NanoViricides has declared that a special purpose company Inno-Haven has closed the purchase of a light industrial building where NanoViricides plans to lease a portion to house its laboratory and current good manufacturing practices (cGMP) production facilities for its nanoviricides drug candidates for the treatment of several viral diseases.
Inno-Haven, a firm established by NanoViricides to purchase the 18,000 sq.ft industrial building in Shelton, Connecticut, has closed the acquisition on August 31, 2011. As its FluCide drug candidate is highly efficient, NanoViricides believes that a cGMP pilot plant at a relatively small scale is sufficient to meet its production needs through the completion of human clinical trials. The company, based on experts’ advice, expects that the industrial building will fulfill all its requirements.
At present, NanoViricides is discussing with potential companies that can perform the needed renovations to begin cGMP manufacturing at this facility on time. The company considers that it has several options to raise the fund to meet the renovation costs. The company’s clinical candidate has been recently selected for Influenza and is currently involved in the development of pre-investigational new drug (IND) application for the candidate.
After the pre-IND application and following FDA input, NanoViricides will require manufacturing the drug candidate’s cGMP batches for human clinical studies before presenting an IND application to the FDA. Hence, the company seeks a significant urgency for building and starting the cGMP production capabilities.