Hikma Pharmaceuticals Regulatory News (HIK)

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®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

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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 Information2

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® is a registered trademark of Wyeth LLC.

2 Desvenlafaxine ER Tablets package insert. West-Ward Pharmaceuticals Corporation; January 2017