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Australia and the Philippines Award Fundamental Patents to NanoViricides

NanoViricides, Inc. (the "Company"), announced today that a fundamental PCT patent application, on which the nanoviricides® technology is based, has resulted in additional issued patents in Australia and the Philippines.

“The issuance of the Australian patent is of particular importance because of the Company’s interest in pursuing the initial human clinical trials in that country,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “Australia offers significant advantages including financial incentives that would help us speed the development of our drugs towards licensure.”

The Australian and Philippine patents have been allowed with a very broad range of claims to a large number of families of chemical structure compositions, pharmaceutical compositions, methods of making the same, and uses of the same.

NanoViricides, Inc. holds exclusive, perpetual, worldwide licenses to these technologies for a broad range of antiviral applications and diseases (see below).

“It is rewarding to see that both the Australian and Philippine patent offices recognized the novelty and the broad utility of the entire ‘pi-polymer’ class of materials as defined by the inventors, and granted a patent with sufficient scope to protect the whole of the invention, for all foreseeable pharmaceutical applications,” said Dr. James Demers, PhD, JD, Gotham Patent Services LLC, who represents the inventors and directs the international patenting effort. He further added, “In addition, the inventors have also filed an original PCT application that covers the nanoviricides® anti-viral substances.”

These compositions result in self-assembling polymers that we call “TheraCour®“ polymers (or “pi-polymers”), and possess significant advantages over the earlier block-copolymer systems, hard nanoparticle systems, as well as liposomal and emulsion systems, that are now advancing in nanomedicines development.

The TheraCour polymers result in polymeric micelles that can be used to encapsulate active pharmaceutical ingredients (APIs) to develop superior drugs where needed. Of greater importance to NanoViricides, they are capable of direct targeting to any desired surface with defined specificity, such as a virus particle.

The current first generation nanoviricides® drug candidates have achieved very high levels of effectiveness only by employing the specific targeting ability of the TheraCour polymer systems. These first generation drugs did not require encapsulation of any additional APIs to achieve their high levels of effectiveness. The Company believes this has simplified the drug approval process for us, because the specifically targeted nanoviricide polymer we make is itself the drug in these cases.

In addition, with this technology, the Company has the ability to develop drugs against intractable viral diseases wherein very little virus may be present in circulation. In such cases, the Company can employ the approach of encapsulating multiple antiviral APIs that act by orthogonal mechanisms, and deliver the payload specifically to infected cells by using ligands that bind preferentially to infected cells. Drug combinations are known to often provide enhanced synergistic effectiveness, and have been approved in viral diseases such as HIV/AIDS and Hepatitis C. The encapsulation approach is known to be superior to the simple formulated “fixed drug” combinations approach that is being employed at present. Nevertheless, fixed drug combinations result in the conventional approach of attacking all cells, and are not restricted to attacking infected cells preferentially, and thus are expected to be relatively toxic. Our next generation nanoviricides approach is anticipated to require significant further development and resources. The Company is therefore focusing at present on its wide drug pipeline of six antiviral projects, namely injectable FluCide™, oral FluCide™, DengueCide™, HerpeCide™, HIVCide™, and the broad-spectrum drug for viral diseases of the external eye.

In addition to this basic PCT application that covers the “pi-polymer” structure itself, another PCT application that discloses making antiviral agents from the TheraCour family of polymers and such structures is in various stages of prosecution in several countries, and has already issued in at least seven countries and regions.

The original “pi-polymer” international application was filed under the Patent Cooperation Treaty (PCT) system in 2006. Several other patents have already been granted previously in this patent family in various countries and regions, including Canada, Europe, Israel, ARIPO, China, HongKong, Japan, Mexico, New Zealand, OAPI, Vietnam and South Africa, and the USA. Prosecution in several other countries continues.

The patents are being issued to the inventors Anil R. Diwan, PhD, Jayant G. Tatake, PhD, and Ann L. Onton, all of who are among the founders of NanoViricides, Inc. The patents have been assigned to AllExcel, Inc., the Company at which the ground-breaking work was performed. AllExcel, Inc. has contractually transferred this intellectual property to TheraCour Pharma, Inc.

NanoViricides, Inc. holds exclusive, worldwide, perpetual, licenses from TheraCour Pharma, Inc. to these technologies and patents for a broad range of antiviral applications and diseases that include all Influenzas including Asian Bird Flu Virus, Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV), Dengue viruses, Rabies virus, Ebola/Marburg viruses, Japanese Encephalitis virus, as well as viruses causing viral Conjunctivitis (a disease of the eye) and ocular herpes.



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