Biotech Values

[DewDiligence]

NVS is keeping Tekturna on the US market with a modified label:

http://www.sec.gov/Archives/edgar/data/1114448/000110465912026605/a12-10059_26k.htm

The label change includes a contraindication against combined use of aliskiren-based products with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes. The FDA has also requested the inclusion of a warning against the use of aliskiren-based products in patients with moderate renal (kidney) impairment (eGFR < 60 ml/min) who are also taking an ACE inhibitor or an ARB. Aliskiren-based products will continue to be available in the US for the treatment of high blood pressure in appropriate patients.

These label changes put Tektruna in the US on an equal footing with Rasilez in the EU, where the EMA recently concluded that the risk/benefit tradeoff was positive.

In the US, NVS will voluntarily withdraw Valturna, a single pill consisting of Diovan + Tekturna that had anemic sales.