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Most Innovative Business Leaders 2016

I am personally involved in the lab, interfacing with everyone in our organization almost every day. We have an expertise-based culture, with very little hierarchical structure. We implement agile project management, with dynamic project teams and concise project definitions that are integral parts of our overall product development plans. We focus on safety aspects of manufacture, transportation, field use, and effects on the patient and the environment, right from design phase. We provide continuous skills improvement programs to ensure that everyone is conversant with safety requirements and implementation. We are not there yet, but we believe we will be helping billions of people as our products become globally available eventually. The very task of developing drugs that can help people overcome debilitating illnesses and avoid death, is its own reward. In 1992, the concept of nanomedicine was largely unknown. When I set out to do this, it was considered a far-fetched dream. Nanomedicines have gone past that initial state of being viewed with disbelief to being a buzzword now. Most of the successes of nanomedicines are in the area of drug delivery, to improve drug solubility and how long the drug stays in the body. Thus we have Taxol®, Doxil®, Abraxane®, and Cerulean’s polymerdrug-conjugates. Nanomedicines have also made non-viral gene therapy possible. The strong potential of address-directed nanomedicines was recognized long ago. However, the industry is only now moving towards enabling it. BIND has attempted such targeting in a limited fashion with limited success.

We are one of the few small bio/pharma companies that possess all the facilities and resources to take a drug from design all the way through clinical trials into initial commercial production. Further, we are defining and developing a novel class of antiviral drugs. This makes us unique in the field. The current antiviral drugs have strong side effects because they function inside human cells and also affect cell function. Antibodies bind to virus in circulation. However, viruses readily mutate to escape antibodies as well as these other drugs. Nanoviricides, in contrast, are designed to dismantle virus particles in circulation, and this provides inherent safety. Further, we have observed strong effectiveness observed in animal models to date. Importantly, we believe that nanoviricides solve the most vexing problem in antiviral therapeutics - viral escape by mutations, as explained earlier. This gives us a strong competitive edge. We are initially targeting acute viral indications that provide objective end-points enabling relatively short human clinical trials. Thus our topical treatments of herpesvirus infections, and our systemic treatment of hospitalized patients with influenza, should require relatively short clinical trials. We are currently advancing these drugs through IND-enabling studies. We depend upon external collaborators for all of our biological testing. This can cause delays in our development plans. So it is difficult to provide accurate timelines. Pharmaceutical drug development is painstakingly slow. It takes years of clinical trials before a drug is licensed.

We have already established that our drug candidates are extremely safe. This is because of the inherent design of the polymeric micelles themselves, and that of the ligands. Since we target the virus itself, the drug effectiveness observed in an animal host should be predictive of effectiveness in human host. Therefore, we are very optimistic, given the great successes we have seen in animal models, that our drug candidates should result in the best available therapies for the viral indications we go after. We believe that we will be transitioning our drug candidates into clinical stage in the very near future. Our pipeline is very broad and rich. So we will be able to advance a number of drugs into clinical trials, one after another, in the near future, limited only by the available finances. We believe that the chances of clinical success of our drug candidates are very high. Thus we anticipate advancing a number of highly effective and safe antiviral drugs in the market, in a sustained manner. With our advanced R&D, we believe that we will remain an innovative and dynamic company, with continuing commercialization even after the first drug goes to market, for a very long time into the future. While we believe we will be able to grow organically to become a successful stand alone pharma company, we plan to seek commercialization options like licensing, joint ventures, and others to improve speed to market, in order to speed up revenue. Thank you for the opportunity and the recognition of our leadership in the industry.

In contrast to all of these other efforts, we at Nanoviricides, Inc. have designed our entire chemistry and platform using a systems-based approach for the task of address-based delivery and encapsulation. Our capabilities of targeting with multiple ligands and encapsulating active ingredients using micellar self-assembly are as yet unmatched. This gives us the confidence that we continue to have technologies with significant leadership. Pharmaceutical industry began with small chemicals as drugs then came the antibiotics - fermentation products. Later, we saw the recombinant technology based biologics revolution. Then came the antibodyas-drug, evolving now to antibody-drug-conjugates. Most of the diseases are now being tackled by combinations of multiple drugs, but each one of them is still a single chemical or biologic. All of these current approaches are like strafing through a war zone with a machine gun or handgrenades, equally causing damage to good cells as well as bad cells (e.g. infected or cancerous), resulting in strong side effects. Address-based drug delivery, enabled by modern nanomedicines such as nanoviricides, would be like the use of drones to hit specific targets, resulting in both enhanced safety and effectiveness. Thus, advanced nanomedicines will be the wave of the future. We believe Nanoviricides, Inc. will be leading the nanomedicines field against viral infections. Acquisition International - February 2016 83

AI Magazine February 2016