Civica Rx  

Lehi,  UT 
United States
http://www.civicarx.org
  • Booth: 1523

Profile

Civica Rx acts in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with Health Systems and manufacturing partners. An advisory committee of hospital system pharmacy leaders prioritizes the drugs Civica makes. Civica aims to stabilize the supply of antibiotics, CNS medications, cardiac medications, and other essential sterile injectable medicines used in hospitals daily.

Civica Rx was established in 2018 by U.S. Health Systems and Philanthropies to reduce chronic generic drug shortages. It is a non-profit, non-stock corporation committed to stabilizing the supply of essential generic medications. As of October 2019, over 40 Health Systems were Civica Rx members, representing over 1000 U.S. hospitals and 30 percent of all licensed U.S. hospital beds.


 Press Releases

  • Hikma and Civica Rx sign long-term agreement to reduce generic drug shortages in the US

    Partnership will supply 14 essential medicines to US hospitals and patients

    LONDON and SALT LAKE CITY, July 23, 2019 -- Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's / BB+ S&P, both stable), the multinational generic pharmaceutical company and Civica Rx (Civica, Inc.) today announce a five-year agreement to manufacture and supply Civica's growing membership of US health systems with medications that are often in short supply in US hospitals.

    Under the agreement, Hikma will produce 14 essential sterile injectable medications for Civica as a private label distributor, using Hikma's Abbreviated New Drug Applications (ANDAs) and Civica's labeling and National Drug Code (NDC). These medicines are used daily by hospitals in emergency care, surgery, pain management and in treating hypertension. The list of products included in the agreement will be publicly announced in the near future, and initial shipments are expected to begin before the end of 2019.

    Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organizations passionate about improving healthcare. To date, more than 30 health systems are Civica members, representing more than 900 US hospitals and approximately 30 percent of all licensed US hospital beds.

    Hikma is the third largest US supplier of generic injectable medicines with a growing portfolio of more than 100 injectable products. Today, one in every six generic injectable medicines used in US hospitals is a Hikma product. During the last three years, Hikma has launched more than 20 medications into US shortage situations and in 2016 the company received a Drug Shortage Assistance Award from the US Food and Drug Administration (FDA) for its role in preventing or alleviating drug shortages.

    "Hikma is thrilled to be partnering with Civica to reduce drug shortages, and we share their commitment to providing hospitals and doctors with a steady and reliable supply of high-quality injectable medicines needed for successful patient care," said Daniel Motto, Hikma's EVP of Commercial & Business Development, US Injectables. "This agreement recognizes both our ability to deliver a large and consistent supply of quality medicines, and the significant investments we have made to expand our injectable manufacturing capacity and capabilities."

    "We applaud Hikma's clear commitment to reducing drug shortages," said Martin VanTrieste, President and CEO of Civica Rx. "Our partnership will help us make an impact as quickly as possible. We specifically chose Hikma because of their strong manufacturing capabilities and believe their excellent quality and supply record will be key to our success in ensuring vital medications are consistently available for hospitals and patients who need them."

    "We are privileged to be working with Civica and we appreciate their five-year commitment to guaranteed demand and fair and sustainable pricing, which supports more effective production planning and long-term investments in manufacturing," said Riad Mishlawi, President, Hikma Injectables. "We believe Hikma's size and scale, broad portfolio of medicines and robust pipeline across growing therapeutic areas will enable us to build on this partnership in the future. We are committed to working with Civica and all of our customers as a reliable partner, capable of serving the growing needs of US hospitals and clinics for a wide-range of essential medicines."

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    About Civica Rx

    Civica was established in 2018 to reduce chronic generic drug shortages in the US and exists in the public interest as a non-profit, non-stock corporation committed to stabilizing the supply of essential generic medications in a hospital setting. Civica's membership includes a Governing Board and Founding and Partnering Members. Civica will act in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. Civica is committed to transparency and will offer fair and sustainable prices to its member hospitals. It will also ensure it has dedicated manufacturing capacity for the medications that are most desperately needed in hospitals across the country through redundant manufacturing and strategic stockpiling of medications to prevent drug shortages in the future. Civica aims to stabilize the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other essential sterile injectable medicines used in hospitals daily. It is actively pursuing a three-pronged product supply strategy: • Working with multiple generic drug manufacturers that have the US FDA approved manufacturing facilities and capacity to produce Civica labeled generic drugs, allowing manufacturers to re-enter the market or increase existing capacity • Developing and acquiring Abbreviated New Drug Applications (ANDAs) for generic drugs and working with contract manufacturing organizations to produce Civica medications • Acquiring and building Civica manufacturing facilities using Civica's ANDAs • More information about Civica can be found at www.civicarx.org and https://civicarx.org/media/.

    About Hikma

    Hikma helps put better health within reach every day for millions of people in more than 50 countries around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. We are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner in the MENA region, and through our venture capital arm, are helping bring innovative health technologies to people around the world.

    For more information, please visit: www.hikma.com

    CONTACT: Hikma Pharmaceuticals PLC, Susan Ringdal, EVP, Strategic Planning and Global Affairs, +44 (0)20 7399 2760/ +44 7776 477050, uk-investors@hikma.uk.com; Steve Weiss, US Communications and Public Affairs, +1 732 720 2830/ +1 732 788 8279, sweiss@hikma.com;

    Civica Rx, Debbi Ford, +1 970 227 3991, Debbi.ford@civicarx.org

  • 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. Xellia will make medications for Civica under Xellia’s Abbreviated New Drug Application (ANDA) and Civica labeling and New Drug Code (NDC).
    “We are honored to work with Civica, an innovator in addressing generic drug shortages,” said Carl-Aake Carlsson, CEO Xellia Pharmaceuticals. “Our collaboration also supports Xellia’s long-term ambition of mitigating anti-infective drug shortages across the U.S."
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    About Civica Rx
    Civica was established in 2018 to reduce chronic generic drug shortages in the U.S. and exists in the public interest as a non-profit, non-stock corporation committed to stabilizing supply of essential generic medications in a hospital setting. Civica’s membership includes a Governing Board and Founding and Partnering Members.
    Civica will act in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. Civica is committed to transparency and will offer fair and sustainable prices to its member hospitals. It will also ensure it has dedicated manufacturing capacity for the medications that are most desperately needed in hospitals across the country through redundant manufacturing and strategic stockpiling of medications to prevent drug shortages in the future. Civica aims to stabilize the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other essential sterile injectable medicines used in hospitals daily. It is actively pursuing a three-pronged product supply strategy: • Working with multiple generic drug manufacturers (with Xellia as its first) that have the US FDA approved manufacturing facilities and capacity to produce Civica labeled generic drugs, allowing manufacturers to re-enter the market or increase existing capacity • Developing and acquiring Abbreviated New Drug Applications (ANDAs) for generic drugs and working with contract manufacturing organizations to produce Civica medications • Acquiring and building Civica manufacturing facilities using Civica’s ANDAs More information about Civica can be found at www.civicarx.org and https://civicarx.org/media/. About Xellia Pharmaceuticals Xellia Pharmaceuticals (“Xellia”) is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. With over 100 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease-of-use for healthcare professionals. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia and North America and is investing significantly to expand its sales and manufacturing capabilities within the United States. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,600 people. Further information about Xellia can be found at: www.xellia.com. About Vancomycin and Daptomycin Vancomycin is an antibiotic administered by an intravenous (IV) infusion over at least 60 minutes. It is used for serious infections caused by bacteria that are resistant to certain other antibiotics, including methicillin resistant Staphylococcus aureus (MRSA). Vancomycin can treat infections throughout the body including: pneumonia (lungs), cellulitis (skin and skin structures), septicemia (blood), osteomyelitis (bone), and endocarditis (inner lining of the heart). 3 Daptomycin is an antibiotic administered by an intravenous (IV) bolus injection or infusion over 2-30 minutes, respectively. It is used to treat complicated infections of the skin and skin structures caused by susceptible isolates of the Gram-positive bacteria including methicillin resistant Staphylococcus aureus (MRSA). Daptomycin is also used to treat infections of the bloodstream and infective endocarditis (an infection of the inner lining of the heart) caused by methicillin-susceptible and methicillin-resistant S. aureus bacteria.
    Enquiries:
    Civica Rx Debbi Ford Tel: +1 (970) 227-3991 Email: Debbi.ford@civicarx.org
    https://civicarx.org/wp-content/uploads/2019/05/Civica-Xellia-Press-Release-FINAL-1.pdfXellia Pharmaceuticals ApS Carl-Åke Carlsson, CEO Tel: +45 32 64 55 00 Xellia Pharmaceuticals USA, LLC Craig Boyd / Shawn Olsson Tel: +1 630 776 9357 Instinctif Partners (Xellia’s international media relations) Eileen Paul / Rozi Morris / Melanie Toyne-Sewell Tel: +44 (0) 20 7457 2020 Email: xellia@instinctif.com