Novartis: Uncertain Future for Hypertension Drug

Suffering from recent FDA rejections, Novartis has been boosted by the recent approval of its first in class antihypertensive, Tekturna. However, the drug is entering a heavily populated market, with a major question mark surrounding its efficacy when administered with the company’s leading hypertensive treatment Diovan (valsartan), damaging Tekturna’s sales growth prospects.

Tekturna, an octanamide, is the first known representative of a new class of completely non-peptide, low-molecular weight, orally active transition-state renin inhibitors. Previously, a wide variety of potential renin inhibitors were being developed. However, poor bioavailability, low potency and short duration of action after oral administration had prevented the transition of pipeline project to marketed entities.

Novartis has bucked this trend however, despite the FDA’s announcement three months ago that the agency’s review of the drug would be delayed while additional new data was gathered. The approval was based on strong clinical data from a trial in which Tekturna was administered as a monotherapy for more than a year to patients with hypertension, meaning Tekturna was at least as good as or better than other classes of hypertensive therapies.

The approval comes at a critical time for Novartis, which has recently struggled in getting its late stage candidates approved by the FDA. Recently, the FDA requested additional clinical data for the company’s new diabetic drug, Galvus (vildagliptin), delaying the potential launch of the product. As a result, Novartis’s competitor Merck & Co. has been handed a significant advantage as its new diabetes drug Januvia (sitagliptin) will benefit from a first-to-market status.

Whilst Novartis has achieved great success by developing innovative, first in class therapies in the past, the future performance of Tekturna is uncertain. As a monotherapy alone and in combination with calcium channel blockers and angiotensin converting enzyme inhibitors, it affords to Novartis revenue growth prospects.

However, the effectiveness of administering the drug in combination with the company’s leading anti-hypertensive, Diovan, an angiotensin receptor blocker, remains unclear. Clinical trial data failed to show a benefit in adding Tekturna to the standard treatment regimen of Diovan in lowering blood pressure and as a result the position of this newly approved drug within Novartis’s cardiovascular franchise remains ambiguous.