Research & Development
Civica Rx, Hikma to Ship Heparin and Seven Other Essential Injectable Medicines
11 December 2019 - - US-based generic drug specialist Civica Rx and UK-based generic pharmaceutical company Hikma Pharmaceuticals plc (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) plans to begin shipments of Heparin Sodium Injection, USP, and seven other essential injectable medicines, with additional products to follow in the near term in the US through its affiliate, Hikma Pharmaceuticals USA Inc, the companies said.

This announcement comes as industry experts work to avoid an extended shortage of Heparin, the preferred anticoagulant for many hospitalized patients.

Heparin is commonly prescribed for patients with significant blood clots in their lungs or clogged arteries, and patients receiving dialysis, or undergoing cardiac surgery. It is prescribed to more than 10 m Americans every year.

Shortages of Heparin, which is derived from porcine intestinal mucosa, may be possible due to an outbreak of African Swine Fever that has killed an unprecedented number of the world's pigs.

The outbreak has predominantly impacted China, home to half of the world's swine population. Hikma sources its Heparin raw materials from the US, and has not been impacted.

In addition to Heparin, the Civica Rx-Hikma partnership will be shipping additional medications, including essential shortage medications^, before the end of the year, including:

Naloxone Hydrochloride Injection, USP Naloxone is an opioid antagonist medication used to block or reverse the effects of opioid drugs, particularly drug overdoses.

It works by blocking the effects of the opioid in the brain and is often used in hospitals and EMS services.

Dexamethasone Sodium Phosphate Injection, USP^ Dexamethasone is a steroid used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases.

It decreases the body's natural defensive response and reduces symptoms such as swelling and other physical reactions.

Glycopyrrolate Injection, USP Glycopyrrolate is used in surgeries to reduce airway secretions or to prevent heart rhythm problems during anesthesia, intubation, or surgery.

Prochlorperazine Edisylate Injection, USP Prochlorperazine is used to control severe nausea and vomiting caused by chemotherapy, radiation therapy, and in the pre- and post-operative setting.

Ondansetron Injection, USP^ Ondansetron is used to prevent nausea and vomiting that may be caused by surgery or cancer chemotherapy.

Morphine Sulfate Injection, USP^ Morphine is a narcotic analgesic medication used to relieve moderate to severe pain. It may be also be used before or during surgery with an anesthetic.

Metoprolol Tartrate Injection, USP^ Metoprolol is a beta-blocker used to treat angina and hypertension. It is also used to lower the risk of death or need for hospitalisation for heart failure.

Under the partnership with Civica Rx, announced last July, Hikma will produce 14 essential sterile injectable medications for Civica, using Hikma's Abbreviated New Drug Applications (ANDAs) and Civica's National Drug Code and label. These medicines are used daily by hospitals in emergency care, surgery, pain management and in treating hypertension.

Importantly, Civica Rx's ability to coordinate directly with manufacturers like Hikma enables it to ensure that the APIs (active pharmaceutical ingredients) in Civica Rx drugs are purchased from reputable, high-quality suppliers.

As a result, Civica Rx and its partners manufacture and deliver generic drugs that conform to strict industry standards of quality, strength and purity.

Civica was founded in 2018 by US hospital systems concerned about generic drug shortages and philanthropic organisations passionate about improving healthcare.

To date, more than 45 health systems are Civica members, representing more than 1,100 US hospitals and over 30% of all licensed US hospital beds.

Hikma is the third largest US supplier by volume 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 for its role in preventing or alleviating drug shortages.

Earlier this fall, Civica delivered two essential antibiotics through its partnership with Xellia Pharmaceuticals to member hospitals which are being administered daily to patients nationwide.

The organisation plans to announce shipments of additional life-saving drugs in the near future.

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 stabilise the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other essential sterile injectable medicines used in hospitals daily.


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