The company is on track to submit the drug to US regulators in early 2006, and EU regulators later on that year. These submissions will be for SPP100 as a monotherapy treatment, together with data supporting co-administration with other anti-hypertensive therapies, based on trials from over 8,000 patients.
The latest results reconfirm the previous findings from clinical studies conducted by Speedel Pharmaceuticals. 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.
“It is encouraging to witness the depth and breadth of the clinical program being run by Novartis to bring this novel first-in-class therapy to market,” said Dr Alice Huxley, Speedel CEO. “Hypertension is one of the largest and growing unmet medical needs across the world and SPP100 potentially offers benefits over current therapies, particularly for improved protection of end-organs such as the heart and kidneys.”