Asthma and allergy conditions are characterized by an imbalance in the immune system. Currently approved agents for the treatment of asthma and allergy conditions, including steroids and antibodies, are designed to suppress symptoms of allergic or asthmatic response. TLR9 agonists are designed to induce immune responses that could be useful in restoring immune system balance. In preclinical studies, Idera’s TLR9 agonists have shown improvements in multiple indices of allergic conditions.
In May 2005, Idera entered into a research collaboration and option agreement and a separate license, development and commercialization agreement with Novartis to discover, develop and potentially commercialize TLR9 agonists that are identified as potential treatments for asthma and allergies.
The agreements with Novartis are structured in two phases. During the research collaboration phase, Idera and Novartis have agreed to work together to evaluate novel TLR9 agonists from which Novartis may select one or more product candidates for further development through human clinical “proof of concept” trials. Based on the results of the research collaboration, Novartis may then elect to implement the commercialization agreement, under which Novartis would complete development on and commercialize one or more of the product candidates.
Under the terms of the agreements:
- Upon execution of the agreements, Novartis paid Idera a $4.0 million upfront license fee;
- Novartis agreed to fund substantially all research activities during the research collaboration phase;
- If Novartis elects to exercise its option to develop and commercialize TLR9 agonists then it may pay up to $136 million in milestone payments for the products, plus royalties.
In March 2007, Novartis extended its research collaboration with Idera by an additional year until May 2008, and in connection with this extension, Novartis paid Idera an additional license fee of $1.0 million.
Novartis selected QAX935 as a lead compound under this collaboration. In March 2008 Idera agreed to extend the research collaboration until December 31, 2008. The extension is anticipated to allow for the advancement of QAX935 into human clinical trials prior to the end of the research collaboration term.