FDA advisory negative on Cornerstone's lixivaptan

The US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) last week recommended against the approval of Cornerstone Therapeutics’ (Nasdaq: CRTX) New Drug Application for lixivaptan (CRTX 080) for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively.

Shares in the North Carolina group fell 21% to $5.10 on the news after trading was resumed Thursday afternoon. The group, majority owned (51%) by Italy’s Chiesi Farmaceutici, is not dependent on lixivaptan to generate sales, note analysts at EP Vantage. However, with the loss of market exclusivity for one marketed drug and competition for another, launch of lixivaptan could have represented a significant source of new revenues, they said.

Cornerstone's approved products include Curosurf (poractant alfa intratracheal suspension), a treatment for respiratory distress syndrome in premature babies, and Zyflo (zileuton) and asthma treatment. Cornerstone acquired rights to lixivaptan along with its buy of privately held Cardiokine (The Pharma Letter January 4).