NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it will be leasing new space for cGMP production of its nanoviricides® drug candidates against various viral diseases.
“This is the least dilutive way to obtain the cGMP manufacturing and lab space we need while avoiding capital expenditure from the Company's current cash reserves”
The Company is planning to lease the space with an option for a future purchase from Inno-Haven LLC, a special purpose company formed for the acquisition of a facility and construction of appropriate laboratory and manufacturing facilities.
The Company will need to produce much larger quantities of the nanoviricides drug candidates for its upcoming toxicological studies than it can handle in the current facilities. Assuming the studies are successful, additional materials will have to be manufactured for human clinical trials if and when approved by the US Food and Drug Administration (FDA). The production of materials for human trials needs to be performed under FDA guidelines called "cGMP" (short for "current Good Manufacturing Practices"). The Company plans to manufacture the bulk cGMP drug materials for its future human clinical trials at the new facility.
In order to support the Company's objectives, Inno-Haven LLC has agreed to purchase certain facilities. Inno-Haven is owned by Anil R. Diwan, PhD, President and Chairman of NanoViricides, Inc. Dr. Diwan plans to finance the purchase from his personal savings, personal borrowings, and a sale of stock of NanoViricides, Inc. that he has obtained as a Founder. To this end, NanoViricides, Inc. has agreed that Dr. Diwan will sell up to 2 million shares of his stock over the next year. In exchange, Inno-Haven LLC, and Dr. Diwan, have agreed to purchase certain facilities and lease a portion as needed to NanoViricides, Inc. Dr. Diwan has also agreed to provide personal guarantees, as needed, for the contemplated transactions. The Company has studied several alternative proposals including those from certain groups of current investors and has determined that this approach provided the best value for the Company and its shareholders. TheraCour Pharma, Inc., a drug development partner of NanoViricides that is controlled by Dr. Diwan, also plans to lease space in the same facility.
"This is the least dilutive way to obtain the cGMP manufacturing and lab space we need while avoiding capital expenditure from the Company's current cash reserves," said Dr. Eugene Seymour, MD, MPH, CEO of the Company, adding, "We are now on our way to clearing a major hurdle in our path towards FDA submissions and human clinical development of our drug candidates."
The Company believes that the urgency for obtaining these manufacturing capabilities has now increased substantially. This is because of the recent successes of the Company's FluCide™ drug candidates in pre-clinical animal studies. The Company has conducted pre-clinical efficacy studies using stringent, high-lethality-oriented, animal study protocols and has examined several parameters such as protection from lung inflammation and lung necrosis, extent and durability of viral load reduction, and extension of survival. The Company has publicized these findings in its recent press releases. On the basis of these findings, the Company believes that its FluCide drug candidates may be orders of magnitude superior to existing drugs in the treatment of influenza.
Inno-Haven, LLC has presented the case to the planning and zoning commission of the city and is in the process of obtaining necessary approvals.
Unlocking the secrets of analytical services: An insider interview with colman byrne