Extraordinary times demand extraordinary efforts. In the past, these outstanding efforts have come from known innovators as well as those who have risen to the task at hand. Perhaps the most apt and timely analog- given the 75th anniversary of VE day just a few short weeks ago- could be drawn from Pfizer rising to the challenge put forth by President Roosevelt during World War II.
Facing an unprecedented crisis, the U.S. Government sought the aid of the pharmaceutical industry to save the lives of the staggering number of soldiers perishing from infection. Years earlier in 1928, British scientist Alexander Fleming discovered the promising anti-biotic, penicillin. However, the miracle drug had a significant drawback; it could only be produced in small quantities. Pfizer rose to the challenge in a remarkable way.
Although the now-mega-pharma did not discover penicillin, the company's innovation put the solution directly into the hands of combat medics, ultimately saving an incredible number of lives throughout the second great war.
The company pioneered a technique to mass-produce the miracle drug, converting the promising anti-biotic, into a widely available life-saving standard.
In 2020, we have seen companies across a myriad of industries swiftly mobilize to make a difference in the national defense against coronavirus - such as automobile companies GM and Tesla churning out ventilators or fitness companies like Rogue Fitness trading barbell outputs for PPE.
Five months into the defining challenge of our generation, how are our pharma innovators faring? Which companies have picked up the torch while others cautioned a 'wait and see' approach during this time of uncertainty and turmoil? The timely release of the IDEA Pharmaceutical Innovation and Invention Indices allows us to evaluate the leaders of medicinal innovation and how they have risen to the unique challenge of COVID-19.
Gilead Sciences, arguably the leader in the COVID-19 battle, is the poster child of nimble adaptation and responsive innovation. They also just so happen to have a significant track record of innovation based on IDEA Pharma analysis over the past several years, landing the top spot on the Pharmaceutical Innovation Index in 2019 - and finishing as the runner up in 2018. The company received an emergency use authorization from the FDA on May 1st based on its preliminary results from two clinical trials of remdesivir, which produced enough sound data for Dr. Anthony Fauci (NIAID director) to proclaim the therapy as the standard of care for COVID-19. To complement and realize this successful innovation, the company told investors on May 1st that it may spend up to $1 billion this year to develop and manufacture remdesivir, and it aims to have 500,000 treatment courses by October and 1 million by the end of 2020.
Close on Gilead's heels are several other companies that have progressed through clinical trials with their own approaches to treatment for the novel coronavirus.
Among them are the 2020 PII top dog, Roche, who has a phase 3 clinical trial of Actemra (first approved in 2010 as an RA drug) designed to ascertain the effectiveness of the drug on patients who have been hospitalized with severe pneumonia. In addition, Roche has scrambled to develop a diagnostic and an antibody test for COVID-19 - both of which have received EUAs from the FDA. Additional serial top 10 finishers on the PII, Regeneron, Sanofi, GSK and J&J all have quickly mobilized to field phase 1 and pre-clinical testing on their candidates for COVID-19 treatment.
Innovation from within is exciting to see, but what new contenders for pharmaceutical innovation are being created in the corona-crucible? Outside of these major players, many smaller biotechs are championing the cause - leveraging their novel platforms and small-company flexibility to overcome the trial. Companies such as CytoDyn, BioNTech have ph2 and ph3 trials ongoing while others, including Moderna, Novavax, and Inovio are close behind with their phase I trials. These companies will certainly face a different set of challenges, including quickly generating funding to drive these trials forward as well as manufacturing and distribution challenges. Companies, like Pfizer, have stepped in to assist - providing support to develop and distribute BioNTechs SE's COVID-19 vaccine candidate.
As the time for ending quarantine draws closer, we face the second wave of infections and the likelihood that we will 'un-flatten the curve' - driving the very real possibility that the rate of severe disease could spike and ultimately overwhelm our healthcare system. Thus, the need and drive to provide these novel treatments - and deliver an actual strategy to save lives - grows greater with each passing day. Who will be the company that first cracks the COVID-code and provides relief for the masses? Will it be a big pharma player or an agile, innovative biotech? Time will tell, and the IDEA Pharma Innovation hawks will be watching...
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