Healthcare Industry News:  angiotensin II 

Biopharmaceuticals

 News Release - May 17, 2006

New Phase III Data on Renin Inhibitor SPP100 (Rasilez) in Treatment of Hypertension Demonstrates Potential of This First-in-Class Drug

Robust efficacy and safety data presented at American Society of Hypertension meeting

BASEL, Switzerland and BRIDGEWATER, N.J., May 17 (HSMN NewsFeed)-- Speedel (SWX: SPPN) is very pleased with the detailed Phase III clinical data on SPP100 (Rasilez)(1) in the treatment of hypertension presented today in New York at the 21st Annual Scientific Meeting and Exposition of the American Society of Hypertension (ASH). The data goes further than the summary findings released by Novartis in September 2005 and confirms in detail the robust efficacy and safety profile of the drug both as monotherapy and in co- administration with the diuretic hydrochlorothiazide (HCTZ). SPP100 is the first-in-class once daily oral renin inhibitor that Speedel successfully developed through Phase I and II clinical trials before Novartis exercised its license-back option in 2002. The U.S. Food and Drug Administration (FDA) in April 2006 accepted for review Novartis' new drug application (NDA) for SPP100 as a treatment for hypertension both as monotherapy and in co-administration with other anti-hypertensives. The NDA includes data from more than 6,000 patients with high blood pressure treated with SPP100 in 34 clinical trials.

Dr. Jessica Mann, Speedel Medical Director, said: "The quality and quantity of the clinical data now available on SPP100 underlines its potential as the 'first-in-class' novel therapy for hypertension for over a decade. SPP100 offers benefits to the many patients who cannot reduce their blood pressure to target levels using current therapies- it provides true 24 hour blood pressure control, and the potential for improved protection of end- organs such as the heart and kidneys."

Prof. Michael Weber (Professor of Medicine, State University of New York, Downstate Medical College), a member of Speedel's Medical Advisory Board, commented: "This new data presented at ASH clearly demonstrates the clear efficacy and safety profile of SPP100. This important and novel drug is well tolerated and provides additional blood pressure control when added to other therapies- this is critical given that so many patients are taking combination treatments in accordance with national treatment guidelines."

On 17 May 2006 in New York at the 21st Annual Scientific Meeting and Exposition of the American Society of Hypertension (ASH), investigators presented data from a number of Phase III clinical trials.

SPP100 administered as a once-daily monotherapy shows effective, smooth 24-hour blood pressure (BP) control in patients with hypertension(2):

-- Significant reduction in mean 24-hour ambulatory BP at dosages ranging from 150 to 600 mg once daily

-- Effective BP reduction was maintained throughout the 24-hour dosing period; this persists overnight and throughout the high-risk period in the early hours of the morning

-- These data suggest that once-daily SPP100 has the potential to maximize end-organ protective benefits through continuous, smooth BP lowering

When administered as a once-daily monotherapy at dosages ranging from 150 to 600 mg, SPP100 is still effective even when patients forget to take the drug from time to time(3):

-- When patients were taken off SPP100, this was not associated with rebound increases in BP

-- BP lowering persists for at least 2 weeks following withdrawal of SPP100, gradually returning towards baseline during this time

-- Sustained BP lowering corresponds to suppression of Plasma Renin Activity (PRA) that is maintained following treatment withdrawal despite continued elevation of renin, suggesting a persistent effect of SPP100 treatment

-- The sustained effect of SPP100 may be clinically beneficial, maintaining BP lowering in patients who miss occasional doses

SPP100 provides effective BP control when used alone or when co- administered with the diuretic hydrochlorothiazide (HCTZ)(4):

-- Effective reduction of BP as monotherapy with statistically significant dose dependent reductions

-- Significant additional BP reduction when administered in combination with HCTZ

-- Combination therapy with SPP100 and HCTZ increased the proportion of patients achieving a successful response compared with the separate monotherapies

-- Excellent overall safety profile, well tolerated, both alone and in combination with HCTZ

SPP100 decreases Plasma Renin Activity (PRA) and neutralizes the increase of this activity by HCTZ(5):

-- Effectively reduces PRA from baseline as monotherapy and blocks the rise in PRA seen during treatment with HCTZ

-- Is likely to be a useful adjunct to diuretic treatment, offering an enhanced antihypertensive effect and potentially improved end-organ protection through effective suppression of the renin system

Inhibition of renin, articulated as Plasma Renin Activity (PRA) is believed to be very important in end-organ protection (e.g. heart and kidneys). PRA is a surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. A renin inhibitor can lower PRA efficiently whereas most current leading anti-hypertensive drug classes such as diuretics, angiotensin converting enzyme inhibitors (ACE-I) and angiotensin receptor blockers (ARB) increase PRA levels.

Speedel notes that this co-administration data builds on Speedel's early clinical findings about the benefits of combination therapy shown in 2001 and 2002 in pilot clinical studies with SPP100 in co-administration with an ARB, as well as with an ACE-I or a diuretic. All three studies showed the potential for beneficial effects of SPP100 with these three different classes of blood pressure modulators while maintaining the placebo-like safety profile of SPP100.

Speedel believes that SPP100 has a five year lead over the next generation of renin inhibitors being developed in the industry. Speedel's own family of renin inhibitors includes SPP635 currently in Phase I with results due in the second half of 2006, followed by the SPP1100 series currently in toxicology testing with a compound due for entry into man before the end of 2006, and the SPP800 series currently in late-stage pre-clinical profiling.

Novartis are holding a webcast for investors and analysts today, 17 May 2006, at 17.00 CET, 16.00 London, and 11.00 EDT. For further information please access the webcast on http://www.novartis.com

About SPP100 (aliskiren, Rasilez)(6)

SPP100 (aliskiren, Rasilez) is the first-in-class oral renin inhibitor. The development of SPP100 is the result of over 20 years of research on renin. Renin is the key 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.

Inhibition of renin, articulated as Plasma Renin Activity (PRA) is believed to be very important in end-organ protection (e.g. heart and kidney). PRA is a surrogate marker for several cardio-renal diseases, such as myocardial infarction and chronic renal disease. It is only a renin inhibitor that lowers PRA efficiently whereas most current leading anti-hypertensive drug classes such as diuretics, 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 in March 2004 Novartis started trials with SPP100 in Phase III as monotherapy for hypertension and in Phase IIb as combination therapy. Phase III trials are ongoing in the US, EU, and Japan, with first regulatory submission in the US already filed in Q1 2006 and planned in the EU during 2006.

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 starting dose of this ARB (Stanton, Jensen, Nussberger, O'Brien, Hypertension. 2003; 42: 1137-1143).

About Hypertension

Hypertension is a major risk factor for heart disease and the main risk factor for stroke and heart attack, and can also lead to heart and kidney failure, so-called "end-organ damage." This disease is estimated to affect approximately 190 million people in the seven key markets (United States, Japan, Germany, France, United Kingdom, Italy and Spain), representing the largest indication for prescription pharmaceuticals worldwide, with approximately USD 39 billion in global annual sales in 2004, according to Datamonitor, IMS Health and Business Insights.

Hypertension is a common disorder in which blood pressure is abnormally high, placing undue stress on the heart, blood vessels and other organs such as the kidney and the brain. Blood pressure is determined in two phases as the heart contracts and relaxes. Systolic blood pressure represents the force that blood exerts on the walls of arteries as the heart contracts to pump out blood. Diastolic blood pressure represents the force as the heart relaxes to allow the blood to flow into the heart.

Due to its wide prevalence and impact on cardiovascular health, hypertension is a major cause of disease and death in Europe and North America. More than one in three Europeans and North Americans over the age of 35 suffers from hypertension- but for the vast majority of patients who undergo hypertension treatment, the causes of high blood pressure are unknown. More than 40% of patients undergoing treatment with current therapies do not reach targeted blood pressure levels, and so there is a considerable unmet medical need.

The latest potential therapeutic agents for hypertension are renin inhibitors. Renin is an enzyme produced in the kidneys in response to reduced renal perfusion. Through a cascade of biological events, renin acts to bring about sodium retention, an increase in blood pressure, and restoration of renal perfusion, which shuts off the signal for renin release. For hypertensive individuals, renin inhibitors are currently being investigated as a therapy that may provide benefits over current therapies to reduce blood pressure, decrease salt retention and may protect end organs such as the kidney, heart and brain.

About Speedel

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 (Rasilez), the first-in- class renin inhibitor, is partnered with Novartis for development and commercialisation in hypertension, and the NDA was filed with the FDA in the US in Q12006. Our pipeline covers three different modes of action, and in addition to SPP100, includes SPP301 in Phase III, SPP200 in Phase II, SPP635 in Phase I, and several pre-clinical projects. 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 70 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. In March 2006 the company raised gross proceeds of CHF 83.95 million (approximately EUR 53m or USD 64m) through the public offering of 500,000 treasury shares. As a private company, we have previously raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 183 million) from private placements of equity securities and two convertible loans and we have had total revenues, principally from milestone payments, of CHF 57.7 million (approximately EUR 37 million or USD 44 million). The company's shares were listed on the SWX Swiss Exchange under the symbol SPPN on 08 September 2005.

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.

(1) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory, including FDA, approval

(2) Study A2308 in 672 hypertensive patients; Poster P-209; J Mitchell, B-H Oh, J Herron, J Chung, M Khan, A Satlin

(3) Study A2308 in 608 hypertensive patients; Poster P-193; J Herron, J Mitchell, B-H Oh, J Chung, M Khan, MF Prescott, DL Keefe

(4) Study A2204 in 2,776 hypertensive patients; Poster P-228; A Villamil, SG Chrysant, D Calhoun, B Schober, H Hsu, J Zhang

(5) Study A2204 in 611 hypertensive patients; Poster P-168; D Calhoun, SG Chrysant, A Villamil, B Schober, H Hsu, MF Prescott

(6) Rasilez (SPP100, aliskiren) is a Novartis trade name pending regulatory, including FDA, approval


Source: Speedel Pharmaceuticals

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