SPP100 (Tekturna/Rasilez) Reduces Left Ventricular Hypertrophy
Latest study reveals further potential benefits of renin inhibitor in heart disease
Dr Chris Jensen, Head of Scientific Affairs, said: This data is yet another important step forward in demonstrating the full potential of SPP100 to treat both hypertension and its consequences, which so often lead to debilitating or fatal illness. As the data from Novartis' ongoing studies are published over the next few years we believe that clinicians will become increasingly convinced of the potential for SPP100 to benefit patients in ways that go beyond other types of drugs.
ALLAY study results
The ALLAY (ALiskiren Left ventricular Assessment of hypertrophY) 36-week study treated 460 patients with SPP100, losartan or a combination of the two. Results showed that treatment with SPP100 alone reduced LVH as effectively as the angiotensin receptor blocker (ARB) losartan (-5.4% vs -4.7% respectively) after nine months of therapy, despite patients having very well-controlled baseline blood pressure. The combination of both medicines achieved a numerically greater reduction in LVH than losartan alone, but the result was not statistically significant. Alone and in combination, SPP100 was well-tolerated.
The ALLAY study is the latest trial in Novartis' ASPIRE HIGHER programme to highlight the organ protection potential of SPP100, the first new kind of high blood pressure treatment in more than a decade. ASPIRE HIGHER is the largest ongoing cardio-renal outcomes programme and involves more than 35,000 patients in 14 trials, including three new mega-trials.
SPP100 was approved by the US Food and Drug Administration (FDA) in the US in March 2007 under the trade name Tekturna and by the European Union under the name Rasilez in August 2007 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 and in January 2008 that the FDA had approved it in combination with a diuretic to treat hypertension. Speedel successfully developed SPP100 through Phase I and II clinical trials before Novartis exercised its license-back option in 2002. Other studies,, including AVOID and ALOFT, have highlighted the protective potential of SPP100 against heart and kidney diseases.
About SPP100 (aliskiren, Tekturna/Rasilez)
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 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).
 Tekturna/Rasilez® are Novartis trademarks
 Solomon S, Appelbaum E, Manning WJ, et al. Effect of the Direct Renin Inhibitor Aliskiren, Either Alone of in Combination With Losartan, Compare to Losartan, on Left Ventricular Mass in Patients With Hypertension and Left Ventricular Hypertrophy: The Aliskiren Left Ventricular Assessment of Hypertrophy (ALLAY) Trial. Late Breaker presentation at American College of Cardiology 57th Scientific Sessions 2008.
 National Institutes of Health; National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (NIH Publication No. 03-5233). Bethesda, MD: 2003. (Cited 2003 December, last accessed 2008 Feb 25.) Available at: http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7full.pdf
 Parving H-H et al. Aliskiren in the Evaluation of Proteinuria in Diabetes (AVOID). Late Breaker presentation at the American Society of Nephrology Renal Week 2007.
 McMurray J et al. ALOFT - a 12 week safety evaluation of aliskiren 150 mg vs. placebo when added to standard therapy for stable heart failure. Oral presentation, Hotline I session at European Society of Cardiology Congress 2007.
 Foreign currency exchange rate as at year end 2007.
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.
Speedel Pharma AG
Speedel is a public biopharmaceutical company that seeks to create value for patients, partners and investors by developing innovative therapies for cardiovascular and metabolic diseases. Speedel is a world leader in renin inhibition, a promising new approach with significant potential for treating cardiovascular diseases. Our lead compound SPP100, Aliskiren (Rasilez/Tekturna) the first-in-class direct renin inhibitor, was in-licensed from Novartis in 1999 and licensed-back to Novartis Pharma in 2002 for further development and commercialisation; SPP100 was approved by the FDA in the US in March 2007, and by the EMEA in the EU in August 2007. Our pipeline covers four different modes of action, and in addition to SPP100, includes SPP301 (an endothelin receptor A antagonist) in Phase II, SPP200 (a direct thrombin inhibitor) in Phase II, the next generation renin inhibitors SPP635 (in Phase Il), SPP1148 and SPP676 (both in Phase I) and several pre-clinical projects, including SPP2745 (aldosterone synthase inhibitor).
Speedel develops novel product candidates through focused innovation and smart drug development from lead identification to the end of Phase II. We either partner with big pharma for Phase III and commercialisation in primary-care indications, or we may ourselves complete Phase III development in specialist indications. Candidate compounds for development and the company's intellectual property come from our late-stage research unit Speedel Experimenta and from in-licensing. Our team of approximately 80 employees, including over 30 experienced pharmaceutical scientists, is located at our headquarters and laboratories in Basel, Switzerland and at offices in New Jersey, USA and Tokyo, Japan.
Speedel was founded in 1998 as a private company. In September 2005 the company's shares were listed on the SWX Swiss Exchange under the symbol SPPN. Further information is available at www.speedel.com.
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