Speedel announces start of SPP635 phase IIA trial in diabetic patients

Next generation renin inhibitor profiled for difficult-to-treat population

Basel/Switzerland and Bridgewater NJ/USA, (PresseBox) - Speedel Holding Ltd (SWX: SPPN) today announced that it has started a Phase IIa clinical trial with its next generation renin inhibitor SPP635 in a more difficult to treat group of patients who suffer from both diabetes and mild-to-moderate hypertension. The new trial will be carried out in Europe with results due in the second half of 2008.

Alice Huxley, CEO, commented: "This is yet another milestone for Speedel following the successful completion of our first Phase IIa trial with SPP635 in essential hypertension. SPP635 is the first drug from Speedel's own research laboratory that has progressed into Phase II as we continue to leverage our exceptional knowledge of renin inhibition, a mode of action that we believe has the potential to be the next gold standard for the treatment of a range of cardiovascular diseases."

Dr. Chris Jensen, Head of Scientific Affairs, said: "The recent results of the AVOID study[1],[2] with the first-in-class renin inhibitor SPP100 highlight the possible long-term benefits of using renin inhibitors in that part of the diabetic population with kidney disease. The more challenging patient group that we have chosen for this study with SPP635, although known to be harder to treat, has already been shown to respond to SPP100 in controlling blood pressure both alone and in combination with an ACE inhibitor.[3],[4] Our next generation compounds are specifically designed to further enhance the benefits of reducing proteinuria, a marker of diabetic kidney disease, as we have demonstrated in our preclinical research. High blood pressure occurs in 74% of diabetes patients[5] and it is clear that new therapies are required to treat this vulnerable patient population."

The proof-of-concept Phase IIa trial for the treatment of hypertension in diabetic patients will be carried out in Europe with first results expected in the second half of 2008. It will study the safety, tolerability and efficacy of two different doses of SPP635 for 4 weeks in about 50 patients with type II diabetes, mild to moderate hypertension and proteinuria.

SPP635 is the most advanced compound in the SPP600 series and is the first of the next generation of renin inhibitors invented by Speedel Experimenta, the company's late-stage research unit. It follows Speedel's lead product SPP100 (aliskiren, Tekturna/Rasilez[6]), which is partnered with Novartis and recently obtained marketing approval in the US and in the EU. Speedel's next generation renin inhibitors include SPP676 and SPP1148 in Phase I clinical development and other compounds in the SPP600 series, the SPP1100 series and the SPP800 series are currently in late-stage pre-clinical profiling. Each series is a different chemical class with distinct properties and is protected by different patent applications.

AVOID[7] study

Promising results of SPP100 (Tekturna/Rasilez) in the AVOID Phase III clinical trial with diabetic patients were presented on 4 November 2007 at the American Society of Nephrology Renal Week Congress in San Francisco, California by Professor Hans-Henrik Parving of the Department of Endocrinology, Righospitalet, Copenhagen, Denmark from a study sponsored by Novartis.[8] The results showed that SPP100, the first-in-class direct renin inhibitor, further lowers proteinuria in diabetic patients, independent of blood pressure, when administered on top of losartan (ARB[9]), a standard therapy used to treat diabetic kidney disease.

Growing global health risks of high blood pressure

The Lancet published an editorial on 17 August 2007 which stated: "The risk of becoming hypertensive during lifetime exceeds a staggering 90% for a person in a developed country." The editorial also observed that: "The increasingly common combination and interaction of obesity, diabetes, hyperlipidaemia and high blood pressure, if left untreated for too long, leads to cardiovascular disease, stroke, renal failure, dementia, and ultimately death. Worldwide, the estimated number of adults with hypertension was 972 million in 2000; 639 million live in developing countries. By 2025, the total number is expected to increase to 1.56 billion."[10]

About SPP600 series

SPP635 is the most advanced compound of the SPP600 series of renin inhibitors being developed by Speedel. The company has made significant progress in the optimisation and development of this series of newly synthesised compounds by using rational drug design, including computer assisted molecular modelling techniques, state-of-the art preclinical disease models and human microdosing.

In December 2001, Speedel acquired a worldwide exclusive license from Roche covering its entire programme in renin inhibition. This license allows Speedel to use the acquired know-how for lead optimisation of its own compounds designated as the SPP600 series. Speedel holds full development and commercialization rights for these product candidates under the license agreement with Roche.

Forward looking statements

This press release includes forward-looking statements that involve substantial risks and uncertainties. These forward-looking statements are based on our current expectations and projections about future events. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The word "may" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations described in these forward-looking statements and you should not place undue reliance on them. There can be no assurance that actual results of our research and development activities and our results of operations will not differ materially from these expectations. Factors that could cause actual results to differ from expectations include, among others: our or our partners' ability to develop safe and efficacious products; our or our partners' ability to achieve positive results in clinical trials; our or our partners' ability to obtain marketing approval and market acceptance for our product candidates; our ability to enter into future collaboration and licensing agreements; the impact of competition and technological change; existing and future regulations affecting our business; changes in governmental oversight of pharmaceutical product development; the future scope of our patent coverage or that of third parties; the effects of any future litigation; general economic and business conditions, both internationally and within our industry, including exchange rate variations; and our future financing plans.

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