Hikma Pharmaceuticals Regulatory News (HIK)

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®. 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® 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.

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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.