TIDMHIK
Hikma Pharmaceuticals Plc
18 January 2017
Hikma receives approval for Sodium Oxybate Oral Solution
London, 18 January 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, Roxane Laboratories, Inc. (Roxane), has received an
approval from the US Food and Drug Administration for its Sodium
Oxybate Oral Solution, 500 mg/mL, the generic equivalent to
Xyrem(R). Roxane's Sodium Oxybate Oral Solution is indicated for
the treatment of cataplexy (sudden loss of muscle strength) and
excessive daytime sleepiness in patients with narcolepsy.
Roxane is currently involved in patent litigation concerning
this product in the US District Court for the District of New
Jersey.
Roxane was the first ANDA applicant to submit a substantially
complete ANDA with paragraph IV certification for Sodium Oxybate
Oral Solution, 500 mg/mL and therefore is eligible for 180 days of
generic drug exclusivity following the launch of its product.
In its 2015 Annual Report, Jazz Pharmaceuticals PLC reported net
sales of Xyrem(R) of approximately $955 million in 2015.
Important safety information
Sodium Oxybate is a central nervous system (CNS) depressant and
has caused changes in alertness (or consciousness) and trouble
breathing (respiratory depression). Call your doctor right away if
you have any of these serious side effects. These effects happened
even when Sodium Oxybate was given in recommended doses. In
studies, almost all of the patients with narcolepsy who were given
Sodium Oxybate were also taking medication to help them stay awake
during the day.
Sodium Oxybate is a form of gamma hydroxybutyrate (GHB). Abuse
of GHB, either alone or in combination with other drugs that cause
changes in alertness (or consciousness), has caused serious side
effects. These effects include seizures, trouble breathing
(respiratory depression), very low levels of alertness
(consciousness), coma, and death.
Because of these risks, Roxane's Sodium Oxybate will be
available only through the Sodium Oxybate REMS Program. Prescribers
and patients must enroll in the program.
Do not take Sodium Oxybate if you take other sleep medicines or
sedatives (medicines that cause sleepiness), drink alcohol, or have
a rare problem called semialdehyde dehydrogenase deficiency.
Sodium Oxybate is a controlled substance (CIII) because it can
be a target for people who abuse prescription medicines or street
drugs. Never give your Sodium Oxybate to anyone else because it may
cause death or harm them. Selling or giving this medication away is
against the law.
Do not drive a car, use heavy machinery, fly an airplane, or do
anything that is dangerous or that requires you to be fully awake
for at least 6 hours after you take Sodium Oxybate. You should not
do these activities until you know how Sodium Oxybate affects
you.
Sodium Oxybate can cause serious side effects, including the
following:
-- Breathing problems, including slower breathing, trouble
breathing, and or/short periods of not breathing while sleeping
(sleep apnea). People who already have breathing or lung problems
have a higher chance of having breathing problems when they use
Sodium Oxybate.
-- Mental health problems, including confusion, seeing or
hearing things that are not real (hallucinations), unusual or
disturbing thoughts (abnormal thinking), feeling anxious or upset,
depression, or thoughts of killing yourself or trying to kill
yourself. Call your doctor right away if you have symptoms of
mental health problems.
-- Sleepwalking. Sleepwalking can cause injuries. Call your
doctor if you start sleepwalking. Your doctor should check you.
Tell your doctor if you are on a salt-restricted diet or if you
have high blood pressure, heart failure, or kidney problems. Sodium
Oxybate contains a lot of sodium (salt) and may not be right for
you.
The most common side effects of Sodium Oxybate include nausea,
dizziness, vomiting, bedwetting, and diarrhea. Your side effects
may increase when you take higher doses of Sodium Oxybate. Sodium
Oxybate can cause physical dependence and craving for the
medication when it is not taken as directed. These are not all the
possible side effects of Sodium Oxybate.
Before you take Sodium Oxybate, tell your doctor if you are:
-- Pregnant or planning to become pregnant. It is not known if
Sodium Oxybate can harm your unborn baby.
-- Breastfeeding or plan to breastfeed. It is not known if
Sodium Oxybate passes into your breast milk. You and your doctor
should decide if you will take Sodium Oxybate or breastfeed.
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate Strategy and Investor Relations +44
(0)20 7399 2760/ +44 7776 477050
West-Ward Pharmaceuticals
Keri Butler, US Public Affairs and Communications +1 614 272
4774/ +1 614 214 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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