CLIN.L Regulatory News (CLIN)

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19 March 2018

Clinigen appointed by Jazz Pharmaceuticals to manage Managed Access Program for Vyxeos® (CPX-351) outside the United States

Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been appointed by Jazz Pharmaceuticals plc (NASDAQ: JAZZ, 'Jazz') to distribute Vyxeos® (daunorubicin and cytarabine) liposome for injection via a Managed Access Program ('MAP') outside the United States.

This MAP is for the treatment of adults aged 60-75 with newly-diagnosed, therapy-related, acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos® is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio respectively.

Initially, the program is being launched in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.

In August 2017, the U.S. Food and Drug Administration ('FDA') approved Vyxeos® liposome for injection for the treatment of adults with newly-diagnosed t-AML or AML-MRC. Vyxeos® is not approved for use outside of the U.S.

AML is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made. It is relatively rare with approximately 21,000 people in the United States and 19,000 in the European Union diagnosed each year.1 However, it is the most common type of acute (aggressive) leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient. It has one of the lowest survival rates of all types of leukemia.

John Lagus, Head of Managed Access, Clinigen, said:

"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos® provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."

Healthcare professionals can obtain details about the Vyxeos MAP by calling the medicine access team at +44 1283 494 340, or emailing medicineaccess@clinigengroup.com. Access to more information can be obtained through Cliniport at https://cliniport.co.uk/.

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Contact details

Notes to Editors

About AML

Acute myeloid leukemia (AML) is a blood cancer that begins in the bone marrow, which produces most of the body's new blood cells.2 AML cells crowd out healthy cells and move aggressively into the bloodstream to spread cancer to other parts of the body.3 The median age at diagnosis is 68 years old, with rising age associated with a progressively worsening prognosis.4-5 There is also a reduced tolerance for intensive chemotherapy as patients age.6 Patients with t-AML or AML-MRC have few treatment options and some of the lowest survival rates compared to people with other forms of leukemia.7-8 A hematopoietic stem cell transplant (HSCT) may be a curative treatment option for patients.9

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. Clinigen acquired Quantum Pharma in November 2017.

For more information, please visit www.clinigengroup.com

References

1 American Cancer Society (2017); SEER (National Cancer Institute);Medeiros et al, Big data analysis of treatment patterns and outcomes among elderly AML patients in the United States, Annals of Hematology 2015 94:1127-1138; NCCN Guidelines, Kantar Health 2015, Internal Jazz Primary Research

2 National Cancer Institute. General Information About Adult Acute Myeloid Leukemia https://www.cancer.gov/types/leukemia/patient/adult-aml-treatment-pdq Accessed June 7, 2017.

3 American Cancer Society. What is Acute Myeloid Leukemia? https://www.cancer.org/cancer/acute-myeloid-leukemia/about/what-is-aml.html Accessed March 20, 2017.

4 SEER Stat Facts: AML. 2017.

5 Baer MR, et al., Leukemia, 2011 May; 25(5):10.1038/eu.2011.9.

6 Klepin HD. Hematology Am Soc Hematol Educ Program. 2014 (1):8-13.

7 Pinto AC, et al. Current Cancer Treatment - Novel Beyond Conventional Approaches. 2011; 693-714.

8 Smith SM, et al. Blood. 2003; 102(1):43-52.

9 Peccatori, J and Ciceri, F. Haematologica. 2010 Jun; 95(6): 857-859. doi: 10.3324/haematol.2010.023184.