The urgent need to have at least a few proven COVID-19 therapies approved in the U.S. before the pandemic’s expected resurgence in the fall has become biopharma’s Manhattan Project – a coming together of industry, researchers and government agencies to take on a single global enemy.
DUBLIN – The Swiss biotech sector raised about CHF1.2 billion ($$1.2 billion) in equity investment in 2019, a significant downward dip on the last two years, but well ahead of its average annual raise of CHF800 million over the past decade, according to the newly published Swiss Biotech Report 2020.
It’s all hands on deck as government agencies, researchers, startups, biopharma giants, health care workers and payers combine their resources to develop proven COVID-19 therapies that can be ready for market by fall when the pandemic is expected to pick up steam again in the U.S. and other northern reaches of the world.
Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic.
Both ballyhooed and questioned as a potential savior from COVID-19, hydroxychloroquine is about to get a high-profile test by Basel, Switzerland-based Novartis AG. The company has reached an agreement with the FDA to run a phase III trial evaluating the drug for the treatment of hospitalized patients with COVID-19, with enrollment of 400 patients beginning within weeks and results to be reported as soon as possible.
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
LONDON – The U.K. treasury announced a £500 million (US$622.5 million) COVID-19 bailout plan for research-based startups, which could see the government holding equity stakes in venture capital-backed firms.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) commitment of up to $483 million to accelerate Moderna Inc.’s mRNA vaccine candidate, mRNA-1273, in efforts to fight coronavirus (SARS-CoV-2) would enable the company to supply millions of doses per month in 2020 and tens of millions per month in 2021 if the vaccine candidate is successful in the clinic.
HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis.
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
