NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced that Inno-Haven LLC has completed acquisition of a light industrial building. The Company anticipates that it will be leasing a portion of this space, in the near future, for laboratory facilities and cGMP production of its nanoviricides® drug candidates against various viral diseases.
“We are making progress in clearing a major hurdle in our path towards FDA submissions and human clinical development of our drug candidates.”
Inno-Haven LLC, a special purpose company formed to acquire the facility, completed the purchase on August 31, 2011. This approximately 18,000 sq.ft. building on a 4.2 acre lot is located in a light industrial-commercial zone on the Route 8 Corridor in Shelton (Fairfield County), CT. A significant advantage to the location is a quick access to state and interstate routes (I-95, Route 8, Route 15, and Route 34).
Financing for the acquisition by Inno-Haven was provided by certain private investors that included Anil R. Diwan, PhD. Dr. Diwan is President and Chairman of the Company and Managing Member of Inno-Haven. Dr. Diwan's part of the financing came from his personal savings, personal borrowings, and a sale of some of his shares of NanoViricides, Inc. received as a founder. TheraCour Pharma, Inc., a drug development partner of NanoViricides that is controlled by Dr. Diwan, also plans to lease space in the same facility.
Additionally, Dr. Diwan has agreed to provide personal guarantees, as needed, for certain additional contemplated transactions. The Company has previously announced that it had determined that this financing approach provided the best value for the Company and its shareholders.
Based on the extremely high efficacy of the FluCide™ drug candidate, a relatively small scale cGMP pilot plant is expected to be sufficient for the Company's production requirements through the completion of human clinical trials. The Company believes, based on advice from experts, that the said facility will meet these requirements.
The Company is currently meeting with various firms capable of performing the extensive renovations necessary to establish cGMP manufacturing at this facility in a timely manner. The production of materials for human trials needs to be performed under FDA guidelines called "cGMP" (short for "current Good Manufacturing Practices"). The Company believes that it has various options available for achieving the financing for the contemplated renovation costs. Dr. Diwan has agreed to provide personal guarantees, as needed, for such additional transactions.
"We believe we will be achieving the cGMP manufacturing and lab space we need without capital expenditure from the Company's current cash reserves," said Dr. Eugene Seymour, MD, MPH, CEO of the Company, adding, "We are making progress in clearing a major hurdle in our path towards FDA submissions and human clinical development of our drug candidates."
The Company recently announced the selection of its clinical candidate for Influenza. The Company is currently working on developing the pre-IND application for this clinical candidate. Following the pre-IND application and subsequent FDA input, the Company will need to produce cGMP batches of the drug candidate for human clinical studies prior to submitting an IND (Investigational New Drug) application to the FDA. Thus the Company perceives a significant urgency for constructing and activating the cGMP manufacturing capabilities.
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