By JAMES FINK
jfink@bizjournals.com | 716-541-1611

The Amherst-based maker of a drug administered to premature infants to combat respiratory distress syndrome has filed a lawsuit in U.S. District Court accusing a rival company of "cherry-picking data" for a recently published report.

At issue is a September report in the Journal of Perinatology that claims a drug made by ONY Inc. of Amherst may not be as effective as one made by a rival company, Curosurf, which is produced by Cornerstone Therapeutics. Cornerstone, based in Cary, N.C., is part of the Chiesi Farmaceutical S.p.A. corporate family. Chiesi is headquartered in Italy.

ONY  is seeking $10 million in damages, citing harm to sales and its financial health in the wake of the report that ONY claims used incomplete data and research which ultimately favored Curosurf, a drug similar to ONY's Infasurf. The article alleges that Curosurf produces significantly lower mortality rates than Infasurf.

"They purposely fudged data and engaged in selective distortion to produce bogus conclusions to promote their product," said Dr. Edmund Egan, ONY president.

Representatives of Cornerstone declined to comment on the lawsuit, which was filed Dec. 2 in U.S. District Court in Buffalo.

Mitchell Banas Jr., a partner in Jaeckle Fleischmann & Mugel LLP who represents ONY, said in court documents that it appears the study that served as the basis for the article was funded by Cornerstone and Chiesi.

"The entire picture, in our belief, was not provided," Banas said. "In my opinion, it was an infomercial disguised as an article."

Egan said the report fails to include all the data from a medical study. It also claims that patients treated with the Curosurf drug have a lower mortality rate and shorter hospital stays.

"A premature baby with a reported short hospital stay either died early or was healthier because it was so close to full term," he said. "The only way Curosurf infants could have both a lower mortality and a shorter hospital stay is if those infants were more mature and less ill than Infasurf-treated babies."

According to Egan, the study's data was not based on an actual clinical study; rather, it came from various hospital and physician databases. The study focused on 14,173 perterm infants from 236 U.S. hospitals who received one of three FDA-approved medications for premature infants. Infasurf and Curosurf are two of the three.

Infasurf was created by Holm and the late Dr. Bruce Holm, two pioneering neonatologists, following a series of trials dating to 1981 at Women & Children's Hospital in Buffalo.

In the lawsuit, ONY alleges the article was evaluated by two reviewers - one of which "found its conclusions to be unreliable" and one who recommended it not be published.

"I personally contacted the editor of the Journal requesting he retract this false and misleading article and he refused to retract it, leaving us with no choice than to file this lawsuit," Egan said.

The court papers indicate that Cornerstone has used the article's conclusions in its press releases and promotional materials that target hospitals, medical groups and physicians.

Named in the suit were Cornerstone, Chiesi, Nature America Inc., Dr. Edward Lawson, editor of Journal of Perinatology, the American Academy of Pediatrics and Premier Inc., and Drs. Jatinder Bhatia, Krisnamurthy Sekar, Rangasamy Ramanathan and Frank Ernst.