Companies Rush to Develop Innovative Viral Medicines

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Apr 16, 2020, 09:00 ET

NEW YORK, April 16, 2020 /PRNewswire/ -- The global pandemic continues to affect day to day life, causing unprecedented public health and socioeconomic impacts and disproportionately affecting the vulnerable. Many communities around the world have already experienced a lack of access to routine, essential health services and financial struggles. The virus spreads fast, and according to the World Health Organization (WHO), is ten times deadlier than the 2009 flu pandemic. In addition, data shows that in some countries, cases are doubling every 3 to 4 days. This means that control measures such as social distancing, early case-finding, testing and isolating care for every case and tracing every contact must be lifted slowly, and with control. The WHO also indicates that control measures can only be lifted if the right public health measures are in place, including a significant capacity for contact tracing. In the meantime, various companies from a vast field of industries, including biotechs, medical device manufacturers, tech conglomerates and others have all made various announcements of products or services related to the pandemic. Codebase Ventures Inc. (OTC: BKLLF) (CSE: CODE), GlaxoSmithKline plc (NYSE: GSK), Moderna, Inc. (NASDAQ: MRNA), Pfizer Inc. (NYSE: PFE), BioNTech SE (NASDAQ: BNTX).

While biotechs reported work on vaccines or possible treatments and medical device companies reported progress on patient monitoring, many others were working on improving testing options. Recently, Rutgers University researchers have received U.S. government clearance for the first saliva test to help diagnose the virus, which is a new approach that could help expand testing options and reduce the risks of infection for healthcare workers. According to a report by the Associated Press, Andrew Brooks, who directs the Rutgers lab that developed the test, explained that the test "prevents health care professionals from having to actually be in the face of somebody that is symptomatic." The Rutgers lab can currently process 10,000 patient samples per day, according to Brooks. It is important to note that in the authorization letter to Rutgers, the FDA specified that the test should only be performed "in a health care setting under the supervision of a trained health care provider." As of right now, the FDA did not approve any tests for use at home, yet several companies have reported that such tests are being developed.

Codebase Ventures Inc. (OTCQB: BKLLF) (CSE: CODE) is also listed on the Canadian Securities Exchange under the ticker (CSE: CODE). The company just announced breaking news this morning that it, "is excited to announce that it has finalized a definitive agreement as of April 15th, 2020, securing the rights to an innovative drug delivery system for hydroxychloroquine.

"Codebase has finalized an exclusive agreement to launch a development transdermal patch program for hydroxychloroquine," said Mr. George Tsafalas, Codebase President & CEO. "Hydroxychloroquine in its current decades-old oral tablet form is subject to inconsistent dosing and side effects including nausea, vomiting, blurred vision, headache and overall toxicity."

Hydroxychloroquine has been heavily publicized as a promising drug treatment available today for Covid-19
CODE has agreed to acquire a 49% interest in a private company that has secured the rights to the recently applied provisional patent application for a transdermal delivery system for hydroxychloroquine (HCQ)
On March 28th, the FDA approved the emergency use of HCQ for Covid-19 patients and health care workers in an unprecedented move
This transformative delivery system will initially target Covid-19 through the FDA 505(b)(2) accelerated pathway provisions, and in the long term for the drug's FDA approved applications for malaria, lupus and rheumatoid arthritis – providing an innovation for those long-term patients who have depended on HCQ for decades and had to accept the side effects related to oral delivery.

Codebase has entered into an arms-length agreement to acquire a 49% interest in a private company, Glanis Pharmaceuticals Inc, that has recently filed for a US provisional patent for the transdermal delivery of hydroxychloroquine. The Company will issue up to 35 million common shares to the shareholders of this private company, as well as another 25 million shares pursuant to a lab services agreement with a New York based laboratory, Reformulation Research Laboratories Inc. (RRL), that developed the patent application and the underlying technology. These shares will be issued at a deemed price of $0.05 per share. The agreement is subject to closing conditions usually found in transactions of this kind.

While hydroxychloroquine is the subject of various early studies of its effectiveness against the Covid-19, its present on-label uses as a treatment against malaria, lupus and rheumatoid arthritis provides a ready market for this proposed new delivery system. This new delivery method should eliminate or reduce a number of the common side effects of this treatment, including nausea, vomiting, loss of appetite, diarrhea, dizziness, or headache by providing a controlled constant delivery.

Transdermal delivery can provide a drug plasma concentration at predetermined rate for a predetermined period of time, potentially drastically reducing side effects from decades-old oral tablets. Safe, consistent doses will make the drug much more effective at reduced dosages required because the GI system is avoided with transdermal delivery.

RRL has a combined 75 years of expertise in transdermal delivery systems that provide the capacity, equipment and capabilities to advance the development program for a hydroxychloroquine molecule for transdermal delivery from research, testing, regulatory approvals through to launch of the hydroxychloroquine transdermal delivery system.

The current phase of development includes literature search and pre-formulation studies.

The Company's scientific expert has read and approved the scientific disclosures contained in the press release.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 at this time."

For our latest "Buzz on the Street" Show featuring Codebase Ventures Inc. recent corporate news, please head over to: https://www.youtube.com/watch?v=KjW9JynKBio

GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology, Inc. announced last week that they have signed a binding agreement to enter into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration will use Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventative options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

Moderna, Inc. (NASDAQ: MRNA) announced last month that the first participant has been dosed in the Phase 1 study of the Company's mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). This Phase 1 study is being conducted by the National Institutes of Health (NIH) under its own Investigational New Drug (IND) application. mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI)."This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak."

Pfizer Inc. (NYSE: PFE) announced last week the company has been collaborating across the healthcare innovation ecosystem ranging from large pharmaceutical companies to the smallest of biotech companies, from government agencies to academic institutions to address the COVID-19 global health care crisis. Researchers and scientists have been relentlessly working to develop an investigational antiviral compound to treat SARS-CoV-2, which causes the current pandemic of coronavirus infections (COVID-19), a vaccine to prevent infection as well as evaluating other therapies that have scientific potential to help infected patients fight the virus. "We are committed to making the impossible possible," said Dr. Albert Bourla, Chairman and CEO. "In the spirit of the Five Point Plan that Pfizer issued, we are facing this public health challenge head on by collaborating with industry partners and academic institutions to develop potential novel approaches to prevent and treat COVID-19. Our researchers and scientists also have been exploring potential new uses of existing medicines in Pfizer's portfolio to help infected patients globally. We are leaving no stone unturned as we explore every option to help provide society with a treatment or cure."

BioNTech SE (NASDAQ: BNTX) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd announced last month a strategic development and commercialization collaboration to advance BioNTech's mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections. Under the terms of the agreement, the two companies will work jointly on the development of BNT162 in China. The companies will collaborate to conduct clinical trials in China leveraging Fosun Pharma's extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China. BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun. BioNTech will retain full rights to develop and commercialize the vaccine in the rest of the world.

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