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

Marks first key milestone for the Civica Rx-Hikma partnership, which is set to supply 14 essential medicines to US hospitals and patients

SALT LAKE CITY & LONDON–(BUSINESS WIRE)–#CivicaCivica 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.1

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 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:

“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 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.

1 Hikma Pharmaceuticals USA Inc. was formerly known as West-Ward Pharmaceuticals Corp.

^ Denotes essential shortage medication

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:

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

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. Headquartered in the UK, 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, 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

See below for Important Safety Information regarding products containing Boxed Warnings, which includes Prochlorperazine Edisylate Injection, USP.

Important Safety Information for Prochlorperazine Edisylate Injection, USP:

BOXED WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine Edisylate Injection, USP is not approved for the treatment of patients with dementia-related psychosis.

CONTRAINDICATIONS

Do not use in patients with known hypersensitivity to phenothiazines. Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.). Do not use in pediatric surgery. Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.

WARNINGS & PRECAUTIONS

The following warnings and precautions should be taken when administering Prochlorperazine Edisylate Injection, USP:

ADVERSE REACTIONS

NOTE: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Cholestatic jaundice has occurred. Motor Restlessness may include agitation or jitteriness and sometimes insomnia. Pseudoparkinsonism symptoms may include mask-like facies, drooling, tremors, pillrolling motion, cogwheel rigidity, and shuffling gait. Avoid getting the injection solution on hands or clothing because of the possibility of contact dermatitis.

Not all of the following adverse reactions have been observed with every phenothiazine derivative but they have been reported with one or more and should be borne in mind when drugs of this class are administered: extrapyramidal symptoms (opisthotonos, oculogyric crisis, hyperreflexia, dystonias, akathisia, dyskinesia, parkinsonism); grand mal and petit mal convulsions; altered cerebrospinal fluid proteins; cerebral edema; intensification and prolongation of the action of central nervous system depressants (opiates, analgesics, antihistamines, barbiturates, alcohol), atropine, heat, organophosphorus insecticides; autonomic reactions (dryness of mouth, nasal congestion, headache, nausea, constipation, obstipation, adynamic ileus, ejaculatory disorders/impotence, priapism, atonic colon, urinary retention, miosis and mydriasis); reactivation of psychotic processes, catatonic-like states; hypotension (sometimes fatal); cardiac arrest; blood dyscrasias (pancytopenia, thrombocytopenic purpura, leukopenia, agranulocytosis, eosinophilia, hemolytic anemia, aplastic anemia); liver damage (jaundice, biliary stasis); endocrine disturbances (hyperglycemia, hypoglycemia, glycosuria, lactation, galactorrhea, gynecomastia, menstrual irregularities, false-positive pregnancy tests); skin disorders (photosensitivity, itching, erythema, urticaria, eczema up to exfoliative dermatitis); other allergic reactions (asthma, laryngeal edema, angioneurotic edema, anaphylactoid reactions); peripheral edema; reversed epinephrine effect; hyperpyrexia; mild fever after large IM doses; increased appetite; increased weight; a systemic lupus erythematosus-like syndrome; pigmentary retinopathy; with prolonged administration of substantial doses, skin pigmentation, epithelial keratopathy, and lenticular and corneal deposits.

EKG changes—particularly nonspecific, usually reversible Q- and T-wave distortions—have been observed in some patients receiving phenothiazines. Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuation in long-term psychiatric patients may cause temporary symptoms, e.g., nausea and vomiting, dizziness, tremulousness.

For additional information, please refer to the Package Insert for full prescribing information, available on www.hikma.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Manufactured by:

Hikma Pharmaceuticals USA Inc. (formerly West-Ward, A Hikma Company)

Eatontown, NJ 07724 USA

Document identification number: WW20374

Contacts

Civica Rx

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

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

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