In July 1998, Aderis entered into a collaboration with Schwarz Pharma to complete worldwide development and commercialization of Rotigotine CDS (SPM-962), a novel dopamine agonist formulated in a skin patch to treat Parkinson's disease. The agreement provides Aderis with license fees and milestone payments, as well as royalties based on product sales. In addition, Schwarz Pharma has made significant equity investments in Aderis.
Schwarz Pharma completed two Phase II trials on rotigotine CDS in 2001. These trials indicated that rotigotine provided a significant dose-related symptom improvement in patients with Parkinson's disease. Based upon data from these trials, Schwarz Pharma began three Phase III trials in 2002 involving both early and late stage patients. Both early-stage-patient Phase III trials are completed. One in Europe and one in the US. The European trial was a 3-arm trial comparing rotigotine to both placebo and an active comparator. Preliminary results indicate that all primary and secondary endpoints have been met. The final US Phase III trial in late-stage patients is fully-enrolled and results are expected in Q2 2004. Schwarz Pharma has announced it will file for both US and European regulatory approval in Q3 2004.
In 2002, Schwarz expanded the indication portfolio for rotigotine by completing a "proof of concept", placebo controlled Phase II trial in patients with Restless Legs Syndrome. Rotigotine demonstrated significant improvement of symptoms in patients treated with rotigotine as measured by the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale compared to the placebo treated patient group. Phase IIb trials in Restless Legs Syndrome are to start in Q2/2003.
"Each of our partners shares Aderis' dedication and commitment to rapid development and commercialization, regardless of whether that partner is providing us with products to develop or developing and commercializing our product candidates"
-Ken Rice,
Vice President and Chief Commercial Officer, Aderis Pharmaceuticals
