Clinigen’s Foscavir® gains approval for HHV-6 encephalitis in Japan

BURTON-UPON-TRENT, England–(BUSINESS WIRE)–Clinigen Group plc (AIM: CLIN, ‘Clinigen’), the global pharmaceutical
and services company, announces that Foscavir (foscarnet sodium) has
received approval for the treatment of HHV-6 encephalitis from the
Ministry of Health, Labour and Welfare (‘MHLW’) in Japan. Approval of
the new indication by the MHLW follows reimbursement received in
November 2018.

Foscavir is the first medicine in the world to receive approval from a
Regulatory Authority for the treatment of HHV-6 encephalitis. The MHLW
was also the first authority to grant the haematological stem cell
transplantation license for this medicine in 2011. The latest approval
follows significant effort and support from key opinion leaders (‘KOLs’)
of the Japan Society of Hematopoietic Cell Transplantation.

This new indication for Foscavir provides healthcare professionals
(‘HCPs’) in Japan with a licensed alternative to treat their patients.
For Clinigen, it offers a further barrier to entry against competitive
threat for Foscavir and diversifies the revenue streams associated with
this medicine. Clinigen will now look to determine which other
geographies could benefit from the new indication.

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

“Gaining approval is great news for Clinigen and HCPs. For Clinigen it
enhances our market offering in the second largest pharmaceutical market
in the world, however, most importantly, we have been able to respond to
the needs of HCPs and their patients directly. The KOLs in Japan have
given us tremendous support to date and, through leveraging our
expertise, we can now provide help to the HCPs to treat their patients.”

“We will continue to ensure that our products provide significant
benefit to HCPs and patients globally.”

– Ends –

Notes to Editors

About Foscavir® (foscarnet sodium)

Foscarnet is an antiviral agent with broad spectrum activity inhibiting
the human virus of the herpes group, including herpes simplex virus
(HSV) type 1 and 2, human herpes virus (HHV) 6, varicella zoster virus
(VZV), Epstein-Barr virus, cytomegalovirus (CMV) and other retroviruses,
including human immunodeficiency virus (HIV) at concentrations not
affecting normal cell growth.

Foscavir^® is licensed in Japan for the treatment of:

i) Cytomegalovirus retinitis in patients with acquired immunodeficiency
syndrome (AIDS)

ii) Cytomegalovirus viremia and cytomegalovirus disease in hematopoietic
stem cell transplant patients

iii) Human herpesvirus 6 encephalitis after hematopoietic stem cell
transplantation

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

Contacts

Contact details
Clinigen Group plc
Tel: +44 (0)
1283 495010
Shaun Chilton, Group Chief Executive Officer
Benjamin
Miny, Senior Vice President of Commercial Medicines

Instinctif Partners
Tel: +44 (0) 20 7457 2020
Melanie
Toyne-Sewell / Alex Shaw / Deborah Bell
Email: [email protected]