WEST HAVEN, CONNECTICUT -- May 14th, 2012 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained the services of Mr. Andrew Hahn to help with the overall design and construction of its laboratory and cGMP pilot production facility. This facility will be built by renovating an existing 18,000 sqft light manufacturing plant on a 4.2 acre lot in Shelton, CT, as previously announced. Mr. Hahn will help the Company in the overall design, architecture, engineering, and construction of the whole facility that includes the cGMP facility, laboratories, and office spaces.
Mr. Hahn recently retired as the Senior Director of Engineering, Pharmaceutical Facilities, Global Engineering, at the Bristol-Myers-Squibb Company Worldwide Medicines Group (BMS). He has almost 30 years of experience in architecture, design and project management in the creation of new and refurbished facilities at Bristol-Myers Squibb Company.
Of importance to the Company’s project, he was responsible for the worldwide design and construction of pharmaceutical plants, pilot plants and clinical supply facilities as well as research laboratories and offices while at BMS. Mr. Hahn holds a BA in Architecture from Princeton University. His responsibilities at BMS included overall management of facilities engineering, design, construction, and validation initiatives, overall project planning and management, as well as team-building and staff training in various aspects from architectural and engineering challenges to project management issues.
The Company has previously announced the acquisition of the Shelton light industrial building that will house the cGMP pilot production plant, research laboratories and offices. The cGMP pilot plant is being designed to produce sufficient quantities of the drug needed for human clinical trials for each of the various nanoviricides® drug candidates as they advance into the clinical pipeline.
“Mr Hahn will assist the Company in realizing its goal of a first class cGMP manufacturing plant as well as laboratory space,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “Andy Hahn will be instrumental in helping the Company achieve this goal that will enable us to expedite our various drug development programs.”
“This will be a unique, state-of-the-art cGMP facility for the pilot scale production of nanomedicines,” said Anil R. Diwan, President and Chairman of the Company, adding, “Along with his great experience, Andy Hahn brings an acute grasp of a wide range of issues that is critically important in making such a challenging endeavor a success.” “We are very pleased with the validation of the novelty of our technologies,” said Dr. Diwan, President and Chairman of NanoViricides, Inc., adding, “This patent establishes a fundamentally new direction in developing biomimetic approaches. It creates a germane field within polymeric micelle technologies, introducing structures that we call pi-polymers. These are the structures that enable the creation of a nanoviricide® with its unique biomimetic features. These biomimetic features allow us to make the nanoviricide look like a host-cell membrane to the virus, with the goal of deceiving the virus to land on it and thereupon destroy itself.” The Company recently announced the selection of its clinical candidate for Influenza, based on extremely high effectiveness observed in certain animal studies as previously announced. The Company also recently held a pre-IND meeting with the US FDA in order to define the product development plan. As the Company develops the data for an Investigational New Drug (IND) Application to the US FDA for FluCide™, its anti-influenza drug candidate, the Company will be required to produce the drug under cGMP conditions. The Company determined after several years of study of cGMP manufacturing options that building a pilot facility for the clinical drug manufacture was the most appropriate option for the Company. In addition to influenza, the Company has several additional drugs in its development pipeline. These include eye drops for viral infections of the external eye (such as EKC and Ocular Herpes), skin cream for treatment of oral and genital warts (caused by HSV-1 and HSV-2 infections), an anti-HIV drug, as well as a broad-spectrum anti-Dengue virus drug.
The Company also intends to pursue human clinical trials in countries other than the USA. Some of these countries may not require a cGMP drug product for certain human clinical studies. The Company is currently investigating such possibilities.