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NOVEMBER 30TH 2015. F2G Ltd, a UK based antifungal drug discovery and development company, today announced that its novel systemic antifungal product F901318 has been accepted to participate in the European Medicines Agency’s (EMA) Adaptive Pathways pilot programme.


Initiated in March 2014, the Adaptive Pathways (formerly Adaptive Licensing) pilot programme forms part of the EMA’s strategy to provide improved access to new therapies treating serious conditions where there is a high unmet medical need.
The concept of Adaptive Pathways foresees either an initial approval in a well-defined patient subgroup with a high medical need and subsequent widening of the indication to a larger patient population, or an early regulatory approval (e.g. conditional approval) which is prospectively planned, and where uncertainty is reduced through the collection of post-approval data on the medicine’s use in patients. This approach is particularly relevant for medicines with the potential to treat serious conditions with an unmet medical need and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups. It involves balancing the importance of timely patient access with the need for adequate, evolving information on a medicine’s benefits and risks. The Adaptive Pathways approach builds on regulatory processes already in place within the existing European Union legal framework. F2G Ltd is one of only a small number of companies who have been accepted into this programme and will seek initial approval for F901318, a novel IV and oral, systemic antifungal targeted at Invasive Aspergillosis on the basis of a Phase IIb randomised controlled clinical trial.
Mr Ian Nicholson CEO said “We are delighted to have been accepted into the EMA Adaptive Pathways programme which has the potential to accelerate the approval process for F901318. This will ultimately lead to patients receiving our drug sooner than would normally be the case and will provide treatment options in settings where current choices are inadequate. We would like to thank the EMA and the European HTAs who contributed to the review and collaborative feedback on our proposal at a recent EMA/HTA parallel scientific advice meeting.”
Mr Nicholson concluded “this has been a tremendous effort by our internal team and external collaborators in order to submit such a detailed proposal to the EMA and we are grateful for the EMA’s positive review.”

About F2G Ltd

F2G is a world leading UK biotech company focusing on the discovery and development of novel therapies to treat life threatening invasive fungal disease. F2G have discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other filamentous moulds and act via a completely different mechanism than currently marketed antifungal agents. This means that orotomides are active against infections resistant to current therapies, a growing problem globally.
F901318 is the leading member of the orotomide class and is currently completing Phase One Intravenous and Oral clinical trials. Phase Two clinical trials in Invasive Aspergillosis and Scedosporium prolificans infections are planned for the end of 2016.
F2G is backed by leading venture capital companies including Advent Life Sciences, Novartis Venture Fund, Sunstone Capital and Merifin Capital.

SEPTEMBER 9TH 2014 | F2G Limited, the UK-based antifungal drug discovery and development company, today announced a major funding award from the Technology Strategy Board’s Biomedical Catalyst.
The prestigious £1.4 million award will expedite the development of F2G’s novel IV/oral systemic antifungal F901318. The Biomedical Catalyst project will focus on the oral Phase I clinical development of F901318 and supporting studies, and will allow the company to accelerate its clinical development activities.

F901318 is being developed by F2G as an IV and oral therapy to treat invasive aspergillosis and other life-threatening fungal infections and is a new class of antifungal acting against a new cellular target. The discovery and development of F901318 represents a major advance in the treatment of serious fungal disease as currently there are very limited treatment options and resistance is becoming a serious problem. F901318 is highly active against all known azole-resistant aspergilli.

Dr Mike Birch, F2G’s Chief Operating Officer said: “We are delighted to have been chosen to receive funding from Biomedical Catalyst as this is a highly competitive programme. The award represents significant validation of the project and project team and follows on from our successful Framework 7 award last year.”
Ian Nicholson, F2G’s CEO commented: “The Technology Strategy Board plays a major role in developing and promoting world class UK science. F901318 is a significant addition to the antifungal armoury and the Biomedical Catalyst award will accelerate its development and entry into Phase II trials.”

About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com

The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org

PRESS RELEASE

SEPTEMBER 2ND 2014 | F2G Limited, the UK-based antifungal drug discovery and development company, today announces commencement of a Phase 1 single ascending dose study of a novel antifungal agent, F901318.

F2G Limited, the antifungal research and development company today announced a major milestone in the development of its novel IV/ oral systemic antifungal (F901318) with the commencement of a Phase I clinical study. This study initiates the IV Phase I clinical development of F901318 with the oral programme expected to commence in the near future.
F901318 is being developed by F2G to treat invasive aspergillosis and other life-threatening fungal infections and is of a novel class of antifungals acting against a new cellular target. The discovery and development of F901318 represents a major advance in the treatment of serious fungal disease as currently there are very limited treatment options and resistance to existing drugs is becoming a serious problem. F901318 is highly active against all known azole-resistant aspergilli.
Dr Tony Kennedy, F2G’s Chief Scientific Officer said: “We are delighted to commence our clinical development of F901318 based on encouraging preclinical safety and efficacy studies and I look forward to rapidly progressing both our oral and IV programmes.”
Ian Nicholson, F2G’s CEO commented: “F901318 is a significant addition to the antifungal armamentarium as there have not been any new classes of antifungal agents s approved for many years and growing resistance presents a considerable challenge in this seriously ill patient population. We believe that F901318 represents a truly innovative approach in this area and we are dedicated to providing improved treatment options for patients with life threatening aspergillus infections.”
About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com

JUNE 25TH 2013 | Manchester, UK, F2G Limited, a privately-held antifungal drug discovery and development company and The University of Manchester, today announced the commencement of a 6.1 million euro EU -funded project to discover and develop novel antifungal drugs to treat serious, life-threatening fungal infections. The NOFUN project is a collaborative project under the 7th Framework Program of the European Commission which brings together five partners to accelerate the development of a number of F2G’s broad spectrum antifungal agents.

About two million people die each year because of fungal infection and resistance is rapidly emerging to the most common drugs used to treat these diseases. This project aims to develop novel agents with completely new ways of acting in order to combat the increasing tide of drug resistant fungal infections. NOFUN will use F2G’s discovery assets and the University’s fungal genomics platforms in addition to the drug development and characterisation expertise of the other partners.

Participants in the NOFUN Project are F2G Ltd (UK), The University of Manchester (UK), Pharmacelsus GmbH (Germany), OncoTargeting AB (Sweden) and Universitat i Rovira Virgili (Spain).

Dr Mike Birch of F2G and Scientific Coordinator of NOFUN added: “Competition for funding in this call was immense and the NOFUN award represents a significant validation of the project and the partners. F2G is delighted to lead the scientific program to develop much needed new antifungal agents”.

Dr Mike Bromley, NOFUN Project Coordinator from The Manchester Fungal Infection Group at The University of Manchester, said: “We are delighted that this project has been funded and it confirms The University of Manchester as a centre of excellence in fungal biology and disease. Hopefully this cash boost will help us to create new treatments to tackle serious, life-threatening fungal infections.”

About F2G Ltd:

Based in Manchester, UK, F2G Ltd is dedicated to the
discovery and development of new and clinically superior drug classes to treat
life-threatening systemic fungal infections in at-risk patient populations. This is a growing health risk for which there are currently limited treatment options and for which demand is increasing globally. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. For more information visit www.f2g.com

MARCH 18th 2013 | Manchester, UK  F2G Limited, the UK-based antifungal drug discovery and development company, today announced the appointment of Ian Nicholson to the position of CEO and to the Board of Directors. Ian has over 25 years of international experience in management and transactions within the life sciences sector. He is currently, and will remain, an Operating Partner of London-based Advent Life Sciences LLP. Previously he spent eight years as CEO of the privately held Oncology R&D company, Chroma Therapeutics Limited. Before that he was senior vice president for business development at UK biotechnology company Celltech Group, and has worked extensively in licensing, M&A, and market development in the UK, Europe and the US. Ian holds a BSc (Hons) from University College London and an MBA from Boston University.

Dr Richard White, Executive Chairman of F2G, commented ‘We are delighted to
welcome such an experienced executive to lead the company, and I look
forward to working closely with him.’ Dr. White will revert to his former role of
Non-Executive Chairman. Ian Nicholson added ‘I am excited to join F2G at this
critical stage and lead the company in the successful development of an
important first-in-class drug to treat Aspergillosis, an area of high unmet medical need.’

About F2G Ltd:

Based in Manchester, UK, F2G Ltd is dedicated to the
discovery and development of new and clinically superior drug classes to treat
life-threatening systemic fungal infections in at-risk patient populations. This is a growing health risk for which there are currently limited treatment options and for which demand is increasing globally. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. For more information visit www.f2g.com

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F2G Ltd
Lankro Way
Eccles
Manchester
United Kingdom
M30 0LX

Telephone | +44 (0)161 785 1270
Fax | +44 (0)161 785 1273
email |  contact@f2g.com


Registered in England and Wales. Company Registration No. 03578625, VAT Reg No. 712680645.