SPP100 (Aliskiren) is the first-in-class oral renin inhibitor. 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, with chronic renal failure, congestive heart failure and other cardiovascular diseases.
The data demonstrated the robust efficacy and good safety profile of SPP100 as a monotherapy and in co-administration with ramipril, an ACE2 inhibitor for the treatment of hypertension in diabetic patients.
Speaking to a select group of analysts and investors, Konrad Wirz, CEO of Speedel said: "The data underlines the potential of SPP100 in diabetic hypertensives, a segment of the hypertension population which is at a higher risk of having cardiovascular events than those hypertensive patients without diabetes."
Indications suggest that Speedel's pipeline remains in a healthy state with treatments for hypertension and cardiovascular disorders in the early stages of development.
SPP200, a direct thrombin inhibitor, is an anti-coagulant treatment for patients undergoing chronic haemodialysis for end stage renal disease, and is currently in a Phase II trial in the US.
In October 2005 SPP635 entered Phase I safety and tolerability testing in human volunteers. It is one of a new series of proprietary renin inhibitors which are being developed for the treatment of hypertension and the protection of end organs, such as the heart, kidneys and blood vessels, from the damage that high blood pressure can cause.
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. This disease is estimated to affect approximately 190m people in the seven key markets (US, Japan, Germany, France, United Kingdom, Italy and Spain.
Strategy-wise, Speedel provided additional details of a successful public offering in March of 500,000 registered treasury shares raising gross proceeds of CHF 83.95 m (€53.4m)
In addition, Novartis Pharma, reconfirmed that it plans the first regulatory submission for SPP100 as a monotherapy and in combination with other antihypertensives for the treatment of hypertension in Q1 2006 in the US and in Q4 2006 in Europe.
"Based on public announcements by Novartis and assuming the receipt of the required regulatory approvals, Speedel expects that Novartis will seek to launch commercial marketing of SPP100 in 2007," said Wirz.
"This event will generate Speedel's first stream."