Placebo-Controlled Cross-Over Pilot Trial of Natesto Testosterone Nasal Gel on Demand for Hypogonadal Men With Sexual Dysfunction Using Daily Phosphodiesterase-5 Inhibitor

To determine if testosterone deficient men who are using daily Tadalafil (a phosphodiesterase-5 Inhibitor), will have a significant improvement in erectile function and satisfaction with erectile dysfunction treatment when using on-demand Testosterone Nasal Gel (TNG) prior to sexual activity compared to placebo.

Start Date01 Jan 2023

Sponsor / Collaborator

University of Utah

[+1]

NCT04976595 / RecruitingPhase 4

A 24-hour Ambulatory Blood Pressure Monitoring Study in Hypogonadal Men Treated With Natesto Nasal Testosterone Gel

The purpose of this study is to assess the change in 24-hour ambulatory blood pressure monitoring (ABPM) between baseline (Day 0) and Day 120 following 4 months of testosterone therapy with Natesto.

Start Date01 Jul 2021

Sponsor / Collaborator

Acerus Pharmaceuticals Corp.

NCT04439799 / CompletedPhase 4IIT

A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections: A Phase IV, Prospective, Randomized, Non-Blinded, Multi-Institutional Study

The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to participant with clinical hypogonadism.

Start Date07 Aug 2020

Sponsor / Collaborator

University of Miami

[+1]

100 Clinical Results associated with Acerus Pharmaceuticals Corp.

0 Patents (Medical) associated with Acerus Pharmaceuticals Corp.

Literatures (Medical) associated with Acerus Pharmaceuticals Corp.

01 Jan 2024·Diabetes, Obesity and Metabolism

Proportion of participants with type 2 diabetes achieving a metabolic composite endpoint with once‐weekly semaglutide treatment versus comparators: Post hoc pooled analysis from SUSTAIN 1‐5, 7‐10 and SUSTAIN China

Article

Author: Ahmann, A J ; Rodbard, H W ; Hu, P ; Sorli, C ; Lingvay, I ; Ji, Linong ; Liu, W ; Capehorn, M S ; Ahrén, B ; Shen, Z

AbstractAimTo compare the proportion of participants with type 2 diabetes (T2D) treated with once‐weekly (OW) subcutaneous (SC) semaglutide versus comparators who achieved a composite metabolic endpoint.Materials and MethodsSUSTAIN 1‐5, 7‐10 and SUSTAIN China trial data were pooled. Participants with T2D (aged ≥18 years) and glycated haemoglobin ≥7.0% (≥53 mmol/mol) who had been randomized to OW SC semaglutide (0.5 or 1.0 mg) or comparator in addition to background medication. Using patient‐level data pooled by treatment, proportions of participants achieving the metabolic composite endpoint, defined as glycated haemoglobin <7% (<53 mmol/mol), blood pressure <140/90 mmHg and non‐high‐density lipoprotein cholesterol <130 mg/dl (<3.37 mmol/L), were evaluated following baseline adjustments. Endpoints were analysed per trial using a binomial logistic regression model with treatment, region/country and stratification factor as fixed effects and baseline value as covariate. Pooled analysis used logistic regression with treatment and trial as fixed effects and baseline value as covariate.ResultsThis post hoc analysis included data from 7633 participants across 10 trials. The proportion of participants who achieved the metabolic composite endpoint was significantly higher with OW SC semaglutide 0.5 and 1.0 mg versus comparators (23.7% and 32.0% vs. 11.5%, respectively; p < .0001). Likewise, when the OW SC semaglutide doses were pooled, significantly higher proportions of patients receiving semaglutide achieved the composite metabolic endpoint versus comparators (29.1% vs. 11.4%, respectively; p < .0001).ConclusionsTreatment with OW SC semaglutide versus comparators was associated with increased proportions of participants with T2D meeting the composite metabolic endpoint.

01 Jan 2021·Sexual Medicine ReviewsQ2 · MEDICINE

The Effect of Longer-Acting vs Shorter-Acting Testosterone Therapy on Follicle Stimulating Hormone and Luteinizing Hormone

Q2 · MEDICINE

Review

Author: Ramasamy, Ranjith ; Westfield, Gerwin ; Masterson, Thomas A ; Bryson, Nathan ; Turner, Darren ; Vo, Duyen ; Best, Jordan C ; Blachman-Braun, Ruben

INTRODUCTIONTestosterone (T) replacement therapy causes suppression of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that can lead to decrease in semen parameters and possible infertility. Different T formulations may have varying suppression on FSH and LH.OBJECTIVETo study whether shorter-acting T (multiple daily dosing) has less suppression on FSH and LH serum levels compared with longer-acting T (transdermal gel, injectable).METHODSA systematic literature search was conducted by following the protocol based on Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocols. We comprehensively reviewed the literature by systematically searching manuscripts indexed in PubMed from 1995 to March 13, 2019 to identify studies reporting changes in FSH and LH in hypogonadal men treated with exogenous T which evaluated the effect of exogenous T on FSH and LH.RESULTSA total of 8 studies reported the effect of T on FSH and LH in 793 hypogonadal men: 2 used long-acting injectables (enanthate or undecanoate) in a total of 16 men, 5 used intermediate-acting daily topical gels or patches in a total of 471 men, and 1 used short-acting intranasal T (125 μL/nostril, twice a day or three times a day) in 306 men. Long-acting injectables decreased FSH by 86.3%, intermediate-acting daily gels/patches decreased FSH by 60.2%, and short-acting intranasal gel decreased FSH by 37.8%. Long-acting injectables decreased LH by 71.8%, intermediate-acting daily gels/patches decreased LH by 59.2%, and short-acting intranasal gel decreased LH by 47.3%.CONCLUSIONSOur findings suggest that short-acting T preparations do not decrease serum FSH or LH to the same extent as longer-acting transdermal gels and injectables. However, further clinical trial data are necessary to determine whether the effect of short-acting TRT on gonadotropins translates into similar changes in semen parameters and fertility. Masterson TA, Turner D, Vo D, et al. The Effect of Longer-Acting vs Shorter-Acting Testosterone Therapy on Follicle Stimulating Hormone and Luteinizing Hormone. Sex Med Rev 2021;9:143-148.

01 Sep 2019·Journal of the Endocrine Society

Efficacy of Nasal Testosterone Gel (Natesto®) Stratified by Baseline Endogenous Testosterone Levels

Article

Author: Gottesman, Irving S ; Bryson, Nathan ; Grober, Ethan D ; Ormsby, Ross W ; Gronski, Matthew A

AbstractObjectivePharmacokinetic and efficacy data from a phase 3 testosterone nasal gel (TNG) study were stratified by baseline endogenous testosterone level in patients with testosterone deficiency. Total testosterone (TT), LH, and FSH levels, as well as erectile function, mood, and lean body mass for each group were compared. In a subset of patients with very low baseline endogenous testosterone levels (<100 ng/dL), we investigated whether TNG is a suitable treatment option.Materials and MethodsPatients with testosterone deficiency (serum TT <300 ng/dL) were treated with TNG for 3 months, followed by safety extension periods of 90 and/or 180 days. Pharmacokinetic parameters were calculated from serum hormone levels on days 30 and 90, along with efficacy measurements, which were analyzed by comparison with baseline values. Baseline and/or predose TT values were used for patient stratification.ResultsPrestudy and predose endogenous testosterone concentrations correlated. The maximal concentration of TT was nearly identical across all cohorts at days 30 and 90, whereas the average concentration over 24 hours had a slight positive dependence relative to predose levels. LH levels remained in the normal range but were decreased more in patients with higher starting baseline levels. These findings indicate that TNG works with an active hypothalamic-pituitary-gonadal axis that responds to each dose of TNG throughout the treatment period. Patients with the lowest endogenous testosterone levels received maximum exposure impact from each TNG dose. Patients with severe testosterone deficiency had similar efficacy improvements as the remainder of the study population.ConclusionAll testosterone-deficient cohorts were successfully treated with TNG.

News (Medical) associated with Acerus Pharmaceuticals Corp.

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

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13 Mar 2024

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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

18 Jan 2024

·www.drugs.com

Testosterone Treatment Does Not Cut Fracture Incidence in Men With Hypogonadism

THURSDAY, Jan. 18, 2024 -- Testosterone treatment does not result in a lower incidence of clinical fractures among middle-aged and older men with hypogonadism, according to a study published in the Jan. 18 issue of the New England Journal of Medicine . Peter J. Snyder, M.D., from the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues examined the risk for clinical fracture in a time-to-event analysis subtrial of a randomized placebo-controlled trial that evaluated the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism. Eligible men were aged 45 to 80 years with preexisting, or a high risk for, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations <300 ng/dL in fasting plasma samples obtained at least 48 hours apart. A total of 5,204 participants were randomly assigned to apply testosterone or placebo gel daily (2,601 and 2,603, respectively). The researchers found that a clinical fracture occurred in 3.50 and 2.46 percent of participants in the testosterone and placebo groups, respectively, after a median follow-up of 3.19 years (hazard ratio, 1.43). For all other fracture end points, the fracture incidence also seemed higher in the testosterone group. "We did not expect these results, because most previous studies showed that testosterone improved many measures of bone structure and quality," the authors write. The study was funded by AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required) Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

100 Deals associated with Acerus Pharmaceuticals Corp.

100 Translational Medicine associated with Acerus Pharmaceuticals Corp.

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Pipeline Snapshot as of 19 Dec 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

Phase 1 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Testosterone ( AR )	Low testosterone levels More	Approved
Lidbree	-	Phase 3
Tefina ( AR )	Female sexual dysfunction More	Phase 1
Desmopressin Acetate ( AVPR2 )	Nocturia More	Withdrawn
Avanafil ( PDE5A )	-	Discontinued

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