NanoViricides Inc. (NNVC)

[changes_iv]

Nanoviricides, Inc. reports that its project for enabling clinical scale drug product cGMP capability is now in the Construction phase. Design, engineering, and architecture for this facility were completed at the end of June, 2013. Subcontractors were retained at the end of June as well. The demolition plan was executed in July, 2013. Initial construction work began on schedule in August and is now being performed at full force. The construction is on schedule to be completed by the end of December, 2013. However, the schedule may be adversely affected if delivery of certain key pieces of equipment with relatively long lead times does not occur in a timely manner.

We must assume all is going according to plan, "...on a path, like being on a track...", because although those "key pieces of equipment" are not yet at 1 Control Dr., Shelton, CT there is no indication that they will not be. If they are delayed, I'm sure MPH Project Management Group/Engineering has taken this possibility into account. When the plant completes December 2013, it will be integrated and commissioned and if not commissioned on schedule time will likely be recouped 1Q 2014.

Otherwise the coming Milestones are-
-cGMP/R&D Center Shelton CT integration completes ~ 4Q 2013
-Commision new cGMP plant ~ 4Q 2013 (equipment moved in/3 identical test batches begin)
-Receive initial results toxicology studies FluCide ~ 4Q 2013
-Prepare IND for submission to regulatory authorities ~ 4Q 2013

The Company has also started sub-kg scale production of our injectable FluCide™ anti-influenza drug candidate at its current facility. Safety and toxicology studies of our injectable and oral FluCide drugs are estimated to require very large quantities of the drugs, because of strong safety data evidenced from our in vivo (animal) efficacy studies to date. The Company will be able to initiate GLP Safety/Toxicology studies (“Tox Package”) studies of our injectable FluCide drug when the requisite large amount of drug substance is produced.

Here Nanoviricides, Inc. seems to be in control and Tox Studies will begin as scheduled. Bioanalytical Systems, Inc. (BASi) has designed the toxicology and safety pharmacology studies that will enable the IND submission and the first-in-human clinical trials of its FluCide® investigational anti-influenza product. BASi will conduct the cGLP and non-GLP studies as required (cGLP = current Good Laboratory Practices). These studies are designed to assess overall safety in animals receiving multiple doses of FluCide. Specific safety pharmacology studies will also be conducted to assess the effects of FluCide® on the cardiovascular, respiratory and central nervous systems. These studies are required for US FDA IND submission, as well as for applications to conduct human clinical trials in other countries such as Australia. Nanoviricides President, Dr. Anil Diwan spoke more about plans for 2013 leading to 2014. --- www.youtube.com/watch?v=tLcEYfxDG84&feature=youtu.be ---

The injectable and oral FluCide drug candidates have already shown strong effectiveness against distinctly different subtypes of influenza viruses, namely H1N1 and H3N2, in highly lethal animal models. This indicates that our FluCide drug candidates are “broad-spectrum”, i.e., they should work against most, if not all, influenza viruses. The injectable FluCide drug candidate has shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care, in a highly lethal influenza infection animal model. The oral FluCide is also dramatically more effective than TamiFlu in these animal studies. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth. The Company believes that these animal model results of both injectable and oral FluCide drug candidates should translate readily into humans.

Tox Studies begin and end according to BASi design. FluCide, injectable and oral, is formulated and ready once plant begins process to be commissioned.

The Company has recently signed confidentiality agreements with both Public Health England (PHE-UK) and the Lovelace Respiratory Research Institute, New Mexico, USA (LRRI). Both of these institutions have the ability to perform further testing of our FluCide drug candidates against additional influenza viruses including H7N9. The Company intends to perform our remaining IND-enabling studies of FluCide at these institutions.

Preliminary results from BASi and key collaborators will be, as scheduled, in order to proceed and prepare IND for submission to regulatory authorities ~ 4Q 2013

BASi is a pharmaceutical development company providing contract research services and monitoring instruments to the world's leading drug development companies and medical research organizations. With over 30 years of experience, BASi conducts IND-enabling drug safety and toxicology studies at its AAALAC-accredited laboratory located on a 52-acre campus near Evansville, Indiana. BASi has an excellent record of regulatory compliance. All facilities have been inspected by the US FDA with no significant adverse findings.

In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models. The US FDA has recently designated DengueCide®, our drug for dengue and dengue hemorrhagic fever, as an “orphan drug”.

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 sold certain amount of his NNVC stock to finance purchase of the building that was completed in August, 2011. Further, Inno-Haven has raised substantial amounts of additional capital for this project independently. NanoViricides has signed a Memorandum of Understanding with Inno-Haven to lease the facility. No lease has been signed at present. This is explained in Dr. Diwan's video. This arrangement with Inno Haven, LLC allowed Nanoviricides, Inc. avoid a major capital expense. Dr. Diwan is the principal in this privately held company.

NanoViricides, Inc. has assembled a marquee team of experienced personnel to help us 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.

In order to be succesful in the integration and commission of the cGMP pilot plant Nanoviricides had to subcontract a seasoned, succesful, experienced personnel to help with the design, architecture, and engineering of the cGMP pilot plant. This greatly reduces the possibility of costly delays (once Inno Haven & Nanoviricides, Inc. signed lease contract) and increases confidence in validation of the plant by the FDA.

FluCide will be the first nanomedicine in the world that is orally active. Oral FluCide will open up a very large market. DengueCide is "the only game in town". Other Dengue drugs have failed in clinical trials. DengueCide will gain extension for patent life (7 years) and be a candidate to earn a Priority Review Voucher (minimum $200 million).