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Small and medium companies stepping into antibiotics development, face huge challenges

Issue discussed at CSE’s webinar ‘Small and Medium Scale Antibiotic Developers: Challenges they face and the way forward’, the second in a series that focuses on the crisis in antibiotic research and development 

  • Worldwide,existing antibiotics are becoming ineffective due to growing antibiotic resistance-- crisis can worsenas pipeline for new antibiotics is weak and thin
  • Most big pharmaceutical companies have quit antibiotic development and are focussing on profitable areas like cancer, autoimmune and metabolic disorders. Small and medium scale biopharmaceutical companies have taken up the responsibility to fill this gap -- but they are struggling
  • Besides funding, concerns related to regulatory harmonisation, clinical trials, accelerated approvals need to be addressed 

Find the webinar proceedings click here

New Delhi, August 25, 2023: At a time when big pharma is shying away from research and development on new antibiotics, it is the small and medium scale biopharmaceutical companies that have taken up the cudgels for filling this gap. But these companies are faced with enormous challenges of their own. Until these challenges are addressed and overcome, the world will continue to be in a dire predicament in which it will see its basket of life-saving antibiotics rapidly becoming smaller and smaller. 

This emerged from the deliberations at a global webinar organised on August 24 by Centre for Science and Environment (CSE).This was the second webinar in a series being conducted by CSE to discuss the crisis in antibiotic research and development. 

In her opening speech in the webinar, CSE director general SunitaNarain said: “We need to conserve the antibiotics that we have, but we also need new antibiotics to treat deadly resistant infections. While the big pharmaceutical companies are no longer keen, it’s the small and medium scale companies which have taken up the responsibility. They have a huge task at hand and a lot depends on how they are supported.”Narainis a member of the Global Leader’s Group on Antimicrobial Resistance (AMR). 

Antibiotic resistance is a silent pandemic. Antibiotics are becoming ineffective and treatment options are reducing -- impacting health, livelihoods and economies. Worldwide, in 2019, about five million deaths were associated with it. 

Moderated by Narain, the webinar – ‘Small and Medium Scale Antibiotic Developers: Challenges they face and the way forward’, focused on developers based in India and brought together key stakeholders and experts includingVasanSambandamurthy, senior vice president, Global Operations, Bugworks Research India Pvt Ltd; Jitendra Kumar, managing director, Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India; Sachin Bhagwat, senior vice president, Drug Discovery, Wockhardt Research Centre; T S Balganesh, president, GangaGen Biotechnologies Pvt Ltd; and Amit Khurana, director, Sustainable Food Systems Programme, CSE. 

The webinar series isbased on a CSE assessment– ‘A Developing Crisis’, -- published in Down To Earth (July 16-31).  The assessment had showed how the global antibiotic pipeline is weak across the pre-clinical and clinical development stages. Analysis of the clinical pipeline of 15 high-earning pharmaceutical companies to understand their R&D focus showed thatmost big pharmaceutical companies have all but quit the R&D of new antibiotics. It is the small and medium scale pharmaceutical companies have taken up the responsibility, but they are facing challenges. 

“Indian small and medium antibiotic developers are facing multiple challenges. They can play an important role in rejuvenating the global pipeline, if their concerns are addressed,” said Amit Khurana from CSE. 

The antibiotic developers who spoke at the webinar clearly highlighted their challenges related to scientific, financial and regulatory aspects of drug development. 

“In addition to the big funding for antibiotic innovators, there is need for regulatory harmonisation at the global level so that the innovators can well use the data generated,” said VasanSambandamurthy from Bugworks, a biopharmaceutical company engaged in developing two traditional antibacterial agents. 

“We need to open up clinical trial testing for innovator drugs in India. We also need accelerated approval pathways so that it is clear how a life-saving antibiotics can qualify. It will spur alot of innovation and help companies across the discovery space,” he added. 

“It is important to strike a right balance while selecting a project to be supported -- between a viable and well differentiated product for the unmetneed in the shortterm and an innovative drug carrying more failure riskfor the longer term,” said Sachin Bhagwatfrom Wockhardt, which is developing four traditional antibiotics. 

“There has to be emphasis on nurturing the discovery talent. If the current situation continues, we won't be able to do much even if we put in all resources,” he cautioned.  

Highlighting a real problem of sourcing funds, T S Balganesh ofGangaGensaid: “The level of resistance in pathogens may vary in India and the western world; western interests would not be keen to fund if it is not a major problem there. This makes us completely dependent on Indian sources or sources from neighbouring countries.” GangaGen Biotechnologies is a biologics company focusing on non-traditional therapies such as protein antibacterials and bacteriophages for treating serious bacterial infections. 

“The problem of commercialisation is different from the problem of development. There are problems at several levels. We need to break it down and address each of them,” he added. 

Responding to the concerns,Jitendra Kumarof BIRAC highlighted several initiatives that have been adopted. “We are keen to support this area as AMR is a pandemic and definitely a crisis. We have been working on it and will do whatever is possible from our side,” he assured. 

CSE researchers, in their assessment, had called for critical reforms to stimulate the antibiotic R&D ecosystem for a sustainable and equitable antibiotic access. There is a need for greater public financing, a coordinated response from nationalgovernments and striking the right balance in public-private partnership for antibiotic development. They had highlighted that antibiotics have attributes of a ‘global public good’ despite not fitting into the strictest definition. 

“We need to see how public funding is used not just for innovation but also to make sure to get these drugs out on the table. This is where we will need to look at our priorities, target what we need and see if we are able to use it for the rest of the world,” said Narain. 

“But it is not just a debate of push and pull incentives. It is a question of what more can be done. It is very clear that there is an agenda beyond just talking about funding,” she said while concluding the webinar. 

For any additional information, please contact Sukanya Nair of The CSE Media Resource Centre, sukanya.nair@cseindia.org, 8816818864.   

 

Key data findings from the DTE story: ‘A Developing Crisis’ 

Global antibiotic pipeline weak

  • WHO database updated until late 2021 shows that of the 297 antibiotic candidates under consideration, 217 are in pre-clinical development, 77 in clinical trial, and only three are in pre-registration stage. This 77 in clinical development is miniscule compared to 10,000+ for cancer, 1800+ for neuropsychiatric conditions and about 1500 for endocrine, blood and immune disorders. 
  • Of the 77 products in clinical development, 45 are traditional antibiotic candidates and 32 are non-traditional candidates. Twenty eight out of 45 traditional candidates target WHO priority pathogens. In 2017, 12 pathogens out of which most were Gram-negative were categorised into critical, high and medium priority pathogens to guide global R&D by the WHO. 
  • Out of 77, only nine traditional small molecules are in phase 3 of clinical development. There is none for tuberculosis. Only two targetWHO’s critical priority pathogens. Among the non-traditional antibiotic candidates, only five are in phase 3. For M. tuberculosis, there is only one product, that too in phase 1. 
  • The pipeline of antibacterial products in preclinical development shows that out of 217, only 3 have their Investigative New Drug (IND) application submitted while 31 are in clinical trial application/IND-enabling studies. This is too less a pool to feed into the clinical development stages. 

Big Exodus

  • Analysis of clinical pipeline of 15 high-earning companies revealed that of the total 1007 candidates, only 13 are antibacterials which are developed by four companies. 400+ were for cancer, about 150 were for immunology, allergy, inflammation or respiratory diseases, and 84 were for cardiology, metabolism or renal. These are developed by most of these companies. Collectively, the 2022 revenue was about $711 billion, 17.5 per cent of which ($124 billion) was total investment in research and development. 
  • Out of these 15, GlaxoSmithKline, Roche, Pfizer and AbbVie are currently developing antibiotics. GSK is developing 8 out of 13 candidates. Few major companies with clinical pipelines focusing on other profitable areas but not on antibiotics are AstraZeneca, Novartis, Johnson and Johnson, Sanofi, Merck and Co, Bristol-Myers Squibb, Eli Lilly and Company, Gilead Sciences, Amgen, Biogen and Viatris. Sanofi, Pfizer, Johnson and Johnson, Merck and Company and GSK have bacterial vaccines under development.
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