NanoViricides Appoints Project Manager and Engineering Firm for FDA cGMP Plant; Provides Update on a
NanoViricides Appoints Project Manager and Engineering Firm for FDA cGMP Plant; Provides Update on anti-Influenza Program
WEST HAVEN, Conn.--(BUSINESS WIRE)-- NanoViricides, Inc. (OTC BB:NNVC) (the "Company") announced today that it has retained the services of Mr. Phil Mader and his firm, MPH Engineering, LLC ("MPH"), to help with the overall project management and design engineering of its laboratory and cGMP pilot production facility. 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, as previously announced. MPH will provide overall engineering and project management services for the whole facility that includes the cGMP facility, laboratories, and office spaces, and will be responsible for overall project management of the detailed design and construction phases. The cGMP area itself will be designed by a separate firm, while MPH will be responsible for successful implementation of the entire project in collaboration with the firm that will provide the cGMP area.
Phil Mader is currently the Director of Engineering at MPH Engineering LLC. Phil has 26 years of mechanical, electrical design and construction leadership experience. His expertise includes design and construction administration of laboratory fit-out projects including the implementation of facility water, air, electrical and process control systems.
Major clients of MPH include well known pharmaceutical companies such as Schering-Plough Corporation and Bristol-Myers Squibb Company.
Prior to founding MPH, from 2000 to 2007, Phil Mader served as the Senior Capital Project Manager at Bristol-Myers Squibb Company in Wallingford, CT ("BMS"). He was involved in the design, implementation, and commissioning of various biology and chemistry laboratory projects within budget and in a timely manner. He was also responsible for performing forensic investigations of complicated mechanical air, steam, electrical and control systems and the implementation of corrective measures. He managed and reviewed the progress and quality of the work performed by consultants and contractors on complex engineering projects from the initiation phase through client turnover and acceptance. He supervised and managed efforts of architects, engineers, construction managers, contractors and client operational staff in the development, design and implementation of construction projects ranging from $0.5MM to 10MM. Mr. Mader holds a BS in Mechanical Engineering, cum laude, from the University of Hartford.
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 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.
"Mr. Mader is uniquely qualified to ensure delivery of this complex laboratory and cGMP manufacturing suite project for us," said Anil R. Diwan PhD, Company Chairman and President, adding, "He has extensive experience in working with various engineering and construction firms and ensuring detailed attention to critical aspects of the project."
The Company has previously announced the appointment of Mr. Andrew Hahn as a consultant for the laboratory and cGMP plant design. Since then, the team has been working on evaluating various aspects of the project and developing a highly optimized floor plan that enables realization of cGMP capabilities, in spite of various limitations of the facility, and while minimizing capital costs. Mr. Mader began working with Mr. Hahn and the Company recently and now the Company has formally engaged MPH for the implementation of this project.
The Company has previously announced the selection of its clinical candidate for Influenza, based on extremely high effectiveness observed in certain animal studies as previously announced. The Company now has two preclinical drug candidates for influenza, in the FluCide™ program. The Company held a pre-IND meeting with the US FDA on its NV-INF-1 drug candidate for severe, hospitalized cases of influenza-like-illness (ILI), including immuno-compromised patients, in March 2012. The Company continues to pursue this candidate for this indication, and is performing further studies that are necessary before producing the large batches for the Safety and Toxicology ("Tox Package") studies. The Company is also developing a scale up laboratory at its current site to enable production of this drug candidate in the large batches needed for these Tox Package Studies. In addition, the Company has recently announced that it has developed an oral anti-influenza drug candidate, for out-patient use, that is also expected to be suitable for use as a prophylactic. The Company intends to pursue this drug candidate towards approval for therapeutic use. The Company will have the ability to produce sufficiently large batches of the oral anti-influenza drug candidate for further development, required safety and toxicology studies, as well as future human clinical trials, upon completion of the new facility.
Both the oral and injectable versions of the Company's anti-influenza drug have shown extremely high efficacy in animal models against two different influenza A virus strains tested. The Company believes that both candidates will be effective against most, if not all, influenza viruses, including bird flu (H5N1), novel epidemic virus strains, high path influenzas, as well as the seasonal influenza viruses.
As the Company develops the data for an Investigational New Drug (IND) Application to the US FDA for these anti-influenza drug candidates, the Company will be required to produce the drugs under cGMP conditions. The Company determined after several years of study of cGMP manufacturing options that building a pilot facility for 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 the active pharmaceutical ingredient (API) to be manufactured in a registered cGMP facility for certain human clinical trials. The Company is currently investigating such possibilities.
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.
Amanda Schuon, 310-550-7200
KEYWORDS: United States North America Connecticut
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