Jazz Pharmaceuticals Public Limited Company, an international biopharmaceutical company, focuses on identifying, developing, and commercializing products that address unmet medical needs. The company has a portfolio of products and product candidates, with a focus in the areas of sleep and hematology/oncology. The company’s primary marketed products are Xyrem (sodium oxybate) oral solution; Erwinaze (asparaginase Erwinia chrysanthemi); and Defitelio (defibrotide). Xyrem Xyrem is the treatment approved by the U.S. Food and Drug Administration (FDA) for both EDS and cataplexy in patients with narcolepsy. The company promotes Xyrem in the U.S. through a specialty sales force of sales professionals. Its marketing, sales and distribution of Xyrem are subject to a risk evaluation and mitigation strategy, which is required by the FDA to ensure the safe distribution of Xyrem and minimize the risk of misuse, abuse and diversion ofsodium oxybate. The company has an agreement with Express Scripts Specialty Distribution Services, Inc. and its affiliate CuraScript, Inc., which it refers to together as Express Scripts, to distribute Xyrem in the U.S. and provide customer support services related to the sales and marketing of Xyrem. Outside of the U.S., UCB Pharma Limited (UCB), has an exclusive license to market Xyrem for the treatment of narcolepsy in 54 countries and sells the product in 18 countries. The company has licensed to Valeant Canada Limited (Valeant), the Canadian marketing rights to Xyrem for the treatment of narcolepsy. The company supplies Xyrem to UCB and Valeant. The company has 20 U.S. patents covering Xyrem, which expire at various times from December 2019 to March 2033. Erwinaze Erwinaze (called Erwinase in markets outside the U.S., and which the company refers to as Erwinaze unless otherwise indicated or the context otherwise requires) is a biologic product used in conjunction with chemotherapy to treat patients with acute lymphoblastic leukemia (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. The company’s hematology and oncology sales force outside of the U.S. has approximately 33 hematology field specialists responsible for promoting Erwinase and Defitelio in approved markets where it commercializes these products. Erwinaze is licensed to the company for worldwide marketing, sales and distribution by Porton Biopharma Limited (PBL), a company that is wholly owned by the U.K. Secretary of State for Health. PBL also manufactures the product for the company and is its sole supplier for Erwinaze. Defitelio/defibrotide Defibrotide, the active pharmaceutical ingredient in Defitelio, is the sodium salt of a mixture of single-stranded oligodeoxyribonucleotides derived from porcine DNA. Defibrotide is a product approved in Europe for the treatment of severe hepatic veno-occlusive disease (VOD), in adults and children undergoing hematopoietic stem cell transplantation (HSCT), therapy. Prialt and Other Products The company commercializes a portfolio of other products, including Prialt. Prialt is an intrathecally administered infusion of ziconotide, approved by the FDA in 2004 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 comprised of a programmable infusion pump and catheter. The company supplies Prialt to Eisai Co. Limited. It also sells psychiatry and other products in the U.S. Strategy The company’s strategy is to create shareholder value by growing sales of the existing products in its portfolio, including by identifying and investin
jazz pharmaceuticals plc (J7Z:Berlin)
One Burlington Road
Phone: 353 1 634 7800
Fax: 353 1 634 7850www.jazzpharma.com
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