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Traumakine Receives PIM Designation from MHRA
Traumakine Receives PIM Designation from MHRA.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \nRNS Number : 3333S Faron Pharmaceuticals Oy 02 October 2017 \n\nFaron Pharmaceuticals Ltd\n(\"Faron\" or the \"Company\")\n \nFaron's Traumakine Receives Promising Innovative Medicine (PIM) Designation from the MHRA for the Treatment of ARDS\n \nTURKU - FINLAND, 02 October 2017 - Faron Pharmaceuticals Ltd (\"Faron\") (LON: FARN), the clinical stage biopharmaceutical company, announced today that the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicines (PIM) designation for its lead product, Traumakine® which is curently undergoing Phase III clinical trials for the treatment of Acute Respiratory Distress Syndrome (ARDS). \n \nThe award of PIM designation is the first stage of the MHRA's Early Access Medicines Scheme (EAMS) and is granted when a medicine shows early signals, based on evidence to date, that it may be a possible candidate for the scheme. PIM designation under the EAMS also illustrates that a medicine has potential value in a disease area with significant and urgent unmet need and further qualifies an accompanying application and progression of the medicine towards the next stage in the EAMS process, which also allows early pricing negotiation with the UK National Institute for Health and Care Excellence (NICE).\n \nCommenting on the MHRA's advice, Dr Markku Jalkanen, CEO of Faron, said: \"We welcome the news that the MHRA has granted PIM status to Traumakine. This designation opens up the pathway to the EAMS and brings us one step closer to providing patients in the UK with access to Traumakine as we await the completion of the ongoing INTEREST phase III trial. There is currently no approved pharmaceutical treatment for ARDS and Traumakine has the potential to address a significant unmet medical need in terms of mortality and cost savings for healthcare providers.\"\n \nARDS 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 with around 300,000+ annual cases in Europe and US.\n \nThe information contained within this annou...