This excerpt taken from the ELN 20-F filed Mar 30, 2006.
Prialt A Different Pain Treatment
On December 28, 2004, the FDA approved Prialt for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal morphine. Prialt is approved for use only in the Medtronic SynchroMed® EL, SynchroMed® II Infusion System and CADD-Micro® ambulatory infusion pump.
Prialt is administered through appropriate programmable microinfusion pumps that can be implanted or external, and which release the drug into the fluid surrounding the spinal cord.
Prialt has been evaluated as an intrathecal infusion in more that 1,200 patients participating in chronic pain trials. The longest treatment duration to date was more than seven years.
Prialt is in a new class of non-opioid analgesics known as N-type calcium channel blockers. It is a synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research suggests that the novel mechanism of action of Prialt works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals.
Prialt represents a unique accomplishment and opportunity for Elan. From a scientific perspective, Prialt is an important innovation a new type of therapy in a field that has not seen a new product in approximately 20 years. The significance of this innovation has received wide industry validation and recognition, including a December 2005 profile in Popular Science, which listed Prialt as one of the 100 best innovations of the year.
In January 2005, we launched Prialt in the United States. The initial introduction of Prialt to the marketplace allowed physicians to gain the necessary experience with this treatment; drove our appropriate responses to reimbursement issues during the year; and clarified the marketing, education and other programs and parameters required to continuously improve patient availability. We believe Prialt represents an important therapeutic option addressing an unmet need, and that it has the potential for significant patient impact and market contribution in the area of severe chronic pain. Revenue from sales of Prialt totalled $6.3 million for 2005.
In February 2005, the European Commission granted marketing authorization for Prialt for the treatment of severe, chronic pain in patients who require intrathecal analgesia. Prialt has been awarded orphan drug status in the European Union, which designates it as a product used for the diagnosis, prevention or treatment of life-threatening or very serious rare disorders or conditions. On March 20, 2006, Elan completed the sale of the Prialt rights in Europe to Eisai, while retaining the product rights in the United States.