Is This Drug Taking on Water?

FDA gives Cornerstone's lixivaptan a mixed review.

Brian Orelli
Brian Orelli
Sep 12, 2012 at 12:00AM

The Food and Drug Administration appears to like Cornerstone Therapeutics' (Nasdaq: CRTX) lixivaptan -- just not for every indication that Cornerstone wants to market the drug for.

The agency released its view of the drug ahead of Thursday's advisory committee meeting. The reviewer thinks lixivaptan should be approved for people with low salt due to a condition called syndrome of inappropriate antidiuretic hormone secretion, which causes the body to have excess water.

The reviewer wasn't as hot on the drug being used in patients with low salt associated with congestive heart failure. More patients taking lixivaptan died in the clinical trial for heart failure patients than those in the control group, although it wasn't clear if the drug was the actual cause or if it just happened randomly.

That could leave the door open for Cornerstone to convince the panel of outside experts that lixivaptan should be approved for heart failure patients as well. The company likely needs a big win with a vast majority of the committee members recommending approval of the drug in the second indication. A simple majority isn't likely to be enough to change the FDA's mind.

Lixivaptan has had many owners over the years. It was first developed by Wyeth, now part of Pfizer (NYSE: PFE), which licensed it to Cardiokine. That biotech brought in Biogen Idec (Nasdaq: BIIB), but it later handed back the rights to the drug. Cornerstone obtained the drug by purchasing Cardiokine.

Normally when a drug gets shuffled around, it's a bad sign. Biogen passed off Zevalin to Cell Therapeutics (Nasdaq: CTIC), which was then licensed to Spectrum Pharmaceuticals (Nasdaq: SPPI); the drug brought in just $28 million last year.

But for lixivaptan, it might not be that bad of a sign. Cornerstone bought Cardiokine, so it's not like the company was trying to pass off a flop. And Biogen lost interest when it left the cardiovascular space completely; the decision wasn't lixivaptan-specific.

Before worrying about its commercial prospects, Cornerstone has to convince the advisory committee to recommend approving the drug for one or more indications, and then the FDA has to approve the drug, which should occur on or around Oct. 29.

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