SOURCE: Cornerstone Therapeutics

May 24, 2012 18:10 ET

Court Orders Dismissal of CUROSURF® Case

CARY, NC--(Marketwire - May 24, 2012) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX) today announced that on May 18, 2012 the United States District Court for the Western District of New York issued a decision and order granting Cornerstone's motion to dismiss all the claims of ONY, Inc. in the case filed by ONY. The case concerned Cornerstone's neonatal lung surfactant, CUROSURF.

ONY, the maker of a competing neonatal lung surfactant, had filed suit on December 2, 2011 in connection with an article appearing in the September 1st 2011 online issue of the Journal of Perinatology. The article was based on a retrospective study in infants with Respiratory Distress Syndrome (RDS) that concluded that CUROSURF was associated with a significantly reduced likelihood of death when compared with ONY's product. ONY alleged that the conclusions of the article were unreliable and misleading. The Court ruled that the article was not misleading with respect to the facts on which it was based, and dismissed ONY's claims against Cornerstone and all the other named defendants.


CUROSURF (poractant alfa) is an intratracheal suspension indicated for the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants. CUROSURF reduces mortality and pneumothoraces associated with RDS.

Important Safety Information

CUROSURF is intended for intratracheal use only. THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING CUROSURF, CAN RAPIDLY AFFECT OXYGENATION AND LUNG COMPLIANCE. Therefore, infants receiving CUROSURF should receive frequent clinical and laboratory assessments so that oxygen and ventilatory support can be modified in response to respiratory changes. CUROSURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm infants. TRANSIENT ADVERSE EFFECTS SEEN WITH THE ADMINISTRATION OF CUROSURF INCLUDE BRADYCARDIA, HYPOTENSION, ENDOTRACHAEL TUBE BLOCKAGE, AND OXYGEN DESATURATION. These events require stopping CUROSURF administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing may proceed with appropriate monitoring. Please see full prescribing information at

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. Key elements of the Company's strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit

CUROSURF® is owned by Chiesi Farmaceutici S.p.A. and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States.