Company Announcements

15 May 2019

Clinigen Group plc

Clinigen to assume control of US commercial rights of

Ethyol® and Totect® by Q4 2019

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a US specialty pharmaceutical company, have mutually agreed to transition the marketing, promotion, and distribution of Ethyol® and Totect® in the US to Clinigen from Cumberland.

The acquisition of the US rights to Proleukin® in April 2019 formed the foundation of the Group's plans to expand its existing footprint in the higher value US market by building out its commercial infrastructure. This agreement with Cumberland is the next step in Clinigen's Commercial Medicines strategy. Following the completion of the transition of Ethyol and Totect later in the year, the Group will have direct control of all three of its oncology products currently available in the US.

As part of the agreement, Cumberland will continue to support the products in the US under the existing license agreements until the end of the transition period, which is expected to last until the fourth quarter of 2019. Clinigen will then assume responsibility for all commercial activities for the products, including distribution and medical support in the US.

The Group will begin to recognise the total benefit of in-market product sales in the first full year post transition of commercial rights (FY21), with a limited financial impact on reported revenues and profits during FY20.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"Proleukin acted as a catalyst to create our own Commercial Medicines infrastructure in the US. Taking back direct control of Ethyol and Totect was the next part of this strategy. To head up the US commercial team, we have recently announced the hiring of Jim Meyer who has significant experience in the North American oncology sector and will help drive our US Commercial Medicines strategy.

"Cumberland's team has done a substantial amount of work during the strategic alliance to reintroduce Ethyol and Totect into the US. This has enabled the provision of an important source of medicines to healthcare professionals and their patients. We have worked well with the Cumberland team and expect the transition to be a relatively smooth one."

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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. In October 2018, the Group acquired CSM, a specialist provider of packaging, labelling, warehousing and distribution services, with sites in the US and Europe, and iQone, a specialist pharmaceutical company in Switzerland.

For more information, please visit www.clinigengroup.com