TIDMHIK
RNS Number : 7335B
Hikma Pharmaceuticals Plc
06 April 2017
Hikma enters into settlement agreement with Jazz for sodium
oxybate
London, 6 April 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 it has entered into a
settlement agreement with Jazz Pharmaceuticals plc (Jazz), that
resolves patent litigation related to Jazz's Xyrem(R) (sodium
oxybate) oral solution, 500mg/mL product.
Under the settlement agreement, Jazz will grant Hikma and its
wholly owned subsidiary, West-Ward Pharmaceuticals Corp.
(West-Ward), the right to sell an authorised generic (AG) of
Xyrem(R) in the US market commencing on 1 January 2023 or earlier
under certain circumstances. The AG product will be marketed
through the XYREM(R) Risk Evaluation and Mitigation Strategy (REMS)
programme. The initial term of the AG arrangement is six months and
Hikma has the option to extend the AG term for up to a total of
five years. Jazz has also granted Hikma a licence to market generic
sodium oxybate pursuant to its ANDA at the end of the AG term.
Hikma will pay Jazz a royalty on net sales of the AG product,
but will initially retain a meaningful percentage of net sales.
Hikma will also pay for the supply of the AG product and will
reimburse Jazz for a portion of the service costs associated with
the operation of the Xyrem(R) REMS and distribution of the AG. The
royalty rate paid to Jazz will increase should the AG term be
extended beyond one year. Specific financial and other terms
related to the settlement agreement are confidential.
In its 2016 Annual Report, Jazz reported net sales of Xyrem(R)
of approximately $1,108 million in 2016.
Hikma, through its wholly owned US subsidiary, Roxane
Laboratories, Inc., 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.
Mike Raya, Chief Executive Officer of West-Ward said, "We are
very pleased to have reached an agreement with Jazz with terms that
are favourable for both parties. Sodium oxybate is an exciting
product in our pipeline and supports our strategy of developing a
differentiated product portfolio to drive sustainable growth for
our US business."
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, sodium oxybate will be available only
through an approved sodium oxybate REMS Program. Prescribers and
patients must enrol 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 diarrhoea. 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 +44 (0)20 7399 2760/
Strategy and Investor Relations +44 7776 477050
Lucinda Baker, Deputy Director +44 (0)20 7399 2765/
of Investor Relations +44 7818 060211
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 2016, Hikma achieved
revenue of $1,950 million and profit attributable to shareholders
of $155 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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