Farmas USA

WHO report highlights shortage of new antibiotics

• "The review, released today, analyzed 43 antibiotics currently in development and found that none address extensively or multidrug-resistant gram-negative bacteria and that novel drugs targeting WHO priority pathogens like carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa*1 are lacking. The analysis also found a gap in oral antibiotic*2 options for multidrug-resistant infections that would allow patients to be treated outside of hospitals."

• In addition, the WHO notes that of the 11 antibiotics approved since 2017, only 2 represent a novel class of antibiotics. The rest are derivatives of already existing antibiotics, which raises concerns that resistance to those drugs will quickly develop and render them ineffective. Many of these new drugs show little distinct benefit over current drugs and are more expensive*3
  
  
• de los 43 agentes, 26 son basados en algo existente, y 27 no tradicionales.
  
  

• The lack of new, innovative antibiotics comes against the backdrop of rising rates of antimicrobial resistance (AMR) around the world, particularly in low- and middle-income countries.
• Says head of the newly formed AMR Action Fund, a pharmaceutical industry-led and WHO-supported effort to invest in and boost antibiotic development.*4

• WHO found 43 antibiotics and antibiotic combination drugs currently in clinical development. Twenty-six of the antibiotics in development are active against the WHO's priority pathogens, 12 are active against Mycobacterium tuberculosis, and 5 target Clostridioides difficile.

• But of the 26 antibiotics targeting priority pathogens, most are derivates of existing antibiotic*5 classes. Only seven meet one of the WHO's innovation criteria (absence of known cross-resistance, new target, new mode of action, and/or new class), and only two of those are active against critical, multidrug-resistant gram-negative bacterial pathogens that have few other treatment options. Eleven of the products in development are beta-lactam/beta-lactamase inhibitor combinations*5 , which have been on the market for more than 30 years.

• To overcome existing cross-resistance, more new classes of antibacterials are needed, including antibacterials addressing new targets and using new modes of action."
  
  
• The WHO estimates that, given average progression rates and development duration, the current pipeline could lead to the approval of eight new antibiotics in the next 5 years.*6

• "In general, failure rates for these nontraditional products will be higher than for new derivatives of existing antibiotic classes," the report says.

• But Beyer said the hope is that one or two of these products could be game changers*7. "That is where we actually have to invest," he said.

• En cuanto a preclinical Analysis of the preclinical pipeline found 292 agents targeting WHO priority pathogens, tuberculosis, and C difficile. These include 115 antibiotics, 101 non-traditional products, 47 vaccines, and 29 adjuvant antimicrobial peptides.

• Pharmaceutical companies have been unable to develop a new class of antibiotics for 30 years, he said.

• "We have new drugs, but bugs become resistant, so it's a constant race against those bacteria, and we have to find newer and newer products," she said.

• But he went on to explain that most new antibiotics are targeting small patient populations with specific drug-resistant infections and that nearly all the new antibiotics that will be approved in coming years will be classified by the WHO as reserve antibiotics—agents that should only be used as a last resort to treat infections with no other treatment options.*8

• "They will be used very conservatively, as they should, meaning that the revenue that you can generate with these antibiotics is relatively small and not sustainable for the companies," he said. "It is very difficult for a company to sustain a product on the market if there is not a minimum revenue that they can generate."

• Beyer echoed the report's call for countries to create a more favorable market dynamic for antibiotic development and create the kind of "pull" incentives that will encourage companies to invest in antibiotic R&D. He cited Germany and the United Kingdom as examples of countries that are exploring different models of antibiotic reimbursement that will pay pharmaceutical companies based on the public health value of a new antibiotic rather than on the amount of antibiotics they sell.
  
  "We need to change the way we purchase and procure these products so that this remains an area where we see private investment and not only public investment," he said.
  
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  Conclusión, tema muy interesante. Carrera contrareloj, falta de incentivos económicos, falta de innovación. Sera un problema grave dentro de una generación dicen. últimamente he leído sobre bacterias que se hacen muy resistentes en las depuradoras, etc. Creo que puede ser algo que escuchemos cada vez más en el futuro. Ark lo mencionaba en su informe anual también de cara a 2050 y entraron en MCRB  en su fondo genomics no siendo ese campo algo muy presente en su porfolio creo. MCRB falló y ahora estan vendiendo.
  
  Parece que la OMS se puso las pilas en 2020 en tema antibióticos, quizás quedó luego más silenciado por el covid. Seguiré el fondo ese AMR Action fund para ver si anuncian primeras inversiones y a ver si cotizan.
  
  Gracias al foro estaba advertido que es un sector difícil, tomo más consciencia. 
  Estoy en SMMT por lo que comenté de su entorno y lo que pude hurgar de su ciencia, voy a reconsiderar el añadir, de momento es casi un 3% de mi porfolio y quería subir al 5% o 6% para ir concentrar algunas apuestas un poco más. Una de las pocas ph3 de antibióticos que hay aún, van cayendo todas.. Veremos! 
  
  Saludos!