Just when it looked as if we were heading into holiday doldrums, a flurry of deals got done this week. GlaxoSmithKline and Dynavax Technologies inked a worldwide strategic alliance to discover, develop, and commercialize novel inhibitors of endosomal toll-like receptors or TLRs for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses. Dynavax will receive an initial payment of $10 million for which GSK will receive an exclusive option over four programs targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis. Under the agreement, Dynavax will conduct research and early clinical development in up to four programs and is eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product. Dynavax’ lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.

 

GSK was not alone. AstraZeneca said it entered into an exclusive worldwide agreement with MAP Pharmaceuticals to develop and commercialize Unit Dose Budesonide, MAP’s proprietary nebulized formulation of budesonide that is in development as a potential treatment for pediatric asthma and currently in late-stage clinical development. AstraZeneca will pay MAP an upfront cash payment of $40 million and an additional $35 million upon the successful achievement of primary endpoint and safety results in the currently ongoing Phase III clinical study. In addition, upon the occurrence of certain events and conditions, The company is eligible to receive up to $240 million in other potential development and regulatory milestones.

 

And then there was Pfizer. The drug giant signed a deal with Auxilium Pharmaceuticals to market XIAFLEX (clostridial collagenase for injection) a first-in-class, late-stage biologic, in Europe and other territories for the treatment of Dupuytren’s disease and Peyronie’s disease. Auxillium will receive $75 million upfront and $410 million in potential additional milestone payments. Of these additional milestones, $150 million are tied to regulatory milestones and $260 million are based on sales milestones.