Profile: Cornerstone Therapeutics Inc (CRTX.OQ)

CRTX.OQ on NASDAQ Stock Exchange Capital Market

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Cornerstone Therapeutics Inc., incorporated on July 14, 2000, is a specialty pharmaceutical company focused on commercializing products for the hospital, respiratory and related specialty markets. The Company’s promoted products include CUROSURF, ZYFLO CR, FACTIVE and SPECTRACEF. On December 30, 2011, the Company acquired Cardiokine, Inc., a specialty pharmaceutical company, focused on developing hospital products for cardiovascular indications. In March 2012, it acquired the North American product rights for FACTIVE (Gemifloxacin Mesylate) tablets. In June 2012, the Company acquired EKR Therapeutics, Inc.

CUROSURF is a porcine-derived natural lung surfactant with the active pharmaceutical ingredient (API) poractant alfa. CUROSURF is approved by the United Sates Food and Drug Administration (FDA) for the treatment of respiratory distress syndrome (RDS) in premature infants. As of December 31, 2011, CUROSURF was available in 1.5 milliliter and 3 milliliter vials in over 60 countries, including the United States and most of Europe. ZYFLO CR and ZYFLO, which contains the API zileuton, are leukotriene synthesis inhibitor drugs. ZYFLO was approved by the FDA as an immediate-release, four-times-a-day tablet for the prevention and treatment of asthma in adults and children 12 years of age and older.

The Company’s anti-infective products include FACTIVE and SPECTRACEF. FACTIVE is a fluoroquinolone antibiotic with the API gemifloxacin mesylate. As of December 31, 2011, FACTIVE was available in 320 milligram, once daily tablets packaged in five-day and seven-day dose packs. FACTIVE is approved for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) and community-acquired pneumonia (CAP) of mild to moderate severity, caused by Streptococcus pneumonia, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

PECTRACEF, an antibiotic administered orally in tablet form, is a third generation cephalosporin with the API cefditoren pivoxil. As of December 31, 2011, the SPECTRACEF product line included SPECTRACEF 200 milligram and SPECTRACEF 400 milligram, cefditoren pivoxil 200 milligram and cefditoren pivoxil 400 milligram. As of December 31, 2011, SPECTRACEF 200 milligram was available in a 10 day Dose Pack. SPECTRACEF 200 milligram, two tablets twice daily, is indicated for the treatment of the same respiratory tract infections as SPECTRACEF 400 milligram. In addition, SPECTRACEF 200 milligram, one tablet twice daily, is indicated for pharyngitis and tonsillitis, and skin and skin-structure infections. As of December 31, 2011, SPECTRACEF 400 milligram was available in a 10 day dose pack and a 14 day dose pack.

The Company competes with ONY, Inc., Abbott Laboratories, Genentech USA, Inc, Novartis Pharmaceutical Corporation, Teva Respiratory LLC, Schering Corporation, Merck Sharp and Dohme Corporation, GlaxoSmithKline, AstraZeneca LP, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Bayer Healthcare Pharmaceutical Inc., Bayer Schering Pharma, Pernix Therapeutics LLC and Lupin Pharmaceuticals, Inc.

Company Address

Cornerstone Therapeutics Inc

Suite 250, 1255 Crescent Green D
CARY   NC   27518
P: +1919.6786611
F: +1302.6365454

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