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Speedel starts Phase III study of SPP301 in diabetic nephropathy
- Speedel pipeline now contains two potential blockbuster drugs in Phase III -


Basel/Switzerland and Bridgewater NJ/USA, 07 July 2005... Speedel announced today the start of its Phase III study for SPP301, its once-a-day oral endothelin A receptor antagonist (ERA) in the indication of diabetic nephropathy (diabetic kidney disease). The ASCEND study has begun with the first patient visit as per the schedule outlined by Speedel in March 2005 when the company reported successful completion of the Phase II clinical trials.

Dr. Alice Huxley, CEO of Speedel, commented: “This milestone is of major strategic importance for Speedel as SPP301 is the first drug which we have progressed into Phase III ourselves and it is a considerable commercial opportunity. Our mature and diverse pipeline now includes two Phase III products with blockbuster potential for major indications – SPP100 partnered with Novartis for hypertension and SPP301 for diabetic kidney disease. Both products have the potential to be first-in-class in their respective indications, and demonstrate Speedel’s commitment to innovative therapies for the large and growing markets of cardiovascular and metabolic diseases.”

Dr. Jessica Mann, Medical Director of Speedel, added: “The prevalence of diabetic nephropathy has been increasing dramatically in line with the rising numbers of diabetes patients worldwide. Diabetic nephropathy has a high mortality rate affecting an estimated 8.0 million people diagnosed with diabetes in the US, Japan, and major European countries. Therapeutic options are limited at present. We believe SPP301 to have considerable potential as a breakthrough therapy with significant medical benefits for the people who suffer from this chronic disease.”

The Phase III pivotal ASCEND study is a randomized, placebo-controlled morbidity and mortality study with over 2,000 patients, designed to assess time to doubling of serum creatinine, end-stage renal disease or death in type 2 diabetes patients with overt diabetic nephropathy . Patients will be given either 25mg or 50mg of SPP301 once per day on top of standard therapy, or will receive standard therapy alone (i.e. the placebo arm). The study, which has been discussed and agreed with the FDA and the EMEA, will be conducted in about 260 clinical sites in Europe, USA and other countries. This is an event-driven study, and the current best estimate is that it will take approximately 3.5 years for enough events to occur in the composite end-point to demonstrate statistically significant efficacy. In view of the high unmet medical need diabetic nephropathy represents, SPP301 has been granted Fast Track Designation and has undergone a Special Protocol Assessment by the FDA . This means that the review process is expedited and that assuming successful registration, SPP301 could be launched in the USA in late 2009 and in other countries in 2010.

The ASCEND study oversight bodies consist of a Steering Committee, Data Safety Monitoring Board and an Endpoint Committee consisting of highly experienced and well respected nephrologists, cardiologists and diabetologists.

Professor Giancarlo Viberti, Chairman of the ASCEND Steering Committee, stated: “SPP301 offers a truly novel approach to treating diabetic kidney disease. The clinical results obtained so far are very encouraging, and suggest that SPP301 could impact on morbidity and mortality in patients suffering from this chronic disease. We look forward to working with our colleagues worldwide on this large and rigorous study to demonstrate the benefits of SPP301 over current therapies.”

The Steering Committee members are professors Giancarlo Viberti, Johannes Mann, Luis Miguel Ruilope and Kenneth Jamerson.

Giancarlo Viberti is professor of diabetes and metabolic medicine at Kings College London, England. Professor Viberti was head investigator of the Microalbuminuria Collaborative Study Group and is Co-chairman of the Steering Committee for the ROADMAP (Randomised Olmesartan And Diabetes MicroAlbuminuria Prevention) study.


Publisher Contact Information:

Speedel
+41 (0) 61 206 40 14
nick.miles@speedel.com

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