Hikma enters into settlement agreement with Jazz

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® (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® 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® 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® 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 Strategy and Investor Relations	[phone]/ [phone]
Lucinda Baker, Deputy Director of Investor Relations	[phone]/ [phone]
FTI Consulting
Ben Atwell/ Matthew Cole	[phone]

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. 

 

END

 

 

AGRUGUGPCUPMPUA