Cornerstone Therapeutics Sues to Enforce Its CARDENE(R) I.V. Patents

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Cornerstone Therapeutics Inc.
CRTX
("Cornerstone" or "the Company") filed a Complaint earlier today in the United States District Court for the District of Delaware alleging that Exela Pharma Sciences, LLC, Exela PharmSci, Inc., and Exela Holdings, Inc. infringed its U.S. Patent Nos. 7,612,102 and 7,659,291 by filing a Supplemental New Drug Application with the FDA seeking approval to market a ready to use injectable formulation of 0.1 mg/ml and 0.2 mg/ml nicardipine hydrochloride in 0.9% sodium chloride. The Company markets a ready to use injectable formulation of 0.1 mg/ml and 0.2 mg/ml nicardipine hydrochloride in 0.86% and 0.83% sodium chloride under the name CARDENE® I.V. (nicardipine hydrochloride) Premixed Injection. U.S. Patent Nos. 7,612,102 and 7,659,291 do not expire until December 26, 2027 and April 18, 2027, respectively. "The initiation of this lawsuit is consistent with Cornerstone's stated intention of vigorously enforcing its intellectual property rights to protect its innovative products and technologies," said Cornerstone Chairman and CEO, Craig Collard. Cornerstone is represented by the law firm of Frommer, Lawrence & Haug LLP. About Cornerstone Therapeutics Cornerstone Therapeutics Inc.
CRTX
, headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies, marketed or registration-stage products and late-stage development 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 www.crtx.com.
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