Novartis said at its annual results briefing yesterday that two potential blockbuster drugs, Galvus (vildagliptin; formerly known as LAF 237) for diabetes and blood pressure treatment Rasilez (aliskiren), will be submitted for approval in the USA in the first quarter of 2006, with European submissions slated for later in the year.
Galvus is a pancreatic islet enhancer for type 2 diabetes that could be a first-in-class new drug. Novartis believes the compound has true blockbuster potential, particularly because it is well tolerated and does not cause the weight gain associated with other oral drugs for type 2 diabetes.
Clinical trials show that vildagliptin has an additive effect in reducing levels of haemoglobin A1c - a measure of glucose control - when combined with the widely-used oral anti-diabetes drugs metformin and sulfonylurea. The drug "has the potential to becime the best add-on to metformin," said Thomas Ebeling, Chief Executive of Novartis Pharma. Metformin is the most widely used oral drug for type 2 diabetes.
Rasilez is a renin inhibitor, licensed from Speedel Laboratories, that is also a first-in-class drug with additive blood pressure lowering effects when combined with other antihypertensives.
Crucially, Rasilez provides full 24-hour control of high blood pressure and has the potential to offer improved end-organ protection, which would differentiate it from other drugs and could make it the drug of choice for hypertensive patients, said Ebeling.
Other regulatory filings scheduled for 2006 will include Exforge, a combination of amlodipine and valsartan for high blood pressure, Lucentis (ranibizumab) for age-related macular degeneration and telbivudine for hepatitis B in Europe and other countries around the world. Telbivudine was recently filed in the USA.
Novartis pipeline now comprises 76 projects, 50 of which are in Phase II or III testing.