TIDMHIK
Hikma Pharmaceuticals Plc
30 May 2018
London, 30 May 2018 - 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 Methylergonovine Maleate Tablets, USP, 0.2mg, the generic
equivalent to Methergine(R) .(1)
Methylergonovine Maleate Tablets are a semi-synthetic ergot
alkaloid used for the prevention and control of postpartum
hemorrhage.
West-Ward has partnered with Granules Pharmaceuticals Inc.
(Granules) to launch Methylergonovine Maleate Tablets. Under the
terms of the agreement, Hikma has the exclusive rights to
distribute and market Granules' Methylergonovine Maleate Tablets in
the US market.
According to IQVIA, US sales of Methylergonovine Maleate
Tablets, USP, 0.2mg were approximately $70 million in the 12 months
ending March 2018.
Brian Hoffmann, President, Generics Division, said, "We are very
pleased to be entering into a partnership with Granules, adding
this important oxytocic agent to our product portfolio in the US.
This partnership demonstrates our focus on improving patient's
access to high-quality, affordable medicines."
"This is the first product we have commercialized from our
manufacturing facility in the Chantilly, VA and we are happy to
have collaborated with West-Ward. The launch of generic Methergine
tablets, the first generic in the market plays into our strategy of
identifying patient needs and catering to them with economical
alternatives." said Ms. Priyanka Chigurupati, Executive Director,
Granules Pharmaceuticals Inc.
Important Safety Information
Methergine tablets are contraindicated for patients with the
following conditions: hypertension, toxemia, pregnancy, and
hypersensitivity.
General
This drug should not be administered I.V. routinely because of
the possibility of inducing sudden hypertensive and cerebrovascular
accidents. If I.V administration is considered essential as a
lifesaving measure, methylergonovine maleate should be given slowly
over a period of no less than 60 seconds with careful monitoring of
blood pressure. Intra-arterial or periarterial injection should be
strictly avoided. Caution should be exercised in presence of
impaired hepatic or renal function.
Breast-Feeding
Mothers should not breast-feed during treatment with
methylergonovine maleate. Milk secreted during this period should
be discarded. Methylergonovine maleate may produce adverse effects
in the breast-feeding infant. Methylergonovine maleate may also
reduce the yield of breast milk. Mothers should wait at least 12
hours after administration of the last dose of methylergonovine
maleate before initiating or resuming breast feeding.
Coronary Artery Disease
Patients with coronary artery disease or risk factors for
coronary artery disease (e.g., smoking, obesity, diabetes, high
cholesterol) may be more susceptible to developing myocardial
ischemia and infarction associated with methylergonovine-induced
vasospasm.
Medication Errors
Inadvertent administration of methylergonovine maleate to
newborn infants has been reported. In these cases of inadvertent
neonatal exposure, symptoms such as respiratory depression,
convulsions, cyanosis and oliguria have been reported. Usual
treatment is symptomatic. However, in severe cases, respiratory and
cardiovascular support is required. Methylergonovine maleate has
been administered instead of vitamin K and Hepatitis B vaccine,
medications which are routinely administered to the newborn. Due to
the potential for accidental neonatal exposure, methylergonovine
maleate injection should be stored separately from medications
intended for neonatal administration.
(1) Methergine(R) is a registered trademark of Lupin.
PRECAUTIONS
General
Caution should be exercised in the presence of sepsis,
obliterative vascular disease. Also use with caution during the
second stage of labor. The necessity for manual removal of a
retained placenta should occur only rarely with proper technique
and adequate allowance of time for its spontaneous separation.
Drug Interactions
There have been rare reports of serious adverse events in
connection with the co-administration of certain ergot alkaloid
drugs (e.g., dihydroergotamine and ergotamine) and potent CYP3A4
inhibitors, resulting in vasospasm leading to cerebral ischemia
and/or ischemia of the extremities. Although there have been no
reports of such interactions with methylergonovine alone, potent
CYP3A4 inhibitors should not be co-administered with
methylergonovine.
Caution should be exercised when methylergonovine maleate is
used concurrently with beta-blockers. Concomitant administration
with beta-blockers may enhance the vasoconstrictive action of ergot
alkaloids.
Caution should be exercised when methylergonovine maleate is
used concurrently with other vasoconstrictors, ergot alkaloids, or
prostaglandins.
Use of methylergonovine maleate is contraindicated during
pregnancy because of its uterotonic effects.
Safety and effectiveness in pediatric patients have not been
established.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal
VP Corporate Strategy
and Director of Investor +44 (0)20 7399 2760/ +44
Relations 7776 477050
Virginia Spring +44 (0)20 3892 4389/ +44
Investor Relations Manager 7973 679502
FTI Consulting
Ben Atwell/Brett Pollard +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.
About Granules India Ltd. (BSE: 532482, NSE: GRANULES)
Granules India is a growing pharmaceutical manufacturing company
with best in class facilities and is committed to operational
excellence, quality and customer service. The Company produces
Finished Dosages (FDs), Pharmaceutical Formulation Intermediates
(PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the
customers flexibility and choice. Granules India support customers
with unique value, extensive product range, and proactive
solutions. The Company's global presence extends to over 250
customers in 60 countries through offices in India, U.S., and U.K.
For more information, please visit www.granulesindia.com.
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
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
NRADMGZKLLZGRZG
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