In July 2002, we entered into a development and commercialization agreement with Curaxis (formerly known as Voyager) under which we granted Curaxis the exclusive, worldwide rights to develop and commercialize a product, Memryte, using the DURIN implant system to deliver the peptide leuprolide acetate to treat Alzheimerís disease based on Curaxisís patented method of treatment. Under the agreement, as amended, we will receive milestone payments from Curaxis if specified development milestones are achieved, and, if the product candidate is commercialized, royalties of betwwen 10% to 14% of net sales depending on the sales volumes. In addition, we will receive 10% of any upfront, milestone and other fees received by Curaxis in the event that the product candidate is sublicensed to a third party.
In October 2005, Curaxis initiated a Phase III clinical trial for Memryte, which was truncated by Curaxis in order to get an earlier look at potential efficacy. In the second quarter of 2007, Curaxis informed its shareholders that it has observed positive outcome trends among women, but no positive effect among men in Curaxisís truncated Phase III clinical trial. Based on these results, Curaxis has stated that it intends to focus its efforts on developing Memryte for the treament of Alzheimerís disease in women and on seeking a potential collaborative partner for the program. There can be no assurance that Curaxis or any other party will continue development of Memryte.
The proteins and genes identified by the biotechnology industry are large, complex, intricate molecules, and many are unsuitable as drugs. If these molecules are given orally, they are often digested before they can have an effect; if given by injection, they may be destroyed by the bodyís natural processes before they can reach their intended sites of action. The bodyís natural elimination processes require frequent, high dose injections that may result in unwanted side effects. As a result, the development of biotechnology molecules for the treatment of human diseases has been limited, and advanced drug delivery systems such as we possess are required to realize the full potential of many of these proteins and peptide drugs. We have active programs underway to apply our drug delivery systems to various biotechnology drugs and drug candidates, and have entered into a number of feasibility studies with biotechnology and pharmaceutical companies to test their products in our systems.
Research Programs in other Therapeutic Categories
We have underway a number of research programs covering medical diseases and conditions other than pain. Such programs include various diseases and disorders of the central nervous system (CNS), including schizophrenia and attention deficit/hyperactivity disorder. Another area of focus includes cardiovascular disease, including congestive heart failure. In conducting our research programs and determining which particular efforts to prioritize for formal development, we employ a rigorous opportunity assessment process that takes into account the unmet medical need, commercial opportunity, technical feasibility, clinical viability, intellectual property considerations, and the development path including costs to achieve various critical milestones.