29 January 2018
FDA grants Fast Track Designation to Faron for Traumakine®
Faron’s wholly-owned product for Acute Respiratory Distress Syndrome on track for Phase III data in H1 2018
TURKU – FINLAND, 29 January 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces it has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine®, the Company's wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS). Traumakine is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan), with top-line data from the INTEREST study on track for the first half of 2018.
Fast Track designation is granted by the FDA to expedite the review and facilitate the development of drugs to treat serious conditions with significant unmet medical need. The purpose of the process is to get new drugs to patients quicker. Today’s announced Fast Track designation is in addition to Traumakine’s Promising Innovative Medicines (PIM) designation from the MHRA, which is the first stage of the MHRA’s Early Access Medicines Scheme (EAMS).
ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%,,, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017.
“We are very pleased that the FDA has granted Fast Track designation for Traumakine. This represents significant additional recognition of the potential that our drug holds to save lives and, in turn, relieve pressure and costs for healthcare systems. With Fast Track designation in the US, and PIM status in the UK, Traumakine is now ideally placed for an expedited route to market, following the top-line data which is on track and due in H1 2018. In accordance with our wider strategy, we continue to accelerate our plans to enable rapid and broad commercial adoption of Traumakine.”
Dr Markku JalkanenCEO of Faron
Traumakine also has an orphan status in Europe, which normally expedites the review also at the European Medicine Agency (EMA). The Company also expects that Faron’s partner in Japan, Maruishi will file an orphan application this year following the INTEREST trial read-out.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
Consilium Strategic Communications
Mary-Jane Elliott, Matthew Neal, Philippa Gardner, Lindsey Neville
Phone: +44 (0)20 3709 5700
Westwicke Partners, IR (US)
Phone: 01 339 970 2843
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley (Corporate Finance)
Tom Salvesen (Corporate Broking)
Phone: +44 207 886 2500
About Faron Pharmaceuticals Ltd
Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company's lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies. There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology ("TIET") may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com
 JAMA. 2016 Feb;315(8):788-800
 Intensive Care Med. 2011;37(12):1932
 N Engl J Med. 2005;353(16):1685