Clinigen Group plc Receives FDA’s First Ever Drug Shortage Assistance Award

Clinigen Group plc Receives FDA’s First Ever Drug Shortage Assistance Award

+44 (0) 1283 495 010Peter George, Group Chief Executive OfficerShaun Chilton, Group Chief Operating OfficerorMelanie Toyne-Sewell/Jen Lewis/Emma Barlow+44 (0) 20 7457 2020

Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM:CLIN) the global specialty pharmaceutical company, today announces that it has received the first Drug Shortage Assistance Award from the US Food and Drug Administration (FDA)in recognition of its contribution in addressing a US shortage of Foscavir® (foscarnet sodium) injection.

Clinigen’s efforts related to the US shortage included making Foscavir® available on a named patient basis whilst acquiring the new drug application and submitting post-approval supplements to restart manufacturing with acceptable compliance records. These actions by Clinigen resolved a critical drug shortage affecting patients.

This award also recognizes companies for their commitment to public health, as well as to quality manufacturing and is the first time the award has been made by the FDA.

Peter George, Chief Executive Officer, Clinigen Group, said: “To be the recipient of this new award from the FDA is a great honor and absolutely reflects Clinigen’s mission to ensure that the right drug reaches the right patient at the right time. Since acquiring Foscavir® from AstraZeneca in 2010, we have worked hard to expand the indications and markets for the drug to increase the number of patients who can benefit. It is a real compliment that the FDA is committed to working with companies, like Clinigen, to prevent and mitigate drug shortages.”

Drug shortages pose a substantial public health threat, delaying, and in some cases even denying, critically needed care for patients. Working with drug manufacturers, the FDA helped prevent over 280 drug shortages in 2012 and 170 in 2013. There were 44 new drug shortages in 2013, down from 117 new drug shortages in 2012. Two key prevention strategies have helped drive this significant decrease in new shortages: 1) early notification and 2) a focus on quality manufacturing.

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering ‘the right drug, to the right patient at the right time’, has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen SP is focused on acquiring its own intellectual property in licensed, niche, hospital-only critical care medicines, increasing the value of these medicines by developing new formulations and indications, then registering and marketing them in defined global markets.

Foscavir® (foscarnet sodium) injection, part of Clinigen’s anti-infectives portfolio, is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS, and for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients.

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