A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forteo in Postmenopausal Women with Osteoporosis

开始日期2011-02-11

申办/合作机构

Unigene Laboratories, Inc.

NCT01321723 / Completed临床2期

A Double Blind, Randomized, Repeat Dose Parallel Group Study of Recombinant Human Parathyroid Hormone Analog Tablets, or Placebo Tablets, Compared to Open Label Forsteo® in Postmenopausal Women With Osteoporosis

This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

开始日期2011-02-01

申办/合作机构

Unigene Laboratories, Inc.

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2013-11-01·Clinical pharmacokinetics2区 · 医学

Pharmacokinetics of Oral Recombinant Human Parathyroid Hormone [rhPTH(1–31)NH2] in Postmenopausal Women with Osteoporosis

2区 · 医学

Article

作者: Jeff Wald ; Sheela Mitta ; Nozer Mehta ; William Stern ; John Trang ; Roxanne Tavakkol ; Amy Sturmer ; Tulin Cagatay ; Jenna Giacchi ; Lorraine Fitzpatrick

BACKGROUND AND OBJECTIVES:

Teriparatide [rhPTH(1-34)OH] is a subcutaneously administered bone anabolic drug that increases bone mineral density (BMD) and reduces the risk of osteoporotic fracture. Because rhPTH(1-34)OH is administered by injection, oral delivery is a desirable alternative. However, the peroral delivery of peptides is challenging due to their susceptibility to protease digestion and low permeability through the intestinal layers. The objective of this study was to assess the pharmacokinetics of a PTH analog (rhPTH(1-31)NH2) in a novel oral tablet formulation and to compare them to subcutaneously administered teriparatide in postmenopausal osteoporotic women in a phase 2 proof-of-concept clinical study.

METHODS:

This was a 24-week repeat-dose, randomized, double blind, parallel group phase 2 study with three once-daily treatment arms: oral rhPTH(1-31)NH2 tablets (5 mg), matching placebo tablets, and open-label teriparatide (20 μg daily subcutaneous injection). The primary endpoint of this study was to assess the change in lumbar spine BMD of orally administered rhPTH(1-31)NH2 tablets compared to baseline. This study was conducted at three sites in Denmark and at one site in Estonia. The patients included were women diagnosed with postmenopausal osteoporosis as detected by lumbar spine dual-energy X-ray absorptiometry, with exclusion of those with prior treatment with bone-active agents. The study treatment consisted of orally formulated recombinant human PTH(1-31)NH2, placebo, or subcutaneous teriparatide as an active comparator.

RESULTS:

The pharmacokinetic profile at first and last dose was evaluated and correlated with the primary endpoint, which was to characterize the percent change from baseline in BMD of the lumbar spine after 24 weeks of once daily treatment with rhPTH(1-31)NH2. The pharmacokinetic profile for the tablets showed a pulsatile peak with durations of at least 1 h but less than 5 h, which is consistent with the requirement for bone anabolic activity. The mean maximum (peak) plasma drug concentration (C max) values for patients receiving tablets at week 0 (n = 32) and week 24 (n = 28) were 295 and 207 pg/mL, respectively. The mean time to reach maximum (peak) plasma concentration following drug administration (t max) for both week 0 and week 24 was 3.25 h. The mean area under the concentration-time curve (AUC) for week 0 and week 24 was 178 and 141 pg·h/mL, respectively. No significant differences were observed between weeks 0 and 24 in any pharmacokinetic parameters tested, demonstrating good reproducibility, no time-dependent changes, and little or no accumulation of the study drug. The systemic exposure as measured by C max values was higher for the oral tablets formulation than for subcutaneous teriparatide.

CONCLUSIONS:

The observed data demonstrate that the enteric-coated tablet formulation technology was able to generate consistently robust and pulsatile levels of exposure of rhPTH(1-31)NH2. There was no apparent correlation between higher exposures and adverse events, even though the pharmacokinetic variability was somewhat higher with the tablets. These positive results recommend this orally delivered drug candidate for further clinical development.

2013-06-15·Journal of immunology (Baltimore, Md. : 1950)2区 · 医学

Proresolving and Tissue-Protective Actions of Annexin A1–Based Cleavage-Resistant Peptides Are Mediated by Formyl Peptide Receptor 2/Lipoxin A4 Receptor

2区 · 医学

Article

作者: Consalvo, Angelo P. ; Dalli, Jesmond ; Mehta, Nozer ; Perretti, Mauro ; D’Amico, Michele ; Di Filippo, Clara ; Ray, Vicki

Abstract:

Endogenous mechanisms regulating the host response during inflammation resolution are critical in ensuring disposal of noxious stimuli and return to homeostasis. In this article, we engineered novel Annexin A1 (AnxA1)–based peptides, AnxA12–50, that displayed specific binding to the AnxA1 receptor (formyl peptide receptor 2/Lipoxin A4 receptor [FPR2/ALX]; IC50 ∼4 nM). Intravenous administration of AnxA12–50 markedly reduced (>60%) leukocyte adhesion to postcapillary venules in wild type and Fpr1−/−, but not Fpr2/Alx−/−, mice. Generation of a metabolically stable form of this peptide (CR-AnxA12–50), engineered by substituting a cleavage site shared by human proteinase 3 and neutrophil elastase, yielded an agonist that was resistant to neutrophil-mediated cleavage and displayed enhanced proresolving actions: accelerated resolution of self-limited inflammation and enhanced macrophage efferocytosis after sterile injury, when compared with AnxA12–50. These actions were retained with human primary leukocytes where CR-AnxA12–50 decreased neutrophil–endothelial interactions (∼25–45%), and stimulated neutrophil apoptosis and macrophage efferocytosis (∼45%). In murine cardiac ischemia/reperfusion injury, CR-AnxA12–50 elicited tissue-protective actions reducing infarct size (∼60%) and incidence of 24-h death. These results identify AnxA12–50 and CR-AnxA12–50 as FPR2/ALX agonists that harness the proresolving actions of AnxA1, and thus may represent therapeutic tools for treatment of inflammatory conditions.

2008-02-01·Tissue engineering. Part A2区 · 医学

Replacement of Bone Marrow by Bone in Rat Femurs: The Bone Bioreactor

2区 · 医学

Article

作者: Carlson, Jodi ; Cuartas, Esteban ; Gilligan, James ; Zhang, Qing ; Vignery, Agnès ; Rajan, Sonali ; Mehta, Nozer ; Kotas, Maya ; Saltzman, W. Mark ; Chalouni, Cécile ; Ma, Mandy ; Ke, Hua-Zhu

During development and repair of bone, two distinct yet complementary mechanisms, intramembranous and endochondral, mediate new bone formation via osteoblasts. Because mechanical bone marrow ablation leads to the rapid and transient formation of new bone in the marrow cavity, we postulated that parathyroid hormone (PTH), which is a bone anabolic hormone, enhances the formation of new bone that forms after marrow ablation. We subjected the left femur of rats to mechanical marrow ablation, or sham operation, and injected the animals daily with PTH or vehicle for 1, 2, or 3 weeks in a first experiment, then with PTH, parathyroid hormone-related peptide (PTHrP), or vehicle for 3 weeks in a second experiment. We subjected both femurs from each rat to soft X-ray, peripheral quantitative computed tomography, computed tomography on a microscale, and histological analysis, and determined the concentration of serum osteocalcin. In addition, in the second experiment, we determined the serum concentration of calcium, tartrate-resistant acid phosphatase (TRAP), and receptor activator of NF-kappaB ligand (RANKL) at 3 weeks, and subjected femurs to biomechanical testing. Following treatment with PTH or PTHrP for 3 weeks, bone filled the marrow cavity of the shafts whose marrow had been ablated. PTH increased trabecular density in the right femur, but failed to induce bone formation in the medullary region of the right unoperated femoral shafts. The newly formed bone endowed left femoral shafts with improved biomechanical properties when compared to those of right femurs and left femurs from control, sham-operated, and vehicle-treated rats. PTHrP, like PTH, increased serum osteocalcin, but neither increased serum calcium, TRAP, or RANKL at 3 weeks. Our results reveal that the newly formed bone that follows marrow ablation is responsive to PTH, expand the role of PTH in bone, and might open new avenues of investigations to the field of regenerative medicine and tissue engineering. Local bone marrow removal in conjunction with pharmacologic intervention with an anabolic agent might provide a technique for rapid preferential site-directed bone growth in areas of high bone loss.

项与 Unigene Laboratories, Inc. 相关的新闻（医药）

2024-10-22

·Endpoints

Ahead of Novo’s CagriSema readout, Lilly returns to a promising new class of obesity drugs

In its quest to stay at the top of the obesity drug market, Eli Lilly is following in Novo Nordisk’s footsteps by pursuing a new class of weight loss drugs. The Indianapolis drug giant said this month it is paying up to $1.4 billion to KeyBioscience to again try to develop dual amylin and calcitonin receptor agonists, or DACRAs, which aim to reduce body weight, control glucose levels and improve insulin action. It’s been seven years in the making. Lilly originally teamed up with the Swiss biotech in 2017 , with plans to develop DACRAs for diabetes and nonalcoholic steatohepatitis. The companies eventually slashed three daily compounds in favor of a once-weekly option, according to Morten Karsdal, CEO of KeyBioscience’s parent company Nordic Bioscience. DACRAs are now shedding its niche status amid the soaring popularity of GLP-1s like Lilly’s weight management drug Zepbound and the hunt for better obesity drugs. Ten years from now, Stifel bankers predict DACRAs, amylin agonists and GIP antagonists could be “good options” for patients who “can’t tolerate GLP-1s.” Novo Nordisk is the furthest along with CagriSema, a combination of its megablockbuster semaglutide — known as Wegovy for weight loss — and an amylin agonist asset known as cagrilintide. It’s expected to have Phase 3 data by the end of the year. Other companies are prepping for the clinic, including Viking Therapeutics and Metsera , which announced a manufacturing deal earlier this month to shore up development capabilities well in advance of commercialization. AstraZeneca , Zealand Pharma and Gubra are also working in the broader amylin class. “As we’re looking for ways to go beyond what a GLP-1 mono-agonist or what a dual-agonist can do in terms of maximum weight loss, adding amylin is probably the next priority in your order of operations for mechanisms you’d want to look at,” Metsera CEO Whit Bernard told Endpoints News . Bernard said Metsera will “soon” enter the clinic with its experimental therapy, a combination of a DACRA, dubbed MET-233, and a GLP-1 injectable, MET-097, which had encouraging early-stage data last month. Executive chair Clive Meanwell previously told Endpoints the combo would be “very competitive” if it induces weight loss of 25% to 30%. Beyond weight loss, Karsdal makes the pitch that DACRAs have additional benefits. “This mode of action should be protecting bone and muscle and other organs,” he said, “so there’s clearly a space for this in the future.” KeyBioscience has been on a winding journey. Its parent company is Danish biomarker and lab services company Nordic Bioscience, which partnered with peptide biotech Unigene Laboratories in 2011 to form a joint venture to create new medicines. Unigene went bankrupt in mid-2013, and Nordic bought out its stake. By 2017, it received $55 million upfront and an undisclosed amount of biobucks as part of a deal with Lilly. But all three assets in that tie-up, including a Phase 2 diabetes drug, wound up on the shelf. Again, KeyBioscience was at a crossroads. “We actually decided with Lilly to terminate those because we wanted to focus on weekly formulations,” Karsdal said, though he declined to detail what led the partners to switch to the once-weekly route after having gone into clinical trials. “I unfortunately cannot comment publicly because the amylin receptor and calcitonin receptor biology is a hot topic for many, and there are some tricks that I cannot disclose,” Karsdal said. KeyBioscience’s once-weekly DACRA known as KBP-336 is now set to enter a global Phase 2 trial investigating the injectable’s ability to reduce weight and tame osteoarthritis pain in people with obesity by the end of the year. KeyBioscience will run the trial, and Lilly has the rights to continue developing it after that, Karsdal said. The trial may include patients who are already on GLP-1s, he said. KBP-336, which is derived from salmon calcitonin , could have broad utility. The calcitonin hormone helps keep bones healthy and can help thwart pain, lending confidence to KeyBioscience’s plans to also test it in osteoarthritis . “We’ve actually been in two Phase 3 studies before with an oral formulation of salmon calcitonin that had an effect on pain in one of the studies, so we’re reasonably convinced that we will get a superior effect on pain,” Karsdal said.

临床2期并购

2024-03-14

·PRNewswire

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 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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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2024-03-13

·Business Wire

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. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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