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Xellia Pharmaceuticals Xellia Pharmaceuticals Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Xellia is a world-leading trusted supplier of several important established anti- infective drugs, comprising active pharmaceutical ingredients as well as finished dosage forms, where the majority are injectable drug products. Headquartered in Copenhagen, Denmark and owned by Novo Holdings A/S, Xellia Pharmaceuticals has more than 1700 employees globally. From state-of-the-art manufacturing sites in the U.S., China, Denmark and Hungary to R&D sites in Norway and Croatia; Xellia Pharmaceuticals excels within innovative product development to deliver high quality products to its customers. Our product portfolio of anti-bacterial and investments within inhalable and injectable through managing orders to delivery. anti-fungal products used for the treatment product technologies as we are committed Xellia Pharmaceuticals’ Global Technical of severe infections, including infections to researching solutions, which improve Support team serves as the main point of caused by multi-resistant bacteria and patients’ quality of life. contact for customers to provide them fungi, is the foundation for our growth with specialized support for all technical strategy within the antibiotics’ sector. Supplying products to more than 70 matters that may be associated with countries worldwide and with more than market entry and launch of products. Xellia is the leading supplier of important 500 customers internationally, Xellia anti-infectives vancomycin and colisti- Pharmaceuticals places a high regard Working collaboratively with the sales methate sodium (CMS). Our success and on maintaining strong relationships team and cross-functionally with Xellia’s strong market position is built on more with its customers. internal departments at all sites, Xellia than 115 years’ of pharmaceutical industry Pharmaceuticals is dedicated to providing experience. Our sales team serves as the first point of reliable outstanding service to its contact for customers, ensuring fast and customers at all times. Xellia Pharmaceuticals’ focus its R&D accurate delivery of product information; INTERNATIONAL SALES OFFICE: Xellia Pharmaceuticals ApS, Copenhagen, Denmark LOCAL SALES OFFICES AND GLOBAL TECHNICAL SUPPORT: A company owned by Novo A/S Tel: +45 32 64 55 00 E-mail: [email protected] www.xellia.com/contact www.xellia.com Product sheet release date: October 8th, 2019 Active Pharmaceutical Ingredients and Finished Dosage Forms APIs FDFs Amphotericin B Bacitracin vials 50.000 units Bacitracin Colistimethate sodium dry-filled vials 1 MIU*, 2 MIU*, 3 MIU* Bacitracin zinc Colistimethate sodium lyophilized vials 150 mg Colistimethate sodium Daptomycin** vials 350 mg, 500 mg Colistin sulfate Polymyxin B vials 500.000 units Daptomycin** Vancomycin HCl capsules 125 mg, 250 mg Gramicidin Vancomycin HCl vials 0.5 g, 1 g, 5 g, 10 g Polymyxin B sulfate Voriconazole vials 200 mg Tobramycin sulfate * Million International Units Tyrothricin ** Products protected by valid patents are not offered Vancomycin hydrochloride for sale in countries where the sale of such products constitutes a patent infringement INTERNATIONAL SALES OFFICE: Xellia Pharmaceuticals ApS, Copenhagen, Denmark Tel: +45 32 64 55 00 E-mail: [email protected] LOCAL SALES OFFICES AND GLOBAL TECHNICAL SUPPORT: www.xellia.com/contact A company owned by Novo Holdings A/S www.xellia.com.
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  • 1 Civica Rx and Xellia Pharmaceuticals Join Forces To
    Civica Rx and Xellia Pharmaceuticals join forces to reduce chronic drug shortages Xellia becomes Civica’s first supplier partner and will produce essential antibiotics in short supply in U.S. hospitals Lehi, UT and Buffalo Grove, IL, May 15, 2019 – Civica Rx (Civica, Inc.) and Xellia Pharmaceuticals today announced they have signed a product supply agreement under which Xellia will manufacture essential antibiotics, including Vancomycin and Daptomycin, for Civica’s member health systems. Shortages of these anti-infective medications are impacting patient care in hospitals across the United States. Today marks the first time that Civica is announcing the production of generic drugs – and the initial medications to be supplied – since the company was established to address chronic drug shortages. It has committed to partnering with suppliers to deliver 14 essential generic medications this year. Xellia, headquartered in Copenhagen, Denmark, is expanding its manufacturing and sales capabilities within the U.S. and has a long-standing heritage of manufacturing with an emphasis on quality and security of supply. The company produces its own active pharmaceutical ingredients, as well as finished injectable drug products for serious and often life-threatening bacterial and fungal infections. “We thank Xellia for helping to lead the way in efforts to reduce chronic generic drug shortages in the U.S., including treatments for serious infections caused by bacteria that are resistant to other antibiotics,” said Martin VanTrieste, President and CEO of Civica. “By helping to stabilize the supply of Vancomycin and Daptomycin, we will have a direct impact on patient safety and public health by providing consistent access to antibiotics that are important treatment options in the management of difficult-to-treat and life-threatening infections.” The partnership with Xellia will help avoid drug shortages and enable the supply security Civica and its member health systems are seeking.
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  • 3746 Xellia 2015 Annual Report AW
    Corporate Report 2015 CONTENTS Contents 3 Xellia at a glance 4 2015 highlights 7 Financial highlights 8 Spotlight on the US 10 Business overview 17 Corporate responsibility 26 Corporate governance Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the fi nancial condition, results of operations, businesses and prospects of New Xellia Group A/S (“Xellia”). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. 2 Xellia 2015 Headquartered Owned by in Copenhagen, Novo A/S since Xellia at a glance Denmark July 2013 Xellia is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often XELLIA AT A GLANCEXELLIA AT life-threatening infections Xellia is developing novel antibiotics effective against resistant species in partnership with SINTEF Materials and Chemistry and the Statens Serum Institut supported by a grant from the Research Council of Norway Oslo, Norway State-of–the-art R&D Center of Excellence focused on APIs and discovery of novel anti-infectives Copenhagen, Denmark Xellia’s headquarters. Our biggest operation, manufactures sterile APIs and FDFs. Provides lyophilized and dry powder fill vials, stability Budapest, Hungary Manufactures several unique testing and packaging products and provides additional capacity for Vancomycin Shanghai, China Cleveland, US Acquired in 2015, the site will significantly Commercial organization supporting strengthen Xellia’s manufacturing capacity for the work with partners in the sterile injectable products Chinese market Tokyo, Japan Commercial organization handling the challenging Japanese market Raleigh, US Acquired in 2014 this became our US commercial headquarters in 2015.
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  • Corporate Report 2015 CONTENTS
    Corporate Report 2015 CONTENTS Contents 3 Xellia at a glance 4 2015 highlights 7 Financial highlights 8 Spotlight on the US 10 Business overview 17 Corporate responsibility 26 Corporate governance Forward-looking statement This report contains certain projections and other forward-looking statements with respect to the fi nancial condition, results of operations, businesses and prospects of New Xellia Group A/S (“Xellia”). These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. 2 Xellia 2015 Headquartered Owned by in Copenhagen, Novo A/S since Xellia at a glance Denmark July 2013 Xellia is a specialty pharmaceutical company focused on providing important anti-infective treatments against serious and often XELLIA AT A GLANCEXELLIA AT life-threatening infections Xellia is developing novel antibiotics effective against resistant species in partnership with SINTEF Materials and Chemistry and the Statens Serum Institut supported by a grant from the Research Council of Norway Oslo, Norway State-of–the-art R&D Center of Excellence focused on APIs and discovery of novel anti-infectives Copenhagen, Denmark Xellia’s headquarters. Our biggest operation, manufactures sterile APIs and FDFs. Provides lyophilized and dry powder fill vials, stability Budapest, Hungary Manufactures several unique testing and packaging products and provides additional capacity for Vancomycin Shanghai, China Cleveland, US Acquired in 2015, the site will significantly Commercial organization supporting strengthen Xellia’s manufacturing capacity for the work with partners in the sterile injectable products Chinese market Tokyo, Japan Commercial organization handling the challenging Japanese market Raleigh, US Acquired in 2014 this became our US commercial headquarters in 2015.
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  • Xellia Pharmaceuticals, Aps Advisory Committee Background Document
    BACITRACIN for Injection (bacitracin) Advisory Committee Background Document Staphylococcal pneumonia and empyema in infants Xellia Pharmaceuticals, ApS Advisory Committee Background Document Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC) on Safety and Efficacy of Bacitracin for Intramuscular Injection BACITRACIN for Injection (bacitracin) AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION Issue/Report Date: 28 March 2019 Approved date: 27 March 2019 Page 1 of 52 BACITRACIN for Injection (bacitracin) Advisory Committee Background Document Staphylococcal pneumonia and empyema in infants Table of Contents 1 EXECUTIVE SUMMARY ............................................................................................................5 2 Introduction .....................................................................................................................................7 3 Clinical data on effectiveness of bacitracin for injection ................................................................8 3.1 Approved Indication: Staphylococcal Pneumonia and Empyema in Infants ........................... 8 3.1.1 Supporting data on the treatment of lung infections in adults ........................................... 9 3.1.2 Data on intrapleural administration in infants and children with empyema ...................... 9 3.2 Alternate uses for Bacitracin for injection .............................................................................. 10 3.2.1 Surgical Site Infection (SSI) Prophylaxis .......................................................................
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  • Xellia Corporate Introduction
    Xellia Pharmaceuticals Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Xellia is a world-leading trusted supplier of several important established anti- infective drugs, comprising active pharmaceutical ingredients as well as finished dosage forms, where the majority are injectable drug products. Headquartered in Copenhagen, Denmark and owned by Novo Holdings A/S, Xellia Pharmaceuticals has more than 1800 employees globally. From state-of-the-art manufacturing sites in the U.S., China, Denmark and Hungary to R&D sites in Norway and Croatia; Xellia Pharmaceuticals excels within innovative product development to deliver high quality products to its customers. Our product portfolio of anti-bacterial and investments within inhalable and injectable through managing orders to delivery. anti-fungal products used for the treatment product technologies as we are committed Xellia Pharmaceuticals’ Global Technical of severe infections, including infections to researching solutions, which improve Support team serves as the main point of caused by multi-resistant bacteria and patients’ quality of life. contact for customers to provide them fungi, is the foundation for our growth with specialized support for all technical strategy within the antibiotics’ sector. Supplying products to more than 70 matters that may be associated with countries worldwide and with more than market entry and launch of products. Xellia is the leading supplier of important 500 customers internationally, Xellia anti-infectives vancomycin and colisti- Pharmaceuticals places a high regard Working collaboratively with the sales methate sodium (CMS). Our success and on maintaining strong relationships team and cross-functionally with Xellia’s strong market position is built on more with its customers.
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  • Vancomycin Xellia 500 Mg and 1000 Mg Powder for Solution for Infusion
    Package leaflet: Information for the user Vancomycin Xellia 500 mg and 1000 mg powder for solution for infusion Vancomycin Read all of this leaflet carefully before you start using this medicine beacause it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 What is in this leaflet: 1. What Vancomycin Xellia is and what it is used for 2. What you need to know before you use Vancomycin Xellia 3. How to use Vancomycin Xellia 4. Possible side effects 5. How to store Vancomycin Xellia 6. Contents of the pack and other information 1. What Vancomycin Xellia is and what it is used for How does the medicine work? Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections. Vancomycin powder is made into a solution for infusion. What is the medicine used for? Vancomycin is used in all age groups by infusion for the treatment of the following serious infections: - Infections of the skin and tissues below the skin. - Infections of bone and joints. - An infection of the lungs called "pneumonia". - Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures - Infection in central nervous system.
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  • Safety and Effectiveness of Bacitracin for IM Injection
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  • Polymyxin B for Injection, USP500,000 Units/Vial
    POLYMYXIN B- polymyxin b sulfate injection, powder, for solution Xellia Pharmaceuticals USA LLC ---------- Polymyxin B for Injection, USP 500,000 Units/vial Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of polymyxin B and other antibacterial drugs, polymyxin B should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria WARNING CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN. RENAL FUNCTION SHOULD BE CARFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE. PATIENTS WITH NEPHROTOXICITY DUE TO POLYMYXIN B SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG. NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLUR-RING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENALFUNCTION AND/OR NEPHROTOXICITY. THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED. THE NEUROTOXICITY OF POLYMYXIN B SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS. USAGE IN PREGNANCY THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED. DESCRIPTION Polymyxin B for Injection is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous).
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  • Polymyxin B-Induced Kidney Injury Assessment of a Novel Formulation of Polymyxin B (VRP-034) in Rats
    antibiotics Article Polymyxin B-Induced Kidney Injury Assessment of a Novel Formulation of Polymyxin B (VRP-034) in Rats Dilip Roy, Amol Kulkarni, Manu Chaudhary, Saransh Chaudhary, Anurag Payasi * and Anmol Aggarwal Venus Medicine Research Centre, Baddi 173205, Himachal Pradesh, India; [email protected] (D.R.); [email protected] (A.K.); [email protected] (M.C.); [email protected] (S.C.); [email protected] (A.A.) * Correspondence: [email protected] Abstract: Despite the crucial role of Polymyxin-B in treating life-threatening gram-negative infections, its clinical utility is limited due to the risk of acute kidney injury. In response, a novel formulation of polymyxin-B is being developed to mitigate drug-induced kidney injury. In this study, we have assessed the toxicity of four variants of that novel formulation (VRP034_F21-F24) in comparison with standard polymyxin-B using kidney injury biomarkers in rats. Sprague-Dawley rats were subcutaneously administered either polymyxin-B (control) or one of the four polymyxin-B formula- tions at a dose of 25 mg/kg/day (HED: 4 mg/kg/day) in four divided doses for two days. Serum samples were collected at baseline and at the end of day 2 for the determination of serum biomarkers. Necropsy was done on day 2 and kidney was collected for histopathological evaluation. In the control group, statistically significant increase (p < 0.0001) in all biomarkers was observed on day 2 as compared to baseline values [urea: 311%; creatinine: 700%; KIM-1: 180%; cystatin-C: 66%] and 50% of the animals died (one after the 7th dose and two after the 8th dose) before scheduled necropsy.
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  • Efficacy of a Fixed Combination of Tetracycline, Chloramphenicol, and Colistimethate Sodium for Treatment of Candida Albicans Ke
    Cornea Efficacy of a Fixed Combination of Tetracycline, Chloramphenicol, and Colistimethate Sodium for Treatment of Candida albicans Keratitis Anna R. Blanco,1 Antonia Nostro,2 Valeria D’Angelo,2 Manuela D’Arrigo,2 Maria G. Mazzone,1 and Andreana Marino2 1SIFI SpA, Aci S. Antonio, Catania, Italy 2Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Polo Annunziata, Messina, Italy Correspondence: Maria G. Mazzone, PURPOSE. To evaluate the antifungal activity of a fixed antibiotic combination (AC) containing SIFISpA,AciS.Antonio,Catania tetracycline (TET), chloramphenicol (CAF), and colistimethate sodium (CS). 95025, Italy; mariagrazia.mazzone@sifigroup.com. METHODS. In vitro: Candida ATCC and clinical strains were used. The minimum inhibitory concentrations (MICs) of AC and of each antibiotic were determined. Fluconazole (FLC) was Submitted: April 13, 2017 tested for comparison. Time-killing curves of selected strains were performed. Ex vivo Accepted: July 18, 2017 keratitis: corneas were injected intrastromally with the selected strains. After the injection, Citation: Blanco AR, Nostro A, D’An- corneas were divided into groups of treatments: AC, FLC, or saline. Then, the tissues were gelo V, D’Arrigo M, Mazzone MG, analyzed for colony-forming units per gram (CFU/g). Propidium iodide (PI) and MitoTracker Marino A. Efficacy of a fixed combi- (MTR) staining were used to investigate the mode of action. nation of tetracycline, chlorampheni- col, and colistimethate sodium for RESULTS. Values of MIC required to inhibit the growth of 90% of organisms for the antibiotics treatment of Candida albicans kera- alone were higher than FLC. However, their activity was enhanced when used in combination titis.
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  • Corporate Report 2018 Contents
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