Hikma launches Flucytosine Capsules USP in US

RNS Number : 4429V

Hikma Pharmaceuticals Plc

03 November 2017

 

PRESS RELEASE

Hikma launches Flucytosine Capsules USP in the US market

London, 3 November 2017 - Hikma Pharmaceuticals PLC (Hikma) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's / BB+ S&P, both stable) announces that its wholly owned US subsidiary, West-Ward Pharmaceuticals Corp. (West-Ward), has launched Flucytosine Capsules USP in 250mg and 500mg strengths, the generic equivalents to Ancobon®¹.

West-Ward's Flucytosine Capsules USP are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. 

According to IMS Health, US sales of Flucytosine Capsules USP in 250mg and 500mg strengths were approximately $47 million for the 12 months ending September 2017.

Brian Hoffmann, President of Generics said, "We are very pleased to be launching this product from the West-Ward Columbus portfolio. We have an excellent pipeline of differentiated products that we expect will drive future growth."

Important safety information

Flucytosine Capsules should be used with extreme caution in patients with impaired renal function. Since Flucytosine Capsules are excreted primarily by the kidneys, renal impairment may lead to accumulation of the drug. Flucytosine serum concentrations should be monitored and dosage adjustments made in patients with renal insufficiency. Flucytosine should be given with extreme caution to patients with bone marrow depression. Bone marrow toxicity can be irreversible and may lead to death in immunosuppressed patients.  Close monitoring of hematologic, renal and hepatic status of all patients is essential.

Flucytosine Capsules are contraindicated in patients with a known hypersensitivity to the drug. Severe adverse reactions have been associated with the use of Flucytosine Capsules, including cardiac arrest, cardiac toxicity, respiratory arrest, acute hepatic injury, renal failure, cytopenia, convulsions, psychosis and Lyell's syndrome. There have been no adequate and well controlled studies of Flucytosine Capsules in pregnant women, but flucytosine has shown teratogenic effects in animal studies. Due to the potential for serious adverse reactions in nursing infants from Flucytosine Capsules, a decision should be made whether to discontinue nursing or discontinue the drug. The efficacy and safety of Flucytosine Capsules has not been systematically studied in pediatric patients. For additional information, please refer to the Package Insert for full prescribing information, available on https://dailymed.nlm.nih.gov/dailymed/.

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Hikma Pharmaceuticals PLC                                                       

Susan Ringdal VP Corporate Strategy and Director of Investor Relations               [phone]/ [phone]

West-Ward Pharmaceuticals Corp.

Keri Butler, Corporate Affairs and Communications                                                        [phone]/ [phone]

FTI Consulting                                                                                  

Ben Atwell/ Brett Pollard                                                                                                             [phone]

About Hikma

Hikma Pharmaceuticals PLC is a multinational pharmaceutical group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.  Hikma's operations are conducted through three businesses: 'Injectables,' 'Generics' and 'Branded,' based primarily in the Middle East and North Africa (MENA) region, where it is a market leader, the United States and Europe.  In 2016, Hikma achieved revenues of $1,950 million and profit attributable to shareholders of $155 million.

 

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1 Ancobon is a registered trademark of Valeant Pharmaceuticals International or its related companies

 

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