Innovative therapy for coronavirus is required as much as a vaccine

The world's leading innovator bio-pharmaceutical companies feel that while vaccines may ultimately bring an end to the coronavirus (Covid-19) pandemic, there is an urgent need for innovation in treatment options. At present, around 300 different treatment 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 trade association that represents pharma companies around the world, pharma giants said that it would be critical to have collaborations amongst rivals to ensure that manufacturing capacities can be scaled up to the extent needed during a global pandemic. In fact, Albert Bourla, chairman and CEO of Pfizer put it quite 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 if that could reduce the disease burden and prevent hospitalisation.

US-based Gilead Sciences, for example, is not only working on 36 clinical trials of its innovative drug remdesivir that include different combination therapies, it is also evaluating the use of remdesivir in an inhaler form. " Remdesivir is now administered in intra-venous (IV) form and it is not suitable for oral use. We are trying to explore other formulations of remdesivir. There is a possibility 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 trying to find ways in which the drug can be administered earlier in the treatment and would prevent patients from ending up in hospitals.

Gilead, meanwhile, has already met all the 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 US FDA soon.

Research on antibodies that would neutralise the virus is also on. Roche, which did not 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 right antibodies to fight the virus, some develop it relatively late in the disease. "If we can identify and give these people neutralising antibodies in early stages, there can be huge benefits. It can also be given 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 along with Ridgeback Biotherapeutics. International news reports have suggested that if one goes by the results from mid-stage studies, there is a possibility that the medicine may reach the market before the year ends. Kenneth Frazier, chairman of the board and CEO of Merck, clarified that one study was checking the effect of the molecule on mild Covid-19 patients, while a separate study was on for hospitalised patients. The results from phase 2 trials are expected soon.

Work on the vaccine front is also on with full fervour. Bourla said that Pfizer and BioNTech vaccine candidate was in 'very advanced' stages. The company has already enrolled 23,000 patients and a significant number of them have already been administered a second dose of the vaccine candidate, he added.

About 15,000 of these volunteers would receive the vaccine, while the remaining would be given a placebo. By the end of October, Bourla feels they should have enough 'events'  (volunteers with vaccines and those with placebos who get exposed to the virus) to say if thw product is working or not. If it is working, Pfizer and BioNTech would immediately file 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 ensure 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 treatment courses (one patient needs 5-6 doses). By the end of 2020, it would have capacity to make two million treatment courses, a 40-fold increase. "We cannot do anything alone. We have 30 partners (in the supply chain) and Pfizer is a key partner," O'Day said.

Schwan said that if every company sat on its manufacturing capacities and one company had a breakthrough and was unable to make the product (drug or vaccine), that would be the most sad thing to happen. Roche, he said, has capacities to make antibodies and it would make it available for others.

As David Ricks, chairman and CEO of Eli Lilly put it - the way pharma giants across the globe are partnering with each 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