WEST HAVEN, CONNECTICUT -- July 5, 2011 -- 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.”