MediQuest Therapeutics Receives Special Protocol Assessment from the U.S. FDA

(Bothell, WA - 10 January 2006). MediQuest Therapeutics, Inc. today announced that it has received recommendations from the U.S. Food and Drug Administration (FDA) under the Special Clinical Protocol Assessment (SCPA) procedure with respect to their protocol on a Phase III "in-life" study of a topical gel formulation, MQX-503, for the treatment and prevention of Raynaud's Phenomenon. The SCPA letter provides a written recommendation from the FDA concerning medical, statistical, biopharmaceutical and chemical requirements for an approvable submission for this indication.

Key recommendations from the FDA, and accepted by MediQuest, include additional clinical observations to be recorded and clarification of other issues relating to efficacy analysis, safety assessment and formulation development history. This special protocol assessment documents the FDA's requirements for the design and planned analysis of the study to adequately address and support all issues of its regulatory submission. Following a Special Protocol Assessment, the FDA may not later alter its perspective on the pivotal study design, execution or analyses unless public health concerns unrecognized at the time of the protocol assessment under this process are evident.

Raynaud's phenomenon is a condition caused by moderate to severe constriction of blood vessels in the hands and feet, usually triggered during colder weather. The condition is either of a primary nature or is secondary to scleroderma and other such autoimmune diseases. More than six million people in the United States suffer from Raynaud's. Approximately 80% of these patients are women, who also experience pain caused by the chronic vasospasm episodes in their hands.