Clinigen :  Clinigen and Galen enter exclusive Global Access agreement for chemotherapydrug DaunoXome®

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Idis Global Access (GA) division has signed an exclusive supply agreement with Galen Ltd ('Galen'), a privately owned pharmaceutical sales and marketing company.

Under the terms of the supply agreement, Idis GA will provide Galen's chemotherapy drug DaunoXome to Healthcare Professionals on an on-demand basis in 20 European countries, Australia, New Zealand and Hong Kong, where it is unlicensed at the point of care. Galen has retained the rights to supply DaunoXome in the UK and selected countries outside Europe.

DaunoXome (daunorubicin citrate - 2 mg/ml-concentrate for solution for Infusion) is a sterile pyrogen-free, preservative-free product in a single use vial for intravenous infusion. It has Medicines and Healthcare products Regulatory Agency (MHRA) approval to treat AIDS-related Kaposi's sarcoma, a rare type of cancer that develops from the cells that line lymph or blood vessels and affects the skin and organs such as the lungs, liver and digestive tract.

Steve Glass, Group Managing Director of Clinigen said:

'Idis GA is the market leader in providing hospital pharmacists with safe, compliant and global on-demand access to medicines like DaunoXome, which are unlicensed at the patient's point of care. This is our first exclusive supply agreement since Clinigen's acquisition of Idis in 2015 and an important part of Idis GA's ongoing strategy to increase the number of product agreements to better meet patients unmet needs.

'Working alongside Galen, we can provide Healthcare Professionals with on-demand access to a medicine that would otherwise be unavailable to them. This agreement enables us to leverage our expertise and international network to ensure that physicians in key European markets receive the right medicine at the right time to better treat their patients.'

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Clinigen Group plc
Tel: +44 (0) 1283 495010
Peter George, Group Chief Executive Officer
Shaun Chilton, Group Deputy Chief Executive Officer
Steve Glass, Group Managing Director

Numis Securities Limited
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Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black / Tom Ballard (Corporate Broking)

Peel Hunt LLP - Joint Broker
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James Steel

Instinctif Partners - Media Relations
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Melanie Toyne-Sewell / Jayne Crook / Jen Lewis
Email: clinigen@instinctif.com

About DaunoXome

DaunoXome is a liposomal preparation of daunorubicin formulated to maximize the selectivity of daunorubicin for solid tumors in situ. While in the circulation, the DaunoXome formulation helps to protect the entrapped daunorubicin from chemical and enzymatic degradation, minimises protein binding, and generally decreases uptake by normal (non-reticuloendothelial system) tissues. The specific mechanism by which DaunoXome is able to deliver daunorubicin to solid tumors in situ is not known. However, it is believed to be a function of increased permeability of the tumor neovasculature to some particles in the size range of DaunoXome. In animal studies, daunorubicin has been shown to accumulate in tumors to a greater extent when administered as DaunoXome than when administered as daunorubicin. Once within the tumor environment, daunorubicin is released over time enabling it to exert its antineoplastic activity

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

For more information, please visit www.clinigengroup.com

About Galen

Galen is a privately owned, specialty pharmaceutical company headquartered in Craigavon (Northern Ireland). The organisation markets products throughout the UK, Ireland, Europe and the US in therapy areas such as gastroenterology, female health and pain management. Galen is also focused on oncology and plans to continue expanding its portfolio with selected specialty products on an international basis. Through organic growth and acquisitions, Galen has product sales in 23 countries.