In addition Novartis has an option to make an equity investment at the end of Phase II clinical trials for four million shares. Under the terms of the agreement AlphaVax will be eligible for milestones and royalties. AlphaVax is responsible for finalization of Phase I clinical trials, and is expected to provide the clinical trial material for the Phase II trials.
Novartis will be responsible for the development of the cytomegalovirus (CMV program) for Phase II clinical trials onwards as well as for registration and world-wide commercialization. The vaccine is expected to enter Phase II clinical trials in 2009.
This CMV agreement adds to Novartis’s early stage pipeline of novel vaccines, which focuses on significant unmet needs for the prevention of fatal diseases such as meningococcal infections and other hospital and community acquired infections.
These include vaccines to prevent Helicobacter pylori infections, a major cause of gastritis that can lead to gastric cancer, and a Group B Streptococcus vaccine candidate which is expected to protect against 85% of neonatal sepsis and meningitis.
Andrin Oswald, CEO of Novartis Vaccines and Diagnostics, said: We are happy to gain access to a promising vaccine candidate for the prevention of cytomegalovirus infections, which are particularly problematic during pregnancy as they can cause permanent disability in newborns.