N&N Pharmaceuticals Inc., an emerging pharmaceutical company focused on developing therapeutics for infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, N-Methanocarbathymidine (N-MCT), for the treatment of neonatal herpes simplex.
Unfortunately 85% of the neonates which are born with HSV-2 infection have one year mortality even with aggressive treatment. Remaining surviving neonates have long term neurodevelopmental problems in 67% of survivors. Approximately 25% of all pregnant women are seropositive for HSV-2, and 1% with a prior history of recurrent genital HSV-2 infects the newborn child. Even in the presence of appropriate therapy, CNS and disseminated neonatal HSV-2 infections are associated with substantial morbidity and mortality due to virus-associated encephalitis and neutropenia.
"This is an extremely important regulatory milestone for N&N Pharmaceuticals and will provide us with a number of benefits as we advance the development and commercialization process for N-MCT which is already in the clinic," said Dr. Aquilur Rahman, President and CEO of N&N Pharmaceuticals. "Neonatal herpes simplex is a serious life threatening infection often with severe long term sequelae in the newborn." He further commented that "our extensive preclinical studies demonstrated significant protection of HSV-2 infection in the newborn neonates. In addition, N-MCT has shown quite superior activity in Shingles and Genital Herpes infection. We intend to develop this alternate therapy quite fast to cure and save the lives of these newborns."
The Orphan Drug Designation provides the sponsor certain benefits and incentives; including a period of marketing exclusivity, potential tax credits for certain activities and other assistance to develop effective therapy for the lethal diseases.