Clarivate’s latest Drug to Watch list highlights new modalities shaping drug development, including gene editing and artificial intelligence.
Pictured: Syringe and vial on background of market stock graph/iStock, MadamLead
Every year, Clarivate curates a list of drugs with the potential of becoming breakthrough and blockbuster medicines in the coming year. This year, 13 molecules made it to the 2024 Drugs to Watch list, the majority of them approved for oncology and rare diseases.
Michael Ward, global head of thought leadership, life sciences and healthcare at Clarivate, told BioSpace that the practice is an opportunity to identify drugs that would be consequential to the life sciences and the health sector in the coming year. The selected drugs were either undergoing Phase II or III clinical trials, in the pre-registration or registration stage, approved early in 2023 or were deemed to have a high chance of impacting patient wellbeing.
Among them is bluebird bio’s lovotibeglogene autotemcel (Lyfgenia), approved last year for treating sickle cell disease in patients aged 12 and above. According to the report, this molecule treats the underlying causes of sickle cell disease and transfusion-dependent beta-thalassemia and is said to be more effective than current treatment options. Another example is Sanofi’s efanesoctocog alfa (Altuviiio) for hemophilia A, which is expected to make sales of $1.77 billion in 2029.
Some of the drugs on the list, such as AstraZeneca’s datopotamab deruxtecan, an antibody drug conjugate, and Johnson & Johnson’s talquetamab (Talvey), a bispecific antibody, represent new modalities. Ward said these drug types are gaining more approvals from the FDA than traditional drug platforms, and this pushes pharmaceutical companies to be more innovative.
“We’re going to see pharmaceutical companies looking around to make sure that they’ve got access to the technology platforms that are going to be the springboard for the next generation of medicines,” said Ward. “That will be RNA technologies, it will be cell and gene therapy and it will be gene editing.”
To achieve this feat, big pharmaceutical companies often collaborate with smaller innovative companies. The best-selling drugs in some of the top pharmaceutical companies are from small companies, said Ward. For instance, all five of Bristol-Myers Squibb’s best-selling drugs are from smaller companies it acquired, he noted. For example, BMS assumed ownership of its best-selling drug Revlimid after purchasing Celegene Corporation in 2019. Ward predicted that 2024 will see many such deals.
Clarivate’s full 2024 Drugs to Watch List:
- Aflibercept (Eylea)
- Budesonide (Tarpeyo/Kinpeygo)
- Datopotamab deruxtecan (Dato-DXd)
- Efanesoctocog alfa (Altuviiio)
- Ensifentrine (RPL554)
- Exagamglogene autotemcel (exa-cel)
- Lovotibeglogene autotemcel (lovo-cel)
- Mirikizumab (LY-3074828)
- Niraparib + abiraterone acetate (Akeega)
- RSVpreF (Abrysvo)
- RSVpreF3 (Arexvy)
- Talquetamab (Talvey)
- Zolbetuximab (IMAB362)
Besides ramping up partnerships in the industry, another trend is that global pharmaceutical companies are becoming very interested in the growing chronic disease market in mainland China, according to Matthew Arnold, principal analyst, life sciences and healthcare at Clarivate. Among seven drugs the report highlights that could either improve treatment outcomes or achieve $1 billion blockbuster status by 2029 is Sanofi and Regeneron Pharma Inc.’s Dupilumab, expected to make sales of $1.5 billion in 2029 in China alone.
“We’ve seen in the last five to ten years significant regulatory reforms in mainland China that have really opened up that market to a lot of pharma products that were previously excluded,” Arnold said. Last year Clarivate reported that mainland China has eased its regulatory protocols for testing and approvals of drugs, allowing more drugs to be available to patients.
The current report also looked at the most successful drug of 2023. Although not on the watch list for 2024, Ward said Merck & Co. was the most successful company last year, mostly because of its cancer drug Keytruda, which has continued to improve clinical outcomes in patients. First approved in 2014 for treating advanced melanoma, Keytruda has since been approved for more than 20 indications, including, recently, the early stages of non-small cell lung cancer.
“It’s described as a pipeline in a drug because there are lots of opportunities for that drug to be used in lots of different cancers in combination with other drugs to be highly effective,” said Ward. Keytruda’s patent exclusivity will expire in 2028.
Clarivate’s report also highlighted the impact of gene editing and artificial intelligence (AI), including machine learning (ML), citing the use of these technologies for developing personalized therapies based on an individual’s genetic makeup. Five hundred AI/ML-related clinical trials were conducted in 2022, and one of the drugs on this year’s list, Bluebird’s Lyfgenia, was developed using the technology. Arnold said using these technologies in drug development means more novel molecules will make it to the market.
“Only one of ten molecules that ever actually enter into human clinical trials ever get anywhere near the regulator for approval,” said Ward. He predicted that using AI in clinical trials would eliminate redundancy in the research and development process and improve these odds, but that the technology would not necessarily reduce healthcare costs. “I don’t expect to see any decline in the amount of money that is going to be put to work for R&D.”
Patience Asanga is a Nigeria-based freelance science journalist who writes about the environment, biotechnology and life sciences.
