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Clinigen Receives Regulatory Approval for Defitelio (Defibrotide) in Australia

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that the Therapeutic Goods Administration (TGA) in Australia has granted regulatory and marketing approval for Defitelio® (defibrotide) for the treatment of severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants one month of age and above1.

Clinigen and Jazz Pharmaceuticals have entered into an exclusive distribution agreement granting Clinigen marketing and distribution rights in Australia. Jazz Pharmaceuticals will continue to manufacture and maintain the trademarks for Defitelio®.

Clinigen has partnered with Jazz Pharmaceuticals to provide access to defibrotide on a named patient, unlicensed basis in Australia since 2011.

Benjamin Miny, Executive Vice President of Commercial Medicines, Clinigen Group, said:

“This is another important marketing authorisation in Australia for Clinigen following similar regional license arrangements. Defitelio® is a clinically significant therapeutic advance for patients with severe VOD and we are pleased to be able to provide licensed access to Defitelio® in Australia.”

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For further information please contact:

Clinigen Group plc
Benjamin Miny, Executive Vice President of Commerical Medicines
Tel: 44 (0) 1283 495010

Instinctif Partners
Melanie Toyne-Sewell / Phillip Marriage / Nathan Billis
Tel: 44 (0) 20 7457 2020
Email: [email protected]

About Veno-occlusive disease (VOD)

VOD is a complication that can occur in 9 – 14% of patients following HSCT therapy, an aggressive, potentially curative procedure to treat patients with malignant and non-cancerous haematologic disorders such as leukemia, lymphoma, aplastic anaemia, congenital immunodeficiency and autoimmune disorders. Hepatic VOD progresses to become life-threatening in approximately 30-50% of cases2,3,4.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and Asia Pacific.

Clinigen now has over 1,100 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 22 of the top 25 pharmaceutical companies; interacting with over 15,000 registered users across over 100 countries, shipping approximately 6.4 million units in the year.

For more information on Clinigen, please visit www.clinigengroup.com

About Jazz Pharmaceuticals plc

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases — often with limited or no options. Jazz has a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. The company’s focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. Jazz actively explores new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Defitelio® Australian Product Information

%u25BCThis medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

References:

1. Defitelio Approved Australian Product Information. 23 July 2020

2. Dignan F, Wynn R, Hadzig N, et al. BCSH/BSBMT Guideline: Diagnosis and management of veno-occlusive disease (sinusoidal obstruction syndrome) following haematopoietic stem cell transplantation. Br J Haematol. 2013;163:444–457.

3. Carreras E. How I manage sinusoidal obstruction syndrome after haematopoietic cell transplantation. Br J Haematol. 2015;168(4):481–491.

4. Mohty M, Malard F, Abecassis M, et al. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation (EMBT). Bone Marrow Transplant. 2016;51(7):906–912.