NanoViricides Reaches Agreement on Terms of License for Shingles Virus Drug Development

NanoViricides has reached an agreement on the terms of the license for the drug development against VZV, the virus that causes chickenpox in children and shingles in adults.

NanoViricides previously tested the nanoviricide drug candidates being developed for HSV-1 against VZV in cell cultures and found them to be highly effective, in early 2017. The Company continued further development of these drug candidates against VZV while it was continuing to develop new collaborations for animal testing of its HSV-1 and HSV-2 drug candidates. The Company and TheraCour Pharma, Inc., the licensor, have been in negotiation regarding the terms of TheraCour's license of VZV to the Company. TheraCour agreed in principle to license VZV upon completion of due diligence and an independent valuation. In the past, TheraCour has never denied any licenses for any virus programs that we initiated, and therefore the Company continued its development of the VZV skin cream drug candidate. Several factors, including the rapidity with which we were able to conduct the pre-clinical candidate optimization studies in the ex vivo human skin organ culture model developed by Professor Moffat at the Upstate Medical Center, SUNY, Syracuse, NY, led to the anti-VZV drug candidate to be our first drug candidate to move into IND-enabling regulatory studies.

The Company and TheraCour have agreed, subject to a definitive agreement between the Company and TheraCour, that TheraCour will not receive any payment upon signing of a License Agreement and that TheraCour will receive no cash but 500,000 shares of the Company's Series A Preferred Stock as a milestone payment when an IND ("investigational New Drug Application") becomes effective. Additionally, if the Company completes Phase I human clinical trials, then, upon completion, TheraCour will receive a milestone payment of $1.5 million in cash. Further, if the Company completes Phase II human clinical trials, then, upon completion, TheraCour will receive a milestone payment of $2.5 million in cash. Other compensation terms will be consistent with the Company's existing license agreements with TheraCour, including a 15% royalty on sales (net of costs) and 15% of sub-licensing revenues.

Recently, on February 4, 2019, the Company has announced that it has selected a clinical candidate for further development under the HerpeCide broad-spectrum drug program. The candidate, called "NV-HHV-101" is now in IND-enabling cGLP Safety/Toxicology studies in the regulatory pathway. Its first indication is for the treatment of shingles rash as a dermal topical cream.

The Company has substantially de-risked this program towards clinical success and has already performed successful safety assessments in a non-GLP preliminary safety/toxicology study against two precursor candidates that led to NV-HHV-101 in a standard rat animal model. In these studies, the candidates were found to be extremely safe, with no evidence of dermal topical or systemic adverse events.

Register as Visitor to CPhI China 2019!

-----------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.