NanoViricides Reports That a Certificate of Occupancy Has Been Issued for the New cGMP Manufacturing and R&D Facility in Shelton, CT
WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (NYSE MKT:NNVC) (the “Company”) reports that the Construction Phase for its total renovation program of the facility at 1 Controls Drive, Shelton, CT is now complete. The City of Shelton has issued a Certificate of Occupancy for this facility after inspection of the new facility. NanoViricides is now performing specific modifications for its custom equipment and utilities needs. Simultaneously, the facility validation process has also been started. The Company is in negotiations to purchase this facility rather than to lease it.
“IAIR Award 2014 for Leadership in Nanomedicines in the North American Sector”
The Company also reports that its CEO, Dr. Eugene Seymour, MD, MPH, will be presenting at the BIO Business Forum in the 2014 BIO International Convention in San Diego today at 2pm PST (Session ID 2775). He will provide an update on the Company’s programs and objectives.
The fully customizable manufacturing facility in Shelton, CT, will enable cGMP manufacture of all of our nanoviricides® drug candidates in kilogram scale, sufficient for pre-IND and human clinical studies. In addition to the state of the art modern clean room suites for cGMP production, the facility also houses extensive R&D and Analytical suites.
The Company recently reported that it was in the preliminary list of additions to certain Russell Indexes including Russell 2000, Russell 3000, and the Russell Small Cap. The final reconstitution of these indexes is expected to take place on Friday, June 27, after close of business.
The Company’s first drug candidate is injectable FluCide™ for all influenzas in hospitalized patients. The market size for an effective influenza drug for treating severely ill hospitalized patients has been estimated in the billions of dollars, worldwide, depending upon the therapeutic value and cost savings. Currently, there is no effective therapeutic available for this indication. The Company believes that it could supply a substantial portion of the demand for this drug from its new small scale cGMP clinical drug facility. This drug is currently in IND-enabling studies.
This drug candidate has demonstrated an unparalleled 1,000-fold reduction in lung viral load in a lethal animal model study. In the same study, the current standard of care, oseltamivir, (Tamiflu®, Roche) exhibited only a 2-fold reduction in lung viral load at the same time point. The Company intends to begin the safety/toxicology studies of this Injectable FluCide™ drug candidate as soon as feasible, and is producing sufficient drug substance for these studies at its existing facility.
This broad-spectrum FluCide drug is expected to work against most, if not all, forms of influenza virus, including epidemic, pandemic (e.g. H1N1/2009), high path influenzas such as H3N2, H7N9, and “bird flu” such as H5N1.
The total market size addressed by the Company’s current drug programs is estimated at about $50 billion. In addition to Injectable FluCide, the Company is working on five more commercially important drug candidates, namely: DengueCide™, HerpeCide™, HIVCide™, Oral FluCide™ for out-patients, and a broad-spectrum antiviral drug for viral diseases of the external eye. All of our programs are for therapeutics to treat viral infections. Our drugs are expected to be useful as prophylactics as well. DengueCide has recently received orphan drug designation by the US FDA as well as the European EMA.
NanoViricides recently received an important international award, the “IAIR Award 2014 for Leadership in Nanomedicines in the North American Sector”.
The Company currently has approximately $36 million cash-in-hand and cash-like-instruments. These funds are estimated to be sufficient for taking at least one of our drug candidates through initial human clinical trials, and possibly take another drug candidate into human clinical trials.
The Company has undertaken the production of certain quantities of its FluCide anti-influenza drug for use in detailed pre-IND Safety/ “Tox Package” studies at its current facilities in West Haven. This process is expected to take some time due to the limitations of scale at the current facility. The Company is making progress in making this material in the required quantities.
The Company has previously reported that it has engaged Inno-Haven, LLC, to renovate the Shelton facility as per NanoViricides’ requirements for expanded R&D facility and a cGMP pilot scale (kg scale) production facility including clean room suites suitable for injectables active pharmaceutical ingredient (API) manufacture. Inno-Haven, LLC, a private company, is controlled by Anil R Diwan, PhD, who is also the President of NanoViricides, Inc. Dr. Diwan initially raised funding since 2011 to purchase an 18,000 sq.ft. facility at this site and to renovate it and build a fully customizable modern nanomedicines manufacturing plant to manufacture drug substances for clinical trials in compliance with the US FDA cGMP and equivalent international guidelines for manufacture of pharmaceuticals. NanoViricides, Inc. has assembled a marquee team of experienced personnel to help with the design, architecture, and engineering of this facility. Mr. Andrew Hahn continues to provide overall stewardship for this project. He was formerly 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. Mr. Phil Mader and his firm, MPH Engineering, LLC (“MPH”), continue to help with the overall project management and design engineering of the laboratory and cGMP pilot production facility. 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. Ms. Kathyann Cowles of ID3A, LLC, serves as the Principal Architect. Ms. Cowles, co-founder of Id3A, has over thirty years of experience as a licensed Architect and Senior Project Manager for diverse and complex design and construction projects in the academic, science, technology, corporate and research sectors.
NanoViricides has signed a Memorandum of Understanding with Inno-Haven to lease the facility. No lease has been signed at present. NanoViricides engaged an external Consulting Firm in order to study the lease or purchase options for this facility. Based on the Consultants’ report, the Company believes that purchase of the facility is the favorable option for its shareholders. The Company is currently negotiating a purchase of this facility from Inno-Haven, LLC.
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel 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.
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.