Profile: Jazz Pharmaceuticals PLC (JAZZ.O)
24 Apr 2014
Jazz Pharmaceuticals plc, formerly Azur Pharma Public Limited Company, is a specialty biopharmaceutical company focused on the identification, development and commercialization of pharmaceutical products. The Company’s marketed products include Xyrem (sodium oxybate oral solution), which is the product approved by the United States Food and Drug Administration (FDA), for the treatment of both cataplexy and excessive daytime sleepiness in patients with narcolepsy; its psychiatry products, FazaClo (clozapine, USP) LD and FazaClo HD, orally disintegrating clozapine tablets indicated for treatment resistant schizophrenia, and Luvox CR (fluvoxamine maleate) marketed for the treatment of obsessive compulsive disorder; Prialt (ziconotide intrathecal injection), and the non-opioid intrathecal analgesic indicated for refractory severe chronic pain. On January 18, 2012, the Company and Jazz Pharmaceuticals, Inc. completed a merger transaction pursuant to which the Company became the parent company of Jazz Pharmaceuticals, Inc. In June 2012, the Company acquired EUSA Pharma. In October 2012, the Company sold its women's health business to Meda. The products included in the sale are Elestrin (estradiol gel), Gastrocrom (cromolyn sodium, USP), Natelle One (prenatal vitamin), AVC Cream. In February 2014, Jazz Pharmaceuticals PLC acquired the 98% interest in Gentium SpA (Gentium), a Villa Guardia-based, Italy, manufacturer of biotechnology products.
As of December 31, 2011, the Company’s products in clinical development pipeline included Clozapine OS and Clozapine QD. Clozapine OS completed its pivotal bioequivalence study in October 2011 and a new drug application (NDA) was submitted to the FDA in December 2011.
Xyrem is the treatment for both excessive daytime sleepiness and cataplexy in patients with narcolepsy. Sodium oxybate, the active pharmaceutical ingredient in Xyrem, is a formulation of the sodium salt of g-hydroxybutyrate, an endogenous neurotransmitter and metabolite of g-aminobutyric acid. Narcolepsy is a chronic neurologic disorder caused by targeted loss of neurons that use the neurotransmitter hypocretin (also known as orexin), which is hypothesized to stabilize sleep-wake states. As of December 31, 2011, Xyrem was being used to treat over 9,000 patients in the United States.
The Company markets FazaClo LD and FazaClo HD, which are orally disintegrating tablet formulations of clozapine, indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia and for reduction in the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. FazaClo LD was approved by the FDA. The Company markets Luvox CR for the treatment of obsessive compulsive disorder. Luvox CR incorporates the SODAS drug delivery technology. Prialt is an intrathecal infusion of ziconotide. Intrathecal therapy is the delivery of the drug into the intrathecal space in the spine through an infusion system consisted of a programmable infusion pump and catheter. Ziconotide is a synthetic neuroactive peptide known as conotoxin and is the synthetic equivalent of a naturally occurring conopeptide found in the piscivorous marine snail, Conus Magus.
The Company competes with Valeant, Shire Pharmaceuticals, Inc., Endo Pharmaceuticals Holdings, Inc., Forest Laboratories, Inc., Teva, Cephalon, Inc, AstraZeneca, Janssen, Eli Lilly and Pack Pharmaceuticals LLC.
Jazz Pharmaceuticals PLC
Fourth Floor, Connaught House
One Burlington Road, Dublin 4