Pharmaceutical Development Ramp up as Viral Infections Continue to Threaten - Algernon Pharmaceuticals (OTC:AGNPF)

NEW YORK, March 24, 2020 /PRNewswire/ -- The global pharmaceutical contract development and manufacturing industry is driven by various major factors; these include the rising demand for generics, the increasing investments in pharmaceutical R&D, and overall investments in advanced manufacturing technologies by contract development and manufacturing organizations (CDMOs). Furthermore, the pharmaceutical manufacturing segment is estimated to account for the largest market share in 2019. This segment can be attributed to the growing need to reduce manufacturing cost as well as the requirement for high-quality bulk manufacturing and the growing demand for generic drugs. This industry also includes pharmaceutical API (active pharmaceutical ingredient) manufacturing and pharmaceutical FDF (finished dosage form) manufacturing – both of which are expected to grow due to the growing drug development activity. Additionally, overall, the global pharmaceutical contract development and manufacturing market is projected to reach USD 126.6 Billion by 2024 from USD 90.0 Billion in 2019 while at a CAGR of 7.1%, according to data provided by MarketsandMarkets. Algernon Pharmaceuticals Inc. AGNPF AGN, Novavax, Inc. NVAX, Moderna, Inc. MRNA, OPKO Health, Inc. OPK, iBio, Inc. IBIO

In the meantime, the current outbreak continues to force governments and business to try and come up with innovative solutions to slow down the spread of the virus. As of Monday, the World Health Organization (WHO) reported that global cases eclipsed 350,000 and deaths soared past 15,000. WHO Director-General Tedros Adhanom Ghebreyesus said at a press briefing that "the pandemic is accelerating … It took 67 days from the first reported case to reach 100,000 cases, 11 days for second 100,000 cases, and just four days for the third 100,000 cases." The real number of those infected is expected to be much higher. Specifically, the number of people who have the virus but don't show symptoms and have not been tested is currently unknown. Yet, studies have shown that it is people without symptoms that are causing substantial amounts of infection. As a result, WHO officials have warned that the outbreak could overwhelm health systems around the world in just a few weeks, urging governments to act swiftly. "Take one look at what's happening in some health systems around the world. Look at the intensive care units completely overwhelmed. Doctors and nurses utterly exhausted," Mike Ryan, Executive Director of the WHO's emergencies program, said Friday. "This is not normal. This isn't just a bad flu season."

Algernon Pharmaceuticals Inc. AGNPF AGN is also listed on the Canadian Securities Exchange under the ticker AGN. Yesterday, the Company announced breaking news that, "it has awarded the contract to manufacture the active pharmaceutical ingredient for NP-120 (Ifenprodil), to U.S. based Cascade Chemistry. Algernon has made the decision to scale-up cGMP manufacturing of Ifenprodil to support its quickly evolving clinical program for acute lung injury (ALI), its urgent clinical focus on COVID-19 (Coronavirus), as well as its idiopathic pulmonary fibrosis (IPF) clinical program. Cascade Chemistry, based in Eugene Oregon, are specialists in chemical synthesis.

As work begins on the synthesis of Ifenprodil, the Company will also be moving forward as soon as possible with toxicity testing, as well as the development of new formulations for parenteral injection for ALI and an oral slow release formulation for IPF.

'We are every pleased to have appointed Cascade Chemistry to start the synthesis of Ifenprodil," said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. "The Company believes strongly in the potential of Ifenprodil to treat patients who are suffering from a severe acute lung injury as a result of various forms of respiratory diseases including coronavirus, influenza, and IPF."

About Cascade Chemistry: Cascade Chemistry, is a contract research and manufacturing organization focusing on developing and scaling synthetic processes and working with client's API's from discovery to clinical manufacturing.

For nearly 40 years, Cascade Chemistry has provided crucial chemistry problem solving services to its clients. Over this time, it has developed a reputation as a reliable and experienced outsourcing partner. Cascade Chemistry continues to expand it's R&D, process chemistry, and cGMP offerings. https://cascadechemistry.com/ …"

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Novavax, Inc. NVAX announced earlier this month that the Coalition for Epidemic Preparedness (CEPI) awarded an initial funding of $4 million to support Novavax' efforts to develop a COVID-19 vaccine. CEPI and Novavax are having ongoing discussions on additional funding from CEPI to address Novavax' costs through Phase 1. "This first stage of funding from CEPI is critical to enable ongoing development of our COVID-19 vaccine candidates," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We commend CEPI for its role as a vital partner to bridge the funding gap for innovative biotech companies like Novavax, which have robust vaccine technology platforms. Novavax is working tirelessly to create a vaccine against this growing epidemic." Novavax has produced and is currently assessing multiple recombinant nanoparticle vaccine candidates in animal models prior to advancing to clinical trials. Initiation of Phase1 clinical testing is expected in late spring of 2020. Novavax' COVID-19 vaccine candidates were created with its proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax also expects to utilize its proprietary Matrix-M™ adjuvant with its COVID-19 vaccine candidates to enhance immune responses.

Moderna, Inc. MRNA announced last week 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."

OPKO Health, Inc. OPK announced a collaboration with the City of Detroit to provide coronavirus disease 2019 (COVID-19) testing. BioReference will provide COVID-19 testing at drive-through locations for Detroit residents by appointment. "The impact that expanded testing will have on residents of the City of Detroit is immeasurable," said Mike Duggan, Mayor of the City of Detroit. "Myself, and the residents of this great city are grateful for our relationship and partnership with BioReference." "This is another example of BioReference assisting local governments around the country to provide COVID-19 testing," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "In addition to providing the residents of Detroit increased access to testing, there are first responders in the city who are waiting to get tested and we are privileged to support the exposed men and women on the front-lines in Detroit."

iBio, Inc. IBIO announced last week its progress towards developing vaccine candidates for preventing infection from the SARS-CoV-2 virus that causes the COVID-19 coronavirus disease. iBio created its SARS-CoV-2 Virus-Like Particle ("VLP")-based constructs in just a few weeks using its FastPharming System™ to produce the nanoparticles in, and purify them from, plants. "We are pleased with both the speed of our development activities and the quality of the VLPs our technology is yielding in practice," said Tom Isett, Co-Chairman & CEO of iBio. "The tightly controlled particle size allows for uniform antigen display, which should translate to a consistent dose response and a highly efficient production process, facilitating a ramp-up to tens of millions of doses if we are successful in the clinic."

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