Atrix Laboratories Inc has submitted an Investigational New Drug Application (INDA) to the U.S. Food and Drug Administration (FDA) for an additional dosage form of Eligard (leuprolide acetate for injectable suspension).
"Market analysis suggested that physicians and health care organizations would be receptive to this product," said David R. Bethune, chairman and chief executive officer at Atrix. "Due to the flexibility of the Atrigel drug delivery system, we have the opportunity to develop a new formulation that may fill a void in the current marketplace."
Earlier this year, Sanofi-Synthelabo Inc, Atrix's North American marketing partner for the Eligard products, licensed this new formulation. Under the terms of the agreement, Atrix will receive reimbursement for research and development expenses related to the development of the new Eligard product. Additionally, Atrix will receive payments for certain regulatory and sales milestones, a royalty based on sales of the product and will manufacture the Eligard products at its facility in Fort Collins, Colorado.