Novartis cardiovascular news

Novartis will restructure its U.S. business and reduce headcount by about 1,960 employees (7%) to about 28,000 in anticipation of lower sales this year from two hypertension drugs, including its $6 billion-a-year drug Diovan valsartan, which loses U.S. patent exclusivity in September. Sales of the second drug, Rasilez/ Tekturna aliskiren, are expected to decline as a result of data from the Phase III ALTITUDE trial released in December. In Type II diabetics with renal impairment, Rasilez led to an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension. Diovan recorded $4.3 billion in worldwide sales for the first nine months of 2011, while Rasilez recorded $449 million in the same period. Diovan is a small molecule angiotensin II receptor (type AT1) antagonist and Rasilez is a renin inhibitor (see BioCentury, Jan. 2).

Additionally, Novartis discontinued all development of cardiovascular product elinogrel (PRT128) due to portfolio reprioritization. Last August, Novartis suspended a Phase III trial in chronic coronary heart disease to reprioritize development of the reversible purinergic receptor P2Y G protein-coupled 12 ( P2RY12; P2Y12) antagonist in another indication. Novartis said it is in discussions with partner Portola Pharmaceuticals Inc. (South San Francisco, Calif.) about next steps (see BioCentury, Aug. 15, 2011). ...