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New Data Highlights Potential of SPP100 (Tekturna) as Gold Standard,Therapy in Treatment of Hypertension

d on data from seven clinical trials involving more than 6,200 patients[4], including the data presented at the ASH meeting. Submissions were made for four different dosage combinations of Tekturna and Hydrochlorothiazide: 150/12.5 mg tablets, 150/25 mg tablets, 300/12.5 mg tablets and 300/25 mg tablets.

Speedel was the first company to demonstrate the benefits of combining a renin inhibitor with a diuretic during its pilot clinical development programme of SPP100 between 2000-2002 [5].

Mr Ben Tan, Speedel Head of Business Development & Licensing commented "In the antihypertensive drug market, the most commonly prescribed fixed combinations contain a diuretic. It is rewarding to know that subject to FDA approval, patients may soon benefit from Tekturna HCT which will increase convenience and compliance, therefore resulting in better control of blood pressure".

Highlights of data presented at ASH

1. Patients treated for 6 months with SPP100 as monotherapy or in co-administration with a diuretic HCTZ showed sustained reductions in blood pressure (BP) and plasma renin activity (PRA), even though plasma renin concentration (PRC) remained elevated. These reductions in BP and PRA were greater than for those patients treated with ramipril (ACE-I[4]) who also showed elevated PRC (Poster P - 445).

2. Two weeks and four weeks after patients stopped receiving SPP100 based therapy, they still showed persistent reductions in BP and PRA respectively, compared to those patients who were taken off ramipril (ACE-I) therapy (Poster P- 445).

3. Patients treated for 12 months with SPP100 as monotherapy or in co-administration with amlodipine (CCB[5]) showed sustained reductions in blood pressure (BP) and plasma renin activity (PRA), while plasma renin concentration (PRC) was stable essentially at the same level after 12 months as it was after 6 months. In contrast, patients treated with a diuretic HCTZ showed increased PRA (Poster P- 421).<
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