Amphion Innovations plc (AIM: AMP), the developer of medical, life science, and technology businesses, notes today’s announcement from Partner Company, Motif Bio plc (“Motif”) that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
London and New York, Amphion Innovations plc (AIM: AMP), the developer of medical, life science, and technology businesses, notes today’s announcement from Partner Company, Motif Bio plc (“Motif”) that it has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (FDA) regarding the New Drug Application (NDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
The CRL states that the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved. Motif plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.
At 31 December 2018, Motif had cash of $12.3 million and $15 million of debt drawn from its Hercules loan facility. Motif is financed into the second quarter of 2019 but will need to raise capital in the near term.
Richard Morgan, CEO of Amphion Innovations plc, commented:
“This is disappointing news for Motif, but they will be requesting a meeting with the FDA to discuss the CRL and to discuss options to advance iclaprim towards approval. We look forward to further updates from Motif in the future.”
For further information please contact:
| Amphion Innovations | Tel: +1 (212) 210 6224 | ||||
| Charlie Morgan |
| ||||
|
|
| ||||
| Panmure Gordon Limited (Nominated Adviser and Corporate Broker) | Tel: +44 (0)20 7886 2500 | ||||
| Emma Earl/ Freddy Crossley (Corporate Finance) |
| ||||
| Charles Leigh-Pemberton (Corporate Broking) |
| ||||
|
|
| ||||
| SP Angel Corporate Finance LLP (Joint Corporate Broker) | Tel: +44 20 3470 0470 | ||||
| David Hignell (Corporate Finance) |
| ||||
| Vadim Alexandre (Corporate Broking) |
| ||||
|
|
| ||||
| Walbrook PR | Tel: +44 (0)20 7933 8780 or amphion@walbrookpr.com | ||||
| Anna Dunphy / Paul McManus |
| ||||
|
|
| ||||
About Amphion Innovations plc
Amphion Innovations is a developer of medical, life science and technology businesses. We use our extensive experience in company building to invest and build shareholder value in high growth companies in the US and UK. Amphion has significant shareholding in 7 Partner Companies developing proven technologies targeting substantial commercial marketplaces. The Amphion model has been refined to optimise the commercialisation of patents and other intellectual property within the Partner Companies. The Partner Companies collectively own or control over 200 separately identified pieces of intellectual property, a number which grows rapidly each year.
On the web: www.amphionplc.com
