Palm Beach, FL – March 16, 2020 – The U.S. and other countries worldwide are sharing information and mobilizing to collectively corral the coronavirus pandemic with all due speed. As a result, a new and private/public collaboration has been formed and it is formidable, and expectations are high. Friday March 13, the White House held a conference with members of the Coronavirus task force and after the meeting in which the President declared a national emergency, the scope of this new collaboration was revealed. Major U.S. companies such as Roche, Quest, LabCorp and others spoke of their recent advancement and their sharing of data. The removal of time consuming regulations was also confirmed. Also the chief executives of Target, Walgreens, Walmart and CVS pledged during the news conference to make space available in their store parking lots. The President said: “The emergency orders I am issuing today will also confer broad new authority to the Secretary of Health and Human Services. The Secretary of HHS will be able to immediately waive provisions of applicable laws and regulations to give doctors, hospital — all hospitals — and healthcare providers maximum flexibility to respond to the virus and care for patients.” Mentioned in today’s commentary include: NanoViricides, Inc. (NYSE: NNVC), OPKO Health, Inc. (NASDAQ: OPK), Gilead Sciences, Inc. (NASDAQ: GILD), Mylan N.V. (NASDAQ: MYL), Eli Lilly and Company (NYSE: LLY).
The President continued: “We’ll remove or eliminate every obstacle necessary to deliver our people the care that they need and that they’re entitled to. No resource will be spared. Nothing whatsoever. Ten days ago, I brought together the CEOs of commercial labs at the White House and directed them to immediately begin working on a solution to dramatically increase the availability of tests. Other countries have called us and worked with us, and they’re doing similar things or will be doing similar things. As a result of that action, today we’re announcing a new partnership with private sector to vastly increase and accelerate our capacity to test for the coronavirus. We want to make sure that those who need a test can get a test very safely, quickly, and conveniently… “
NanoViricides, Inc. (NYSE American: NNVC) Breaking News: Coronavirus Drug Development Update from NanoViricides, Inc. – NanoViricides, Inc. (the “Company”), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines platform (the “Company”), is providing an update on its efforts towards drug development for the current novel coronavirus SARS-CoV-2 that causes COVID-19.
The Company has completed the synthesis of a number of nanoviricide drug candidates for testing in just a few weeks after identification of virus-binding ligands. This was possible because the Company is boot-strapping its efforts on the basis of its inventory of novel custom chemicals in hand. Additionally, the polymer backbone was previously manufactured in multi-kilogram quantities. However, there can be no assurance that any of these candidates would show sufficient effectiveness and safety for human clinical development at this time.
The Company has acquired and expanded two different, low-threat circulating coronaviruses in its own BSL2 lab, and has already expanded them to enable testing of drug candidates. One of these coronaviruses, namely NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2, although it does not cause a similar severe disease in humans.
If the Company’s test candidates are effective against these cell culture studies against coronaviruses, then that would provide a strong rationale that they may be expected to be effective against the current SARS-CoV-2. Presently, the Company does not have any collaboration established for further testing of its drug candidates against SARS-CoV-2. The Company is working to establish such collaborations, however, there can be no assurance that we will be successful in establishing the necessary collaborations or that our drug candidates will succeed in further testing. In the past, the Company has established and worked on collaborations with the U.S. Center for Diseases Control and Prevention (CDC), as well as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).
The Company has already successfully developed antiviral drug testing assays based on cell culture infection of certain low-threat coronaviruses viruses in our own BSL2 certified virology lab. Development of an assay to test the effectiveness of a drug candidate is an important milestone in the drug development process. We have been able to complete this milestone in just a few weeks because of the extensive experience and expertise in medium throughput drug testing antiviral assays development of our Senior Virologist.
Testing of our drug candidates against these BSL2 coronavirus strains is expected to begin shortly in our BSL2 virology lab.
As of March 11th, SARS-CoV-2 has caused at least 800 confirmed cases in more than 30 states, and the virus has led to more than 26 deaths in the U.S., with area lockdowns, quarantines, and state of emergency being declared in several states. The entire country of Italy is under quarantine. Japan is also experiencing a severe outbreak. This COVID-19 outbreak has caused cases in at least 99 countries, with confirmed cases totaling over 110,000, of which 62,000 have already recovered, with deaths of over 3,800 patients, according to CBS news (https://www.cbsnews.com/live-updates/coronavirus-outbreak-death-toll-us-infections-latest-news-updates-2020-03-09/). The health risks associated with the virus rise significantly with age and many younger, otherwise healthy people who contract it might show only mild symptoms, if any. It appears that the outbreaks in China and in South Korea are now showing signs of being controlled, with new cases having decreased significantly.
The U.S. Government has approved $8.3 Billion for COVID-19 response that includes development of drugs as well as vaccines, patient care, containment, and education, in a holistic approach.
Although vaccine development has started very quickly against the SARS-CoV-2, an effective vaccine may take at least 12-18 months before it can be used to treat patients.
Viruses are known to escape antibody drugs and vaccines via mutations. In contrast, the NanoViricides platform technology enables development of a drug that a virus is unlikely to escape by mutation. This is because we develop biomimetics that are designed to interfere with the virus binding to its cognate cellular receptor, and are further capable of disabling the virus from binding to cells. Coronaviruses mutate less rapidly than other RNA viruses such as influenza and HIV.
One of the coronaviruses we are using for testing of our drug candidates uses the same ACE2 receptor as the current SARS-CoV-2 virus (aka nCoV-2019). However, this coronavirus does not cause similar, severe disease in humans. Another coronavirus we are testing against uses a different but somewhat related receptor (in terms of biophysics). Investigating against both of these strains would allow us to examine which of the test candidates have more broad-spectrum effectiveness. However, there can be no assurance that successful results against these forms of coronavirus will lead to similar results against nCoV-2019 aka SARS-CoV-2. Moreover, the path to typical or standard drug development of any pharmaceutical product is extremely lenghty and requires substantial capital. However, regulatory agencies in China created expedited processes to enable rapid clinical testing of exploratory drug candidates. Accelerated pathways were also developed for enabling anti-Ebola clinical drug candidates in the 2017-18 epidemic in DRC. Nevertheless, there can be no assurance that even successful results against SARS-CoV-2 will lead to successful clinical trials or a successful pharmaceutical product, which is true of every drug development effort against SARS-CoV-2 at present.
Previously, on January 30th, the Company confirmed that it is working on a drug to treat the SARS-Cov-2 virus infections. The Company said that it had successfully completed the important milestone of finding potential virus-binding ligands that mimic the ACE2 interaction with SARS-CoV (2002) using molecular modeling. The current coronavirus strain, namely SARS-CoV-2 is closely related to the 2002 SARS-CoV, and uses the same human cellular receptor. We have now completed the next two milestones, namely synthesis of test candidates, and development of anti-CoV assays for testing them.
In other biotech news in the markets this week:
OPKO Health, Inc. (NASDAQ: OPK) Recently, BioReference Laboratories, Inc., an OPKO Health company, is now accepting specimens for testing of coronavirus disease 2019 (COVID-19) from healthcare providers, clinics and health systems throughout the United States. In addition, BioReference has announced a partnership with the New York State Department of Health to provide testing for the first public drive-through testing facility on the East Coast. The facility will be located in New Rochelle, NY, the epicenter for the New York State outbreak. BioReference, in partnership with the state of New York, also expects to begin offering up to 5,000 tests a day at additional satellite testing sites to be set up next week.
“Cases of COVID-19 are increasing across the US, making access to testing a critical component in helping healthcare providers identify infected patients more quickly. BioReference has been working expeditiously to develop and offer this test that will yield high-quality and accurate results,” said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. “I believe that the private sector should be part of the solution in controlling the COVID-19 outbreak and am proud that BioReference can assist Governor Cuomo as he leads New York State through this crisis.”
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March. The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing for remdesivir for the treatment of COVID-19.
The new clinical studies expand the ongoing research into remdesivir, which includes two clinical trials in China’s Hubei province led by the China-Japan Friendship Hospital as well as the recently initiated clinical trial in the United States led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from those in China expected in April.
Mylan N.V. (NASDAQ: MYL) recently announced the launch of Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), the first available bioequivalent alternative to ADVAIR DISKUS in Canada . Wixela Inhub was approved by Health Canada in January for the twice daily maintenance treatment of asthma in patients age 4 and older not adequately controlled on long-term asthma control medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta2-agonists; or maintenance treatment of COPD.
Eli Lilly and Company (NYSE: LLY) and AbCellera recently announced they have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera’s rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
Within one week of receiving a blood sample from one of the first U.S. patients who recovered from COVID-19, AbCellera screened over 5 million immune cells looking for ones that produced functional antibodies that helped the patient neutralize the virus and recover from the disease. From this effort, AbCellera has identified over 500 unique fully human antibody sequences, the largest panel of anti-SARS-CoV-2 antibodies ever reported. The next step is to screen these antibodies to find the ones most effective in neutralizing SARS-CoV-2. Many of these antibodies will be expressed in collaboration with partners at the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and pending agreement with NIAID will be tested for their ability to neutralize the virus.
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