Atrix Laboratories Inc has entered into an exclusive North American marketing agreement with EmerGen Inc for a one-month and a three-month leuprolide product (leuprolide acetate for injection) for the treatment of endometriosis, a chronic, painful female condition that, if left untreated can ultimately affect fertility.
In the agreement, EmerGen receives rights to develop and market the one-month and three-month leuprolide product. Atrix receives a license fee, R&D support and payments for certain clinical, regulatory and sales milestones. In addition to the milestone payments, Atrix will receive royalty payments based on sales of the products upon approval for marketing by the U.S. Food and Drug Administration (FDA). Atrix will manufacture the endometriosis products at its facility in Fort Collins, Colorado.
David R. Bethune, Atrix's chairman and chief executive officer said, "I am pleased to be working with EmerGen. Their singular focus on women's health make them an excellent partner for endometriosis."
Atrix has developed and received approval for two leuprolide acetate products, Eligard 7.5mg and Eligard 22.5mg one- and three-month products. These products are currently available on the U.S. market for the treatment of advanced prostate cancer. The new leuprolide products for endometriosis involve the development and clinical testing of a 'half-strength' dose, which is the standard of care for endometriosis. Currently, these products are in pre-clinical testing at Atrix.
"These products, combined with our expertise in the understanding of the genetic basis of endometriosis and other diseases affecting women, fit perfectly with our goal of becoming a leading women's health company and will accelerate the forward integration of our company," said Richard L. Jackson, EmerGen's president and chief executive officer.
These new endometriosis products, as well as the Eligard prostate cancer products use Atrix's proprietary Atrigel drug delivery technology to deliver leuprolide acetate for a period of one or three months. The liquid products are injected subcutaneously with a small gauge needle, forming a solid implant in the body that slowly releases leuprolide as the implant is bioabsorbed.