Calliditas Therapeutics France SAS

DUBLIN, June 8, 2022 /PRNewswire/ -- The "Global Precision Medicine Partnering Terms and Agreements 2015-2022" report has been added to ResearchAndMarkets.com's offering. The Global Precision Medicine Partnering Terms and Agreements 2015-2022 report provides comprehensive access to available deals and contract documents for over 1,900 Precision Medicine deals. The report takes the reader through a comprehensive review Precision Medicine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Precision Medicine partnering deals. The report presents financial deal term values for Precision Medicine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals. The middle section of the report explores the leading dealmakers in the Precision Medicine partnering field; both the leading deal values and most active Precision Medicine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market. One of the key highlights of the report is that over 1,900 online deal records of actual Precision Medicine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal. In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment 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. A comprehensive series of appendices is provided organized by Precision Medicine partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand. The report also includes numerous tables and figures that illustrate the trends and activities in Precision Medicine partnering and dealmaking since 2015. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Precision Medicine technologies and products. Global Precision Medicine Partnering Terms and Agreements 2015-2022 provides the reader with the following key benefits: In-depth understanding of Precision Medicine deal trends since 2015 Access to headline, upfront, milestone and royalty data Detailed access to actual Precision Medicine contracts entered into by leading biopharma companies Identify most active Precision Medicine dealmakers since 2015 Insight into terms included in a Precision Medicine partnering agreement, with real world examples Understand the key deal terms companies have agreed in previous deals Undertake due diligence to assess suitability of your proposed deal terms for partner companies Available deals are listed by: Company A-Z Headline value Stage of development at signing Deal component type Specific therapy target Technology type Analyzing actual contract agreements allows assessment of the following: What are the precise rights granted or optioned? 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 Chapter 2 - Trends in Precision Medicine dealmaking 2.1. Introduction 2.2. Precision Medicine partnering over the years 2.3. Most active Precision Medicine dealmakers 2.4. Precision Medicine partnering by deal type 2.5. Precision Medicine partnering by therapy area 2.6. Deal terms for Precision Medicine partnering 2.6.1 Precision Medicine partnering headline values 2.6.2 Precision Medicine deal upfront payments 2.6.3 Precision Medicine deal milestone payments 2.6.4 Precision Medicine royalty rates Chapter 3 - Leading Precision Medicine deals 3.1. Introduction 3.2. Top Precision Medicine deals by value Chapter 4 - Most active Precision Medicine dealmakers 4.1. Introduction 4.2. Most active Precision Medicine dealmakers 4.3. Most active Precision Medicine partnering company profiles Chapter 5 - Precision Medicine contracts dealmaking directory 5.1. Introduction 5.2. Precision Medicine contracts dealmaking directory Chapter 6 - Precision Medicine dealmaking by technology type Appendices Appendix 1 - Precision Medicine deals by company A-Z Appendix 2 - Precision Medicine deals by stage of development Appendix 3 - Precision Medicine deals by deal type Appendix 4 - Precision Medicine deals by therapy area Appendix 5 - Deal type definitions Appendix 6 - Further reading on dealmaking Companies Mentioned Microbiotica Mitsubishi Tanabe Pharma HMNC Brain Health Clearbridge Biomedics Sunnybrook Health Sciences Centre Unilabs Pittsburgh Life Sciences Greenhouse AmpTec Evotec GenVec Nordic Bioscience Cystic Fibrosis Foundation Fabric Genomics Cyclica Clinica Ruiz Critical Diagnostics Clinical Genomics Clinical Outcomes Tracking and Analysis American Association for Cancer Research American Association of Neuromuscular & Electrodiagnostic Medicine American Diabetes Association Lung Cancer Alliance Covance Valence Discovery Science Foundation Ireland Advanced Cell Diagnostics Advanced Nuclear Medicine Ingredients Genticel HiberCell ReproCell Fibrocell Science ZERO Childhood Cancer Rady Children's Institute for Genomic Medicine West China Hospital Massachusetts General Hospital Massachusetts Institute of Technology Massachusetts Life Sciences Center Fundacion Progreso y Salud 2bPrecise Mayo Clinic For more information about this report visit 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 SOURCE Research and Markets

STOCKHOLM, Jan. 18, 2021 /PRNewswire/ -- Genkyotex SA, a subsidiary of Calliditas Therapeutics AB (publ) ("Calliditas") (Nasdaq OMX - CALTX; NASDAQ - CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset. The Phase 1 study demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The study assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. Previously, doses of up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. In that trial, setanaxib dosed at 800 mg/day achieved reductions in markers of cholestasis, including alkaline phosphatase, and in multiple non-invasive markers of liver fibrogenesis, including liver stiffness and PRO-C3 and C3M. Significant improvement in fatigue was also achieved. All doses tested in that trial were well-tolerated, with no safety signal compared to placebo. "This result provides a foundation for a clinical development program using higher doses of setanaxib across a variety of orphan indications. This includes the potential to launch a pivotal phase 2/3 trial with a clearly differentiated drug candidate in PBC but will also allow us to further explore a select number of kidney related orphan diseases in which inflammation and fibrosis play a part.", said CEO Renée Aguiar-Lucander. Calliditas acquired 62.7% of the share capital and voting rights of Genkyotex, in November 2020, before submitting a simplified public mandatory offer to the shareholders of Genkyotex on 26 November 2020. Calliditas controls 86.2% of the share capital and total number of votes of Genkyotex. For further information, please contact: Marie Galay, IR Manager, Calliditas Tel.: +44 79 55 98 12 45, email: marie.galay@calliditas.com The information was sent for publication, through the agency of the contact persons set out above, on January 18, 2021 at 08:00 a.m. CET. About Calliditas Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit for further information. About Genkyotex Genkyotex (Euronext Paris and Brussels: GKTX) is a leader in NOX therapies. Its unique therapeutic approach is based on a selective inhibition of NOX enzymes, which amplify disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex's discovery platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. From this, Genkyotex has developed a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate setanaxib, a NOX1 and NOX4 inhibitor, demonstrated clinical evidence of anti-fibrotic activity in liver fibrosis and improvement of fatigue in patients in a Phase II trial in primary biliary cholangitis (PBC, a fibrotic orphan disease). Setanaxib is also being evaluated in investigator-initiated Phase II clinical trials in Type 1 Diabetes and in idiopathic pulmonary fibrosis (IPF), a chronic lung disease that results in fibrosis of the lungs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the regulatory pathway for setanaxib, development plans for setanaxib, plans for the conduct of and likelihood of success of planned and ongoing clinical trials of setanaxib, Calliditas' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to regulatory filings submissions for setanaxib, the ongoing and planned clinical trials of setanaxib, Calliditas' business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled "Risk Factors" in Calliditas' reports and other filings filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information was brought to you by Cision The following files are available for download: View original content: SOURCE Calliditas Therapeutics Company Codes: Stockholm:CALTX, NASDAQ-NMS:CALT, Berlin:LC8, Bloomberg:CALTX@SS, ISIN:SE0010441584, LSE:0A5R, OTC-PINK:CLTEF, RICS:CALTX.ST, Munich:LC8, Stuttgart:LC8

Dublin, Dec. 31, 2020 (GLOBE NEWSWIRE) -- The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering. The "Chronic Kidney Disease (CKD) - Pipeline Insight, 2020," report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Chronic Kidney Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Chronic Kidney Disease Emerging Drugs Chapters This segment of the Chronic Kidney Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Chronic Kidney Disease Emerging Drugs AZD5718: AstraZeneca AstraZeneca is conducting a study to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease. The study will be conducted in approximately 118 study centers across 12 countries. The overall study period will be around 28 weeks. Approximately 632 participants comprising of 67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. DDO-3055: Jiangsu HengRui Medicine Co., Ltd. Jiangsu HengRui Medicine is conducting a randomized, double-blind, dose-escalating, placebo controlled, phase I study to evaluate the safety and pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with Chronic Kidney Disease. This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease. 48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B. Chronic Kidney Disease: Therapeutic Assessment This segment of the report provides insights about the different Chronic Kidney Disease drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Chronic Kidney Disease There are approx. 50+ key companies which are developing the therapies for Chronic Kidney Disease. The companies which have their Chronic Kidney Disease drug candidates in the mid to advanced stage, i.e. phase III and Phase II include, AstraZeneca, UnicoCell Biomed, Jiangsu Hansoh Pharmaceutical, Bio Sidus, Keryx Biopharmaceuticals, AMAG Pharmaceuticals, inRegen, AbbVie etc. Phases The report covers around 50+ products under different phases of clinical development like Mid-stage products (Phase II and Phase I/II) Early-stage products (Phase I/II and Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Chronic Kidney Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Subcutaneous Intravenous Oral Intramuscular Molecule Type Products have been categorized under various Molecule types such as Small molecules Proteins and peptides Polymers Diamines Chlorinated hydrocarbons Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Chronic Kidney Disease: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Kidney Disease therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Kidney Disease drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Kidney Disease R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Kidney Disease. August 2020: DAPA-CKD trial meets primary endpoint in patients with chronic kidney disease. Dapagliflozin reduces the risk of kidney failure, death from cardiovascular causes or heart failure hospitalisation and all-cause mortality in chronic kidney disease patients with or without type 2 diabetes. That's the main result of the DAPA-CKD trial presented in a Hot Line session today at ESC Congress 2020. Chronic Kidney Disease Report Insights Chronic Kidney Disease Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Chronic Kidney Disease Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: How many companies are developing Chronic Kidney Disease drugs? How many Chronic Kidney Disease drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Kidney Disease? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Chronic Kidney Disease therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Chronic Kidney Disease and their status? What are the key designations that have been granted to the emerging drugs? Key Players AdAlta Ltd Allena Pharmaceuticals Inc apceth Biopharma GmbH Arch Biopartners Inc Astellas Pharma Inc AstraZeneca Plc Bayer AG BiOrion Technologies BV Boehringer Ingelheim GmbH Boryung Pharmaceutical Co Ltd Celgene Corp Certa Therapeutics Pty Ltd Conatus Pharmaceuticals Inc Corvidia Therapeutics Inc DiaMedica Therapeutics Inc Dimerix Bioscience Pty Ltd DiscoveryBiomed Inc DURECT Corp Epigen Biosciences Inc Galectin Therapeutics Inc GenKyoTex SA GNI Group Ltd iBio Inc IC-MedTech Inc Ipsen SA Isarna Therapeutics GmbH KBP BioSciences Co Ltd Kidney Fibrosis Klotho Therapeutics Inc Les Laboratoires Servier SAS ManRos Therapeutics Mironid Ltd NovaTarg Therapeutics Inc Novo Nordisk AS OPKO Health Inc Opsidio LLC Otsuka Holdings Co Ltd Pharmaxis Ltd Q BioMed Inc Redx Pharma Plc Regulus Therapeutics Inc Resverlogix Corp Sanwa Kagaku Kenkyusho Co Ltd Sarfez Pharmaceuticals Inc Scholar Rock Inc Sirnaomics Inc Sphaera Pharma Pte Ltd Symic Biomedical Inc Taisho Pharmaceutical Holdings Co Ltd Theravance Biopharma Inc Unity Biotechnology Inc Vascular Biogenics Ltd Vascular BioSciences VESSL Therapeutics Ltd Vicore Pharma AB Key Products AZD5718 MEDI8367 efepoetin alfa Verinurad Empagliflozin DDO-3055 KBP-5074 Doxercalciferol TRC101 Pegol-Sihematide For more information about this drug pipelines report visit Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research. CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com 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