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Positive Results From Discovery Therapeutics Clinical Trial of Anti-Parkinson Patch February 12, 1998 RICHMOND, Va.--(BW HealthWire) via Individual Inc. -- Discovery Therapeutics Inc. Wednesday reported that preliminary analyses of a Phase IIb clinical trial showed significant efficacy and reduced adverse events in the treatment of patients with mild to severe Parkinson's disease using a novel transdermal patch. The once-a-day patch, formulated with Discovery's proprietary dopamine D2 agonist N-0923, reduced daily levodopa in the three highest dosage groups by more than 30 percent. All patients in the efficacy evaluable group were able to completely eliminate use of oral agonists for the full 21-day study, and 27 percent were able to reduce their levodopa intake to less than the minimum daily dose (300 mg). There were no serious or unexpected adverse events, and only two of the 82 patientswere discontinued because of adverse events. This double-blind, placebo-controlled study was conducted at nine major Parkinson centers in North America. The study tested the N-0923 patch in a total of 82 patients in five dosage arms, including one placebo group, for 21 days. Patients were taken off their regular dopamine agonists and levodopa therapy the night before starting treatment with the patch. Levodopa was then added back, if needed, to maintain control of symptoms. The primary endpoint was the daily dosage of levodopa. Other measures of efficacy included the Clinical Global Impression and Unified Parkinson Disease Rating Scales. All patients tolerated the immediate transition to the N-0923 patch well, without the need for a gradual dose escalation typically required of oral agonists. The adverse event rate, particularly nausea, was remarkably lower than that associated with oral agonists. Scores from some of the efficacy measures suggested that the patch provided superior control of symptoms relative to the response to the usual oral therapy. "These exciting results confirm that our unique molecule and delivery system represents a significant advance in the treatment of Parkinson's disease," said Dr. Donald McAfee, president and chief executive officer of Discovery Therapeutics. "Many patients, especially those intolerant to oral agonists, showed excellent responses to the patch therapy." The company previously announced an agreement with Yoshitomi Pharmaceutical Industries Ltd. for Japanese development and marketing. It is currently in negotiations with potential corporate partners for territories in the rest of the world. Discovery Therapeutics invents, develops and will commercialize pharmaceuticals for poorly met medical needs using novel signal molecule technologies. The company has two technology platforms: one based on dopamine receptors for the treatment of movement disorders and the other based on adenosine receptors for the treatment of cardiovascular indications. CONTACT: Discovery Therapeutics Inc., Richmond | Donald A. McAfee, 804/358-9468 | or | EMM Communications | Ellen M. Martin, 510/832-2044