Novartis achieved positive phase III clinical results in hypertension on SPP100 (aliskiren, Rasilez) as a monotherapy and in co-administration with amlodipine (calcium channel blocker) and ramipril (ACE inhibitor).

According to a company release, Novartis 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 Holding Ltd 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."

The phase III trial, in which SPP100 was co-administered with amlodipine (calcium channel blocker), showed the following excellent tolerability and safety in co-administration with amlodipine and increased benefit on blood pressure control at a SPP100 dose of 150 mg with 5 mg of amlodipine .

The phase III trial in which SPP100 was used as monotherapy and was co-administered with ramipril (ACE-I) decreased double digit 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 when SPP100 was added to ramipril, excellent responder rates of SPP100 both as monotherapy and in co-administration with ramipril were observed.

The phase III trial in which SPP100 was given as monotherapy, demonstrated 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:

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. 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.