Hikma announces the launch of Levoleucovorin for Injection in the US
London, 16 August 2016 – Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody’s / BB+ S&P, both stable), the fast growing multinational pharmaceutical group, announces that its wholly owned US affiliate, West-Ward Pharmaceuticals Corp. (West-Ward), has launched Levoleucovorin for Injection, 50 mg/vial, having been granted a 180-day generic drug exclusivity by the Food and Drug Administration (FDA).
Levoleucovorin for Injection is therapeutically equivalent to the reference listed drug Fusilev® Injection, 50 mg/vial of Spectrum Pharmaceuticals, Inc.
Levoleucovorin for Injection is a folate analog indicated for rescue after high dose methotrexate therapy in osteosarcoma and for diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. According to IMS Health, total US combined sales of Levoleucovorin were approximately $116 million for the 12 months ending June 2016.
Said Darwazah, Chairman and CEO of Hikma, said, “We are very pleased to be launching Levoleucovorin in the US market. This launch demonstrates our strong regulatory capabilities and the successful execution of our strategy to develop a more differentiated injectable product portfolio. We continue to work closely with the FDA leveraging our R&D, regulatory and high-quality manufacturing facilities, prioritising the re-introduction of Bedford products for patients in need.”
Important safety information
pneumonia in patients with HIV infection was associated with increased rates of treatment failure and morbidity in a placebo-controlled study. Levoleucovorin is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid. Pneumocystis carinii leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of d,l--leucovorin, usually in association with fluoropyrimidine administration. The concomitant use of d,lleucovorin and 5-fluorouracil. Additionally, seizures and/or syncope have been reported rarely in cancer patients receiving d,l-content of the levoleucovorin solution, no more than 16 mL (160 mg of levoleucovorin) should be injected intravenously per minute. Patient serum creatinine and methotrexate levels should be determined at least once daily. Patients receiving Levoleucovorin should be monitored as increases in toxicity of 5-fluorouracil have been seen. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly ++ Due to Ca. -leucovorin and is indicated for intravenous administration onlyd,lLevoleucovorin for Injection should be administered at one-half the usual dose of racemic For additional information, please refer to the Package Insert for full prescribing information, available on west-ward.com.
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Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Investor Relations +44 (0)20 7399 2760/ +44 7776 477050
Keri Butler, US Public Affairs and Communications +1 614 272 4774/ +1 614 214 6657
Ben Atwell/ Matthew Cole +44 (0)20 3727 1000
Hikma Pharmaceuticals PLC is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products. Hikma operates through three businesses: “Injectables”, “Branded” and “Generics”, based principally in the United States, the Middle East and North Africa (MENA) and Europe. In the United States, Hikma operates through its wholly owned subsidiary, West-Ward Pharmaceuticals Corp., with operations based in New Jersey, Ohio and Tennessee.
 Fusilev is a registered trademark of Spectrum Pharmaceuticals, Inc.