Healthcare Industry News: Rasilez
News Release - January 19, 2006
Novartis New Phase III Data With SPP100 (aliskiren, Rasilez) Reconfirms Strong Efficacy and Excellent Safety Profile as Monotherapy and Co-Administration Therapy for Treatment of HypertensionSPP100 (Rasilez) on track for US regulatory submission in early 2006
BASEL, Switzerland and BRIDGEWATER, N.J., Jan. 19 (HSMN NewsFeed) -- Speedel Holding Ltd (SWX: SPPN ) welcomes the positive Phase III clinical results in hypertension released today by Novartis on SPP100 (aliskiren, Rasilez(1)) as a monotherapy and in co-administration with amlodipine (calcium channel blocker) and ramipril (ACE inhibitor). Novartis also confirmed it is on track for first regulatory submission of SPP100 in the US in early 2006 and in the EU in the fourth quarter of 2006. These submissions will be for SPP100 as a monotherapy treatment, and as co-administration with other anti-hypertensive therapies, based on trials from over 8,000 patients. SPP100 is the first-in-class once daily oral renin inhibitor being developed for the treatment of hypertension. Speedel in-licensed the compound from Novartis and successfully developed SPP100 through Phase I and II before Novartis exercised a license-back option in 2002.
Dr. Alice Huxley, CEO, stated: "We are delighted with the latest data from Novartis reconfirming SPP100 as a potential gold standard, first-in-class therapy for treating hypertension. The clinical data generated so far by both Novartis and Speedel shows the potential benefits of co-administration of SPP100 with the four most common classes of blood pressure modulators. Hypertension is one of the largest and growing unmet medical needs across the world. SPP100 potentially offers benefits over current therapies, particularly for improved protection of end-organs such as the heart and kidneys. The success of SPP100 clearly demonstrates the viability of Speedel's business model and our research and development capabilities."
On 19 January, 2006 at its Financial Results Conference for 2005 in Basel, Novartis disclosed the results from three Phase III clinical trials of SPP100 in co-administration with amlodipine (calcium channel blocker), with ramipril (ACE -I), and as long-term monotherapy. During 2005 Novartis released data on SPP100 in co-administration with an ARB (angiotensin II receptor antagonist) and a diuretic. Speedel notes that this new co-administration data builds on Speedel's clinical findings about the benefits of co-administration 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 (angiotensin converting enzyme inhibitor) or a diuretic.
The Phase III trial, in which SPP100 was co-administered with amlodipine (calcium channel blocker), showed the following results(2):
-- Excellent tolerability and safety in co-administration with amlodipine -- Increased benefit on blood pressure control at a SPP100 dose of 150 mg with 5 mg of amlodipine -- Decrease in edema (water retention) -- a common side-effect of calcium channel blockers -- at a SPP100 dose of 150 mg co-administered with 5 mg of amlodipine
The Phase III trial in which SPP100 was used as monotherapy and was co-administered with ramipril (ACE-I) gave the following results(3):
-- Double digit decreases in systolic and diastolic blood pressure with SPP100 monotherapy -- Statistically and clinically significant additional decreases in systolic and diastolic blood pressure in co-administration with ramipril -- Decrease in dry cough -- a common side effect of ACE inhibitors -- when SPP100 was added to ramipril -- Excellent responder rates of SPP100 both as monotherapy and in co-administration with ramipril -- Confirmation of efficacy and tolerability shown in an earlier Phase II pilot trial performed by Speedel
The Phase III trial in which SPP100 was given as monotherapy, demonstrated(4):
-- Excellent safety and placebo-like tolerability of SPP100 monotherapy in
hypertensive patients treated longer than one year
This new data together with previous data released by Novartis and Speedel, confirms the attractive profile of SPP100 as a first-in-class therapy for treating hypertension:
-- Strong monotherapy efficacy at least as good as or better than other classes of hypertensive therapies -- Superior blood pressure lowering when co-administered with ACEIs, ARBs, diuretics, and calcium channel blockers -- 24-hour blood pressure control -- particularly in the early morning hours when blood pressure can surge -- No rebound effect upon withdrawal; important when patients forget to take their medication -- Placebo-like tolerability and safety similar to that shown for ARBs -- Potential for improved end-organ protection
Novartis also disclosed today that: -- Extensive data for SPP100 is planned to be presented at the American Society of Hypertension meeting in New York in May 2006 -- Further data are to be presented in 2006 from Phase III clinical trials Registration files are on track for submission in the US early in 2006 and in the EU in Q4 2006
Novartis Financial Results 2005 webcast Presentation slides with the data from these Phase III trials will be available via a webcast today at 12:00 UK / 13.00 CET on the website http://www.novartis.com/investors
About SPP100 (aliskiren, Rasilez)
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 (ACE) inhibitors 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 an independent and direct 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 ACEIs 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 planned for early 2006 and in the EU for Q4 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 Speedel's co-administration studies
The three pilot clinical studies conducted by Speedel in 2001 and 2002 investigated the safety and efficacy of SPP100 in co-administration with the ACE-inhibitor (ramipril), the diuretic (hydrochlorothiazide - HCTZ) and the ARB (irbesartan), in hypertensive patients. All three studies were open label and blood pressure effects were assessed by 24-hour Ambulatory Blood Pressure Monitoring.
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.
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), the first-in-class renin inhibitor, is partnered with Novartis for Phase III development and commercialisation in hypertension with filing for registration expected in 2006. 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. Since being founded in 1998, we have raised gross proceeds of CHF 239 million (approximately EUR 154 million or USD 191 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 46 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 (previously SPP100, aliskiren) trade name pending regulatory approval
(2) Study 2305 in hypertensive patients treated with SPP100 and amlopidine
(3) Study 2307 in 837 hypertensive diabetic patients treated with SPP100 and ramipril
(4) Study 2302 in hypertensive patients treated with SPP100
Source: Speedel Pharmaceuticals
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