TIDMHIK
Hikma Pharmaceuticals Plc
10 March 2017
Hikma launches Desvenlafaxine Succinate Extended-Release (ER)
Tablets in the US market
London, 10 March 2017 - Hikma Pharmaceuticals PLC (Hikma) (LSE:
HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY), (rated Ba1 Moody's / BB+
S&P, both stable), the fast growing multinational
pharmaceutical group, announces that its wholly owned US subsidiary
West-Ward Pharmaceuticals Corp. (West-Ward), has launched generic
Pristiq(R)(1) (Desvenlafaxine Succinate) ER Tablets, 50 mg and 100
mg.
West-Ward's Desvenlafaxine Succinate ER Tablets, 50 mg and 100
mg, are indicated for the treatment of major depressive disorder,
and are in a class of medications called selective serotonin and
norepinephrine reuptake inhibitors (SNRIs).
According to IMS Health, US sales of Desvenlafaxine Succinate ER
Tablets in 50 mg and 100 mg strengths were approximately $853
million in the 12 months ending January 2017.
Mike Raya, Chief Executive Officer of West-Ward said, "We are
pleased to be adding this product to our non-injectables portfolio
in the US. The launch demonstrates our strong R&D and
regulatory capabilities and we have a large pipeline of
differentiated products to drive sustainable growth for this
business."
Antidepressants increase the risk of suicidal thinking and
behavior in children, adolescents and young adults. Patients of all
ages who are started on antidepressant therapy or when the dose is
changed should be monitored appropriately and observed closely for
clinical worsening, suicidality, or unusual changes in behaviour,
such as becoming agitated, irritable, hostile, aggressive,
impulsive or restless. Should these occur, report them to a doctor
right away. Desvenlafaxine ER Tablets are not approved for use in
children under 18. Desvenlafaxine ER Tablets should not be used in
patients who are allergic to desvenlafaxine, venlafaxine or any
other ingredients in Desvenlafaxine ER Tablets. A potentially
life-threatening condition called serotonin syndrome can occur
while taking medicines like Desvenlafaxine ER Tablets, both alone
or in conjunction with another therapy such as monoamine oxidase
inhibitors (MAOIs) and medications meant to treat migraines or
psychiatric disorders (including other antidepressants or
amphetamines). Desvenlafaxine ER Tablets should not be used in
patients who currently take MAOIs, including linezolid or methylene
blue, or have taken a MAOI within the last 14 days. Patients should
wait at least 7 days after stopping Desvenlafaxine ER Tablets
before starting a MAOI.(2)
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate +44 (0)20 7399 2760/
Strategy and Investor Relations +44 7776 477050
West-Ward Pharmaceuticals
Keri Butler, US Public Affairs +1 614 272 4774/ +1
and Communications 614 214 6657
FTI Consulting
Ben Atwell/ Matthew Cole +44 (0)20 3727 1000
About Hikma
Hikma Pharmaceuticals PLC is a fast growing multinational group
focused on developing, manufacturing and marketing a broad range of
both branded and non-branded generic and in-licensed products.
Hikma operates through three businesses: "Injectables", "Branded"
and "Generics", based principally in the United States, the Middle
East and North Africa (MENA) and Europe. In 2015, Hikma achieved
revenues of $1,440 million and profit attributable to shareholders
of $252 million. In the United States, Hikma operates through its
wholly owned subsidiary, West-Ward Pharmaceuticals Corp., with
operations based in New Jersey, Ohio and Tennessee.
Important Safety Information(2)
Antidepressants increase the risk of suicidal thinking and
behavior in children, adolescents, and young adults. Depression and
certain other psychiatric disorders are themselves associated with
the risk of suicide. Patients of all ages who are started on
antidepressant therapy or when the dose is changed should be
monitored appropriately and observed closely for clinical
worsening, suicidality, or unusual changes in behavior such as
becoming agitated, irritable, hostile, aggressive, impulsive, or
restless. Should these occur, report them to a doctor right away.
Desvenlafaxine ER Tablets are not approved for use in children
under 18.
Do not take Desvenlafaxine ER Tablets if:
-- You are allergic to desvenlafaxine or venlafaxine or any
other ingredients in Desvenlafaxine ER Tablets.
-- You currently take, or have taken within the last 14 days,
any medicine known as a MAOI (including the antibiotic linezolid
and intravenous methylene blue). If you have taken a MAOI within
the last 14 days, be sure to talk to your doctor. Wait at least 7
days after stopping Desvenlafaxine ER Tablets before you start a
MAOI. Taking a MAOI with Desvenlafaxine ER Tablets can cause
serious or even life-threatening side effects.
A potentially life-threatening conditions called serotonin
syndrome can happen when medicines such as Desvenlafaxine ER
Tablets are taken, alone or with other serotonergic drugs
(including triptans, tricyclic antidepressants, fentanyl, lithium,
tramadol, tryptophan, buspirone, amphetamines and St. John's Wort).
Serotonin syndrome can cause mental status changes (e.g.,
hallucinations, coma), instability in the autonomic nervous system
(e.g., increased heart rate, fluctuating blood pressure,
dizziness), neuromuscular symptoms (e.g., tremor, rigidity),
seizures and/or gastrointestinal symptoms (e.g., nausea, vomiting,
diarrhea). Before taking Desvenlafaxine ER Tablets, tell your
healthcare professional about all prescription and over-the-counter
medications and supplements you take or plan to take.
Tell your healthcare provider if you have: heart problems; high
cholesterol (or triglyceride levels); a history of stroke, kidney
or liver problems; or low sodium levels in your blood.
Desvenlafaxine ER Tablets can cause serious side effects,
including:
-- New or worsened high blood pressure (hypertension), which
should be controlled before starting Desvenlafaxine ER Tablets and
monitored regularly.
-- Abnormal bleeding or bruising. Taking aspirin, NSAIDs
(non-steroidal, anti-inflammatory drugs), or blood thinners may add
to this risk. Tell your healthcare provider right away about any
unusual bleeding or bruising.
-- Visual problems including eye pain, changes in vision, or
swelling or redness in or around the eye. You may want to undergo
an eye examination to see if you are at risk and receive
preventative treatment if you are.
-- Mania or bipolar disorder
-- Seizures or convulsions
-- Low sodium levels in your blood. Symptoms of this may
include: headache, difficulty concentrating, memory changes,
confusion, weakness, and unsteadiness on your feet. In severe or
sudden cases, symptoms can include: hallucinations (seeing or
hearing things that are not real), fainting, seizures and coma. If
not treated, severe low sodium levels could be fatal.
-- Lung problems including difficulty breathing, cough, or chest
discomfort. Tell your healthcare provider right away if you have
these problems.
Discontinuation symptoms may occur when stopping or reducing
Desvenlafaxine ER Tablets, so talk to you healthcare professional
before stopping or changing your dose.
Before taking Desvenlafaxine ER Tablets, tell your healthcare
provider if you:
-- Are pregnant or plan to become pregnant. It is not known if
Desvenlafaxine ER Tablets will harm your unborn baby
-- Are breastfeeding. Desvenlafaxine ER Tablets can pass into
your breast milk and may harm your baby. Talk to your healthcare
provider about the best way to feed your baby if you take
Desvenlafaxine ER Tablets.
Until you see how Desvenlafaxine ER Tablets affects you, be
careful driving a car or operating machinery. Avoid drinking
alcohol while taking Desvenlafaxine ER Tablets.
Common side effects with Desvenlafaxine ER Tablets include
nausea, sweating, dizziness, insomnia, constipation, dry mouth,
sexual problems, anxiety, tiredness, and decreased appetite.
Please see full Prescribing Information, including BOXED WARNING
and Medication Guide.
(1) Pristiq(R) is a registered trademark of Wyeth LLC.
(2) Desvenlafaxine ER Tablets package insert. West-Ward
Pharmaceuticals Corporation; January 2017
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRAZMGGFFLFGNZM
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