Hikma launches Pantoprazole Sodium for Injection

RNS Number : 9517U

Hikma Pharmaceuticals Plc

30 October 2017

 

PRESS RELEASE                                                                     

Hikma launches Pantoprazole Sodium for Injection

London, 30 October 2017 - Hikma Pharmaceuticals PLC (Hikma, Group) (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 Pantoprazole Sodium for Injection, 40mg.

According to IMS Health, US sales of Pantoprazole Sodium for Injection were approximately $104 million in the 12 months ending August 2017.  

Riad Mechlaoui, Chief Executive Officer of Injectables said, "We are very pleased to launch Pantoprazole Sodium for Injection, reducing the shortage of this product in the US market. We are successfully executing our Injectables pipeline and leveraging the additional capacity we have been adding to our Portuguese facility to support future growth."

Indications

Gastroesophageal reflux disease associated with a history of erosive esophagitis

Pantoprazole Sodium for Injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of EE for more than 10 days have not been demonstrated.

Pathological hypersecretion including Zollinger-Ellison Syndrome

Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome in adults.

For additional information, please refer to the package insert for full prescribing information, available on www.west-ward.com.

Important safety information

Warnings and precautions

·     Gastric malignancy: In adults, symptomatic response to therapy with Pantoprazole Sodium for Injection does not preclude the presence of gastric malignancy.  Consider additional follow-up and diagnostic testing

·     Hypersensitivity and severe skin reactions: Anaphylaxis has been reported.

·     Injection site reactions: Thrombophlebitis is associated with intravenous use

·     Acute Interstitial Nephritis: Observed in patients taking proton pump inhibitors (PPIs)

·     Clostridium difficile - associated diarrhea: PPI therapy may be associated with increased risk.

·     Bone fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine

·     Cutaneous and systemic lupus erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Pantoprazole Sodium for Injection and refer to specialist for evaluation

·     Hepatic effects: Elevations of transaminases observed

·     Hypomagnesemia: Reported rarely with prolonged treatment with PPIs

Pantoprazole Sodium for Injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticarial.  PPIs, including Pantoprazole Sodium for Injection, are contraindicated in patients receiving rilpivirine-containing products. Consult the labelling of concomitantly used drugs to obtain further information about interactions with PPIs.

Most common adverse reactions are: headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

Enquiries

Hikma Pharmaceuticals PLC                                                       

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

Lucinda Baker   Deputy Director of Investor Relations                                                    [phone]/ [phone]

Virginia Spring  Investor Relations Manager                                                                       [phone]/ [phone]

West-Ward Pharmaceuticals Corp.

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

FTI Consulting                                                                                  

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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