Accordingly, Urigen has acquired worldwide rights to develop and commercialize intra-nasal testosterone. In exchange, Mattern will receive an undisclosed up-front number of Urigen common shares and will receive additional milestone payments based on certain development and regulatory milestones. In addition, Mattern will receive royalties on net sales of the product until an undisclosed pre-determined amount of royalties has been paid.
Phase II clinical trials in hypogonadal men have demonstrated the formulation is well tolerated and increases total testosterone blood levels in a dose-dependent manner. Urigen said that the product will be provided in a convenient unit dose configuration which minimizes the risk of inadvertent transference to others in close contact with the patient.
William Garner, president and CEO of Urigen, said: “The addition of this product to our pipeline provides us with two Phase II programs for urologic disorders. We are honored to be chosen by Mattern to complete the development and commercialization of this very important new product. This license agreement demonstrates Urigen’s commitment to achieve its goal of becoming the preferred specialty pharmaceutical company servicing the urology market.”
Dennis Giesing, chief scientific officer of Urigen, said: “Licensing this product is a very significant milestone for Urigen. We believe intra-nasal testosterone has important characteristics that will provide advantages over currently approved and in development testosterone replacement products, thus enabling us to successfully compete in the marketplace.”