Hikma Pharmaceuticals Plc Hikma launches Pantoprazole Sodium for Injection
October 30 2017 - 5:26AM
RNS Non-Regulatory
TIDMHIK
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 +44 (0)20 7399 2760/ +44 7776 477050
Lucinda Baker Deputy Director of Investor Relations +44 (0)20
7399 2765/ +44 7818 060211
Virginia Spring Investor Relations Manager +44 (0)20 3892 4389/
+44 7973 679502
West-Ward Pharmaceuticals Corp.
Keri Butler, Corporate Affairs and Communications +1 614 272
4774/ +1 614 214 6657
FTI Consulting
Brett Pollard +44 (0)20 3727 1000
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.
This information is provided by RNS
The company news service from the London Stock Exchange
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