The Efficacy and Safety of Erdosteine in the Long-term Therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study

The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.

Start Date01 Aug 2009

Sponsor / Collaborator

Edmond Pharma SRL

100 Clinical Results associated with Edmond Pharma SRL

0 Patents (Medical) associated with Edmond Pharma SRL

Literatures (Medical) associated with Edmond Pharma SRL

International Journal of Chronic Obstructive Pulmonary DiseaseQ3 · MEDICINE

Erdosteine reduces inflammation and time to first exacerbation postdischarge in hospitalized patients with AECOPD

Q3 · MEDICINE

ArticleOA

Author: Moretti, Maurizio ; Fagnani, Stefano

PURPOSEMucolytics can improve disease outcome in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD). The objectives of this study were to investigate the effects of erdosteine (ER), a mucolytic agent with antioxidant activity, on systemic inflammation, symptoms, recurrence of exacerbation, and time to first exacerbation postdischarge in hospitalized patients with AECOPD.PATIENTS AND METHODSPatients admitted to hospital with AECOPD were randomized to receive either ER 900 mg daily (n=20) or a matching control (n=20). Treatment was continued for 10 days until discharge. Patients also received standard treatment with steroids, nebulized bronchodilators, and antibiotics as appropriate. Serum C-reactive protein levels, lung function, and breathlessness-cough-sputum scale were measured on hospital admission and thereafter at days 10 and 30 posttreatment. Recurrence of AECOPD-requiring antibiotics and/or oral steroids and time to first exacerbation in the 2 months (days 30 and 60) postdischarge were also assessed.RESULTSMean serum C-reactive protein levels were lower in both groups at days 10 and 30, compared with those on admission, with significantly lower levels in the ER group at day 10. Improvements in symptom score and forced expiratory volume in 1 second were greater in the ER than the control group, which reached statistical significance on day 10. ER was associated with a 39% lower risk of exacerbations and a significant delay in time to first exacerbation (log-rank test P=0.009 and 0.075 at days 30 and 60, respectively) compared with controls.CONCLUSIONResults confirm that the addition of ER (900 mg/d) to standard treatment improves outcomes in patients with AECOPD. ER significantly reduced airway inflammation, improved the symptoms of AECOPD, and prolonged time to first exacerbation. The authors suggest ER could be most beneficial in patients with recurring, prolonged, and/or severe exacerbations of COPD.

Farmaco

Synthesis and free radical scavenging properties of the enantiomers of erdosteine

Author: Fregnan, Giancarlo B. ; Bradamante, Silvia ; Nicola, Massimo ; Inglesi, Marco ; Pagani, Giorgio

The synthesis of enantiomers R and S of erdosteine, a derivative of homocysteine-γ-thiolactone, and the NMR studies for the determination of the enantiomeric excess with chiral shift reagent on the more soluble Et esters, are described.Pharmacol. data relative to the free radical scavenging properties of the R and S enantiomers are reported.In particular, it has been documented that the S isomer is more effective than R isomer in protecting mice against LDs of paraquat (substance able to form free radicals when administered by i.p. route).

Farmaco, Edizione Scientifica

-S-{2-[N-3-(2-Oxotetrahydrothienyl)acetamido]}thioglycolic acid: a novel mucolytic agent of the class of homocysteine thiolactone derivatives

Author: Bradamante, S. ; Pedrazzoli, A. ; Gobetti, M.

Homocysteine thiolactone (I) was acylated with XCOCHR(CH₂)_nX (R = H, X = Cl, n = 0, 1; R = Me, Et, X = Br, n = 0) to give haloacyl derivatives II, which were converted into thioglycolic acid derivatives III (R = H, R¹ = H, Ph, C₆H₄NO₂-p, C₆H₄OMe-o, n = 0; R = Me, R¹ = K, Et, n = 0; R = R¹ = Et, n = 0; R = H, R¹ = Et, n = 1).Thus, II (R = H, X = Cl, n = 0) was treated with HSCH₂CO₂H to give III (R = R¹ = H, n = 0) (IV).The structure of IV was determined by ¹H and ¹³C NMR spectroscopy.III exhibited mucolytic activity in rabbits with acute bronchitis.

News (Medical) associated with Edmond Pharma SRL

15 Jun 2022

·www.prnewswire.com

Global Orphan Diseases Partnering Deals Report 2022: Access to Headline, Upfront, Milestone and Royalty Data

DUBLIN, June 15, 2022 /PRNewswire/ -- The "Global Orphan Diseases Partnering 2010-2022: Deal Trends, Players and Financials" report has been added to ResearchAndMarkets.com's offering. The Global Orphan Diseases Partnering 2010-2022 report provides comprehensive access to available deals and contract documents for over 280 orphan diseases deals signed between the world's pharmaceutical and biotechnology companies since 2010. Trends in Orphan Diseases partnering deals Financial deal terms for headline, upfront and royalty by stage of development Orphan Diseases partnering agreement structure Orphan Diseases partnering contract documents Top Orphan Diseases deals by value Most active Orphan Diseases dealmakers Most of the deals included within the report occur when a licensee obtains a right or an option right to license a licensor's product or technology. More often these days these deals tend to be multi-component including both a collaborative R&D and a commercialization of outcomes element. The report takes readers through the comprehensive Orphan Diseases disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Orphan Diseases deals. The report presents financial deal terms values for Orphan Diseases deals, where available listing by overall headline values, upfront payments, milestones and royalties enabling readers to analyse and benchmark the value of current deals. The initial chapters of this report provide an orientation of Orphan Diseases dealmaking trends. Chapter 2 provides an overview of the trends in Orphan Diseases dealmaking since 2010 covering trends by year, deal type, stage of development, technology type and therapeutic indication. Chapter 3 includes an analysis of financial deal terms covering headline value, upfront payment, milestone payments and royalty rates. Chapter 4 provides a review of the leading Orphan Diseases deals since 2010. Deals are listed by headline value. The chapter includes the top 25 most active Orphan Diseases dealmakers, together with a full listing of deals to which they are a party. Where the deal has an agreement contract published at the SEC a link provides online access to the contract. Chapter 5 provides comprehensive access to Orphan Diseases deals since 2010 where a deal contract is available, providing the user with direct access to contracts as filed with the SEC regulatory authorities. Each deal title links via Weblink to an online version of the deal record contract document, providing easy access to each contract document on demand. Chapter 6 provides a comprehensive directory of all Orphan Diseases partnering deals by specific Orphan Diseases target announced since 2010. The chapter is organized by specific Orphan Diseases therapeutic target. 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 contract document on demand. In addition, a comprehensive appendix is provided with each report of all Orphan Diseases partnering deals signed and announced since 2010. The appendices are organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc) and technology type. 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 contract document on demand. The report also includes numerous tables and figures that illustrate the trends and activities in Orphan Diseases partnering and dealmaking since 2010. In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Orphan Diseases technologies and products. Report scope Global Orphan Diseases Partnering 2010 to 2022 includes: Trends in Orphan Diseases dealmaking in the biopharma industry since 2010 Access to headline, upfront, milestone and royalty data Access to hundreds of Orphan Diseases deal contract documents Comprehensive access to over 280 Orphan Diseases deal records The leading Orphan Diseases deals by value since 2010 Most active Orphan Diseases dealmakers since 2010 In Global Orphan Diseases Partnering 2010 to 2022, available deals and contracts are listed by: Headline value Upfront payment value Royalty rate value Stage of development at signing Deal component type Technology type Specific therapy indication 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 Orphan Diseases dealmaking 2.1. Introduction 2.2. Orphan Diseases partnering over the years 2.3. Orphan Diseases partnering by deal type 2.4. Orphan Diseases partnering by industry sector 2.5. Orphan Diseases partnering by stage of development 2.6. Orphan Diseases partnering by technology type Chapter 3 -Financial deal terms for Orphan Diseases partnering 3.1. Introduction 3.2. Disclosed financials terms for Orphan Diseases partnering 3.3. Orphan Diseases partnering headline values 3.4. Orphan Diseases deal upfront payments 3.5. Orphan Diseases deal milestone payments 3.6. Orphan Diseases royalty rates Chapter 4 - Leading Orphan Diseases deals and dealmakers 4.1. Introduction 4.2. Most active in Orphan Diseases partnering 4.3. List of most active dealmakers in Orphan Diseases 4.4. Top Orphan Diseases deals by value Chapter 5 - Orphan Diseases contract document directory 5.1. Introduction 5.2. Orphan Diseases partnering deals where contract document available Chapter 6 - Orphan Diseases dealmaking by therapeutic target 6.1. Introduction 6.2. Deals by Orphan Diseases therapeutic target Appendices Appendix 1 - Directory of Orphan Diseases deals by company A-Z since 2010 Appendix 2 - Directory of Orphan Diseases deals by deal type since 2010 Appendix 3 - Directory of Orphan Diseases deals by stage of development since 2010 Appendix 4 - Directory of Orphan Diseases deals by technology type since 2010 Table of figures Figure 1: Orphan Diseases partnering since 2010 Figure 2: Orphan Diseases partnering by deal type since 2010 Figure 3: Orphan Diseases partnering by industry sector since 2010 Figure 4: Orphan Diseases partnering by stage of development since 2010 Figure 5: Orphan Diseases partnering by technology type since 2010 Figure 6: Orphan Diseases partnering by indication since 2010 Figure 7: Orphan Diseases deals with a headline value Figure 8: Orphan Diseases deals with upfront payment values Figure 9: Orphan Diseases deals with milestone payment Figure 10: Orphan Diseases deals with royalty rates Figure 11: Active Orphan Diseases dealmaking activity since 2010 Figure 12: Top Orphan Diseases deals by value since 2010 Companies Mentioned MSD Action Foundation (MSDAF) Oxford BioMedica Edmond Pharma Ligand Pharmaceuticals Florida Biologix Abbvie Castle Creek Pharmaceuticals Nestle Health Science Enable Injections BioTie Therapies European Commission G-treeBNT OncoSec Medical BioNTech Hematech DBV Technologies Videregen CSL Behring BioXcel Vericel Leukaemia & Lymphoma Research ArmaGen Abiogen Pharma Janssen Sciences Soligenix Medicenna Therapeutics Catalent Cutaneous Lymphoma Foundation Novasep OncoPep Moulder Center for Drug Discovery Research Spooner Girls Foundation Jupiter Orphan Therapeutics Marnier-Lapostolle Foundation Plexcera ProThera Kalytera Therapeutics Acceleron Pharma Regenerx Fortress Biotech Synageva BioPharma ImmuneWorks Rare Expertise 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 SOURCE Research and Markets

100 Deals associated with Edmond Pharma SRL

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