Novartis is the latest big pharma player to decide that developing new anti-infectives isn’t on its priority list.
The company is shutting down antibacterial and antiviral research at its Novartis Institutes for Biomedical Research campus in Emeryville, California, with the loss of 140 jobs, and is putting the current projects up for sale.
The lead program up for grabs is LYS228, which is in phase 2 testing for complicated intra-abdominal infection (cIAI) and complicated urinary tract infection (cUTI). The company has also been working on viral diseases such as dengue fever.
In a statement, Novartis said that “while the science for these programs is compelling, we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines that will have a positive impact for patients.”
It appears other anti-infectives are staying in the pipeline, notably two malaria drugs—PfATP4 inhibitor cipargamin (KAE609) and imidazolopiperazine derivative KAF156—in early development at the Novartis Institute for Tropical Diseases (NITD).
Novartis’ decision follows similar moves by AstraZeneca, Roche, Bristol-Myers Squibb and Eli Lilly, taken because it’s proving hard to develop new drug classes and—even if they reach the market—they tend to be saved for last-line use and, as a result, sales are tiny.
At the same time, more than 700,000 people die each year from infections resistant to most or all antibiotics, and by 2050 antimicrobial resistance (AMR) is projected to claim more lives than cancer.
The question is, does big pharma’s exit from the sector really matter? Smaller biopharma players are still conducting research into new antibiotics, and promising drug candidates or even entire companies can be acquired—witness Merck & Co’s $9.5 billion takeover deal for Cubist Pharma in 2014.
Meanwhile, big pharma companies are also participating in the development of new drugs for resistant infections indirectly, via public-private consortia that take an open approach to discovery and development—often spearheaded by academia—and so don’t require the same level of in-house staffing or facilities. Examples include the DRIVE-AB and ENABLE initiatives, partly funded by the European Commission, and the World Health Organization-backed CARB-X project.
There are smaller, more focused projects on the go as well. Novartis took the decision to transfer all its tuberculosis candidates to the TB Alliance in 2014 for free, saying it was better placed to bring them forward. That included an elderly leprosy drug (clofazimine) in development for multidrug resistant TB that is due for filing this year.
All that aside, according to a recent report by the Access to Medicine Foundation (AMF), the multinational pharma companies’ retreat from the sector is a problem. While companies like GlaxoSmithKline, Johnson & Johnson and Pfizer are leading the charge, there is still not enough being done on an industrywide basis to avert a future healthcare crisis.
The report identified 28 novel drugs for problem pathogens but concluded many more were needed and the threat that once-deadly infections could again become life-threatening is “intensifying.” MDR infections are responsible for 700,000 deaths a year worldwide, but it is estimated that by 2050, without a concerted effort to develop new drugs and use the ones we have more carefully, they could kill up to 10 million people a year.
An industry group—the AMR Industry Alliance—also said earlier this year that pull incentives need to be introduced to stimulate industry R&D into antibiotics. In response, FDA Commissioner Scott Gottlieb published proposals last month to incentivize biopharma investment in antibiotic R&D, including a pull mechanism in which hospitals would pay a fixed licensing fee in return for access to a set number of annual doses of a new antibiotic, rather than reimbursing on a per-use basis.