TIDMHIK
Hikma Pharmaceuticals Plc
29 March 2018
Hikma launches Palonosetron Hydrochloride Injection
London, 29 March 2018 - 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 Palonosetron Hydrochloride (HCl) Injection,
0.25mg/2mL.
West-Ward's Palonosetron HCI Injection is a serotonin-3 (5-HT3)
receptor antagonist indicated in adults for:
-- Moderately emetogenic cancer chemotherapy - prevention of
acute and delayed nausea and vomiting associated with initial and
repeat courses
-- Highly emetogenic cancer chemotherapy - prevention of acute
nausea and vomiting associated with initial and repeat courses
According to IQVIA, US sales of Palonosetron HCI Injection were
approximately $447 million in the 12 months ending January
2018.
Riad Mechlaoui, Chief Executive Officer, Injectables Division,
said, "We are very pleased to add Palonosetron HCI Injection to our
oncology portfolio. The launch of this product further expands our
broad Injectables portfolio, bringing value to our customers and
patients in the US hospital setting, as well as driving long-term,
sustainable growth for our business."
Important Safety Information
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when
administering Palonosetron Hydrochloride Injection:
-- Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists.
-- Serotonin syndrome has been reported with 5-HT3 receptor
antagonists. Signs and symptoms include: mental status change,
autonomic instability, neuromuscular symptoms, and seizures, with
or without gastrointestinal symptoms. Inform patient of the
increased risk.
Palonosetron HCl Injection is contraindicated in patients known
to have hypersensitivity to the drug or any of its components.
In clinical trials of palonosetron hydrochloride, the most
common adverse reactions were headache, constipation, diarrhea, and
dizziness.
Infrequent adverse reactions include, hypertension, myocardial
ischemia, rash, hearing and vision irritation, diarrhea, dry mouth,
fatigue, flu-like syndrome, asymptomatic increases in AST and/or
ALT and bilirubin, hyperglycemia, anorexia, arthralgia, dizziness,
insomnia, anxiety, urinary retention and vein discoloration.
Very rare cases of hypersensitivity reactions including
anaphylaxis and anaphylactic shock and injection site reactions,
including burning, induration, discomfort and pain, have been
reported from post approval use.
Patient Counselling Information should be shared with the
patient prior to administration. Patients should be advised to read
the FDA-approved Patient Information.
Please refer to the Package Insert for full prescribing
information, available here. Additional information on West-Ward
products is available at www.west-ward.com.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate +44 (0)20 7399 2760/
Strategy and Investor Relations +44 7776 477050
Virginia Spring, Investor +44 (0)20 3892 4389/
Relations Manager +44 7973 679502
FTI Consulting
Ben Atwell/Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma helps puts better health within reach every day for
millions of people in more than 50 countries around the world. For
40 years, we've been creating high-quality medicines and making
them accessible to the people who need them. We're 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
8,500 colleagues are helping to shape a healthier world that
enriches all our communities. We are a leading licensing partner in
the MENA region, 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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