NNVC - Description of Business Model
NanoViricides, Inc. (the “Company”), is a nano-biopharmaceutical company whose business goals are to discover, develop and commercialize therapeutics to advance the care of patients suffering from life-threatening viral infections. We are a development stage company with several drugs in various stages of early development. Our drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc., to which we have the necessary licenses in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Influenza and Asian Bird Flu Virus. We focus our research and clinical programs on specific anti-viral solutions.
We are seeking to add to our existing portfolio of products through our internal discovery and clinical development programs and through an in-licensing strategy. The Company owns exclusive worldwide license in perpetuity to technology that enables the creation of “nanoviricides (tm)”. A nanoviricide is a flexible nano-scale material about the size of a few billionths of a meter,that is chemically programmed to specifically target and attack a particular type of virus, like a guided missile. A nanoviricide also is capable of simultaneously delivering a devastating payload of active ingredients into the virus particle, thereby completely destroying the enemy, like a suicide bomber.
Nanoviricides thus act by completely novel and distinctly different mechanisms compared to most existing anti-viral agents. The self- assembling nanoviricide “trojan horses” course through the blood stream, seek their target, i.e. a specific virus particle, attach themselves to the virus particle target, fuse with the virus particle, thereby destroying the virus particle's ability to infect host cells, and go further to deploy active ingredients into the virus particle that can be chosen so as to destroy the virus genetic material (such as viral DNA, viral RNA, etc.), as well as to destroy key viral components that the virus carries inside its “belly” (such as the reverse transcriptase, the protease, and the integrase carried by HIV particles). We believe this gives us an edge in the field of anti-viral therapy.
The nanoviricides function without any dependence on the body's immune system, and therefore may be expected to be superior to antibody- based anti-viral agents, as well as therapeutic vaccines, which depend upon immune system components of the body for effectiveness to various extents. Anti-body based viral agents such as Hepex B(tm) (Cubist/ XTL Bio) have been approved by regulatory agencies.
The Company believes that because the nanoviricide assembly hides the toxic anti-viral agents in its “belly” and delivers these only into the viral particles in a specifically targeted manner, the side effects related to systemic toxicity of anti-viral agents may be substantially lower with the nanoviricides than with the existing anti-viral therapies. Existing anti-viral therapies simply load the naked toxic active pharmaceutical ingredient (API) into the entire body, thereby affecting human cells, which may be responsible for substantial portion of their toxic effects. This current approach is akin to strafing with a rifle through busy city streets with the hope of hitting a terrorist or a criminal! In contrast,
nanoviricides are like guided missiles.
The Company believes that nanoviricides act by a novel set of multiple,concerted, mechanisms. We believe that this makes them unique, and gives them an edge in the marketplace. However, being so novel, our drugs are not directly comparable to existing anti-viral therapies and classes of drugs. Thus, the safety and efficacy of the nanoviricides needs to be established by experimentation, and cannot be anticipated on the basis of any similar information regarding existing drugs.
A typical nanoviricide drug is designed like a chemical missile. It has a number of recognition "ligands" on its surface, that are specific to a single type of virus, say HIV. They are like the GPS on a directed missile. They will identify the enemy and attach to specific "landing sites" on the enemy target.
The nanoviricide micelle, after landing onto a virus particle, is capable of spreading itself all over the virus particle, and thus it can completely envelope and thereby neutralize and disable the virus particle from binding to its target, a human cell.
This is the uniqueness of the flexible TheraCour nanomaterials. Hard sphere nanomaterials such as dendritic materials, nanogold shells, silica, gold or titanium nanospheres, polymeric particles, etc., are generally not capable of completely enveloping and neutralizing the virus particle in this fashion.
The Company thus believes that our approach is far superior to existing approaches to anti-viral therapy. The Company believes that our drugs will form the major weapons of fight against HIV/AIDS even after the other therapies have failed, or in conjunction with the existing therapies. This is because the current nanoviricides approach is based on reduction in viremia, i.e. free virus particles in the blood stream, in contrast to existing agents which are directed against control of intercellular replication of HIV. Uncontrolled viremia occurs in the AIDS stage of HIV, even if current drugs are still in use in that patient. Control of viremia is known to be very important for arresting further progression of the disease as well as for reducing the likelihood of secondary opportunistic infections. Secondary infections are the major cause of HIV/AIDS-related deaths.
The Company does not claim to be creating a cure for HIV or any other viral disease. The Company's objectives are to create the best possible anti-viral nanoviricides. We believe that we are creating weapons in the fight against a number of viral diseases that are far superior to the existing therapies. Our long-term research efforts are aimed at augmenting the nanoviricides currently in development with additional agents that together may lead to either total long term control of or in many cases even cure of many viral diseases.
The Company plans to develop several drugs through the preclinical and clinical trials phases and obtain US FDA approvals for these drugs. The Company also plans to seek regulatory approvals in several international markets, including developed markets such as Europe, Japan, Australia, and underdeveloped regions such as India, China, and the African subcontinent. The Company anticipates partnering with medium and big pharmaceutical companies at various opportunities in order to advance the various drugs into commercialization. The Company may receive license fees and development fees for such partnerships, in addition to royalties based on sales of any resultant drugs..
The Company currently has in early development stage, products against HIV/AIDS and against Influenza. We plan on undertaking the development of drugs against other viruses when adequate financing becomes available |
