Solvay Pharmaceuticals and partner CV Therapeutics have won a US Food and Drug Administration nod to expand the labelling for their heart drug Aceon (perindopril erbumine). The drug’s use will now be broadened to include the treatment of patients with stable coronary artery disease, to cut the risk of cardiovascular death or heart attack, having previously been approved solely for essential hypertension.
The new label is based on data from the so-called EUROPA study, which involved over 12,000 patients with stable CAD, and demonstrated a 20% reduction in the combined endpoint of cardiovascular mortality, non-fatal MI and cardiac arrest amongst individuals given the ACE inhibitor Aceon versus placebo.
CVT and Solvay joined forces in 2004 to co-promote Aceon. Solvay books all sales and CVT will receive a cut above a specified baseline.
- Meanwhile, Solvay Organics – a wholly-owned unit of the Belgian firm – has acquired speciality chemicals company Girindus AG for 45 million euros. Shareholders representing 70% of the company’s capital have already signed up to the offer, and this figure could be boosted as under German law a two-week additional acceptance period will give shareholders a second opportunity to accept the 7 euro a share bid.
The relevant competition authorities have cleared the acquisition, which is expected to close after finalization of the bid. Girindus produces oligo-nucleotides, compounds active in treating genetic diseases, and has operations in Germany and the USA, with 140 employees.