Scientists Present Positive Progress in the Development of a New Class of Broad-Spectrum Organogold Antibiotics

Poster and Oral Presentation at the 19th RSC / SCI Medicinal Chemistry Symposium, 10th-13th September 2017, Churchill College, Cambridge, UK

Cambridge, UK and Stevenage, UK – 12 September 2017 – Domainex and Auspherix have announced new data from their collaboration to develop novel candidate drugs to tackle the growing threat of resistance to antibiotics.

The exciting data, disclosed yesterday in both a poster and an oral presentation by Dr Jonathan Powell from Domainex at the 19th RSC / SCI Medicinal Chemistry Symposium in Cambridge, UK, describe the discovery of three distinct chemical series, all with broad-spectrum antibacterial activity against both Gram-positive and Gram-negative bacteria. Importantly the Auspherix compounds are active against the so-called ESKAPE pathogens1 which are responsible for the majority of hospital infections.

Founding research behind Auspherix’s antibacterial compounds, identified auranofin (Ridaura) as being active against Gram-positive bacteria. Auranofin is an FDA-approved organogold compound with a long history of clinical use as an anti-rheumatic medicine.

The focus of the collaboration with Domainex has been to develop novel organogold compounds with activity against Gram-negative bacteria and deliver a novel class of broad-spectrum antibiotics. Using their medicinal chemistry expertise, the teams at Domainex and Auspherix have explored the Structure-Activity-Relationships (SAR) of the two ligands coordinated to the central gold atom and have now demonstrated that the physiochemical properties of the phosphine ligand in particular are a key determinant of Gram-negative activity. Robust synthetic routes are now in place to enable the team to further explore the chemical space around this organogold chemical template.

Tom Mander, Chief Operating Officer of Domainex, said: “As far as we know, we are the only teams working on the challenging task of developing broad-spectrum antibiotics based on organogold chemistry. In our collaboration with Auspherix, we have made tremendous progress towards identifying novel pre-clinical drug candidates that address the growing global burden of multi-drug resistant bacterial infections.”

Dr Neil Miller, Auspherix CEO said “This has been a highly productive scientific collaboration with Domainex and I look forward to seeing the data generated with our lead compounds in rodent infection models as we move towards our goal of identifying a pre-clinical development candidate from one of our three lead series. We anticipate progressing into human clinical studies in 2019, with an initial focus on the treatment of complicated urinary tract infections (cUTI).”

“Given that our organogold compounds retain activity against multi-drug resistant (MDR) clinical isolates and they show a low propensity for the emergence of resistance, they have great potential to address the greatest unmet medical need and treat patients suffering from life-threatening drug-resistant infections.” he added.

There is a well-defined clinical and regulatory path to approval for new antibiotic treatments for cUTIs with the opportunity to receive Qualified Infectious Disease Product (QIDP) designation, which offers fast-track status and priority review with the FDA, plus potentially five years’ additional market exclusivity, thus making our focus on cUTIs an attractive investment proposition.”

 

[1] ESKAPE pathogens encompasses the six pathogens with growing multidrug resistant virulence: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter, Pseudomonas aeruginosa and Enterobacter spp

-Ends-

Notes to Editors

For a copy of the poster, please contact Domainex using the details below.

About Auspherix

Auspherix Ltd. is an anti-infectives company engaged in the discovery and development of a new class of organogold-based antibiotics for serious and difficult to treat, or potentially life threatening infections.

Its new class of antibiotics demonstrate potent and broad-spectrum activity against both Gram-positive and Gram-negative bacteria including many Gram-negative multi-drug resistant (MDR) strains where there is a global rising unmet medical need and large market potential.

The Company is utilising its proprietary organogold chemistry platform to build a pipeline of novel antibacterials with an initial focus on treating complicated urinary tract infections (cUTI). Auspherix pipeline comprises three structurally distinct, small molecule lead series currently in pre-clinical development.

As a private company, Auspherix is backed by experienced investors including the Australian Medical Research Commercialisation Fund (MRCF) and UK-based Touchstone Innovations plc (AIM IVO). The Company is located at the Stevenage Bioscience Catalyst facility, UK a world-leading hub for open innovation and centre for fast growing biotech, pharma and medtech businesses.

For further information please visit www.auspherix.com. Follow us on twitter @auspherix and on LinkedIn.

About Domainex

Domainex Ltd. is a Cambridge-based, privately-owned small-molecule therapeutics company that provides integrated drug research services to global pharmaceutical, biotechnology and academic partners. Its services cover a wide span of the drug research value chain, from disease target selection to pre-clinical candidate nomination.

Domainex’s services include recombinant protein expression and use of its proprietary technology platform, Combinatorial Domain Hunting to identify soluble protein fragments for structural biology and assay development. Hit finding activities encompass assay development and screening by means of its BioassayBuilder, FragmentBuilder and LeadBuilder platforms. The core of the Domainex service offering is multi-parameter medicinal chemistry optimisation of hits and leads – using its ‘every compound counts’ philosophy, which can save up to 30% on the average industry time from target to candidate.  For more information, please visit www.domainex.co.uk.

 

For more information please contact:

 

Domainex Auspherix
Dr Tom Mander

T: +44 (0) 7584 578 024

E: tom.mander@domainex.com

Dr Neil Miller

T: +44 (0)1438 906755

E: neil.miller@auspherix.com

Media Relations – Sciad Communications

Deborah Cockerill

T: +44 (0)7930 317 729

E: deborah@sciad.com

Media Relations – Instinctif Partners

Sue Charles / Gemma Harris

T: +44 (0)20 7457 2020

E: auspherix@instinctif.com

 

Auspherix to Present Organogold Pipeline at Superbugs & Superdrugs

Stevenage, UK – 20 March 2017 – Auspherix Limited, the anti-infectives company meeting the urgent need for new antibiotics by developing a novel class of antibacterials, is pleased to announce that it has been invited to present at this year’s Superbugs & Superdrugs conference in London, 20-21 March 2017.

Chief Scientific Officer Richard Rutter will present on Auspherix’s discovery of a novel class of organogold antibiotics and will focus on antimicrobial profiling, in vitro characterisation and mechanistic insights at 16.10 on Tuesday 21 March.

Last month the WHO published its first ever list of antibiotic-resistant “priority pathogens” – a focused list of 12 families of bacteria that pose the greatest threat to human health.

“Being active against Gram negative and Gram positive bacteria, Auspherix’s organogold compounds have shown activity against a number of the 12 pathogens on the WHO list, including all three critical threats,” noted Dr Neil Miller CEO of Auspherix.

SMi’s 19th annual Superbugs & Superdrugs Conference will host an international audience of scientific leaders, funding bodies and drug discovery scientists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.

– ENDS –

Notes To Editors

About Auspherix Ltd

Auspherix is an anti-infectives company engaged in the discovery and development of a new class of organogold-based antibiotics for serious and difficult to treat, or potentially life threatening infections.

Its new class of antibiotics demonstrate potent and broad-spectrum activity against both Gram-positive and Gram-negative bacteria including many Gram-negative multi-drug resistant (MDR) strains where there is a global rising unmet medical need and large market potential.

The Company is utilising its proprietary organogold chemistry platform to build a pipeline of novel antibacterials with an initial focus on treating complicated urinary tract infections (cUTI). Auspherix pipeline comprises three structurally distinct, small molecule lead series currently in pre-clinical development.

As a private company, Auspherix is backed by experienced investors including the Australian Medical Research Commercialisation Fund (MRCF) and UK-based Touchstone Innovations plc (AIM IVO). The Company is located at the Stevenage Bioscience Catalyst facility, UK a world-leading hub for open innovation and centre for fast growing biotech, pharma and medtech businesses.

For further information please visit www.auspherix.com. Follow us on twitter @auspherix and on LinkedIn.

For more information please contact:
Media Relations
– Instinctif Partners
Sue Charles / Gemma Harris
T: +44 (0)20 7457 2020
E: auspherix@instinctif.com

Auspherix
Dr Neil Miller
T: +44 (0)1438 906755
E: neil.miller@auspherix.com

Auspherix Provides Update on its New Class of Organogold Antibiotics

Stevenage, UK – 5 January 2016 – Auspherix Limited, the anti-infectives company meeting the urgent need for new antibiotics by developing a novel class of antibacterials, today provided an update on its organogold chemistry platform and its pipeline of compounds.

Auspherix’s new class of antibiotics are differentiated from current antibiotics by their chemical structure and distinct antibacterial profile.

Furthermore, preliminary data indicates that Auspherix’s organogold molecules show low propensity for the emergence of resistance. Auspherix CEO Dr Neil Miller said, “Our pipeline comprises three structurally distinct series of organogold small molecules, with potent and broad spectrum activity against Gram-positive and Gram-negative bacteria, including life threatening multi-drug resistant (MDR) pathogens.

“We are currently in the lead optimization phase and are on track to progress a development candidate from one of our three lead series into human clinical studies by early 2019, with an initial focus on treating complicated urinary tract infections (cUTI).”

Auspherix co-founders, Professor Ian Charles and Dr Dagmar Alber, were in the vanguard of renewed interest in developing new classes of antibiotics in response to the worldwide healthcare crisis of rising antimicrobial resistance (AMR). Some six years ago the team embarked on a discovery programme that used phenotypic assays to identify antibacterial compounds with drug-like properties that had activity against bacterial communities in various life forms. This research identified auranofin (Ridaura), a FDA approved anti-rheumatic agent, with a long history of clinical use, as being active against Gram-positive bacteria in planktonic, biofilm and persister forms.

Mechanistic investigations are ongoing but both in-house data and recent publications from several academic groups suggest that auranofin’s antibacterial activity is a likely due to a complex MOA involving modulation of multiple cellular pathways.

Auranofin’s structure comprises a central gold(I) atom bound to two ligands, a sugar thiol and a trialkylphosphine. Auspherix has applied its chemistry expertise to modify both of these gold ligands to create novel chemical compounds which, in comparison to auranofin itself, inhibit both Gram-positive and Gram-negative bacteria, including life-threatening MDR pathogens. These include the ESKAPE pathogens (that encompasses the six pathogens with growing multidrug resistance: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species). Its organogold antibacterials have also been shown to have a rapid bactericidal (killing rather than growth inhibition) activity against Gram-negative bacteria.

The choice of cUTI as a lead clinical indication reflects a number of factors including high unmet medical need, the profile of Auspherix’s compounds and the significant commercial opportunity: over one million patients suffer from cUTIs in the USA every year, with a high prevalence of pathogenic Gram-negative bacteria in patients with cUTIs. There is also an increasing proportion of cUTI patients who have a MDR infection that is not sensitive to standard-of-care antibiotics thus requiring treatment with last-in-line antibiotics such as colistin.

“There is a well-defined clinical and regulatory path to approval for new antibiotic treatments for cUTIs with the opportunity to receive Qualified Infectious Disease Product designation which offers fast-track status and priority review with the FDA, plus potentially five years’ additional market exclusivity, thus making our focus on cUTIs an attractive investment proposition,” said Dr Miller, adding “Given the extensive clinical history with auranofin and other members of the organogold class of drugs, we are confident we can deliver a novel antibiotic medicine to patients.”

In addition to its cUTI programme, Auspherix plans to explore additional indications such as complicated intra-abdominal infections and nosocomial pneumonia.

Auspherix has a robust and growing portfolio of patent applications that protects new composition of matter discoveries and covers a range of therapeutic uses including prevention of and treatment for bacterial infections with our proprietary organogold compounds.

The Company’s new website with information on its team, R&D, investors and business model can be viewed at www.auspherix.com. 

Biotech Showcase 2017

Auspherix will be holding a company presentation at Biotech Showcase at 9am on Monday 9 January 2017 in Room 1, Hilton San Francisco Union Square.

-Ends-

Notes to Editors

About Auspherix Ltd

Auspherix is an anti-infectives company engaged in the discovery and development of a new class of organogold-based antibiotics for serious and difficult to treat, or potentially life threatening infections.

Its new class of antibiotics demonstrate potent and broad-spectrum activity against both Gram-positive and Gram-negative bacteria including many Gram-negative multi-drug resistant (MDR) strains where there is a global rising unmet medical need and large market potential.

The Company is utilising its proprietary organogold chemistry platform to build a pipeline of novel antibacterials with an initial focus on treating complicated urinary tract infections (cUTI). Auspherix pipeline comprises three structurally distinct, small molecule lead series currently in pre-clinical development.

As a private company, Auspherix is backed by experienced investors including the Australian Medical Research Commercialisation Fund (MRCF) and UK-based Touchstone Innovations plc (AIM IVO). The Company is located at the Stevenage Bioscience Catalyst facility, UK a world-leading hub for open innovation and centre for fast growing biotech, pharma and medtech businesses.

For further information please visit www.auspherix.com. Follow us on Twitter @auspherix and on LinkedIn.

For more information please contact:

Media Relations – Instinctif Partners

Sue Charles / Gemma Harris
T: +44 (0)20 7457 2020
E: auspherix@instinctif.com

Auspherix

Dr Neil Miller
T: +44 (0)1438 906755
E: neil.miller@auspherix.com

Management Team Strengthened as Auspherix Drives New Class of Antibacterials Towards the Clinic

17 November 2016

Stevenage, UK – 17 November 2016 – Auspherix, the anti-infectives company meeting the urgent need for new antibiotics by developing a novel class of organogold antibacterials, today announced further strengthening of its Management team, with Dr Neil Miller transitioning to Chief Executive Officer (CEO) from Chief Scientific Officer (CSO), and the Company announcing two new appointments of Dr Richard Rutter as CSO and Dr Paul King as Head of Chemistry.

Dr Miller has served as CSO of Auspherix over the past 12 months, where he has been responsible for the Company’s antibiotic R&D programmes, having previously gained two decades of experience working at GlaxoSmithKline. In his role as CEO he will take on overall responsibility not only for driving Auspherix’s novel compounds through pre-clinical development and into the clinic, but also for extending the Company’s contacts with future potential investors and partners.

Auspherix Chairman Dr Roberto Solari said: “Neil has provided excellent hands-on scientific leadership as CSO. His proven expertise in drug discovery has been instrumental in focusing our R&D and driving our programmes forward. As CEO I am confident that he will continue to ensure scientific progress as well as to secure the finance and partnerships needed to give our innovative organogold antibiotics the best chance of success.”

In line with its R&D strategy, Auspherix has further strengthened its senior scientific team.

An expert pharmacologist and biologist with over 15 years of industry experience, Dr Rutter joins the Company as CSO with responsibility for leading and progressing its drug discovery programmes. Prior to his role at Auspherix, Richard was the Head of Biology at GlaxoSmithKline’s Neuroscience R&D Centre in Singapore. Previously, Richard was a Senior Research Biologist at Merck Sharpe and Dohme in the UK. Richard has a PhD in Molecular Neuroscience from the University of London, UK.

A medicinal chemist, Dr King joins Auspherix as Head of Chemistry bringing to the company over 15 years of experience in small-molecule drug discovery, working across multiple therapeutic areas. Prior to his appointment at Auspherix, Paul also held a number of positions at GlaxoSmithKline, including Team and Programme Leader in the Neural Pathways Discovery Performance Unit, Singapore. Paul has a PhD in Chemistry from Imperial College, UK and conducted post-doctoral research at the Scripps’ Research Institute, USA.

Welcoming Richard and Paul, Dr Neil Miller, CEO of Auspherix, said: “We believe our new class of organogold antibiotics has the potential to make a major contribution to the treatment of bacterial infections and are committed to diligently progressing our antibacterial pipeline, in order to help address the worldwide healthcare crisis of rising antibiotic resistance and the need to expand the repertoire treatment options. Auspherix will greatly benefit from the expertise that Richard and Paul bring to the Company.”

-Ends-

Notes to Editors

About Auspherix Ltd

Auspherix Ltd has discovered a novel class of antibacterials based on its proprietary organogold chemistry platform. Its compound series show activity against a broad range of important Gram-negative and Gram-positive bacteria, including multidrug resistant (MDR) clinical isolates, with profiles consistent with their use as antibiotics in a number of indications with high unmet need and large market potential.

Based in Stevenage UK (in the Stevenage Bioscience Catalyst facility), the Company was founded in late 2013 based on discoveries made at the ithree institute at the University of Technology Sydney (UTS). The Company has raised AUS $2million in Seed investments (2013-2014) from Australia’s Medical Research Commercialisation Fund (MRCF) and £6 million in Series A round (2015) from the MRCF and the UK’s Imperial innovations plc (AIM IVO).

For further information please visit www.auspherix.com

For more information please contact:

Media Relations – Instinctif Partners

Sue Charles / Gemma Howe / Rosanna Forrest

T: +44 (0)20 7457 2020

E: auspherix@instinctif.com  

Auspherix

Dr Neil Miller

T: +44 (0)1438 906755

E: neil.miller@auspherix.com  

Auspherix Shortlisted for Biotech and Money’s ‘Start-Up UK Company of the Year’ Award

Auspherix, an early stage anti-infectives company, today announces that it has been shortlisted for the ‘Start-Up UK Company of the Year’ category of the inaugural Biotech and Money 2016 Awards.

Auspherix was nominated for the award and selected as a shortlisted finalist for its focus on developing new antibiotics in the fight against antimicrobial resistance and its commitment to UK bioscience. It also recognised the fact that the company has raised significant investment, given its pre-clinical stage of development: Auspherix announced a £6 million financing in 2015 by its seed investor Brandon Capital and new investor Imperial Innovations plc. Auspherix was co-founded by Dr Dagmar Alber and serial entrepreneur Professor Ian Charles and has attracted an impressive board, management team and scientific advisory board.

The winner of the award will be selected during final voting during the Biotech & Money Assembly and Gala Awards Dinner being held in London on 6 September 2016. Other finalists in the Start-Up UK Company of the Year Award category are Autolus, Blue Earth Diagnostics, Freeline Therapeutics, Mereo Biopharma, NightStarX, Orchard Therapeutics, Oxford Antibodies, Precision Ocular and Puridify.  Information on the awards can be found here.

Dr Neil Miller, CSO of Auspherix, said: “It is great that our pioneering work in the fight against antimicrobial resistance is being recognised. It is a credit to our founders that they identified innovative ways to identify new classes or antibiotics and to our investors who have recognised and backed the promise in our discoveries.”

-Ends-

Notes to Editors

About Auspherix Ltd

Auspherix Ltd has discovered a novel class of antibacterials with a profile suggestive of a novel mechanism of action and therefore offer the potential to address the rising global problem of resistance to current antibiotics. Its proprietary compound series show activity against a broad range of multidrug resistant (MDR) Gram-negative and Gram-positive bacteria, with profiles consistent with their use as antibacterial drugs for a number of indications with high unmet need and large market potential.

Based in Stevenage UK (in the Stevenage Bioscience Catalyst facility), the Company was founded in late 2013 based on discoveries made at the ithree institute at the University of Technology Sydney (UTS). The Company has raised AUS $2million in Seed investments (2013-2014) from Australia’s Medical Research Commercialisation Fund (MRCF) and £6 million in Series A round (2015) from the MRCF and the UK’s Imperial innovations plc (AIM IVO).

For further information please visit www.auspherix.com

For more information please contact:

Media Relations – Instinctif Partners

Sue Charles / Gemma Howe / Rosanna Forrest

T: +44 (0)20 7457 2020

E: auspherix@instinctif.com

Auspherix

Dr Neil Miller

T: +44 (0)1438 906755

E: neil.miller@auspherix.com

Auspherix Appoints Experienced Anti-Infectives Clinician to Scientific Advisory Board

4 July 2016

Auspherix, an early stage anti-infectives company, today announces that it has expanded its Scientific Advisory Board (SAB) with the appointment of highly experienced clinician, Professor William Hope.

William’s career to date has focused on research in antimicrobial pharmacokinetics and pharmacodynamics, mathematic modelling of antimicrobial agents and individualisation of antimicrobial therapy.  He is an NIHR Clinical Scientist and Professor of Therapeutics and Infectious Diseases at The University of Liverpool, UK and was recently appointed as Chair in the Department of Molecular and Clinical Pharmacology at The University of Liverpool. A Fellow of the Royal Australasian College of Physicians and the Royal College Pathologists of Australasia. He was previously Chair in Therapeutics and Infectious Diseases at The University of Manchester. He has a PhD in antimicrobial pharmacology from The University of Manchester.  Alongside his advisory role to Auspherix, William is also Scientific Advisor to the ESCMID Fungal Infection Study Group, Secretary to the EUCAST Antifungal Susceptibility Testing Sub-Committee and was recently appointed to the ICAAC Program Committee for Antimicrobial Pharmacokinetics, Pharmacodynamics and General Pharmacology.

Founded in 2013, Auspherix is developing a new class of anti-bacterials with a unique profile suggestive of a novel mechanism of action.

Dr Neil Miller, CSO of Auspherix, said: “With his hands on clinical experience, and a depth of knowledge gained during his careers in the anti-infectives space, William’s input and guidance will make an invaluable addition to the insight and steer we get from our SAB as we progress our novel anti-bacterial drug candidates through pre-clinical development towards our first-in-human clinical trial.”

The Auspherix’s SAB is chaired by Professor Ian Charles, co-founder and previously CSO of the Company, and now Director of the Institute of Food Research/Quadram Institute. He has a strong focus on translational research and infectious diseases, and was previously co-founder and CSO of Arrow Therapeutics. As well as new member Professor William Hope, other SAB members are: Auspherix CSO Neil Miller; Auspherix Board member Dr Jared Silverman, VP of Research at VL32 and who contributed to the discovery of three novel antibiotics during his career within Cubist Pharmaceuticals; Dr Alan Naylor, an independent consultant and medicinal chemist with over 30 years of R&D experience within GlaxoSmithKline; and Professor David Livermore, Professor of Medical Microbiology at the University of East Anglia  and serves on the UK Government’s Antimicrobial Resistance & Healthcare Associated Infection Advisory Committee.

 

-Ends-

Notes to Editors

About Auspherix Ltd

Auspherix Ltd has discovered a novel class of antibacterials with a unique profile suggestive of a novel mechanism of action and therefore offer the potential to address the rising global problem of resistance to current antibiotics. Its compound series show activity against a broad range of multidrug resistant (MDR) important Gram-negative and Gram-positive bacterial infections, with profiles consistent with their use as antibacterial drugs for a number of indications with high unmet need and large market potential.

Based in Stevenage UK (in the Stevenage Bioscience Catalyst facility), the Company was founded in late 2013 based on discoveries made at the ithree institute at the University of Technology Sydney (UTS). The Company has raised AUS $2million in Seed investments (2013-2014) from Australia’s Medical Research Commercialisation Fund (MRCF) and £6 million in Series A round (2015) from the MRCF and the UK’s Imperial innovations plc (AIM IVO).

 

For more information please contact:

Media Relations – Instinctif Partners

Sue Charles / Gemma Howe / Rosanna Forrest

T: +44 (0)20 7457 2020

E: auspherix@instinctif.com

Auspherix

Dr Neil Miller

T: +44 (0)1438 906755

E: neil.miller@auspherix.com

 

Auspherix Welcomes O’Neill Report on Drug Resistant Infections

19 May 2016

Auspherix, an early stage anti-infectives company, today welcomes the O’Neill report on antimicrobial resistance “Tackling Drug-Resistant Infections Globally” which calls for large pharmaceutical companies to participate in the development of new treatments. Research has almost halted in the past 25 years because antibiotics are expensive to develop and provide relatively small returns.

Dr Neil Miller, CSO of Auspherix said, “We chose to establish operations in the UK in order to access the pool of highly qualified scientific talent and to leverage the supportive environment for entrepreneurs and the biotech sector that the UK government has encouraged. Our lead programmes are making excellent progress and we believe the antimicrobial profile of our proprietary compound series offers enormous potential for the development of a new arsenal of drugs that will be required to treat the growing numbers of resistant bacterial infections.”

Read the full report here.

Management Update

Co-founder of Auspherix Ltd. and VP Biology, Dr Dagmar Alber, has left the business to pursue new opportunities. Dagmar’s expertise and passion has been pivotal to Auspherix’s success. We thank Dagmar for her contribution and wish her every success for the future.

Auspherix, as part of the BEAM Alliance, Signs Industry Declaration on Beating Antibiotic Resistance

Auspherix, an early stage anti-infectives company, today announces that it has signed the BEAM Alliance’s call to governements and industry to work in parallel to take comprehensive action against drug-resistant infections, launched today at the World Economic Forum in Davos, Switzerland.  Full release below.

GLOBAL PHARMACEUTICAL INDUSTRY CALLS ON GOVERNMENTS TO WORK WITH THEM TO BEAT THE RISING THREAT OF DRUG RESISTANCE

More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections – socalled ‘superbugs’ – with a joint declaration launched today at the World Economic Forum in Davos, Switzerland. The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance.

The Declaration on Combating Antimicrobial Resistance – drafted and signed by 85 companies and nine industry associations across 18 countries1 – represents a major milestone in the global response to these challenges, with commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The industry is calling on governments around the world to now go beyond existing statements of intent and take concrete action, in collaboration with companies, to support investment in the development of antibiotics, diagnostics, vaccines, and other products vital for the prevention and treatment of drug-resistant infections.

In particular, the Declaration supports a continuation of efforts towards improved conservation of antibiotics, including a call for improved uptake of rapid point-of-care diagnostics to improve how antibiotics are prescribed, and changes to incentive structures within health systems that directly reward doctors, pharmacists and veterinarians for prescribing antibiotics in greater volumes.

In what the Review on Antimicrobial Resistance recognises to be a notable step for the industry, the signatory companies call on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. These mechanisms are needed to provide appropriate incentives (coupled with safeguards to support antibiotic conservation) for companies to invest in R&D to overcome the formidable technical and scientific challenges of antibiotic discovery and development. These include mechanisms to ensure that, where appropriate, the pricing of antibiotics more adequately reflects the benefits they bring; and novel payment models that reduce the link between the profitability of an antibiotic and the volume sold. An integral part of these models is a reduced need for promotional activity by companies.

As well as calling for continued progress by governments on these fronts, the Declaration sets out a commitment to further action on drug resistance by its signatories, which the Review warmly welcomes. These span across three broad areas:

  • Reducing the development of drug resistance. The companies commit to encouraging better and more appropriate use of new and existing antibiotics, including through work that supports the antibiotic stewardship principles set out by the World Health Organization (WHO) Global Action Plan on antimicrobial resistance (AMR), and via improved education of clinicians. This support extends to promoting more judicious use of antibiotics in livestock, as part of a ‘one health’ approach.
  • Increasing investment in R&D that meets global public health needs. Recognising the need to increase research into new antibiotics, diagnostics, vaccines and other alternative treatments, the companies commit to a continuation and extension of collaborative initiatives between industry, academia and public bodies to improve how R&D in the field is done and provide greater opportunities for the scientific barriers to antibiotic discovery to be overcome.
  • Improve access to high-quality antibiotics for all. In light of the gaps that remain in global access to our existing antibiotics and vaccines, and the importance of ensuring that new generations of products are available to all those who need them, the signatories commit to supporting initiatives aimed at ensuring affordable access to antibiotics in all parts of the world, at all levels of income.

By bringing together such a wide range of companies in this unprecedented way, the Declaration provides a valuable roadmap to guide further collaborative efforts between industry, governments and NGOs in the global fightback against AMR. The Review will continue to work to drive progress towards a series of key international milestones in 2016 – including likely discussions on AMR at the UN General Assembly and as part of China’s G20 programme in the autumn – and in support of progress against the WHO Global Action Plan on AMR. The Declaration will be updated every two years, to take account of the evolving global landscape of AMR and changing challenges and priorities. It remains open to accept new signatory companies and bodies at any time, with a complete list maintained on the Review on AMR’s website, www.amrreview.org/industry-declaration

1 This reflects the final confirmed number of signatories at the time of publication, and updates the figure used in earlier versions of this press notice.

Notes to Editors

About antimicrobial resistance

1. Antimicrobial resistance (AMR) is the natural process by which bacteria and other microbes develop resistance to the drugs commonly used to treat them. Antimicrobials include antibiotics (which act only on bacteria), antivirals, antiparasitics and antifungals. The independent Review on AMR, chaired by the economist Lord Jim O’Neill, estimated in 2014 that without effective global action, the rise of AMR could claim 10 million lives globally each year by 2050, and result in a cumulative loss from global output of 100 trillion USD.

2. The growth of resistance to antibiotics represents a particular threat to modern healthcare. We rely on effective antibiotics to treat common infections and to ensure that other medical procedures (such a surgery or cancer chemotherapy) remain safe and routine, but a combination of scientific, regulatory and commercial challenges has meant that the discovery of new antibiotics in recent decades has failed to keep pace with the rise of antibiotic-resistant infections. Meanwhile, we face the dual problems of pervasive over-use and misuse of antibiotics and other antimicrobials in animals and humans in most parts of the world – something that exacerbates the development of drug resistance – and a lack of affordable access to antimicrobials in others.

About the Declaration

3. The Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance marks a major step forward in the global battle against the growing problem of AMR. It reflects and welcomes the progress towards a comprehensive global response to AMR made by governments over the past 18 months in major multilateral forums including the World Health Organization (WHO) and the G7, and the contribution to these efforts provided by the work of the Review on AMR and other key international organisations.

4. The Declaration has been signed by 85 companies (74 pharmaceutical and biotechnology companies, and 11 diagnostics companies) and nine industry associations from 18 different countries. This final count reflects the number of signatory organisations at the point of launch, and updates the figure included in earlier versions of this press notice. The Declaration remains a living document, with signatories free to add or remove their endorsement at any time.

5. The Declaration text was collectively drafted and agreed by its signatory companies. The Review on Antimicrobial Resistance is not a signatory to the Declaration but it has assisted its development and supports its aims. The Review has agreed to host the Declaration on its website (www.amr-review.org/industry-declaration – page live from Thursday, January 21) on behalf of the signatory companies.

About the Review on Antimicrobial Resistance

6. The Review on Antimicrobial Resistance was commissioned by the UK Prime Minister, David Cameron, in July of 2014 to address the growing global problem of drug-resistant infections. The Review has been exploring in detail the challenges associated with drug resistance over the past 18 months, working extensively with companies, NGOs and governments around the world to identify the interventions required to overcome these challenges and to reinvigorate antibiotic discovery and development. The Review will deliver its final report and recommendations by the 9 summer of 2016, and has so far published a series of interim reports looking at individual aspects of AMR.

7. The Review is Chaired by Lord Jim O’Neill and backed by the Wellcome Trust and the UK Government, although operates and speaks independently of both. Lord Jim O’Neill is also the current Commercial Secretary to HM Treasury, but chairs the Review in an independent capacity. He is an internationally published economist and until 2013 was Chairman of Goldman Sachs Asset Management, having previously been the organisation’s Head of Economic Research. The Wellcome Trust is providing part-funding for the work of the Review, and hosting the team at its London headquarters.

Auspherix Appoints Dr. Neil Miller as Chief Scientific Officer

Stevenage, UK, 2 December 2015 – Auspherix Limited (UK), an early stage anti-infectives company, has announced the appointment of Dr. Neil Miller as its Chief Scientific Officer, effective 1 December.

As CSO, Dr Miller will take full responsibility for driving forward the Company’s antibiotic R&D programmes, both in house and through partners, into clinical Proof-of-Concept studies. The Company’s discovery platform has led to the invention of novel compound series with activity against both gram-positive and gram-negative bacteria.

Prior to joining Auspherix, Dr Miller has spent two decades in the pharmaceutical industry at GlaxoSmithKline (GSK), most recently as Senior Director and Head of Chemistry, DMPK & External Discovery in Singapore. In this role he led a research collaboration with the National University of Singapore, to evaluate monoclonal antibodies for the potential treatment of Dengue Fever.  Dr Miller has held a variety of managerial and scientific roles at GSK, including that of Site Head at GSK’s R&D Centre in Singapore.  He has a degree in Chemistry with Pharmacology and a PhD in Organic Synthesis from the University of Liverpool, UK.

Dr Miller replaces Professor Ian Charles, co-founder and previously consultant Chief Scientific Officer, who will continue to actively contribute to the Company’s scientific direction as both a member of the Board and as Chair of the Scientific Advisory Board.

Commenting on Neil’s appointment, Auspherix Chairman Dr Roberto Solari said: “At this stage, Auspherix needs a CSO with hands on scientific leadership and proven expertise in driving drug discovery. With a strong track record of progressing compounds into clinical development coupled with his extensive drug discovery experience and global perspective, Neil has the ideal mix of skills, and we are delighted that he has joined the Company.”

Dr Neil Miller, CSO added “Auspherix has achieved a huge amount to date and its pipeline of novel antibacterial compounds are showing very strong early potential against a broad range of multidrug resistant (MDR) important Gram-negative and Gram-positive bacterial infections. It is an exciting time to be joining the Company and I look forward to working with the R&D team, our partners, the Board and our investors to deliver on our potential.”

Having raised £6million earlier in 2015, Auspherix is well placed to make rapid progress in its quest to develop a new class of antibiotics that will strengthen the existing arsenal of antibacterial treatments. The Company is expanding its UK-based microbiology and management teams at the Stevenage Bioscience Catalyst and is intensifying its discovery research, and intends to explore further the potential in its antibiotic platform.

-Ends-

Notes for editors

About Auspherix Ltd

Auspherix Ltd has discovered a brand new class of antibacterials with a unique profile and novel mechanism of action that could overcome rising problems of resistance to current antibiotics. Its compound series show activity against a broad range of multidrug resistant (MDR) important Gram-negative and Gram-positive bacterial infections, with profiles consistent with their use as antibacterial drugs for a number of indications with high unmet need and large market potential.

Based in Stevenage UK (in the Stevenage Bioscience Catalyst facility), the Company was founded in late 2013 based on discoveries made at the ithree institute at the University of Technology Sydney (UTS). The Company has raised AUS $2million in Seed and Series A1 investments (2013-2014) from Australia’s Medical Research Commercialisation Fund (MRCF) and £6 million in Series A2 round (2015) from the MRCF and the UK’s Imperial Innovations plc (AIM IVO).

For further information please visit www.auspherix.com

For more information please contact:

Media Relations – Instinctif Partners

Sue Charles/ Gemma Howe/ Rosanna Forrest

T: +44 (0)20 7457 2020

E: auspherix@instinctif.com

Auspherix

Dr Neil Miller

T: +44 (0)1438 906755

E: neil.miller@auspherix.com