FinancialBuzz.com News Commentary
New York, NY (7/23/2020) – The healthcare industry has made significant progress when it comes to efficiency and scope in the last several years, yet many complex issues remain unsolved. These issues are now particularly visible as the current pandemic is still spreading and ramping up the toll on healthcare systems. However, various segments of the healthcare industry have shifted focus to deal better with the consequences of the pandemic. For example, biotech companies are focusing on vaccine developments, personal protective equipment makers have accelerated production of masks and gloves, while medical device innovators focus on tests as well as devices that allow more efficient patient monitoring. Traditionally, patient monitoring devices are used in hospitals to monitor a patient’s vital signs. Nowadays, with the advancements in wireless technology, these devices can be used to remotely monitor a patient’s various physiological parameters. Today, during a severe viral pandemic, remote monitoring medical devices have become a crucial component of healthcare. Nemaura Medical, Inc. (NASDAQ: NMRD), Gilead Sciences, Inc. (NASDAQ: GILD), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), BioNTech SE (NASDAQ: BNTX), Vir Biotechnology, Inc. (NASDAQ: VIR)
According to a recent report by STAT from back in March, physicians at several hospitals said their discussions with makers of these devices have kicked into high gear in recent times after the FDA issued guidance indicating it would not object to modifications in the use or functionality of remote patient monitoring tools during the outbreak. “Traditional health care delivery is inadequate in dealing with this pandemic,” Raj Khandwalla, a physician and Director of Gigital Therapeutics for the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles. “We have to use a health care strategy that deploys resources throughout an entire community, and that’s where remote monitoring comes in.”
Nemaura Medical, Inc. (NASDAQ: NMRD) announced earlier last week breaking news that it has, “issued a presentation outlining potential new applications for monitoring disease progression in Covid-19 patients using Continuous Lactate Monitoring (CLM).
The Company has previously discussed the market for athletic performance monitoring using its non-invasive continuous lactate monitor (CLM), and based on recently published independent clinical evaluations, the measurement of blood lactic acid has been established as an indicator for disease progression in Covid-19 patients. The company has issued a presentation on this subject, which can be found here: https://nemauramedical.com/wp-content/uploads/2020/07/BEAT-CLM-in-Covid19-July-2020-1.pdf
Both the CGM and CLM products are based on Nemaura’s BEAT
platform, which is designed to non-invasively extract a number of analytes through the skin. By adapting the sensor chemistry, algorithm and mobile app interface initially developed for sugarBEAT®, the BEAT platform has the potential to be utilized for several markets beyond glucose monitoring and diabetes. Nemaura is evaluating the timelines for bringing the CLM to market as a Class 2 approved Medical Device.
About Nemaura Medical, Inc.: Nemaura Medical Inc. (NMRD) is a medical technology company developing micro-systems-based wearable diagnostic devices and currently commercializing sugarBEAT®, and proBEAT. sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse and prevent the onset of diabetes. Nemaura has also submitted a PMA application for sugarBEAT® to the U.S. FDA. proBEAT comprises a non-invasive glucose monitor and a digital healthcare subscription service and is due to be launched in the US as a general wellness product.”
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Gilead Sciences, Inc. (NASDAQ: GILD) announced earlier this month additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir. The data are being presented at the Virtual COVID-19 Conference as part of the 23rd International AIDS Conference (AIDS 2020: Virtual) and include a comparative analysis of the Phase 3 SIMPLE-Severe trial and a real-world retrospective cohort of patients with severe COVID-19. In this analysis, remdesivir was associated with an improvement in clinical recovery and a 62 percent reduction in the risk of mortality compared with standard of care – an important finding that requires confirmation in prospective clinical trials. Separate subgroup analyses from the Phase 3 SIMPLE-Severe trial, including an evaluation of the safety and efficacy of remdesivir across different racial and ethnic patient subgroups treated in the United States, found that traditionally marginalized racial or ethnic groups treated with remdesivir in this study experienced similar clinical outcomes as the overall patient population in the study.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) announced earlier this week that it had received clearance from the FDA to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms. Abivertinib is a novel small molecule tyrosine kinase inhibitor (TKI) that selectively targets both mutant forms of the epidermal growth factor receptor (EGFR) and Bruton’s tyrosine kinase (BTK). On May 21, 2020, Sorrento announced that it had entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ Abivertinib across all indications for all territories outside of China. The parties have since entered into an exclusive license agreement. Abivertinib irreversibly binds to the BTK receptor, preventing the phosphorylation of the receptor. Due to this effect, it has shown potent immunomodulatory activities in vitro by inhibiting key pro-inflammatory cytokine production, including IL-1beta, IL-6 and TNF-alpha. These cytokines are associated with cytokine release syndrome (CRS) or cytokine storm and COVID-19 disease progression with poor outcomes in patients with acute respiratory distress syndrome (ARDS).
BioNTech SE (NASDAQ: BNTX) Pfizer Inc. announced yesterday the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine candidate jointly developed by Pfizer and BioNTech, after Pfizer successfully manufactures and obtains approval or emergency use authorization from U.S. Food and Drug Administration (FDA). The U.S. government will pay the companies USD 1.95 Billion upon the receipt of the first 100 million doses, following FDA authorization or approval. The U.S. government also can acquire up to an additional 500 million doses.
Vir Biotechnology, Inc. (NASDAQ: VIR) reported back in May that is has finalized a process development and manufacturing agreement with Biogen Inc. based on the letter of intent that the companies announced in March. Under the agreement Biogen will perform process development activities and specified manufacturing and process transfer services to enable commercial supply of Vir’s SARS-CoV-2 monoclonal antibodies. “Biogen’s world-class cell line and process development expertise is a tremendous asset as we work with great urgency to develop our antibody candidates, including employing technology that is designed to maximize the yield of each manufacturing batch produced,” said Michael Kamarck, Ph.D., Chief Technology Officer of Vir. “The willingness of both Vir and Biogen to begin work before the definitive agreement was in place exemplifies our shared commitment to working in unconventional ways in the interest of the public good, and mutual recognition that bringing these therapies to people at the speed and scale that is needed requires the combined resources of multiple collaboration partners and significant manufacturing capacity.”
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