Ringing alarm bells: Discussing the action required to support pharma in tackling AMR

by

There is rising tide of drug-resistant microbes that is thought of as one of the greatest threats to public health today, yet the pipeline of new antibiotics is dwindling. Here, Dr Peter Jackson, executive director of the AMR Centre, which is spearheading the UK’s response to AMR, discusses what action is needed to support the pharmaceutical industry in this fight.

For many years now, the alarm bells have been sounding on the dwindling pipeline of new antibiotic treatments. Antibiotic patent applications worldwide have dropped by over a half in the past decade and there are fewer new drugs emerging from clinical trials, with only two new molecular entities approved by US regulators between 2008 and 2012, down from 16 in the early 1980s. Most worrying of all, there have been no new classes of antibiotics introduced, effective against the most serious Gram-negative infections, in over 30 years.

Over the last few decades, many innovative pharmaceutical companies have pulled out of antibiotics research due to negative returns on investment in R&D and the low commercial value placed on antibiotic drugs compared to more lucrative sectors such as cardiovascular disease and cancer.

Big pharma needs encouragement

While a new army of smaller biotechs is focusing on AMR innovation, to truly drive research forward and strengthen the dwindling global pipeline, big pharma must be encouraged to remain in — and return to — the antibiotics sector.

In the past 12 months, great progress has been made in mobilising international support for so-called PUSH incentives — providing grant support to new product developers to push their innovations through testing into clinical trials.

Funding initiatives such as CARB-X, ENABLE and GARD-P, have pledged around $600 million for pre-clinical to clinical translation of new treatments and diagnostics. This is a great start, but as highlighted in the recent expert report by DRIVE-AB, such PUSH funding needs to be increased significantly to provide a sustainable early-stage pipeline of new treatments effective against AMR.

AMR Centre — key to UK efforts

The AMR Centre has been established as a key part of the UK’s effort to rebuild the antibiotic pipeline by working with innovative SMEs to ensure that new drugs can be developed and brought to market as quickly and efficiently as possible.

Alongside other sources of PUSH grants, the AMR Centre works in partnership with institutes, biotech companies and pharma to co-develop their programmes as fast as possible into patients by providing funding, expertise and practical assistance with pre-clinical and early clinical development, leveraging the world-class R&D infrastructure at Alderley Park and across the wider support network in the UK. The Centre has announced its first three international co-development programmes with biotech companies since opening its labs in July 2017 and has more to come in 2018.

But PUSH incentives are not enough to fix the problem with the antibiotics market.

Progress required in market PULL

For biotechs, pharma companies and their investors, there must be progress on the market PULL side of the equation. This means ensuring that there are clear financial rewards available to drug developers if they succeed in bringing life-saving new AMR medicines to patients.

We now need international action to establish mechanisms such as Market Entry Rewards for new drugs that might never have a commercial future, but can provide the last line of defence against the most serious resistant pathogens.

And we need healthcare payers to recognise the true value of innovative antibiotics to the healthcare system. After all, so many of today’s life-saving healthcare advances, from cancer chemotherapy to heart surgery, rely on effective antibiotics being available to prevent infections in patients.

So, for the ‘biotech army’ to be truly successful, we also need to have big pharma fully on board and incentivised to provide their infrastructure and experience in bringing new antibiotics to market.

That's why urgent action must be taken to fix the market PULL in 2018.