Tuesday, 15 May 2012

NanoViricides appoints Andrew Hahn as design consultant for pilot cGMP plant

NanoViricides (OTCBB:NNVC) appointed Monday Andrew Hahn as a consultant for the design and construction of its laboratory and cGMP pilot production facility.
The facility, under current good manufacturing practice (cGMP) standards, will be constructed by renovating an existing 18,000 square foot light manufacturing plant on a 4.2 acre lot in Shelton, Connecticut.
Hahn will help with the design, architecture, engineering, and construction of office spaces, and the cGMP facility and laboratory.
NanoViricides is a development stage company that designs drugs to specifically attack and dismantle enveloped virus particles. Its drug pipeline includes candidates to treat diseases like H5N1 bird flu, HIV, hepatitis C, rabies, dengue fever and the Ebola virus.
The cGMP pilot facility will be used to produce sufficient quantities of drugs needed for human clinical trials for the various drug candidates as they advance into the clinical pipeline, such as the recently selected anti-influenza drug candidate.
NanoViricides recently announced the selection of its clinical candidate FluCide, based on positive results seen in previous animal studies.
The company also held a pre-investigational new drug application meeting with the US FDA to define the development plan for the project. As NanoViricides develops the data for the IND application, the company will be required to produce the drug under cGMP conditions.
The company said it had determined after several years of studying cGMP manufacturing options, that building a pilot facility for clinical drug manufacturing was the most appropriate move.
"This will be a unique, state-of-the-art cGMP facility for the pilot scale production of nanomedicines," said president and chairman of NanoViricides’ Anil R. Diwan.
"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."
Hahn, who holds a BA in Architecture from Princeton University, has almost 30 years of architecture, design, and project management experience in the creation of new and refurbished facilities from his time at the Bristol-Myers Squibb Company.
He was the senior director of engineering, pharmaceutical facilities, and global engineering at this company, and is recently retired.
His responsibility at Bristol-Myers Squibb entailed the worldwide design and construction of pharmaceutical plants, pilot plants, clinical supply facilities, and research laboratories and offices, all relevant to NanoViricides’ current project.
"Mr Hahn will assist the company in realizing its goal of a first class cGMP manufacturing plant as well as laboratory space," said NanoViricides’ CEO Eugene Seymour.
"Andy Hahn will be instrumental in helping the company achieve this goal that will enable us to expedite our various drug development programs."
In addition to influenza, the company has several additional drugs in its development pipeline, including eye drops for viral infections of the external eye, skin cream for treatment of oral and genital warts, an anti-HIV drug, as well as a broad-spectrum anti-Dengue virus drug.
NanoViricides also plans to pursue human clinical trials in countries other than the US, which may not require a cGMP product for certain studies. The company said it is currently investigating such possibilities.

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