Novartis pipeline promises cardiovascular advances
pharmafile | September 22, 2005 | News story | Research and Development |Â Â Â
Novartis hopes to expand its presence in cardiovascular medicine with the filing next year of two potentially first-in-class products with regulators.
The company was also keen to highlight the convergence of hypertension, dyslipidaemia and diabetes, all cardiovascular risk factors, when it presented an update on its product pipeline.
There are 75 compounds in development and the company plans to make five major regulatory submissions in the next 12 months. Of these it is most excited about LAF237 (vildagliptin), a potentially first-in-class treatment for type II diabetes, and SPP100 (aliskiren).
Developed in collaboration with Speedel, SPP100 is the first in a new class of anti-hypertensives called renin inhibitors.
In phase III clinical trials Novartis said it showed excellent 24-hour blood-pressure control and strong efficacy as a monotherapy and in combination with the diuretic hydrochlorothiazide.
A US regulatory submission is planned for SPP100 in the early part of 2006 and this will be followed in Europe in the fourth quarter of the year.
Next year the company plans to present the results of clinical trials that combined SPP100 with two older hypertensive drugs – an ACE-inhibitor and a calcium-channel blocker.
The type II diabetes treatment LAF237 is an oral DPP-IV inhibitor that Novartis aims to file for approval in the US in the first half of 2006.
Novartis says it has the potential to become a first-line treatment, either as a monotherapy or in combination, but one clinical trial comparing its efficacy to that of one of the current first-line treatments for type II diabetes, metformin, found LAF237 narrowly missed its primary endpoint of non-inferiority versus the drug.
Novartis already has a strong presence in the cardiovascular market. Its biggest selling drug Diovan recently became the first in its angiotensin receptor blocker class to gain a US licence for use in reducing cardiovascular death amongst high-risk heart attack survivors.
Diovan's sales are growing at a faster rate than any other major anti-hypertension treatment in the world, a momentum Novartis hopes to maintain with a new fixed-dose combination of Diovan and amlodipine (a calcium-channel blocker).
Diovan registered first half sales in 2006 of nearly $1.9 billion, a leap of nearly 19% from last year, but still trails Pfizer's Norvasc which recorded sales of over $2.3 billion in the same period.
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