Last checked at 1 Mar 2016 07:00
Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Faron files patent application to further strengthen protection for its novel Traumakine®
(FP-1201-lyo) formulation
TURKU - FINLAND, 1 March 2016 - Faron Pharmaceuticals Ltd ("Faron") (LON: FARN), the drug discovery and development company is pleased to announce that it has filed a national application for a new formulation patent in Finland with filings to be expanded over the next two years to almost all countries worldwide under the Patent Co-operation Treaty (PCT). The patent further protects Faron's final FP-1201-lyo (lyophilised interferon-beta or Traumakine®) formulation for the intravenous treatment of acute respiratory distress syndrome ("ARDS") and other vascular diseases.
Interferon-beta, especially if freeze-dried, is known to form aggregates or stick to container surfaces, requiring careful control of dosing and in-use stability during administration. Faron has developed a proprietary new product formulation for which tests have shown almost 100 per cent recovery of solubilised interferon-beta for intravenous use. With this patent formulation filing, Faron is seeking to protect this discovery for the next 20 years. Based on patent database searches, no similar formulation has been reported previously.
Dr Markku Jalkanen, CEO of Faron, said: "As of today, our Traumakine treatment is the only known intravenously administered human interferon-beta preparation and it is important that dosing is optimal for patients lacking peripheral circulation, as is the case with ARDS patients. We have carefully tested various ingredients to optimise interferon-beta use in these patients and have now completed all necessary tests for patent purposes. If our claims are approved, we could have a proprietary product for the next two decades, further increasing Traumakine's significant, commercial potential. We already have new use patents for interferon-beta in ischaemic conditions and multi organ failure, and this new formulation patent will reinforce our global patent protection strategy".
The new formulation, which has not previously been made public, is already in use in Faron's pivotal, pan-European INTEREST trial, the recruitment of which the Company expects to be completed in 10-16 months from now. Besides several granted patents and pending filings, Faron has also sought exclusivity for Traumakine through orphan drug designations (ODD) and has been successful in Europe regarding ARDS. The Company has also sought ODD in the USA where the application is ongoing. Faron's Japanese licensing partner Maruishi Pharmaceutical, Co. is also planning to file an orphan application in Japan.
For more information contact:
Faron Pharmaceuticals Oy
Katja Wallenlind
Phone +358 (50) 577 4807E-mail: katja.wallenlind@faronpharmaceuticals.com
Cairn Financial Advisers LLP, Nominated Adviser
Emma Earl, Tony Rawlinson and Rebecca Anderson
Phone: +44 207 148 7900
Whitman Howard Limited, Nominated Broker
Niall Devins, Francis North
Phone: +44 207 659 1234
Hume Brophy, PR
Mary Clark, Eva Haas, Hollie Vile
Phone: +44 207 862 6390
E-mail: faron@humebrophy.com
About Faron Pharmaceuticals Ltd
Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. Faron is based in Turku, Finland. The Company has identified several molecular mechanisms involved in the control of endothelial functions as a source of innovations. Faron currently has a pipeline of products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company's lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome ("ARDS"), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron's pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating representing a novel immuno-oncology approach.
Further information is available at www.faronpharmaceuticals.com.
About Traumakine®
Faron completed a Phase I/II trial in respect of Traumakine® in 2011 where treatment with Traumakine® was associated with an 81% reduction in the odds of 28 day mortality in patients with ARDS. These data were published in The Lancet Respiratory Medicine, a leading medical journal (Bellingan et al. 2014).
The scientific rationale for Traumakine® treatment is based on the proprietary use of room temperature stable formulation of interferon-beta-1a (FP-1201-lyo) for the restoration of the endothelial barrier function in ARDS patients. In Phase I/II trials interferon-beta was found to be safe and well tolerated in ARDS patients and the optimal tolerated dose was established. The selected pharmacodynamic marker for interferon-beta bioactivity showed clear dose response and the treatment target molecule CD73 levels were induced during the dosing period.
The Traumakine® research consortium (www.traumakine.eu) led by Faron has received €6 million funding from the European Union Seventh Framework Programme (FP7) targeting European marketing application as a final milestone of the programme.