The collaboration centers on the production of ANA975 and additional Toll-Like Receptor 7 (TLR7) oral prodrugs for the treatment of infectious disease. Under the exclusive global license and co-development program Anadys will receive an initial license payment of $20 million.
The small-time developer which currently has no marketed products will then be eligible to receive up to $550 million in regulatory and commercial milestone payments and a further $10 million following a successful new drug application to the FDA. The agreement also includes potential royalty payments and a US co-promotion option for Anadys.
Following news of the partnership, shares in Anadays soared by 24%. Novartis also experienced a slight rise.
ANA975 is an oral prodrug of isatoribine, a small molecule TLR7 agonist. During clinical trials involving intravenous administration to 68 participants, isatoribine significantly reduced viral loads of hepatitis C. Anadys and Novartis expect to initiate a 28-day study of ANA975 in hepatitis C virus (HCV) patients in the second half of 2005.
The license to Novartis includes rights to additional oral prodrugs of TLR7 agonists for potential use in infectious disease indications. The two companies will work closely to develop ANA975 and may collaborate to develop next-generation TLR-based compounds for HCV and hepatitis B virus (HBV) in addition to other infectious disease indications.
“Anadys is at the forefront of TLR-based small molecule therapeutics,” said Thomas Ebeling, CEO of Novartis. “This agreement is a further step in our strategy to augment internal activities with externally sourced products in key therapeutic areas such as HCV and HBV, where Novartis is working to meet the needs of these patients.”