COVID-19 dominates 2020 for biotech sector … and everyone else

The rumblings of the COVID-19 pandemic began in late 2019, when a coronavirus outbreak ripped through Wuhan in Central China. In January of this year, the large European pharmaceutical sector was preparing for a productive year, its only concerns geopolitical – Brexit and the US election. Fast forward a couple of months, however, and the pandemic had taken hold across the globe, and most biotech and pharma companies were scrambling to figure how they could apply their technology and expertise to find solutions – not only for the pandemic, but also for their bottom lines, injured as they were by the economic downturn. Meeting needs of a COVID world The pandemic saw things like regular drug development, elective surgeries, routine appointments and clinical trials put on hold, and many companies decided to pivot in some way to meet the needs of a COVID-19 world. There were humorous examples – like Scottish whiskey distilleries pivoting to produce hand sanitiser – but the prime example was Uğur Şahin and Özlem Türeci, founders of German firm BioNTech (NASDAQ:BNTX), focusing all their resources on developing a potential vaccine. BioNTech partnered with US pharma giant Pfizer (NYSE:PFE) and soon became the first company to have developed a COVID-19 vaccine approved by regulators. This vaccine was ready for rollout within 10 months, a remarkable effort considering many drugs take upwards of five years to go from development to approval. mRNA vaccines It was also the first-ever messenger RNA (mRNA)-based drug – which teaches cells how to make a protein that triggers an immune response inside the human body – to be approved for human use. Shore Capital analyst Adam Barker told Proactive mRNA vaccines would be remembered as a highlight of 2020. “It was a big year for the proof of concept of the technology, and it will be very interesting to see how it is expanded going forward,” he said. Other recent approvals for vaccines to treat COVID-19 have come from Chinese companies CanSino Biologics, Sinovac and Sinopharm, all approved for use in China, Russia’s Gamaleya Research Institute, approved for use in Russia, Belarus and Argentina and US company Moderna Therapeutics (NASDAQ:MRNA), approved for use in the US and Canada. AstraZeneca buzz Significant buzz has also surrounded Anglo-Swedish company AstraZeneca (LON:AZN), which is developing a vaccine in partnership with the University of Oxford, for which approval is imminent. Australia’s Therapeutic Goods Administration (TGA) has tacitly approved the AstraZeneca and BioNTech/Pfizer vaccines. And while there have been no ASX-listed companies making global headlines with vaccine developments, there was no shortage of news, ahead of what BB Healthcare Trust PLC (LON:BBH) portfolio manager Paul Major predicts will be a “better than normal” 2021. Setting stage for 2021 Paradigm Biopharmaceuticals Ltd (ASX:PAR) has been exceptionally busy, proceeding with development of its osteoarthritis drug Zilosul® with the US Food and Drug Administration (FDA), as well as dosing patients in its Phase II trial of its drug iPPS in patients with the ultra-rare orphan disease mucopolysaccharidosis. Speaking of the FDA, Pharmaxis Ltd (ASX:PXS) has received FDA approval for its Bronchitol® cystic fibrosis treatment, bringing US$10 million of cash milestones into the company’s coffers. Emyria Ltd (ASX:EMD) is talking up its potential in 2021, as it expects to make strong progress with its drugs EMD-003 and EMD-004, for mental health and irritable bowel syndrome respectively. Anteris Technologies Ltd (ASX:AVR) (OTCMKTS:AMEUF) (FRA:DDF) had an award-winning 2020, with its 3D single-piece aortic valve DurAVR™ being selected as Best Innovation at PCR London Valves 2020. Kazia Therapeutics Ltd (ASX:KZA) is rated as a speculative buy by equities researcher Bell Potter, with its drug paxalisib to be studied as a treatment for the rare paediatric brain cancer known as diffuse intrinsic pontine glioma. SUDA Pharmaceuticals Ltd (ASX:SUD) recently secured $2.7 million in funding, designed to develop its current assets including the cancer-fighting anagrelide, which has secured an Australian patent and had its potential rubber-stamped by a pharmacokinetic study. Cardiex Ltd (ASX:CDX) had record half-year sales and is on track for a 30 per cent year-on-year sales increase thanks to demand for its wearable health monitoring devices. CEO Craig Cooper said he expected sales to the clinician market to be strong as vaccine distribution rolled out across the US. Orthocell Ltd (ASX:OCC) recently received TGA approval for its collagen medical device CelGro®, holding it in good stead for FDA approval in 2021, while Imugene Ltd (ASX:IMU (OTCMKTS:IUGNF) has enrolled patients for its Phase I clinical trial of its checkpoint immunotherapy drug PD1-Vaxx. In medical technology, Nanoveu Ltd (ASX:NVU) is focusing its attention on securing international distribution agreements for antiviral products and advancing sight-correction EyeFyx technology, while VIP Gloves Ltd (ASX:VIP) is seeing increasing demand for its nitrile gloves in line with increased PPE requirements. - Daniel Paproth