Profile: Jazz Pharmaceuticals PLC (JAZZ.O)
8 Dec 2016
Jazz Pharmaceuticals Public Limited Company, incorporated on March 15, 2005, is a biopharmaceutical company. The Company is focused on developing and commercializing products that address unmet medical needs. The Company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology. The Company's lead marketed products include Xyrem (sodium oxybate oral solution) for the treatment of both cataplexy and excessive daytime sleepiness in patients with narcolepsy; Erwinaze for the treatment of acute lymphoblastic leukemia (ALL), and Defitelio (defibrotide) for the treatment of severe hepatic veno-occlusive disease (VOD). Its other product candidates include JZP-110 for treatment of excessive daytime sleepiness (EDS) in narcolepsy and EDS in patients with obstructive sleep apnea (OSA) and JZP-386 for the treatment of EDS in narcolepsy.
Xyrem is a treatment for both EDS and cataplexy in patients with narcolepsy. Sodium oxybate, the active pharmaceutical ingredient in Xyrem, is a formulation of the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous neurotransmitter and metabolite of gamma-aminobutyric acid. Xyrem approved in the United States for the treatment of cataplexy in patients with narcolepsy and approved for EDS in patients with narcolepsy.
Erwinaze, a biologic product, is used in conjunction with chemotherapy to treat patients with ALL who have developed hypersensitivity to E. coli-derived asparaginase. Erwinaze is an asparaginase, a type of enzyme that can deprive leukemic cells of an amino acid essential for their growth. It is derived from a rare bacterium (Erwinia chrysanthemi) and is immunologically distinct from E. coli-derived asparaginase and suitable for patients with hypersensitivity to E. coli-derived treatments. Erwinaze approved by the United States Food and Drug Administration (FDA) under a biologics license application (BLA) for administration through intramuscular injection in conjunction with chemotherapy. The FDA has also approved a supplemental BLA for administration of Erwinaze through intravenous infusion in conjunction with chemotherapy.
Defibrotide, the active pharmaceutical ingredient in Defitelio, is the sodium salt of a complex mixture of single-stranded oligodeoxyribonucleotides derived from porcine deoxyribonucleic acid (DNA). In in-vitro studies, defibrotide has shown pharmacological effects that suggest it has a role in both protection of the endothelial cells that form the inner lining of blood vessels and the restoration of the balance between clot formation and breakdown in the blood. Defibrotide has been developed for the treatment and prevention of VOD. The European Commission (EC) granted marketing authorization for Defitelio for the treatment of severe VOD in adults and children undergoing hematopoietic stem cell transplantation (HSCT) therapy.
Prialt and other products
The Company also commercializes a portfolio of other products, including Prialt. Prialt is an intrathecally administered infusion of ziconotide, approved by the FDA for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal morphine. Intrathecal therapy is the delivery of the drug into the intrathecal space in the spine through an infusion system consisting of a programmable infusion pump and catheter. Prialt is the non-opioid intrathecal analgesic.
The Company competes with Teva Pharmaceutical Industries Limited.
Jazz Pharmaceuticals PLC
1 Burlington Road
Connaught House, 4th Floor
Company Web Links
- BRIEF-Jazz Pharmaceuticals posts Q3 adj. earnings $2.57/shr
- BRIEF-Jazz pharmaceuticals plc - initiates rolling nda submission
- BRIEF-Jazz Pharma Q2 adjusted earnings per share $2.63
- BRIEF-Jazz Pharmaceuticals says majority of Celator's outstanding shares has been validly tendered
- BRIEF-Jazz Pharma presents data from study for treatment for excessive sleepiness