Rotavirus Vaccine Manufacturing Agreement Between BIOVIRx and IDT

BIOVIRx and IDT announced today an agreement intended to develop the oral rotavirus vaccine RotaShield(R) for commercialization. Worldwide, rotavirus gastroenteritis causes more than 2 million hospitalizations and up to 600,000 deaths annually in infants and young children. BIOVIRx has an exclusive worldwide license for RotaShield(R) and is planning global commercialization upon appropriate regulatory approvals. IDT currently has existing vaccine production capacity for RotaShield(R) and has initiated construction of a new manufacturing facility for expanded production of the vaccine. The new facility will be located at the IDT complex in Dessau-Tornau, Germany.

Leonard P. Ruiz, CEO of BIOVIRx states, “BIOVIRx is very pleased to be working with the well established vaccine manufacturer IDT, which has 80 years of vaccine manufacturing experience. This agreement will allow us to deliver to the world markets a safe, effective and affordable vaccine that can help in the prevention of a major disease problem and assist in saving the lives of 1,600 children lost every day due to this highly infectious virus”.

IDT is very proud to contribute to the reintroduction of RotaShield(R). Heinz Hofmann, managing director of IDT, pointed out that the mission of IDT is to introduce vaccines as safe, very effective and low cost tools for prevention of infectious diseases and the collaboration between IDT and BIOVIRx is an excellent fit with that mission.

RotaShield(R) received FDA approval in 1998 and was administered to over 600,000 infants in the United States in only 9 months before being voluntarily withdrawn from the market in 1999 because of a temporal association with a higher risk of a naturally occurring blockage of the intestine called intussusception. However, recent re-analysis of the data on intussusception and RotaShield(R) (More on RotaShield(R) and Intussusception: The Role of Age at time of Vaccination. Journal of Infectious Diseases, 2005:192:S36-S43) revealed that the higher intussusception risks were related to the vaccine being used in infants older than what was recommended in the RotaShield(R) package insert. In this re-analysis of RotaShield(R) there were no cases of intussusception in 71,000 infants that had received the first dose of the vaccine before 60 days of age.

BIOVIRx and IDT are planning to meet with the appropriate regulatory authorities to discuss the requirements for reintroduction of the vaccine.

About IDT

Impfstoffwerk Dessau-Tornau GmbH (IDT) based in Tornau, Germany, is an autonomous company originally established in 1921 in the pharmaceutical sector. IDT is wholly owned by the Klocke Group – known as contract manufacturers for the pharmaceutical and cosmetic industries on an international scale.

IDT develops, manufactures and markets vaccines in Germany and exports them throughout the world. Based on modern cGMP Standards, advanced technologies and in brand new facilities IDT provides contract manufacturing services for vaccines and pharmaceuticals for many pharmaceutical companies. IDT has a total of 400 highly-qualified employees.

  Contact Information: Heinz Hofmann +49 34901 885 220 Heinz.hofmann@idt-direct.de www.idt-direct.de 

About BIOVIRx

BIOVIRx, Inc. is a privately held biopharmaceutical company located in Minneapolis that was formed in 2002 to acquire and distribute pharmaceutical and health products in the U.S. and global markets. Its initial product, RotaShield(R), was acquired under an exclusive, worldwide license from the U.S. National Institutes of Health (“NIH”). RotaShield(R) is an oral pediatric vaccine intended for use in preventing rotavirus infection.