Novartis was cheered late last week by positive opinions for new hypertension treatment Exforge and blindness treatment Lucentis from the EU’s Committee for Medicinal Products for Human Use (CHMP), setting them up for approval across the region.
The CHMP backed the approval of Exforge (amlodipine plus valsartan), which combines the two most widely-prescribed blood pressure drugs on the market, in patients who cannot control their hypertension when given either of the drugs as a monotherapy.
Around 70% of patients with hypertension find that they cannot control their blood pressure on monotherapy, and the rationale behind combining two drugs from different classes is that the efficacy of treatment may be increased, while tolerability could be enhanced.
Novartis is hoping that doctors and patients will prefer to take combination therapy in a single pill, rather than having to take multiple tablets each day which can affect compliance and the success of treatment.
Exforge is one of two high blood pressure treatments filed by Novartis in 2006. The other is Rasilez (aliskiren), a first-in-class renin inhibitor licensed from Speedel Laboratories.
Analysts have suggested that Exforge could achieve sales of around $500 million, while Rasilez could bring in more than $1 billion a year at peak, helped by a profile that suggests it provides potent and 24-hour blood pressure control.
Lucentis backed for macular degeneration
The CHMP also gave its blessing to Lucentis (ranibizumab) for the treatment of the wet form of age-related macular degeneration, an indication which has already been cleared in the USA, where it is sold by Genentech, and Switzerland.
Lucentis has been tipped as a potential market leader in the AMD treatment market, because of data showing that it can not only halt progression of the disease, but also improve vision. Once fully approved, it will compete with Pfizer and OSI Pharmaceuticals’ Macugen (pegaptanib), which was cleared in the USA in February.
At present, the market for AMD therapies is valued at around $600 million, with Novartis' own Visudyne (verteporfin) dominating the sector with sales of around $450 million last year. Evidence to date suggests that the optimistic appraisal of Lucentis’ prospects is justified – Genentech reported sales of Lucentis were $153 million in the third quarter.