NanoViricides Inc. reports that construction of the modern R&D Lab and cGMP Clinical Production facility in Shelton, Conn., is nearing completion with some weather-related delays, and that the R&D lab section of the facility is ahead of schedule. Once construction of the cGMP Cleanroom Production Suite is completed, the project will enter the facility testing and validation phase.
The company is performing certain scale-up studies and production of the quantities of FluCide needed for the “Tox Package” study at its current facility, as previously reported. NanoViricides anticipates transitioning staff to the new facility upon obtaining a Certificate of Occupancy.
The new facility project was started by Inno-Haven LLC, a company whose member, Dr. Anil R. Diwan is also the co-founder of NanoViricides. Dr. Diwan purchased a building in Shelton in August 2011.
“By 2011, when Dr. Diwan went all out and bought the Controls Drive property, we had spent several years searching for a third party contract manufacturer, capable of producing our drug candidates under the rigorous standards required for clinical trials, without success,” says Eugene Seymour, MD, MPH. “NanoViricides continued to search for available contract manufacturing capability even after Diwan’s purchase of the Controls Drive property. Most facilities we interviewed could not manufacture our novel polymer molecules without extensive renovations. The cost of such custom renovations and equipment would be passed on to us, as is customary. In addition, we would have to train their technicians and scientists and transfer important know how and other aspects of our intellectual property.”
The company signed a Memorandum of Understanding with Inno-Haven in January 2013, to lease the facility with an option to purchase.
“With our registered direct offering in September 2013, and the additional raise of $20M that we completed in January 2014, we are now in a strong position to be able to purchase the building outright,” says Dr. Eugene Seymour, CEO of NanoViricides. “I delayed signing of the lease because I always believed that the Company would be better served if it owned the facility rather than leased it.”
NanoViricides is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The company’s 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.
Release Date: February 20, 2014