Oscient Pharmaceuticals Stock Trading Halted Today; FDA Advisory Committee to Discuss FACTIVE(R) sNDA for Acute Bacterial Sinusitis.WALTHAM, Mass. -- Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) today announced that NASDAQ has halted trading of Oscient common stock.
The Anti-Infective Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) meets today to review and discuss the Company's supplemental New Drug Application (sNDA) for FACTIVE Fac´tive
a. 1. Making; having power to make. (R) (gemifloxacin mesylate gemifloxacin mesylate
Pharmacologic class: Quinolone
Therapeutic class: Broad-spectrum anti-infective
Pregnancy risk category C
Action) tablets seeking approval as treatment for acute bacterial sinusitis bacterial sinusitis (bak·tēˑ·rē· (ABS).
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs. The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis chronic bronchitis
Inflammation of the bronchial mucous membrane, characterized by cough, hypersecretion of mucus, and expectoration of sputum over a long period of time and associated with increased vulnerability to bronchial infection. and community-acquired pneumonia of mild to moderate severity and ANTARA(R) 130 mg (fenofibrate) capsules, FDA-approved for the adjunct treatment of hypercholesterolemia Hypercholesterolemia Definition
Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal.
Cholesterol circulates in the blood stream. It is an essential molecule for the human body. (high blood cholesterol) and hypertriglyceridemia (high triglycerides Triglycerides
Fatty compounds synthesized from carbohydrates during the process of digestion and stored in the body's adipose (fat) tissues. High levels of triglycerides in the blood are associated with insulin resistance. ) in combination with diet. Oscient has a novel antibiotic candidate, Ramoplanin, in advanced clinical development for the treatment of Clostridium clostridium
Any of the rod-shaped, usually gram-positive bacteria (see gram stain) that make up the genus Clostridium. They are found in soil, water, and the intestinal tracts of humans and other animals. Some species grow only in the complete absence of oxygen. difficile-associated disease (CDAD CDAD Clostridium Difficile-Associated Diarrhea
CDAD Component Data Administrator ).
This news release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 including statements related to the review by the Anti-Infective Drugs Advisory Committee to the FDA regarding the sNDA for FACTIVE seeking approval as treatment for ABS. Forward-looking statements represent our management's judgment regarding future events. Forward-looking statements typically are identified by use of terms such as "may," "will," "should," "plan," "expect," "intend," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. For example, our ability to increase our revenue and accelerate the time of our profitability may be limited by: (i) our ability to successfully commercialize and market FACTIVE or ANTARA due to: the limitations on our resources and experience in the commercialization of products; lack of acceptance by physicians, patients and third party payors; unanticipated safety, product liability, efficacy, or other regulatory issues; delays in recruiting and training sales personnel; problems relating to manufacturing or supply; inadequate distribution of the products by wholesalers, pharmacies, hospitals and other customers; and competition from other products; (ii) our ability to integrate ANTARA into our business; (iii) whether we will be able to expand the indications for which FACTIVE is approved; (iv) the delay or inability to find sublicensing partners for FACTIVE or to negotiate favorable licensing terms; (v) the delay in or inability to obtain additional regulatory approvals of our products and product candidates due to negative, inconclusive or insufficient results in ongoing or future clinical trials, the FDA requiring additional information or data, delays in the progress of ongoing clinical trials, safety concerns arising with respect to our products or product candidates and disputes with the third parties from whom we license our products or product candidate; and (vi) delays by the FDA. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ending June 30, 2006 and in other filings that we may make with the Securities and Exchange Commission from time to time.