NanoViricides, Inc., shares gained ground (NYSE:NNVC) to begin Monday. The leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted an "Orphan Drug Designation" (ODD) by the US FDA Office of Orphan Products Development (OOPD).
The orphan drug designation will qualify NanoViricides for incentives including:
• Tax credits for qualified clinical trials;
• Exemption from certain user fees;
• Potential seven years of market exclusivity after approval;
according to the US FDA.
"The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 for the Treatment of Measles," said Anil R. Diwan, PhD., adding, "NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved."
NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study.
Measles cases, this morning’s release reports, “have been rising globally. This year, a major epidemic has broken out in Bangladesh with over 227 children dead and over 35,000 cases, while Guatemala has an on-going Measles outbreak with over 5,300 cases and four deaths.”
The release continues, “measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally, Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks.
NNVC shares took on four cents, or 3.1%, to $1.35.
