WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has retained AES Clean Technology, Inc. (“AES”), for the design, engineering, and construction of the Cleanroom Suite for its laboratory and cGMP pilot production facility project. The Cleanroom Suite comprises the main cGMP manufacturing sections of the pilot plant. This Suite provides for walk-in, process scale, Class 100 laminar hoods; walk-in, process scale chemical fume hoods; Class 1,000 and Class 10,000 work areas; entry airlock and egress systems.
AES is the leader in turnkey design, manufacturing, and construction, of modular cleanroom systems (www.aesclean.com). Modular cleanroom technology delivers more speed, cleanliness, quality, and repeatable performance to the cleanroom project. AES is the leading vendor in cGMP-compliant manufacturing facilities for Pharmaceutical and BioPharma Manufacturing industries. Their pharma client list comprises several industry leaders and can be found at Leading Industry Leaders in Pharma, Biotech, Medical Device, Semicon, Micro | AES (http://www.aesclean.com/aes-portfolio/industry-leaders).
“AES has the industry expertise in designing and building modular, validated, cGMP manufacturing suites for pharmaceutical industries,” said Anil R. Diwan, PhD, President, NanoViricides, Inc., adding, “We are very pleased to have such experts working with us to enable this project in a cost effective fashion without compromising on quality or performance.”
As previously announced, this facility will be built by renovating an existing 18,000 sq. ft. light manufacturing plant on a 4.2 acre lot in Shelton, CT. AES will be responsible for the critical cGMP manufacturing suites space. In addition, NanoViricides, Inc. has retained ID3A architects as the Principal Architect for the project and integration of the separately constructed Clean Room Suite for cGMP production. Ms. Kathyann Cowles, AIA, of ID3A joins Mr. Phil Mader of MPH Engineering, LLC (MPH) , and Mr. Andrew Hahn, to complete our architecture, design and construction management team. As previously announced, Mr. Hahn continues to provide overall stewardship of the project, while Mr. Mader is responsible for detailed project management, and his firm, MPH, is providing engineering services.
The Company has previously reported about the Shelton light industrial building that will house the cGMP pilot production plant, research laboratories, and offices. The cGMP pilot plant is being designed for the production of 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.
The light industrial building at 1 Controls Drive, Shelton CT was purchased by Inno-Haven, LLC. Inno-Haven is a private company that was founded by Dr. Anil R. Diwan, the Company’s CEO, and financed by himself and certain of his friends and associates, with the specific purpose of enabling clinical cGMP manufacturing capabilities for NanoViricides, Inc. drug substances. Acquisition of this 18,000 sqft building on 4.2 acres of land was previously announced by NanoViricides, Inc. in September, 2011. Renovation of the building is to be performed as per the requirements of NanoViricides, Inc. for the production of the nanoviricides drug candidates for clinical trials under cGMP processes. The drug substance produced in this facility will then be delivered to a third party for final processing and labeling, as required, for human clinical trials when ready. NanoViricides, Inc. expects to lease this facility. No lease has been signed yet and no terms of lease have been finalized as of now.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class 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.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the Company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.