Civica Rx and Hikma Announce Shipments of Heparin and Seven Other Essential Injectable Medicines

Utah-based Civica Rx (Civica, Inc.) and Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P), the multinational generic pharmaceutical company, today announced imminent 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.

Today’s 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 major orthopedic and cardiac surgery. It is prescribed to more than 10 million 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 hospitalization for heart failure. 

"We are thrilled to be delivering on our partnership’s promise to ensure vital medications are consistently available for hospitals and patients who need them," said Martin VanTrieste, President and CEO of Civica Rx. "These shipments reinforce our confidence in Hikma’s expertise and manufacturing capabilities and it’s especially gratifying that the initial deliverable of our partnership will help ensure an increased supply of heparin at a time when there is an ongoing threat to supply.”

“As a leading provider of generic injectable medicines, Hikma is committed to working across the US healthcare system on long-term, sustainable solutions to help ensure a consistent supply of needed medicines to patients,” said Riad Mishlawi, President, Hikma Injectables. “Our partnership with Civica is an excellent example of combining Hikma’s strong manufacturing capabilities and strong quality and supply record with Civica’s extensive network of more than 1,100 US hospitals. We are pleased that patients and healthcare providers across the country will now begin benefiting from Civica’s forward-thinking approach.”

Civica Rx & Hikma’s Partnership

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 (NDC) 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 leading US hospital systems, including Intermountain Healthcare, concerned about generic drug shortages and philanthropic organizations passionate about improving healthcare. To date, more than 45 health systems are Civica members, representing more than 1,100 US hospitals and over 30 percent 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 (FDA) 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 organization plans to announce shipments of additional life-saving drugs in the near future.