Swiss drugmaker Novartis headlined its R&D update held in London yesterday with positive Phase III data on two first-in-class compounds LAF237 for diabetes and SPP100 for high blood pressure which are due to be filed for approval next year.
The two drugs are among 75 compounds currently in development at Novartis, including 52 in Phase II trials or later, said Novartis CEO Daniel Vasella. Novartis has been at the forefront of the pharmaceutical industry in terms of bringing novel medicines to market, he added, launching 13 new biologics or pharmaceuticals since 2000, more than any other company in the Industry and ahead of Sanofi-Aventis and Pfizer, which have launched nine apiece.
LAF237 (vildagliptin), an oral DPP-IV inhibitor for type 2 diabetes, achieved tight blood glucose control in the clinical study, was well-tolerated and did not appear to cause the weight gain, a side effect that plagues many other oral drugs for type 2 diabetes, including the $3 billion dollar glitazones class. Moreover, the data suggest that vildagliptin could also protect pancreatic beta cells, potentially slowing down the progression of the disease and delaying the need for patients to start insulin therapy [[13/09/05e]].
Novartis said it expects to file for approval of the drug in the USA in the first half of 2006, giving it a head start over nearest rival Merck & Co whose DPP-IV inhibitor sitagliptin is in the midst of Phase III testing [[15/09/05e]].
Meanwhile, Novartis also said at the presentation that SPP100 (aliskiren), the first in a new class of antihypertensive drugs called renin inhibitors, is also on schedule for US regulatory submission in early 2006, followed by a filing in the European Union in the fourth quarter of that year.
Data presented in London showed that aliskiren provided 24-hour blood-pressure control from a single daily dose, was well-tolerated and achieved double-digit reductions in blood pressure versus placebo. Its blood pressure-lowering effect was boosted by the addition of a thiazide diuretic, and Novartis is particularly encouraged by data suggesting that the drug can protect organs from the damaging effects of high blood pressure.
Novartis also said it was on track for three other new product submissions during next 12 months, namely LDT600 for hepatitis B, Lucentis (ranibizumab) for age-related macular degeneration, and a combination product based on Diovan (valsartan) and amlodipine for hypertension.
At the meeting Vasella also defended Novartis' strategy to build a broad business portfolio - spanning pharmaceuticals, generics and over-the-counter drugs - at a time when many drugmakers are divesting non-core assets - saying that this reduces risk and enhances growth opportunities. He also reiterated his commitment to adding a fourth pillar to the business, vaccines, via the addition of Chiron, whose shareholders rejected a $40 dollars-a-share takeover offer last month [[07/09/05e]] [[01/09/05a]].