Technological Advancements Expand Biopharmaceuticals' Production Capabilities

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Jan 10, 2020, 09:00 ET

NEW YORK, Jan. 10, 2020 /PRNewswire/ -- The biopharmaceutical industry is driven by multiple factors, all while rapidly evolving in the digital era. The need to engineer drugs to treat emerging diseases, an increase in the geriatric population and rare medical conditions all fall under this umbrella. Additionally, investments in the research and development within the field have resulted in several novel drugs for diseases that are both effective and affordable. Data published by IQVIA™ Institute for Human Data Science shows that global drug spending reached USD 1.2 Trillion in 2018 and an estimated USD 1.5 Trillion will be spent by 2023. The key drivers of growth during the next five years are expected to be the United States as well as various emerging markets, with expected 4-7% and 5-8% compound annual growth rates, respectively. Meanwhile, artificial intelligence is transforming the development of medicines, with expedited processes and a larger range of areas researched. Currently, the use of smart algorithms to analyze large complex datasets is most advanced in areas of clinical and pre-clinical research and has applications in assessing preclinical compounds, identifying potential targets based on real-world data, and in driving efficiencies in clinical development. As a result, the number of new products launched by biopharmaceuticals is expected to increase from an annual average of 46 in the past five years to an average of 54 through 2023. NanoViricides, Inc. (NYSE: NNVC), Gilead Sciences, Inc. (NASDAQ: GILD), Sarepta Therapeutics, Inc. (NASDAQ: SRPT), AbbVie Inc. (NYSE: ABBV), Ionis Pharmaceuticals, Inc. (NASDAQ: IONS)

A major segment of the biopharmaceutical industry is the antiviral drug market. Antiviral drugs are medicines that diminish the ability of flu viruses to reproduce. Overall, antiviral drugs were manufactured to help reduce the duration of flu symptoms in otherwise healthy children and adults and may reduce the severity of common flu symptoms. The drugs are suggested for both treatment and prevention of flu, while some may also reduce the risk of complications such as ear infections in children, respiratory complications requiring antibiotics, and hospitalization in adults. Viruses use the host's cells to replicate, therefore producing a harmless and effective antiviral drug is very complicated. Most antivirals are used for specific viral infections, while a broad-spectrum antiviral is effective against a wider range of viruses. Factors such as rising occurrences of viral infection, increased public awareness, a rise in healthcare expenditure and effective investments in R&D are expected to boost the global antiviral drug market growth. And according to a research report published by Reports and Data, the global antiviral drugs market was valued at USD 49.87 Billion in 2018 and is projected to reach USD 71.48 Billion by the year 2026 while rising at a CAGR of 4.6%.

NanoViricides, Inc. (NYSE: NNVC) announced yesterday that it has, "successfully completed genetic toxicology testing required to support the IND application for NV-HHV-101 moving towards human clinical trials.

NV-HHV-101 was found to be safe in terms of potential genotoxicity in the suite of tests that were performed by an independent laboratory. The drug did not induce mutations in bacteria and did not cause chromosomal damage in human cells.

In the Ames test, NV-HHV-101 was negative for the ability to induce mutations in genes of several strains of Salmonella typhimurium and of Escherichia coli, both in the presence and absence of an exogenous metabolic activation system. The Ames test is used to assess the direct ability of a drug to cause mutations in DNA or genes, using bacterial cells.

Similarly, in the standard "Micronucleus" test NV-HHV-101 was negative at all doses tested for the induction of chromosomal damage in the human TK6 cell line, both in the presence and absence of the exogenous metabolic activation system. The Micronucleus test is used to assess the potential of a drug candidate to cause chromosomal damage in human cells.

These tests, taken together, are conducted to identify potential carcinogens. These tests are conducted in the presence and absence of metabolic activation system. This is because metabolism of a drug can cause the formation of potential carcinogens. A high, but not complete, correlation has been found between carcinogenicity in animals and mutagenicity in the Ames test or chromosomal damage in the micronucleus test. NV-HHV-101 was found to have no DNA, gene, or chromosome damaging activity in these tests.

The US FDA and other international regulatory authorities require these genetic toxicological studies to support the Investigational New Drug (IND) Applications for entering human clinical trials.

Upon completion of all of the required IND-enabling studies, and receiving the relevant reports from our external collaborators, the Company anticipates filing an IND with the US FDA to advance NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication.

The market size for the treatment of shingles is estimated at about one billion dollars by various estimates. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1million cases of shingles occur in the USA alone every year.

The market size for our immediate target drugs in the HerpeCide™ program is variously estimated into billions to tens of billions of dollars. The Company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials. The Company believes that additional topical treatment candidates in the HerpeCide™ program, namely, HSV-1 "cold sores" treatment, and HSV-2 "genital ulcers" treatment are expected to follow the shingles candidate into IND-enabling development and then into human clinical trials. These additional candidates are based on NV-HHV-101, thereby maximizing return on investments and shareholder value.

About NanoViricides: NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-HHV-101 with its first indication as dermal topical cream for the treatment of shingles rash. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. FDA refers to US Food and Drug Administration."

Gilead Sciences, Inc. (NASDAQ: GILD) announced recently that the company has licensed The Rockefeller University's portfolio of broadly neutralizing antibodies (bNAbs) against HIV, including the two clinical-stage agents 3BNC117 and 10-1074. These investigational agents have potential for use in HIV long-acting therapies for treatment and prevention, as well as cure strategies. Initial pre-clinical and clinical research has shown that HIV bNAbs can produce an enhanced, prolonged immune response to HIV, representing a promising new approach for HIV treatment or prevention in combination with other long-acting agents, or prolonged virologic remission in the absence of antiretroviral use. "The Rockefeller University's broadly neutralizing HIV antibodies are well studied and have shown exceptional promise in early clinical trials," said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. "By harnessing the body's own immune system against HIV, we seek to continue driving scientific innovation that will transform care and improve overall outcomes for all people living with HIV."

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) and StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV) based gene therapies, announced earlier last year the signing of a collaboration and license agreement to develop in vivo AAV-based therapies for up to eight central nervous system (CNS) and neuromuscular targets. Pursuant to the agreement, Sarepta is granted an exclusive license on selected targets to leverage StrideBio's novel, structure-driven capsid technology, intended to enhance specific tropism to tissues of interest and evade neutralizing antibodies. The parties also plan to focus on strategies intended to address re-dosing challenges in patients who have received AAV-delivered gene therapy. StrideBio will conduct all investigational new drug (IND) enabling research, development and manufacturing for the first four CNS targets, which are MECP2 (Rett syndrome), SCN1A (Dravet syndrome), UBE3A (Angelman syndrome), and NPC1 (Niemann-Pick). Additionally, Sarepta will have an exclusive option to four additional targets based on StrideBio's capsid technology. "With our partnership with StrideBio, Sarepta continues to build on its leadership position in gene therapies to treat rare diseases. We are excited to work with StrideBio and access its innovative AAV platform for next-generation capsids," said Doug Ingram, Sarepta's President and Chief Executive Officer. "Our partnership with StrideBio expands our research portfolio by up to eight new targets and, through our strategic partnering approach that has our collaborator lead all IND-enabling research and development, ensures that we gain access to new technology and targets while not distracting Sarepta from its near-term priorities."

AbbVie Inc. (NYSE: ABBV) announced earlier in September that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET® (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). In August 2017, MAVYRET received regulatory approval in the U.S. as an 8-week, pan-genotypic treatment for treatment-naïve HCV patients without cirrhosis. "While over 100,000 patients have been prescribed MAVYRET for chronic HCV in the US‡, there are still a significant number of patients that need options," said Janet Hammond, M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. "This approval provides more HCV patients an option to treat their disease in as little as 8 weeks." The label expansion was based on data from the Phase 3b EXPEDITION-8 study, a single-arm, open-label study evaluating the safety and efficacy of MAVYRET in treatment-naïve adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatment (SVR12).

Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced last year that GSK exercised its option to license Ionis' antisense medicines for people with chronic hepatitis B virus (CHB) infection following positive Phase 2 results. CHB is a chronic viral infection of the liver that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer. Current treatments for patients with CHB provide low levels of hepatitis B virus S antigen seroclearance, leaving many patients without a treatment to achieve sustained disease remission. There are more than 200 million patients worldwide living with CHB. "By targeting the root cause of CHB-related liver disease, our antisense technology can potentially deliver a transformative medicine for people who suffer from chronic hepatitis B virus infection," said Brett P. Monia, chief operating officer at Ionis. "We believe GSK's development and commercialization expertise in infectious diseases makes them the ideal partner to help address this high unmet need."

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