The Threat of Infectious Diseases Impulses Governments and Businesses Towards Adjustments

NEW YORK, April 3, 2020 /PRNewswire/ -- Infectious diseases are caused by pathogenic microorganisms such as bacteria, viruses, fungi and parasites, and can be transmitted by direct or indirect contact. Worldwide, infectious diseases such as malaria, HIV, tuberculosis, influenza, hepatitis A, hepatitis C and the more recent pandemic have put major strains on public health. According to recent reports, Italy announced a record number of deaths as the outbreak continued to spread, while Spain reporting a similarly alarming death-toll spike. As a result, more governments are taking extreme measures in an attempt to 'flatten the curve' of the spread, including increasing social distancing protocols and restricting mass gatherings. According to the Center for Disease Control (CDC), the goal of using mitigation strategies in communities with local virus transmission is to slow the transmission and in particular protect individuals at an increased risk for severe illness, including older adults and persons of any age with underlying health conditions. "By intervening early in an epidemic we are wanting to limit the spread of an infection," says Hussan Vally, an epidemiologist in public health at La Trobe University, Australia, according to CNET. "This reduces the number of cases that will present at any one time as the epidemic progresses and it also reduces the number of cases at the peak of the epidemic... This changes the shape of the epidemic curve and flattens it out. By flattening out the epidemic curve we are aiming to reduce the load on the health system at any one time to prevent a situation where the sheer number of cases means the health system is overwhelmed." BioELife Corp. (OTC: LITH), Co-Diagnostics, Inc. (NASDAQ: CODX), Vir Biotechnology, Inc. (NASDAQ: VIR), Novavax, Inc. (NASDAQ: NVAX), Moderna, Inc. (NASDAQ: MRNA)

The implications from the outbreak are vast and complicated for business stakeholders and customers alike, as international and local supply chains are under unprecedented economic pressure. Major industries, such as tourism, airlines, dining, film and others are now in system paralysis. As for other, younger industries, the implications are not as clear. Companies in the cannabis industry, for example, can go through a rollercoaster of supply shortages on one hand, and an increase in sales on the other. According to Forbes, Danny Davis, CEO and founder of Offstage Holdings (investing in hemp extraction and CBD companies), the pandemic would disrupt the supply chain of CBD products because companies rely on China as a major provider of hardware in their industry. Yet, Cannabis Business Time reported that the outbreak had caused an increase in cannabis sales including emergent delivery sales. According to Pedro Fonseca, General Manager of the company's San Jose location in California, sales were up 5% this week across Harborside's four retail locations.

BioELife Corp. (OTC: LITH) announced earlier last month that, "William (Bill) Marciniak is joining its Advisory Board of external experts to assist the Company in its strategic development. Mr. Marciniak brings over 35 years of pharmaceutical and manufacturing experience to help BioELife expand its product line, manufacturing and distributor relationships.

As a co-founder of RxElite, Mr. Marciniak achieved great success developing and producing albuterol and ipratropium. After acquiring the appropriate ANDA certification for each product, contracting with the top manufacturers and leading the distribution efforts, RxElite captured 33% market share in just 18 months. Their clients were the top wholesalers, distributors and pharmacy chains in America. RxElite was eventually acquired by Piramal Medical, a ten-billion-dollar healthcare organization based in India.

Over the past decade Mr. Marciniak has worked with some of the top wound care physicians in the world developing topical solutions for resistant microbials in the wound care sector. Mr. Marciniak's experience will be integral to the development of products for BioELife, particularly in the BioEDefense product line targeted at viral and bacterial infections.

Gregory Rotelli, Chairman of the Board and President of BioELife stated 'We are very excited that Mr. Marciniak has committed to work with BioELife to help grow our business. His experience will be fundamental in helping BioELife rapidly deploy solutions that are effective and help individuals defend themselves during this pandemic crisis. The future is full of challenges and BioELife will continue to develop its BioEDefense line of products to help people defend themselves against this viral and bacterial offensive. In addition, Mr. Marciniak will assist the Company in expanding its manufacturing, sourcing and strategic partnerships. Many of Bill's associates and contacts have already agreed to participate and help in our endeavors.'

About the Company: BioELife Corp was created by successful pharmaceutical entrepreneurs dedicated to using nature's resources to fight pain and infection while reducing the dependency on opioids and their terrible side effects. The Company is uniquely positioned to capitalize on the emerging Cannabinoid market that is growing at phenomenal rates and is expected to reach $20 Billion over the next five years. The Company has created a 'seed to shelf' value-added product development and marketing organization with direct contracts for raw materials, scientific proprietary formulation, manufacturing, and distribution of medically focused Cannabinoid products. Additionally, the Company has a BioEDefense line of products that provide advanced protection from viral and bacterial contamination."

Co-Diagnostics, Inc. (NASDAQ: CODX) announced last month that following a successful clinical evaluation of its Logix Smart(TM) COVID-19 Test, the Company will begin fulfilling orders from a wider array of U.S. customers, including thousands of additional laboratories in the country who can now run the Company's test as a clinical diagnostic. A recent FDA policy change aimed at expediting the availability of COVID-19 diagnostics has allowed the Company to expand domestic sales of its test immediately. Co-Diagnostics' COVID-19 polymerase chain reaction (PCR) test can yield results in under two hours, and successfully passed the clinical evaluation as requested in the policy change, showing sensitivity of 100% and specificity of 100% in detecting SARS-CoV-2, the virus which causes COVID-19, without demonstrating any cross-reactivity with other coronaviruses.

Vir Biotechnology, Inc. (NASDAQ: VIR) announced last week a collaborative research agreement to explore the potential for Generation Bio's non-viral gene therapy platform to extend the impact and reach of Vir's current or future human monoclonal antibodies (mAb) against SARS-CoV-2, the virus responsible for COVID-19. Generation Bio's technology has the potential to deliver genetic information directly to cells without the use of adeno-associated viruses (AAV), in effect instructing the patient's body to produce the antibody itself. "Together, we believe we can develop long-lasting therapies suitable for population-wide prevention and treatment," said Generation Bio President and CEO Geoff McDonough, M.D. "We are moving with urgency to explore leveraging our platform to build protection against COVID-19 for the long term."

Novavax, Inc. (NASDAQ: NVAX) and Emergent BioSolutions Inc. announced an agreement last week according to which Emergent will provide molecule-to-market contract development and manufacturing (CDMO) services to produce Novavax's NanoFlu(TM), its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M(TM) adjuvant. Novavax recently announced that NanoFlu met all primary objectives in its Phase 3 clinical trial evaluating immunogenicity and safety in adults aged 65 and older. Syed T. Husain, SVP and CDMO business unit head at Emergent BioSolutions said, "Our flexible and integrated CDMO offerings allow us to work with expedited timelines, execute on simultaneous engagements, and serve varying needs and approaches of customers like Novavax. As a trusted partner, we are committed to supporting Novavax's goals to advance their influenza program while maintaining the option to allocate capacity for a potential scaled-up COVID-19 program."

Moderna, Inc. (NASDAQ: MRNA) last week provided an update on the impact of the rapidly evolving COVID-19 pandemic on its business operations and clinical program development. Moderna's paramount obligation is to ensure the safety of all participants in its clinical programs and the integrity of the studies in which they participate. Moderna is actively monitoring the situation and making adjustments where necessary, and is responding to regulatory, institutional, and government guidance and policies related to COVID-19. The Company is using a risk-based framework to evaluate new participant enrollment and new site initiation on a case-by-case basis. Moderna remains committed to its clinical development plans and is working closely with all stakeholders to try to mitigate the impact of the pandemic on the Company's ongoing clinical trials.

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