Alarm As Novartis Exits Antibiotics Space
Executive Summary
The Swiss major says that while the science for its antibacterial and antiviral research programs is compelling, "we have decided to prioritize our resources in other areas where we believe we are better positioned to develop innovative medicines."
Novartis AG is the latest big pharma to exit the antibiotics arena, deciding to ditch its antibacterial and antiviral research programs and spend its resources in other areas.
The Swiss major confirmed the decision in an email to Scrip saying that workers at its Emeryville, California facilities have been told of the plans. It is also confirmed that some 140 jobs could be cut with other departments being affected including pharmacology, protein sciences and informatics.
It has taken some observers by surprise, given the considerable pipeline of drugs to treat bacterial and microbial infections that had been built up at the Novartis Institutes for BioMedical Research (NIBR). These include a novel monobactam codenamed LYS228 to treat infections caused by multi-drug resistant Enterobacteriaceae which has been granted fast track and Qualified Infectious Disease Product designations by the FDA.
Novartis noted 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." The company added that "the need for these types of medicines is clear and to maximize the chances that these programs will one day help patients we are actively engaged in out-licensing discussions with companies focused on developing medicines in these areas."
The reaction to Novartis' withdrawal was one of concern, especially as antimicrobial resistance (AMR) has shot to the top of the global health agenda in recent years amid concerns that not enough is being done to prevent a worldwide catastrophe. Jeremy Farrar, director of the Wellcome Trust, the charitable foundation that is investing heavily in a number of AMR schemes, described the Basel-headquartered group's decision in a tweet as "incredibly bad news and more to come."
He added that "modern medicine depends on controlling infection," writing that "R&D anti-cancer therapies meaningless if cannot prevent/treat infection, same with routine surgery, safe child birth." Novartis has been narrowing its R&D focus since Vas Narasimhan took over as CEO in February, with its priorities lying in cutting-edge medicines for oncology and rare diseases and exploring cell and gene therapy approaches.
The AMR arm of the Wellcome Trust also expressed its fears on Twitter, saying that it was "deeply concerning news" to see that Novartis is the latest big pharma to quit antibiotics R&D, and highlighted the "uncertain future for its promising pipeline."
Novartis joins a number of companies that, put simply, have decided the difficulty and cost involved in developing an antibiotic and then being unlikely to get a reasonable price at the end of it all, is probably not the best use of their resources. Others include AstraZeneca PLC, which sold its small-molecule antibiotics portfolio for up to $1.5bn to Pfizer Inc. in August 2016. (Also see "Gottlieb Floats New Antibiotic Payment Model In LPAD Announcement" - Pink Sheet, 12 Jun, 2018.) (Also see "AstraZeneca Sells Small-Molecule Antibiotics To Pfizer But Still Investing In R&D" - Scrip, 24 Aug, 2016.)
However not all is doom and gloom on the pharma front in the fight to tackle AMR. In March, Evotec AG unveiled a partnership with Sanofi to develop an infectious disease pipeline using its technology platform, seeded with more than 10 undisclosed early-stage, preclinical assets from the French drug giant's infectious disease portfolio. Also in February, the $165m REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) Impact Fund was set up by Novo Holdings to address the early-stage funding gap, which will invest $20–40m per year over three–five years in about 20 projects. (Also see "Novo $165m Superbug Fund is Fillip For Antibiotic Start-Ups" - Scrip, 28 Feb, 2018.) (Also see "Evotec Leverages Infectious Diseases Space With Sanofi R&D Deal" - Scrip, 9 Mar, 2018.)
At the beginning of 2018, the Dutch non-profit Access to Medicine Foundation issued a report saying that GlaxoSmithKline PLC and Johnson & Johnson were leading the way in responding to the AMR threat among the large research-based pharmaceutical companies. It added that Pfizer performs particularly well in stewardship measures. (Also see "Pfizer Biosimilars And Anti-Infectives Get Higher Profile Under New Structure" - Scrip, 11 Jul, 2018.)
As for biotechs, among the 12 firms that AMF's benchmark covered, Entasis Therapeutics Holdings Inc. was top, "particularly when it comes to planning ahead to help ensure successful candidates will be made accessible but also used wisely". It was followed by Polyphor Ltd., Summit Therapeutics PLC and TetraPhase Pharmaceuticals Inc. in joint second place.
Indeed, it is often argued that solutions to AMR are more likely to come from biotech rather than big pharma and in Europe there is the BEAM (Biotech companies in Europe combating AntiMicrobial Resistance) Alliance, which has 52 members which are collectively developing projects focused upon the cure and prevention of bacterial infections. Biotechs are also tapping into CARB-X (Combating Antibiotic Resistant Bacteria Pharmaceutical Accelerator), the $450m global initiative backed by the US government and the Wellcome Trust. (Also see "ABAC Chief Calls For Better Antibiotic R&D Incentives In Europe " - Scrip, 26 Feb, 2018.)
As for Novartis, it told Scrip that the San Francisco Bay area would continue to be home to the Novartis Institute for Tropical Diseases (NITD) and global drug discovery teams focused on 'undruggable' targets in collaboration with the Novartis-Berkeley Center for Proteomics and Chemistry Technologies. NITD's research programs are focused on developing new medicines for malaria, cryptosporidiosis, human African trypanosomiasis, Chagas disease, and leishmaniasis.