SPP100 (Rasilez) Receives EU Approval

Approval Validates Speedel's Long Standing Commitment to Renin Inhibition

Basel, (PresseBox) - Speedel (SWX: SPPN) today welcomed the announcement that Novartis has received European Union approval of SPP100 (Rasilez[i]) the first major innovation in high blood pressure treatment for more than a decade. Nearly half of all adults in Europe's largest countries, such as Germany, Italy and the UK, suffer from this potentially life-threatening condition.[ii]

The European Commission approved Rasilez alone or in combination with other high blood pressure therapies, based on data from more than 7,800 patients in 44 clinical studies which was submitted by Novartis in September 2006. The Approval applies to all 27 EU member states plus Iceland and Norway.

SPP100 was approved by the US Food and Drug Administration (FDA) in the US in March 2007 under the trade name Tekturna[iii] to treat hypertension both as monotherapy and in combination with other anti-hypertensives. Novartis announced in July 2007 that it was also approved in Switzerland. Speedel successfully developed SPP100 through Phase I and II clinical trials before Novartis exercised its license-back option in 2002.

Dr. Alice Huxley, CEO, said: "There is a clear unmet medical need in this therapeutic area with more than 40% of treated patients not achieving control levels for their high blood pressure - even when using existing therapies. This approval is a welcome step bringing SPP100 (Rasilez) to patients in Europe as the first novel therapy for treating high blood pressure since 1995."

Dr. J. Chris Jensen, Head of Scientific Affairs, commented: "Hypertension is a leading cause of cardiovascular disease, the world's No 1 killer. Speedel remains at the forefront of research and clinical development of next generation direct renin inhibitors with SPP635 in Phase IIa and SPP1148 in Phase I. This approval validates Speedel's long standing commitment to direct renin inhibition as the potential gold standard therapy for treatment of hypertension and other related disorders."

The Lancet published an editorial on 17 August which stated that: "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." [iv]

The clinical data submitted by Novartis showed that Rasilez provided significant blood pressure reductions for a full 24 hours [v] [vi] [vii] Furthermore, Rasilez provided added efficacy when used in combination with other commonly used blood pressure therapies [viii] [ix] [x] [xi]

Novartis is also conducting a large outcome trial programme to evaluate the potential long-term effects of SPP100 and direct renin inhibition beyond high blood pressure. Data from the programme in high blood pressure patients with heart failure or kidney failure are expected to be released later this year.


About SPP100 (aliskiren, Tekturna/Rasilez [xii])

SPP100 (aliskiren, Tekturna/Rasilez) is the first-in-class oral direct renin inhibitor. The development of SPP100 is the result of over 20 years of research on renin. Renin is the rate-limiting enzyme at the top of the Renin Angiotensin System (RAS), one of the key regulators of blood pressure. The RAS is a cascade, starting with renin, leading to angiotensin I and finally to angiotensin II. Angiotensin-converting enzyme inhibitors (ACE-Is) and angiotensin II receptor antagonists (ARBs) have been developed to block this system "down stream" and have shown clinical efficacy in patients with hypertension and other cardiovascular diseases.

By inhibiting renin at the top of the RAS, SPP100 decreases the system's activity, as measured by plasma renin activity (PRA). Lowering PRA is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is an independent risk factor and direct surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. Direct Renin inhibitors lower PRA whereas most current leading anti-hypertensive drug classes such as ACE-Is and ARBs increase PRA levels.

Speedel in-licensed SPP100 from Novartis in 1999 and successfully completed 18 clinical trials, through Phase I and II in about 500 patients and healthy volunteers. Based on the results generated during this programme, Novartis exercised a license-back option in 2002, and subsequently Novartis started trials with SPP100 in Phase III as monotherapy for hypertension and in Phase IIb as combination therapy. Regulatory approval was given by the US FDA in March 2007 and by the EU in August 2007.

Speedel believes that it is the first company to establish successfully a clinical proof of concept in Phase II and to have developed and filed for patent protection a commercially viable manufacturing process for a renin inhibitor, an area of industry research for over 20 years. In a Phase II study of 200 patients conducted by Speedel, it was demonstrated that SPP100 achieves dose-dependent blood pressure reduction. The study also showed that 150mg and 300mg SPP100 once daily were comparable to Losartan 100mg, which is double the usual starting dose of this ARB (Stanton, Jensen, Nussberger, O'Brien, Hypertension.2003; 42: 1137-1143).

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