Cornerstone Therapeutics (NASDAQ: CRTX) is in the cross hairs of competitor ONY over a published study concluding that its respiratory drug is riskier to infants than Cornerstone’s.

Privately-held ONY claims damages of $10 million and is now seeking to recover them through a lawsuit whose targets include Cornerstone; Italian company Chiesi Farmaceutici, which licensed the drug to Cornerstone; and the Journal of Perinatology, which published the study in its September 2011 edition.

Amherst, New York-based ONY filed the suit last week in U.S. District Court in Buffalo, the Buffalo News first reported. Cornerstone, based in Cary, has not yet filed an answer to the complaint and is not commenting on the suit.

But the claims against its drug Curosurf are no trivial matter for the company. The drug, currently its top seller, generated $25.4 million through the third quarter for Cornerstone, up 7 percent compared with the same nine month period of 2010.

Cornerstone’s Curosurf and ONY’s Infasurf are surfactants that are used to treat respiratory distress syndrome in infants. Along with Survanta from Abbott (NYSE: ABT), the three drugs are the only U.S. Food and Drug Administration-approved surfactants to treat the condition. Survanta entered the market in 1991. Infasurf was commercialized in 1999. Cornerstone started marketing Curosurf in the United States after licensing the drug from Chiesi in 2009.

The Journal of Perinatology article said that there are no published studies comparing infant mortality with the three surfactants because such studies would require a large sample size, are expensive and take years to complete. As an alternative, the study authors conducted a retrospective analysis of hospital data. But ONY challenged the approach and its conclusions. Cornerstone manipulated data so it would yield the desired results, ONY President Dr. Edmund Egan told the Buffalo News.

“There have been multiple clinical trials comparing lung surfactants, yet in no completed trial has one surfactant been identified as being superior with respect to the outcome of death,” Egan said.

The study that ONY’s Infasurf was associated with a 49.6 percent greater likelihood of death compared to Cornerstone’s Curosurf. Abbott’s Survanta was linked to a 37 percent increased mortality compared to Curosurf but study said “the difference did not reach statistical significance.” The study found no differences in mortality comparing Infasurf to Survanta.

The study was commissioned by Chiesi, which the report disclosed. Additional conflicts of interest are also disclosed, including the note that three of the study’s authors have consulted for Chiesi.

In the suit, ONY notes that two of the study’s authors sit on the Journal of Perinatology’s editorial board. The suit claims the study was published despite the objections of one reviewer who found the study’s conclusions unreliable and recommended that it not be published. ONY says in the suit that Cornerstone has been using the study in its promotional materials for Curosurf.

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