Key Developments For Cornerstone Therapeutics Inc.
Cornerstone Therapeutics Inc. (CRTX.O) (Consolidated Issue listed on NASDAQ Capital Market)
Cornerstone Therapeutics, Inc. Provides Response To FDA Warning Letter On Deconsal
Cornerstone Therapeutics, Inc. reported that it had received a Warning Letter from the Food and Drug Administration (FDA) alleging that its Deconsal CT chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg) and Deconsal DM chewable tablets (Phenylephrine HCl 10 mg, Pyrilamine Maleate 16 mg, Dextromothorphan HBr 15 mg) are new drugs lacking an approved application and as such should not be introduced into interstate commerce. Cornerstone is preparing an appropriate response to the FDA. Cornerstone has not sold any Deconsal CT products since July 2009 and has not sold any Deconsal DM products since January 2009. Cornerstone does not intend to manufacture, or have manufactured, any further lots of this product.
Cornerstone Therapeutics, Inc. Gets U.S. FDA Warning-Reuters
Reuters reported that U.S. regulators warned Cornerstone Therapeutics, Inc. that the Company has distributed drugs without approved applications, a letter released said. In a November 13 letter, the Food and Drug Administration said: Based on information, there are no FDA-approved applications on file for these drug products. The names of the drugs were redacted from the public version of the letter. The letter also said the drug labeling fails to bear adequate directions for their intended uses.
Cornerstone Therapeutics, Inc. Raises FY 2009 Guidance
Cornerstone Therapeutics, Inc. raised its revenue guidance from in excess of $95 million to in excess of $104 million for fiscal 2009. In addition, the Company anticipates achieving income from operations (EBIT) on a GAAP basis of $15 million and on a non-GAAP basis of $26.1 million. According to Reuters Estimates, analysts are expecting the Company to report EBIT of $17.8 million on revenues of $104 million for the same period.
Cornerstone Therapeutics, Inc. Receives Approval To Acquire Commercial Rights Of Antibiotic Factive
Cornerstone Therapeutics, Inc. announced that it has received the approval of the United States Bankruptcy Court for the District of Massachusetts for its acquisition of the commercial rights to the antibiotic Factive (gemifloxacin mesylate) in North America and certain countries in Europe from Oscient Pharmaceuticals Corporation and expects to promptly close the transaction. At the closing, the Company will purchase the Factive assets for a cash payment of $5,000,000 plus an amount for purchased inventory to be mutually determined prior to closing, quarterly royalty payments based on adjusted net sales for a period of five years and the assumption of certain liabilities, including aggregate cure amounts of $110,000 under certain contracts that were assumed by the Company.
Cornerstone Therapeutics, Inc. Reiterates FY 2009 Outlook
Cornerstone Therapeutics, Inc. reiterated its fiscal 2009 outlook and expects net revenues in excess of $95 million and continues to anticipate achieving income from operations (EBIT) in excess of $17 million. According to Reuters Estimates, analysts were expecting the Company to report revenues of $116 million and EBIT of $21 million for the same period.
