Faron Pharmaceuticals Ltd
("Faron" or the "Company")
Faron hosts R&D Day today in London
TURKU - FINLAND, 21 February 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, will today host an R&D Day to discuss its R&D strategy and pipeline developments, including a focus on Clevegen, Faron's second wholly-owned pipeline product. The event will take place today from 13:00 to 15:00 GMT at the offices of Panmure Gordon, One New Change, London, EC4M 9AF. No new price sensitive information will be disclosed.
Markku Jalkanen, Chief Executive Officer, will host the event together with members of the Executive Leadership and senior management teams. In addition, the following external experts will provide additional perspectives on both Traumakine and Clevegen:
· Professor Geoff Bellingan, Medical Director, University College London Hospital
· Assistant Professor Maija-Leena Hollmén, Medicity Laboratory, University of Turku
· Dr. Shishir Shetty, Honorary Consultant Hepatologist, University of Birmingham
Traumakine
Traumakine, the Company's wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS) is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan). Top-line data from the INTEREST trial continue to be expected in early Q2 2018, and completion of recruitment into the Japanese trial is anticipated around mid-2018.
Faron will provide an update on regulatory, commercial and manufacturing activities for Traumakine including:
· Allocation of resources in preparation of filing a Marketing Authorisation Application (MAA) and Biologics License Application (BLA) with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively, in H1 2019.
· Preparations for commercial launch in order to meet the expected market demand for Traumakine both pre- and post-launch, including an update on manufacturing capabilities.
Clevegen
Clevegen is Faron's second wholly-owned pipeline product approaching the start of Phase I/II development in 2018. An update will be provided on progress to date and an outline of the next steps and timelines including:
· The update includes results from GMP manufacturing in collaboration with Abzena, the overview from the first set of toxicological studies which indicate no sign of serious adverse events, and an outline of adaptive trial design, the MATINS trial, which accommodates dose escalation and efficacy reading in four different solid tumours (liver, pancreas, ovarian and melanoma).
· Clevegen clinical trial plans with initiation planned during Q3 2018.
· The expert talks include both in vivo and ex vivo information on Clevegen efficacy activity in animal and human tumours.
Agenda and presentations
Time |
Presentation |
Presenter |
12:15 |
Registration and lunch |
13.00 |
Faron corporate review - update on R&D strategy and pipeline developments |
Markku Jalkanen
CEO, Faron Pharmaceuticals |
13.10 |
Traumakine in ARDS: Hope is there |
Prof. Geoff Bellingan
Medical Director, University College London Hospital |
13.30 |
Expansion of Traumakine use to single organ protection |
Dr. Juho Jalkanen
VP Business Development, Faron Pharmaceuticals |
13.45 |
Traumakine pre-launch and launch commercialisation strategy |
Dr. Juhana Heinonen
Chief Commercial Officer, Faron Pharmaceuticals |
14.00 |
Clevegen introduction and strategy |
Markku Jalkanen |
14.05 |
Clevegen - promoting anti-tumour immunity |
Ass. Prof. Maija-Leena Hollmén
Medicity Laboratory, University of Turku |
14.25 |
Solid tumour targeting with Clevegen |
Dr. Shishir Shetty
Honorary Consultant Hepatologist, University of Birmingham |
14.45 |
Clevegen program update |
Dr. Jami Mandelin
Research Director, Faron Pharmaceuticals |
14.55 |
Summary |
Markku Jalkanen |
15:00 |
Q&A and networking |
Webcast and Conference Call Details
The event will be webcast live and can be accessed here: https://edge.media-server.com/m6/p/k75yvfgm
Dial in details:
International: +44 (0)330 336 9415
US: +1 646-828-8143
Confirmation code: 9982787
A replay will be made available on the investor section of Faron's website shortly after the event.
If you would like to register for the event, please contact [email protected].
For more information please contact:
Faron Pharmaceuticals Ltd
Dr Markku Jalkanen, Chief Executive Officer
[email protected]
Consilium Strategic Communications
Mary-Jane Elliott, Matthew Neal, Philippa Gardner, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: [email protected]
Westwicke Partners, IR (US)
Chris Brinzey
Phone: 01 339 970 2843
E-Mail: [email protected]
Panmure Gordon (UK) Limited, Nomad and Broker
Freddy Crossley, Ryan McCarthy (Corporate Finance)
Tom Salvesen, Amy Sarra (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
