EU must do more to promote antibiotic R&D - CEO

A specialist biotech has warned that Europe may struggle to sustain R&D into badly-needed new antibiotics, because of a lack of US-style incentives to innovate.

Nicholas Benedict, CEO and co-founder of Allecra Therapeutics, has just seen the company’s lead product get Fast Track designation from the FDA – where the regulator hurries development of badly-needed drugs by offering extra support during development and a potential fast review when trials are complete.

Allecra’s drug could also have an extended period of market exclusivity under the US system, which aims to use market incentives to stimulate development of new antibiotics.

The drug known as AAI101, a next generation beta-lactamase inhibitor is about to enter phase 3 development and is designed to prevent build-up of resistance to the antibiotic cefepime when taken in combination.

Although the company based in Lorrach, Germany, and Saint Louis, France was only founded in 2013, it has already got AAI101 to phase 2 and now plans phase 3 trials thanks to the support on offer from the FDA and US legislation.

But in an interview with pharmaphorum, Benedict said that the approach to encouraging development of antibiotics in Europe may not lead to sustained progress because of its reliance on governments and the intervention of politicians.

In the US, the Obama administration implemented the Generating Antibiotics Incentives Now (GAIN) Act, which introduced a series of incentives to encourage pharma to develop new antibiotics.

New antibiotics are badly needed but have been seen as rather unsexy by big pharma over the past few decades because of the relatively poor return on investment in comparison with other fields, where approved products can command much higher prices.

Benedict says that GAIN has fixed enough of the issue to make development worthwhile once again – it gives qualifying antibiotics up to five years extra protection during which time the FDA cannot accept applications from potential generic rivals.

For orphan antibiotics, this adds five years to the seven years exclusivity already granted because of a drug’s rare disease status, meaning the FDA must wait at least 12 years after a regulatory filing before it considers applications from generic rivals.

Even for new drugs used in wider patient groups, GAIN gives a decade of exclusivity, doubling the standard protection period from the time of a regulatory filing.

Coupled with the regulatory help and fast review period, this makes antibiotic development much more attractive, said Benedict.

Allecra CEO Nicholas Benedict

He told pharmaphorum: “The model is very attractive to venture investment and that is a very sustainable approach.”

In the EU, antibiotic research is more driven by grants from the European Commission, rather than using commercial incentives – and while authorities are currently keen to drive forward research this could change in the future, said Benedict.

“I am not sure that the political will is so sustainable,” said Benedict. “We will have trouble making this kind of investment sustainable. Market forces are more sustainable than governments.”

Thanks to the progress so far Benedict is optimistic about the drug’s sales potential as it could be used in large hospitals to prevent cefepime resistance, and reliance on other antibiotics that are used as a backstop that are also threatened by resistant strains.

AAI101 has similar use to AstraZeneca’s already-approved Avycaz, a combination of a beta-lactamase inhibitor avibactam, and the antibacterial ceftazidime, but can be used in a wider group of patients.

The drug could also be used in other combinations, leading to the possibility of partnerships and joint working with other biotechs and pharma companies, said Benedict. “That is definitely a possibility.”