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Civica Rx Partners with Thermo Fisher Scientific to Develop and Manufacture Drugs with a History of Drug Shortages

SALT LAKE CITY–()–Civica Rx (Civica, Inc.) today announced it has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future.

This partnership has an initial seven-year term and represents a key component of Civica’s manufacturing strategy. By partnering with Thermo Fisher, Civica will begin to build its internal pipeline of medications for use in emergency and critical care in the United States. To date, Civica has worked with multiple quality drug manufacturers that already have U.S. FDA approved manufacturing facilities and capacity to produce Civica labeled drugs in an effort to get shortage medications to market immediately.

“We are thrilled to enter into a partnership with a world class organization that is dedicated to helping Civica serve patients,” said Martin VanTrieste, Civica’s President and CEO. “The Thermo Fisher team is known for top manufacturing talent, supply reliability, product quality and innovation. We look forward to working with them to develop and produce Civica medicines.”

“We thank Civica for their confidence in our team and capabilities and welcome this opportunity to work with them to help mitigate the risk of drug shortages in the U.S.,” said Mike Shafer, President of Thermo Fisher’s Pharma Services business. “Together we will be able to deliver medicines to the market sooner to the patients who are waiting.”

Initially the Thermo Fisher collaboration will focus on nine critical medications that have been in short supply or where the drug supply chain is fragile because there are too few manufacturers making these drugs. Civica’s hospital-led drug selection and medical trends advisory committees helped prioritize these medications for Civica’s Research & Development efforts.

Civica was founded in 2018 by leading US hospital systems concerned about generic drug shortages and philanthropic organizations passionate about improving healthcare. To date, nearly 50 health systems are Civica members, representing more than 1,200 US hospitals and over 30 percent of all licensed US hospital beds. Civica currently has 18 medications in production and/or shipped for use in hospitals across the country.

About Civica Rx

Civica Rx was established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. It 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 is committed to transparency and offers 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 a strategic safety stock of medications to help 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 generic drugs under Civica’s National Drug Code, allowing manufacturers to re-enter the market or increase existing capacity. Civica is currently working with five supplier partners and in negotiations with several more.
  • Developing Abbreviated New Drug Applications (ANDAs) for generic drugs and working with contract manufacturing organizations like Thermo Fisher to produce Civica medications.
  • Acquiring/building Civica manufacturing facilities using Civica’s ANDAs

Find more information about Civica Rx at www.civicarx.org.

Source

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