Morley Foods Joincare Pharmaceutical Journey Medical Jubilant Life Sciences Jumpcan Pharmaceutical Juniper Pharmaceuticals Junshi Biosciences Jupiter Wellness Juventas Therapeutics K2M Kadmon Pharmaceuticals Kaken Pharmaceutical Kalbe Genexine Biologics KaloBios Pharmaceuticals Karveer Meditech KemPharm Kensey Nash Kieran Murphy Kinetic Concepts Kiniksa Pharmaceuticals Kintor Kiromic Biopharma Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia NewLeaf Brands Newsoara Biopharma New York University NexMed NextCure Nextleaf Solutions Nexvet NGM Biopharmaceuticals Nicox Nkarta Therapeutics NLS Pharmaceutics Nordic Bioscience Norgine NorthStar Medical Radioisotopes Notable Labs Novadaq Technologies NovaDel Pharma Novan Novan Therapeutics Novartis Novartis Vaccines and Diagnostics Novocure Novo Nordisk Novus Biologicals NRx Pharmaceuticals Nucorion Numab Nunzi Pharmaceutical Nurix Therapeutics Nutech Medical NutraOrigin NXTGEN Nymox Pharmaceutical Oberland Capital Ocugen Oculus Innovative Sciences Ocumension Therapeutics Omeros Oncologie Oncolytics Biotech OncoMed Pharmaceuticals Onconova Therapeutics Onegevity One Way Liver Genomics (OWL) ONK Therapeutics Ono Pharmaceutical Onxeo Onyx Pharmaceuticals Opexa Therapeutics Opthea OptiBiotix OptiNose Oragenics Oramed Pharmaceuticals Orexigen Therapeutics Organovo Orgenesis Orion Orox Pharmaceuticals OrthoCyte Otsuka OvaMed Ovid Therapeutics Oxford BioMedica Oxis Biotech Oxygen Biotherapeutics OxySure Systems Oyster Point Pharma Pan-Provincial Vaccine Enterprise Parnell Pharmaceuticals Par Pharmaceutical PDL BioPharma PDS Biotechnology Penwest Pharmaceuticals Pernix Therapeutics Perugia University Pfenex Pfizer Pharmacyclics PharmaCyte Biotech PharmaMar PharmaNova Pharmastrip Philogen Phosphagenics Photocure ASA Phusion Laboratoies Phyto Nutricare Pipex Pharmaceuticals Plandai Biotechnology Pluristem Therapeutics POINT Biopharma Portola Pharmaceuticals Poseida Therapeutics Pozen PreMD Premier Biomedical Professional Compounding Centers of America Progenics Pharmaceuticals Prometic Life Sciences ProQR Therapeutics Prosidion Protagonist Therapeutics Protalix BioTherapeutics Proteonomix Prothena ProtoKinetix Pulmatrix Puma Biotechnology QED Therapeutics QRxPharma Quick Med Technologies Quigley Corporation Quoin Pharmaceuticals Rayner Surgical Reata Pharmaceuticals Recordati Recro Pharma RedHill Biopharma Reedy Creek Investments RegenaStem Regeneron Pharmaceuticals Regenxbio Regnum Relay Therapeutics Relief Therapeutics Relmada Therapeutics RenalytixAI ReNeuron Repare Therapeutics Replicel Life Sciences Repligen Reprise Biomedical Resarci Therapeutics Retrophin rEVO Biologics Revolution Medicines Rigel Pharmaceuticals RNL Bio Roche Rockefeller University Roivant Sciences Royalty Pharma RST Biomedikal Sanayi Ruthigen RXi Pharmaceuticals S2 Therapeutics SACCO Sagard Healthcare Royalty Partners Sage Therapeutics Salix Pharmaceuticals Sam Amer Sanara MedTech Sandoz Sanofi Sanofi-Aventis Sanofi-Pasteur Sanpellegrino Cosmetics Santarus Santen Pharmaceutical Sanuwave Health SA Pathology Sapientia Pharmaceuticals Sarepta Therapeutics Schrodinger Scopus BioPharma Seagen Seattle Genetics Seelos Therapeutics Sekris Biomedical Senetek Senior Paradise Sensory Cloud Seqirus Seres Therapeutics Sermonix Pharmaceutical Sesen Bio SevenScore Pharmaceuticals Shanghai Pharmaceuticals Holdings Sheba Medical Center Shenzhen BioScien Pharmaceuticals Shield Therapeutics Shionogi Shire Pharmaceuticals Shore Therapeutics Siemens Healthcare Diagnostics Sigma-Tau Sinclair Pharmaceuticals Sinobiopharma Sinopharm Sio Gene Therapies Skinvera Skyline Diagnostics Solarvest BioEnergy Soliance Soligenix Sonoma BioTherapeutics Sorrento Therapeutics Spectranetics Spencer Pharmaceutical Spinal USA St. Jude Children's Research Hospital STADA Arzneimittel Staidson (Beijing) BioPharmaceuticals Stanford University Stealth BioTherapeutics Stellar Biotechnologies St Jude Medical Stoke Therapeutics Strongbridge Biopharma Sucampo AG SUDA Pharmaceuticals Sumitomo Dainippon Pharma Sunesis Pharmaceuticals Sunovion Pharmaceuticals Sun Pharmaceutical SuperNova Diagnostics Sutro Biopharma Swedish Orphan Biovitrum SymBio Pharmaceuticals Symbollon Syndax Pharmaceuticals Synergy Strips Syntopix Tactical Relief Taiba TaiGen Biotechnology Taiho Takeda Pharmaceutical Talaris Therapeutics Tango Therapeutics Target Group Tauriga Sciences TB Alliance TearLab Technion Research and Development Foundation Teijin Telomir Pharmaceuticals Tesaro Tetra Bio-Pharma TetraLogic Pharmaceuticals Teva Pharmaceutical Industries Texas A&M University Texas Heart Institute TFF Pharmaceuticals TG Therapeutics Therakine TherapeuticsMD Theravance Theravance Biopharma The Regents of the University of California Thorne Research Threshold Pharmaceuticals TiGenix Tilray Titterington Veterinary Services Tiziana Life Sciences Tocagen TONIX Pharmaceuticals Torii Pharmaceutical TRACON Pharmaceuticals Tramorgan Transgene Travere Therapeutics Trellis Bioscience Trevena Trimedyne Trimeris TrovaGene TTFactor Tufts University Turnstone Biologics Tyme Technologies Ultragenyx Pharmaceuticals Uluru Unigene Laboratories UniQure Universal Cells University College Dublin University Health Network University of Alberta University of California University of Central Florida Research Foundation University of Colorado University of Florida Research Foundation University of Geneva University of Louisville University of Missouri University of Notre of Dame University of Pennsylvania University of Texas University of Virginia University of Western Sydney University of Zurich UOP Uppsalagruppen Medical Upstream Peripheral Technologies UroGen Pharma Valeant Pharmaceuticals ValiPharma Valneva Valor Biotherapeutics Vanderbilt University Vasomune Therapeutics Vaxent VBL Therapeutics Veloxis Pharmaceuticals Veracyte Verenium Verity Pharmaceuticals VeroScience Vertex Pharmaceuticals Vida Concepts Vifor Pharma ViiV Healthcare Virbac Viropharma VistaGen Therapeutics Vividion Therapeutics Vivus VolitionRX Voronoi Voyager Therapeutics Vyera Pharmaceuticals VYNE Therapeutics Vyrix Pharmaceuticals Watson Pharmaceuticals WAVE Life Sciences Wigen Biomedicine Wisconsin Alumni Research Foundation World Class Extractions WPD Pharmaceuticals WUGEN Xbrane Bioscience Xencor Xlife Sciences XPhyto Therapeutics XTL Biopharmaceuticals Xynomic Pharmaceuticals Yale University Yeda Research and Development Company Yeugnam University Yissum Research Development ZAI Laboratory Zalicus Zenitech Zenith Epigenetics Ziopharm Oncology Zogenix ZS Pharma Zymeworks For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

VaccineAcquisition

13 Mar 2024

·www.businesswire.com

Pharmaceutical and Biotechnology Royalty Rates Report and Directory 2024: Technology Licensed, License Fees, Upfront and Milestone Payments for Deals Signed Since 2020 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Royalty Rates in Pharmaceutical and Biotechnology Deals" report has been added to ResearchAndMarkets.com's offering. Royalty Rates in Pharmaceutical and Biotechnology Deals is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments. This report provides details of the latest partnering deals which disclose a royalty rate, announced in the pharmaceutical, biotechnology and diagnostic sectors. The report provides details of partnering deals disclosing royalty rates from 2010 to 2024. The report provides an overview of how and why companies enter partnering deals where a royalty is payable upon commercialization of the compound or technology. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not. This report contains a comprehensive listing of all partnering deals announced since 2010 where a quantitative royalty rate has been disclosed, as recorded in the Current Agreements deals and alliances database. Each deal record and royalty disclosure is available in further detail via a link to online copy of the deal including actual contract document, where available, as submitted to the Securities Exchange Commission by companies and their partners. The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in royalty rates in the pharma and biotech sectors since 2010. Chapter 3 provides a more detailed insight into the structure of a royalty rate clause and how it fits with the other financial terms of the partnering deal. Chapter 4 provides an insight into companies active in disclosing royalty rates as well as those deals attracting the highest royalty rates. Chapter 5 provides comprehensive and detailed access to deals which disclose a royalty rate since 2010 where a contract document is available. Contract documents provide an in-depth insight into the actual deal terms agreed between the parties with respect to the royalty rate. In addition the report includes a comprehensive deal directory listing of all deals where a royalty rate has been disclosed announced since 2010. Each listing is organized as a directory by company A-Z, stage of development at signing, therapeutic area, and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document. The report also includes numerous table and figures that illustrate the trends in royalty rates in pharma and biotech deal making since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about royalty rates in the pharma and biotech sector. Royalty Rates in Pharmaceutical and Biotechnology Deals provides the following benefits: Understand royalty rate trends since 2010 Analysis of the structure of royalty clauses with real life case studies Browse collaboration and licensing deals which reveal a royalty rate Benchmark analysis - identify market value of transactions Financials terms - upfront, milestone, royalties Directory of deals by company A-Z, therapy focus and technology type Access contract documents - insights into deal structures Due diligence - assess suitability of your proposed deal terms for partner companies Save hundreds of hours of research time Analyzing actual contract agreements allows assessment of the following: What are the precise royalty rates granted? What is actually granted by the agreement to the partner company? What exclusivity is granted? What is the payment structure for the deal? How are sales and payments audited? What is the deal term? How are the key terms of the agreement defined? How are IPRs handled and owned? Who is responsible for commercialization? Who is responsible for development, supply, and manufacture? How is confidentiality and publication managed? How are disputes to be resolved? Under what conditions can the deal be terminated? What happens when there is a change of ownership? What sublicensing and subcontracting provisions have been agreed? Which boilerplate clauses does the company insist upon? Which boilerplate clauses appear to differ from partner to partner or deal type to deal type? Which jurisdiction does the company insist upon for agreement law? Key Topics Covered: Executive Summary Chapter 1 - Introduction 1.1. What are royalties? 1.2. History of royalty rates 1.3. Royalties in pharmaceuticals and biotechnology 1.4. Royalties versus revenue share 1.5. Overview of the report Chapter 2 - An overview of pharmaceutical and biotechnology royalty rates 2.1. Trends in royalty rates 2010 - 2024 2.2. How do revenue shares figure? 2.3. A review of recent literature 2.4. Royalty rates in the future Chapter 3 - The royalty clause in pharmaceutical and biotechnology deals 3.1. Partnering agreement structure 3.2. Structure of a typical royalty clause 3.3. Example royalty clauses 3.3.1. Case study 1 3.3.2. Case study 2 3.3.3. Case study 3 3.3.4. Case study 4 Chapter 4 - Companies actively disclosing royalty rates 4.1. Most active companies in disclosing royalty rates Chapter 5 - Royalty rate contract directory Explore royalty rates within the deal contract document to gain greater insight Deal directory Deal Directory - Royalty rates in deals - by company A-Z Deal Directory - Royalty rates in deals - by therapy area Deal Directory - Royalty rates in deals - by stage of development at signing Deal Directory - Royalty rates in deals - by technology type Royalty rate references Example royalty rate deal contract document List of Figures Figure 1: Trends in pharma and biotech royalty rates, 2010 - 2024 Figure 2: Components of the partnering deal structure Figure 3: Components of the partnering royalty clause Figure 4: Most active companies disclosing royalty rate 2010 - 2024 Figure 5: Licensing agreement for rhAAT - rEVO Biologics, LFB Biotechnologies Companies Mentioned 2seventy bio 3a-diagnostics 3D Medicines 4SC 23andMe Abbott Laboratories Abbvie Abeona Therapeutics Ablynx Abraxis BioScience ABVC BioPharma ACADIA Pharmaceuticals Acceleron Pharma Acelrx Pharmaceuticals Acer Therapeutics Acerus Acrotech Biopharma Actavis (acquired by Watson) Active Biomaterials Acura Pharmaceuticals Adamis Pharmaceuticals Adaptimmune ADC Therapeutics Adeona Pharmaceuticals Adial Pharmaceuticals Aditx Therapeutics Adlai Nortye Aduro BioTech Advanced Dosage Forms Advanz Pharma Advaxis Advirna Aegerion Pharmaceutical Aeglea BioTherapeutics Aerie Pharmaceuticals AEterna Zentaris Aexon Labs Affimed Therapeutics Afritex Medical Products AFT Pharmaceuticals Agenus Bio Agios Pharmaceuticals Aguettant AiBtl BioPharma AIT Therapeutics Akcea Therapeutics Akebia Therapeutics Albert Einstein College of Medicine Alchemia Alder Biopharmaceuticals Alector Alexion Pharmaceuticals Alexza Pharmaceuticals Alfasigma Alfa Wassermann Allergan Allergan (name changed from Actavis) Almirall Alnylam Pharmaceuticals Alora Pharmaceuticals Alpha Biopharma Alternavida Altman Enterprises AltrazealTrading Altum Pharmaceuticals Alvogen Amarantus BioSciences American Type Culture Collection (ATCC) Amgen Amherst Pharmaceuticals Amorfix Life Sciences Ampio Pharmaceuticals Amryt Pharma Amylin Pharmaceuticals Amyris AnaBios AnaptysBio AnGes MG Angion Biomedica AnnaMed Antares Pharma Antibe Therapeutics Antigen Express Applied Therapeutics Apricus Biosciences Aquestive Therapeutics Aradigm Aratana Therapeutics Arcellx Arch Pharmalabs Arctic Vision Arcturus Therapeutics Arcus Biosciences Ardelyx Arena Pharmaceuticals Arrowhead Pharmaceuticals Artiva Biotherapeutics Arvinas Ascendis Pharma Ascentage Pharma Ashvattha Therapeutics Assembly Biosciences Astellas Pharma Astellas Pharma Europe Asterias Biotherapeutics AstraZeneca Athenex Atossa Therapeutics Atreca Audeo Oncology Augmenta Aurigene Discovery Technologies Aurinia Pharmaceuticals Authentic Brands Group AVEO Oncology Avita Therapeutics Avivagen Axovant Gene Therapies Axsome Therapeutics Aytu BioPharma Azaya Therapeutics Azure Biotech Baker Brothers Investments BAKX Therapeutics Baliopharm BASF Baxter International Bayer Healthcare Bayer Innovation Baylor Research Institute Beam Therapeutics BeiGene Beijing Defengrei Biotechnology Belgian Volition Bellerophon Therapeutics Benitec Biopharma Besins Healthcare Beth Israel Deaconess Medical Center BetterLife Pharma Bharat Biotech BIND Biosciences BioCorRx BioCryst Pharmaceuticals Bioeq IP Biogen BioGene Technology Biohaven Pharmaceuticals BioInvent BiolineRX BioMarin Pharmaceutical BioNovion BioNTech BioNxt Solutions Biopharmex BiopharmX BioPorto Bioprocess Capital Ventures BioProspect Biostem US Biotech Investment Biotechnology Value Fund BioTime Acquisition Bioton Biovail BioZone Laboratories BioZone Pharmaceuticals Blackstone Bluebird Bio Blueprint Medicines BMV Medica Boehringer Ingelheim Bone Therapeutics Braeburn Pharmaceuticals BrainStorm Cell Therapeutics Breathtec BioMedical Brickell Biotech BridgeBio Pharma Bridge Biotherapeutics Bristol-Myers Squibb Caleco Pharma Calico Can-Fite BioPharma Cancer Prevention Pharmaceuticals Cannassure Therapeutics CanniMed Therapeutics Cann Pharmaceutical Australia Canntab Therapeutics Cannus Partners Cantex Pharmaceuticals Cara Therapeutics Cardigant Medical Cardium Therapeutics CareFusion Carna BioSciences Cary Pharmaceuticals CASI Pharmaceuticals Castle Creek Biosciences Catalent CB2 Therapeutics Celdara Medical Celgene Cell Cure Neurosciences Cellvera Cel Sci Celyad Cereal Ingredients Cerebain Biotech Cerus CGA 369 cGreen Chi-Med Chiesi Farmaceutici Chimerix Chong Kun Dang Chongqing Jingdong Pharmaceutical Cimtech Cipher Pharmaceuticals Cipla Circassia Clal Biotech Clalit Health Services Clearmind Medicine Clearside Biomedical Clemson University Cleveland BioLabs Clinigen CMIC CNS Pharmaceuticals Cocrystal Pharma Coeptis Pharmaceuticals CohBar Cohen-McNiece Foundation Coherus Biosciences Colby Pharmaceuticals Collegium Pharmaceuticals Columbia Laboratories Columbia University Common Sense Conatus Pharmaceuticals Concile Consilient Health ContraFect Coronado Biosciences Cosmofix Cosmo Pharmaceuticals Coya Therapeutics CRISPR Therapeutics Crossject Crucell CSL CTI BioPharma CTT Pharmaceutical Cullinan Oncology Cumberland Pharmaceuticals Cures Within Reach CureTech Curis Currax Pharmaceuticals CURx Pharmaceuticals Cutanea Life Sciences Cybin CymaBay Therapeutics Cypress Bioscience Cytodyn Cytokinetics Cytori Therapeutics Daewoong Pharmaceutical Daiichi Sankyo Dana-Farber Cancer Institute Dance Biopharm DAS Therapeutics Defiante Farmaceutica Denali Therapeutics DepoMed Derma Sciences Dermavant Sciences Dermin Dianomi Therapeutics Dicerna Pharmaceuticals DNA Biomedical Solutions Dr. Falk Pharma Dr. Reddy's Laboratories Dragonfly Therapeutics DRI Capital Drugs for Neglected Diseases Initiative DS Healthcare Duke University Dyax Eagle Pharmaceuticals Eagle Pharmaceuticals (US) Easton Pharmaceuticals Echo Therapeutics Ecology Coatings Eczacibasi Pharmaceuticals Eddingpharm Egalet Eisai Elencee Eli Lilly Elite Pharmaceuticals Emergent BioSolutions Emory University Enalare Therapeutics Endocyte Endo Pharmaceuticals EnGeneIC Enochian Biosciences Entera Bio Entest BioMedical EnWave Epizyme Epocal Esperion Therapeutics Eternity Healthcare Eton Pharmaceuticals Eureka Genomics EUSA Pharma Evolva Ewopharma Exact Sciences Exelixis ExScientia Eyevance Fairview Health System FasTrack Pharmaceuticals Ferozsons Laboratories Ferring Pharmaceuticals Fibrocell Science Foghorn Therapeutics Forest Laboratories Fosun Pharmaceutical Fox Chase Chemical Diversity Center Fresenius Kabi Pharmaceuticals FSD Pharma Fusion Pharmaceuticals FusionVax Galapagos Galmed Pharmaceuticals GE Healthcare Genentech Generex Biotechnology Genevant Sciences Genexine Genfit Genmab Gentium Genzyme Geron Gilead Sciences Glaukos Glenmark Generics Inc USA Glenmark Pharmaceuticals Goldfinch Bio Government of Israel GPCR Therapeutics Gravocore Grifols GSK GT Biopharma Hai Kang Life Hail First Pharma Hainan Sihuan Pharmaceutical Halo Labs Halozyme Therapeutics Hansen Medical Health Canada Healthcare Royalty Partners Health Discovery Heartseed Heat Biologics Hefei Life Science Hefei Tianhui Incubation of Technologies HekaBio Helsinn Therapeutics HemoCleanse Hemogenyx HemPup Henlius Biotech Hetero Labs HIBM Research Group Hikma Pharmaceuticals Hoffmann La Roche Hollister Biosciences Hookipa Pharma Horizon Pharma Inc Huadong Medicine HyperGenomics I-mab Icahn School of Medicine at Mount Sinai Ice + Jam Iconovo IDC-GP Pharm IDEAYA Biosciences Idera Pharmaceuticals Idorsia Idun Pharmaceuticals IGM Biosciences iMetabolic Biopharma Immugenyx Immunic ImmunityBio Immunomedics Immunomic Therapeutics Immunovative Therapies ImmVira Impax Laboratories Imprimis Pharmaceuticals In4Derm iNAP Incannex Healthcare Incuron Incyte Indiana University Infinity Pharmaceuticals InflaRx Inhibitor Therapeutics Innate Pharma Innocoll Innovate Biopharmaceuticals Innovation Pharmaceuticals Innovent Biologics Innovet Innovus Pharmaceuticals INO Therapeutics Inspiration Biopharmaceuticals Instrumentation Laboratory IntelGenx Intellia Therapeutics IntelliCell BioSciences Intellikine Internet Marketing Consortium Intrexon Intuitive Surgical Invekra Inverness Medical Innovations Ionis Pharmaceuticals Ipsen Iroko Pharmaceuticals Ironwood Pharmaceuticals Israeli National Authority for Technological Innovation Itrom Pharmaceutical Group Ivantis Jaguar Health Janssen Biotech Janssen Pharmaceuticals Jazz Pharmaceuticals JFC Technologies Jiangsu Alphamab Jiangsu Lianhuan Pharmaceuticals Jiangsu NHWA Pharmaceutical Ji Xing Pharmaceuticals John Morley Foods Joincare Pharmaceutical Journey Medical Jubilant Life Sciences Jumpcan Pharmaceutical Juniper Pharmaceuticals Junshi Biosciences Jupiter Wellness Juventas Therapeutics K2M Kadmon Pharmaceuticals Kaken Pharmaceutical Kalbe Genexine Biologics KaloBios Pharmaceuticals Karveer Meditech KemPharm Kensey Nash Kieran Murphy Kinetic Concepts Kiniksa Pharmaceuticals Kintor Kiromic Biopharma Kite Pharma Kitov Pharma Klaria Klinge Biopharma Knighton Foods Knight Therapeutics Kodiak Sciences Kowa Kraig Biocraft Laboratories KVK-Tech Kwang Dong Pharmaceutical Kymera Therapeutics Kyowa Hakko Kirin Kyverna Therapeutics L1 Systems Laboratories Acbel Lantheus Holding Launch Therapeutics Lee Moffitt Cancer Center Legend Biotech LegoChem Biosciences Level Brands LFB Biotechnologies Lifestyle Delivery Systems Ligand Pharmaceuticals Lineage Cell Therapeutics Link Health Lipidor Lipocine Lixte Biotechnology Lorna Linda University Lotus Pharmaceuticals Loxo Oncology Lubrizol Lumenis Lundbeck Lung Therapeutics MabCure Macrogenics Magenta Therapeutics MainPointe Mallinckrodt Pharmaceuticals Marvanal Marv Enterprises Massachusetts General Hospital Matrix Biomed Mayne Pharma McComb Foundation McEwen Centre for Regenerative Medicine Meda Medica Medica Avante Medical Technologies Innovation Asia Medice Arzneimittel Putter Medicines Patent Pool Foundation Medicox MediGene Medigus MedImmune Medison Pharma Medivation Medivir Medovex MEI Pharma Melmed Memory Dx Mercer University Merck and Co Merck KGaA Merck Serono Merus Methodist Hospital Houston Micromet Mikah Pharma Millennium Mimi's Rock Mindset Pharma Ministry of Health Labor and Welfare MiNK Therapeutics Miraculins Miralogx Mira Pharmaceuticals Miromatrix Medical Mitsubishi Tanabe Pharma Moderna Modis Therapeutics Moleculin Biotech Mologen Momenta Pharmaceuticals Monash University Monopar Therapeutics Morgan Stanley MorphoSys Mount Sinai Health System MultiCell Immunotherapeutics Munich Leukemia Laboratory Mylan Laboratories Mylan Pharmaceuticals Myovant Sciences NanoVibronix NanoViricides NantCell NantKwest Nantong Jinghua Pharmaceutical NantWorks Napo Pharmaceuticals Natac Biotech Natco Pharmaceuticals National Green Biomed Nektar Therapeutics Neogenomics Neotope Nephrogenex Nephros Nestle Health Science Neuraxpharm Neurocrine Biosciences NeuroRx NeuroSigma NeuroVive Pharmaceutical NeuroVive Pharmaceutical Asia NewLeaf Brands Newsoara Biopharma New York University NexMed NextCure Nextleaf Solutions Nexvet NGM Biopharmaceuticals Nicox Nkarta Therapeutics NLS Pharmaceutics Nordic Bioscience Norgine NorthStar Medical Radioisotopes Notable Labs Novadaq Technologies NovaDel Pharma Novan Novan Therapeutics Novartis Novartis Vaccines and Diagnostics Novocure Novo Nordisk Novus Biologicals NRx Pharmaceuticals Nucorion Numab Nunzi Pharmaceutical Nurix Therapeutics Nutech Medical NutraOrigin NXTGEN Nymox Pharmaceutical Oberland Capital Ocugen Oculus Innovative Sciences Ocumension Therapeutics Omeros Oncologie Oncolytics Biotech OncoMed Pharmaceuticals Onconova Therapeutics Onegevity One Way Liver Genomics (OWL) ONK Therapeutics Ono Pharmaceutical Onxeo Onyx Pharmaceuticals Opexa Therapeutics Opthea OptiBiotix OptiNose Oragenics Oramed Pharmaceuticals Orexigen Therapeutics Organovo Orgenesis Orion Orox Pharmaceuticals OrthoCyte Otsuka OvaMed Ovid Therapeutics Oxford BioMedica Oxis Biotech Oxygen Biotherapeutics OxySure Systems Oyster Point Pharma Pan-Provincial Vaccine Enterprise Parnell Pharmaceuticals Par Pharmaceutical PDL BioPharma PDS Biotechnology Penwest Pharmaceuticals Pernix Therapeutics Perugia University Pfenex Pfizer Pharmacyclics PharmaCyte Biotech PharmaMar PharmaNova Pharmastrip Philogen Phosphagenics Photocure ASA Phusion Laboratoies Phyto Nutricare Pipex Pharmaceuticals Plandai Biotechnology Pluristem Therapeutics POINT Biopharma Portola Pharmaceuticals Poseida Therapeutics Pozen PreMD Premier Biomedical Professional Compounding Centers of America Progenics Pharmaceuticals Prometic Life Sciences ProQR Therapeutics Prosidion Protagonist Therapeutics Protalix BioTherapeutics Proteonomix Prothena ProtoKinetix Pulmatrix Puma Biotechnology QED Therapeutics QRxPharma Quick Med Technologies Quigley Corporation Quoin Pharmaceuticals Rayner Surgical Reata Pharmaceuticals Recordati Recro Pharma RedHill Biopharma Reedy Creek Investments RegenaStem Regeneron Pharmaceuticals Regenxbio Regnum Relay Therapeutics Relief Therapeutics Relmada Therapeutics RenalytixAI ReNeuron Repare Therapeutics Replicel Life Sciences Repligen Reprise Biomedical Resarci Therapeutics Retrophin rEVO Biologics Revolution Medicines Rigel Pharmaceuticals RNL Bio Roche Rockefeller University Roivant Sciences Royalty Pharma RST Biomedikal Sanayi Ruthigen RXi Pharmaceuticals S2 Therapeutics SACCO Sagard Healthcare Royalty Partners Sage Therapeutics Salix Pharmaceuticals Sam Amer Sanara MedTech Sandoz Sanofi Sanofi-Aventis Sanofi-Pasteur Sanpellegrino Cosmetics Santarus Santen Pharmaceutical Sanuwave Health SA Pathology Sapientia Pharmaceuticals Sarepta Therapeutics Schrodinger Scopus BioPharma Seagen Seattle Genetics Seelos Therapeutics Sekris Biomedical Senetek Senior Paradise Sensory Cloud Seqirus Seres Therapeutics Sermonix Pharmaceutical Sesen Bio SevenScore Pharmaceuticals Shanghai Pharmaceuticals Holdings Sheba Medical Center Shenzhen BioScien Pharmaceuticals Shield Therapeutics Shionogi Shire Pharmaceuticals Shore Therapeutics Siemens Healthcare Diagnostics Sigma-Tau Sinclair Pharmaceuticals Sinobiopharma Sinopharm Sio Gene Therapies Skinvera Skyline Diagnostics Solarvest BioEnergy Soliance Soligenix Sonoma BioTherapeutics Sorrento Therapeutics Spectranetics Spencer Pharmaceutical Spinal USA St. Jude Children's Research Hospital STADA Arzneimittel Staidson (Beijing) BioPharmaceuticals Stanford University Stealth BioTherapeutics Stellar Biotechnologies St Jude Medical Stoke Therapeutics Strongbridge Biopharma Sucampo AG SUDA Pharmaceuticals Sumitomo Dainippon Pharma Sunesis Pharmaceuticals Sunovion Pharmaceuticals Sun Pharmaceutical SuperNova Diagnostics Sutro Biopharma Swedish Orphan Biovitrum SymBio Pharmaceuticals Symbollon Syndax Pharmaceuticals Synergy Strips Syntopix Tactical Relief Taiba TaiGen Biotechnology Taiho Takeda Pharmaceutical Talaris Therapeutics Tango Therapeutics Target Group Tauriga Sciences TB Alliance TearLab Technion Research and Development Foundation Teijin Telomir Pharmaceuticals Tesaro Tetra Bio-Pharma TetraLogic Pharmaceuticals Teva Pharmaceutical Industries Texas A&M University Texas Heart Institute TFF Pharmaceuticals TG Therapeutics Therakine TherapeuticsMD Theravance Theravance Biopharma The Regents of the University of California Thorne Research Threshold Pharmaceuticals TiGenix Tilray Titterington Veterinary Services Tiziana Life Sciences Tocagen TONIX Pharmaceuticals Torii Pharmaceutical TRACON Pharmaceuticals Tramorgan Transgene Travere Therapeutics Trellis Bioscience Trevena Trimedyne Trimeris TrovaGene TTFactor Tufts University Turnstone Biologics Tyme Technologies Ultragenyx Pharmaceuticals Uluru Unigene Laboratories UniQure Universal Cells University College Dublin University Health Network University of Alberta University of California University of Central Florida Research Foundation University of Colorado University of Florida Research Foundation University of Geneva University of Louisville University of Missouri University of Notre of Dame University of Pennsylvania University of Texas University of Virginia University of Western Sydney University of Zurich UOP Uppsalagruppen Medical Upstream Peripheral Technologies UroGen Pharma Valeant Pharmaceuticals ValiPharma Valneva Valor Biotherapeutics Vanderbilt University Vasomune Therapeutics Vaxent VBL Therapeutics Veloxis Pharmaceuticals Veracyte Verenium Verity Pharmaceuticals VeroScience Vertex Pharmaceuticals Vida Concepts Vifor Pharma ViiV Healthcare Virbac Viropharma VistaGen Therapeutics Vividion Therapeutics Vivus VolitionRX Voronoi Voyager Therapeutics Vyera Pharmaceuticals VYNE Therapeutics Vyrix Pharmaceuticals Watson Pharmaceuticals WAVE Life Sciences Wigen Biomedicine Wisconsin Alumni Research Foundation World Class Extractions WPD Pharmaceuticals WUGEN Xbrane Bioscience Xencor Xlife Sciences XPhyto Therapeutics XTL Biopharmaceuticals Xynomic Pharmaceuticals Yale University Yeda Research and Development Company Yeugnam University Yissum Research Development ZAI Laboratory Zalicus Zenitech Zenith Epigenetics Ziopharm Oncology Zogenix ZS Pharma Zymeworks For more information about this report visit https://www.researchandmarkets.com/r/pilfnx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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Vaccine

10 Jan 2024

·www.fiercebiotech.com

Alcon’s dry eye ambitions take off as $770M Aerie takeover delivers phase 3 wins

Alcon says dry eye affects an estimated 38 million people in the U.S. Alcon’s $770 million takeover of Aerie Pharmaceuticals has delivered an early win. The lead candidate in the acquired pipeline met the primary endpoint in a pair of phase 3 dry eye trials, positioning Alcon to file for FDA approval in the middle of the year. The studies randomized around 930 people with dry eye to receive AR-15512, a topical transient TRPM8 agonist, or vehicle control. After 14 days, a higher proportion of patients on AR-15512 had a 10 mm or greater increase in tear production, causing the program to meet its primary endpoint with a p value of less than 0.0001. Alcon saw improvements in tear production as early as day one. The effects persisted through to day 90, although the former Novartis unit is yet to share data from the trial. Alcon is also yet to comment on the phase 3 trial’s other secondary endpoints such as ocular discomfort, which was once a focus of AR-15512 development. AR-15512 failed to improve tear production or ocular discomfort on day 28 in an earlier study, causing that trial to miss its co-primary endpoints. Aerie looked past the setback, focused on successes against secondary goals—including tear production at day 14—designed a phase 3 program around the lessons of the earlier trial and was rewarded with a buyout bid from Alcon, plus positive top-line phase 3 data. Alcon plans to use the data, which is free from serious ocular adverse events, to file for FDA approval in the middle of 2024. Talking to investors on a quarterly results conference call in November, Alcon CEO David Endicott said it would “probably take four months, five months to get [the data] into a submission format.” The eye care specialist is also working to wrap up a long-term safety study by April. Approval will position Alcon to start selling a first-in-class treatment for dry eye disease, a condition that the company says affects an estimated 38 million people in the U.S. Around 20 million of those people are undiagnosed, according to Alcon, and fewer than 10% of people with a diagnosis take a prescription drug. Most patients initially try artificial tears, and most pharmacologic topical therapies, including Bausch + Lomb’s Xiidra, target inflammation. AR-15512 has a different mechanism, as researchers have tied TRPM8 to the detection of ocular surface dryness.

Phase 3Clinical ResultAcquisition

100 Deals associated with Aerie Pharmaceuticals, Inc.

100 Translational Medicine associated with Aerie Pharmaceuticals, Inc.

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Pipeline

Pipeline Snapshot as of 22 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 2 Clinical

Phase 3 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Acoltremon ( TRPM8 )	Dry Eye Syndromes More	Phase 3
AR-13503 ( PKC x ROCK )	Dystrophy, Macular More	Phase 2
ROCKi/PKCi	Glaucoma More	Phase 2
AR-6121 ( ROCK )	Post procedural inflammation More	Preclinical
AR-13154 ( JAK x PDGFRβ x ROCK )	Dystrophy, Macular More	Preclinical

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