The world’s leading innovator bio-pharmaceutical companies feel that while vaccines may in the end bring an end to the coronavirus (Covid-19) pandemic, there is an pressing need for innovation in remedy options. At present, around 300 different remedy options are being researched across the globe – while some are repurposed therapies, some are novel.
Speaking at an event organised by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), a Geneva-based commerce organization that represents pharma companies world wide, pharma giants said that it would be critical to have collaborations amongst rivals to make certain that manufacturing capacities may also be scaled up to the extent needed right through a global pandemic. If truth be told, Albert Bourla, chairman and CEO of Pfizer put it moderately emphatically – “the only rival is the virus and the only competitor is time”.
Pharma giants have already started work on different formulations and combination therapies of their existing molecules to see whether that could minimize the disease burden and prevent hospitalisation.
US-based Gilead Sciences, for instance, isn’t just working on 36 clinical trials of its innovative drug remdesivir that come with different combination therapies, additionally it is evaluating the usage of remdesivir in an inhaler form. ” Remdesivir is now administered in intra-venous (IV) form and it’s not suitable for oral use. We are trying to explore other formulations of remdesivir. There’s a opportunity of use as an inhaler,” said Daniel O’ Day, chairman and CEO of Gilead. O’Day feels that inhalers are a ‘good idea’ as the drug directly reaches the lungs where the virus primarily attacks. The firm is attempting to find ways in which the drug may also be administered earlier in the remedy and would prevent patients from ending up in hospitals.
Gilead, meantime, has already met the entire requirements for a full authorisation for remdesivir, which currently has an emergency use authorisation (0ff label use in Covid-19), and expects the same to come through from the United States FDA soon.
Research on antibodies that would neutralise the virus could also be on. Roche, which didn’t taste success with its innovative drug tocilizumab (Actemra) in clinical trials as a mono-therapy, has now turned its focus on antibody research. Severin Schwan, CEO of Roche, explained that while some patients do not develop the correct antibodies to fight the virus, some develop it moderately late in the disease. “Whether we will be able to identify and give these people neutralising antibodies in early stages, there may also be immense benefits. It may also be provided as a prophylaxis to high risk individuals,” Schwan said.
US pharma giant Merck is working on an experimental antiviral pill (code named MK-4482) that is currently under investigation. International news reports have suggested that whether one goes by the results from mid-stage studies, there’s a opportunity that the medicine may reach the market before the year ends. Kenneth Frazier, chairman of the board and CEO of Merck, elucidated that one study was once checking the effect of the molecule on gentle Covid-19 patients, while a separate study was once on for hospitalised patients. The results from phase 2 trials are expected soon.
Work on the vaccine front could also be on with full fervour. Bourla said that Pfizer and BioNTech vaccine candidate was once in ‘very advanced’ stages. The company has already enrolled 23,000 patients and a remarkable number of them have already been administered a second dose of the vaccine candidate, he added.
Approximately 15,000 of these volunteers would receive the vaccine, while the remaining would be provided a placebo. By the end of October, Bourla feels they will have to have enough ‘events’ (volunteers with vaccines and those with placebos who get exposed to the virus) to say whether thw product is working or not. Whether it is working, Pfizer and BioNTech would immediately dossier for approval, he added.
Therapy or vaccine – the key concern area is scaling up in time to meet the global demand. O’Day emphasised how Gilead had already signed voluntary licensing agreements on a no-cost basis to make sure remdesivir reaches a larger number of people. It has signed agreements with nine generic manufacturers to give access to 127 countries, most of which are low-medium income countries (LMIC).
Admitting that the manufacturing process of remdesivir is complex (involving 36 chemical steps), O’Day said that when Gilead started in January, it could make only 5000 remedy courses (one patient needs 5-6 doses). By the end of 2020, it would have capacity to make two million remedy courses, a 40-fold increase. “We cannot do anything alone. We have 30 partners (in the provide chain) and Pfizer is a key partner,” O’Day said.
Schwan said that whether each company sat on its manufacturing capacities and one company had a breakthrough and was once unable to make the product (drug or vaccine), that will be the most sad object to happen. Roche, he said, has capacities to make antibodies and it would make it to be had for others.
As David Ricks, chairman and CEO of Eli Lilly put it – the way pharma giants across the globe are partnering with every other and former rivals, it is indeed ‘unprecedented’.
300 potential therapies under research globally
Gilead says capacity to make remdesivir will be 40-times of what it had it January
Working on inhaler version of remdesivir
Merck’s MK-4482 antiviral drug shows promise in trials
Phase 2 data of MK-4482 expected soon
Roche working on antibodies; can work as prophylaxis
Pfizer expects clarity on vaccine efficacy by October