TIDMHIK
Hikma Pharmaceuticals Plc
29 January 2019
London, 29 January 2019 - Hikma Pharmaceuticals PLC (Hikma,
Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1
Moody's / BB+ S&P, both stable) announces that Hikma
Pharmaceuticals USA Inc., formerly known as West-Ward
Pharmaceuticals Corp., has launched Mitomycin for Injection, USP,
20mg and 40mg.
Hikma's Mitomycin for Injection, USP is not recommended as
single-agent, primary therapy. It has been shown to be useful in
the therapy of disseminated adenocarcinoma of the stomach or
pancreas in proven combinations with other approved
chemotherapeutic agents and as palliative treatment when other
modalities have failed. Mitomycin is not recommended to replace
appropriate surgery and/or radiotherapy.
According to IQVIA, US sales of Mitomycin for Injection were
approximately $43 million in the 12 months ending November
2018.
Riad Mechlaoui, President of Injectables said, "We are excited
to add Mitomycin for Injection to our oncology portfolio in the US,
improving patients' access to this important medicine. This
demonstrates the successful execution of our strategy to expand our
portfolio in key therapeutic areas."
This new product introduction expands Hikma's broad US offering
of more than 90 injectable products and further solidifies our
position as one of the top three suppliers of generic injectable
products to US hospitals.
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Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
FTI Consulting
Ben Atwell/Andrew Ward +44 (0)20 3727 1000
About Hikma
Hikma helps put 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.
Important Safety Information for Mitomycin for Injection, USP,
20mg and 40mg:
WARNING
Mitomycin should be administered under the supervision of a
qualified physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of therapy and
complications is possible only when adequate diagnostic and
treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and
leukopenia, which may contribute to overwhelming infections in an
already compromised patient, is the most common and severe of the
toxic effects of mitomycin.
Hemolytic Uremic Syndrome (HUS) a serious complication of
chemotherapy, consisting primarily of microangiopathic hemolytic
anemia, thrombocytopenia, and irreversible renal failure, has been
reported in patients receiving systemic mitomycin. The syndrome may
occur at any time during systemic therapy with mitomycin as a
single agent or in combination with other cytotoxic drugs; however,
most cases occur at doses >= 60 mg of mitomycin. Blood product
transfusion may exacerbate the symptoms associated with this
syndrome.
The incidence of the syndrome has not been defined.
WARNINGS AND PRECAUTIONS
Mitomycin is contraindicated in patients who have demonstrated a
hypersensitive or idiosyncratic reaction to it in the past as well
as in patients with thrombocytopenia, coagulation disorder, or an
increase in bleeding tendency due to other causes.
The following warnings and precautions should be taken when
administering Mitomycin for Injection, USP:
-- Patients be must be observed carefully during and after treatment.
-- Advise patients of the potential toxicity of this drug.
-- Safe use of mitomycin in pregnant women has not been established.
-- It is recommended that women receiving mitomycin not breast
feed because of the potential for serious adverse events.
-- Acute shortness of breath and severe bronchospasm have been
reported following administration of vinca alkaloids in patients
who had previously or simultaneously received mitomycin.
-- Respiratory distress syndrome may occur. Caution should be
exercised using only enough oxygen to provide adequate arterial
saturation since oxygen itself is toxic to the lungs.
-- Follow proper handling and disposal of anticancer drugs.
The following adverse reactions have been reported: bone marrow
toxicity, integument and mucous membrane toxicity, renal toxicity,
pulmonary toxicity, hemolytic uremic syndrome, and cardiac
toxicity.
Acute side effects of mitomycin were fever, anorexia, nausea,
and vomiting.
Other adverse events include: headache, blurred vision,
confusion, fatigue, thrombophlebitis, diarrhea, and pain. Malaise
and asthenia have been reported in postmarketing surveillance.
Bladder fibrosis/contraction has been reported with intravesical
administration (not an approved route of administration).
For additional information, please refer to the Package Insert
at
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5917f7a7-cd20-407b-8dda-9fd58c5f47a6
for full prescribing information, available on www.hikma.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit http://www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Manufactured by:
THYMOORGAN PHARMAZIE GmbH,
Schiffgraben 23, 38690 Goslar, Germany
Distributed by:
West-Ward Pharmaceuticals
Eatontown, NJ 077224 USA
Document Identification Number: WW30017
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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