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NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has entered into a consulting agreement with Biologics Consulting Group, Inc. (BCG) for the preparation and submission of Investigational New Drug (IND) applications to the FDA for its nanoviricides® drug candidates against various viral diseases.
The Company has previously reported the successes of the Company's FluCide™ drug candidates in pre-clinical animal studies. The Company is on schedule for the development of its FluCide® investigational anti-influenza product. The Company believes that it has made strong progress in optimizing its anti-influenza drug candidates towards the Pre-IND and IND stages. To facilitate the FDA review and approval process, BCG will advise the Company on the Pre-IND application and provide expert assistance in the design and implementation of additional pre-clinical development activities that are necessary for the IND application.
Further, the Company anticipates that when it submits the first IND to the FDA, the Company will need to have produced certain quantities of the associated drug candidate under cGMP (current Good Manufacturing Practices) conditions. The Company has recently announced that it is making certain leasing arrangements so that it will have the appropriate cGMP facilities available in a timely manner.
Biologics Consulting Group, Inc. (BCG) is an international consulting firm whose consultants provide national and international regulatory and product development assistance on the development and commercial production of drug, biological, and device products. BCG has expertise in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation.
As previously announced, Anil R. Diwan, PhD, President and Chairman of the Company has agreed to facilitate and finance the purchase of a certain facility and improvements to avail NanoViricides, Inc. of the necessary cGMP capabilities. In order to facilitate this capital-intensive program, Dr. Diwan has agreed to personally act as a Guarantor for the transactions involved. A separate entity, Inno-Haven, LLC, was formed, as a good business practice, to facilitate the real estate transactions.
"By agreeing to act as a guarantor, Dr. Diwan is making a strong commitment to accelerate our drug programs," said Eugene Seymour, MD, MPH, CEO of the Company, adding, "Our Executive Team is committed to achieve our objectives while minimizing capital expenditures, and also minimizing dilution to the benefit of all our investors."
About NanoViricides, Inc.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.
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 pre-clinical 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.
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