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Oscient Pharmaceuticals Receives Notice of Allowance for Ramoplanin Patent Application
Friday, September 07, 2007
The United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance to Oscient Pharmaceuticals (Nasdaq: OSCI) for a U.S. patent relating to methods of use of Ramoplanin for the treatment of Clostridium difficile-associated disease (CDAD), a serious form of colitis. Ramoplanin is a glycolipodepsipeptide antibiotic positioned for Phase III development for the potential treatment of CDAD, pending the conclusion of ongoing partnership discussions. A Notice of Allowance is the official notification that the USPTO finds the claimed subject matter allowable and intends to issue the patent pending payment of the issue fee. Given this action, Oscient expects the patent to issue within the next several months.
"Enhancing the intellectual property position for Ramoplanin is an important part of our overall strategy for advancing the development of the candidate through an appropriate partnership," stated Steven M. Rauscher, President and CEO of Oscient Pharmaceuticals. "Given the need for novel approaches to treat this serious condition, we remain committed to partnering Ramoplanin in order to extract the full financial value of this promising product candidate and to advance Ramoplanin closer to market."
The patent has claims relating to the treatment of CDAD by administering Ramoplanin and the treatment of patients infected with C. difficile resistant to metronidazole and vancomycin. Upon the U.S. FDA approval of Ramoplanin for a CDAD indication, Oscient believes this patent would likely be eligible to list in the FDA Orange Book. Provided that the patent issues within the expected timeframe, the USPTO will grant this patent an additional 565-day Patent Term Adjustment, thus extending the expected patent term to December 20, 2024. In addition to this patent, the intellectual property portfolio for Ramoplanin includes 16 other pending and issued U.S. and foreign patents with claims relating to additional methods of treatment, methods of manufacturing as well as various Ramoplanin formulations.
About C. difficile-Associated Disease
C. difficile is a spore-forming bacterium known to cause diarrhea and colitis. In the past, C. difficile-associated disease has been mainly a concern in patients who have had recent antibiotic therapy and/or are hospitalized. In recent years, the incidence and severity of CDAD has increased with the emergence of virulent strains creating a serious unmet need. Many countries across the globe have reported rising numbers of CDAD cases in addition to the U.S., including Australia, Canada and the United Kingdom. Currently, it is conservatively estimated that 400,000-500,000 cases of CDAD occur each year in the U.S. The disease generates an estimated $1.1 billion in hospital health care costs annually in the U.S., and can prolong hospital stays by one to three days. Presently, vancomycin and metronidazole are used to treat CDAD, although only vancomycin is FDA-approved for such use.
Oscient Pharmaceuticals' Ramoplanin is an investigational new drug being studied for the treatment of Clostridium difficile-associated disease (CDAD). Ramoplanin has been shown to be bactericidal in vitro against Clostridium difficile. Because it is not absorbed systemically from the gastrointestinal (GI) tract following oral dosing and exerts its bactericidal activity in the GI tract, Ramoplanin represents a potential new method for managing certain pathogens commonly found in the hospital. The Company has reached agreement with the FDA on a Special Protocol Assessment for the Phase III program.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage pharmaceutical company marketing two FDA-approved products through its national primary care sales force. ANTARA(R) (fenofibrate) capsules is FDA-approved for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE(R) (gemifloxacin mesylate) tablets is an antibiotic FDA-approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient also has a novel, late-stage antibiotic candidate, Ramoplanin, under investigation for the treatment of Clostridium difficile-associated disease (CDAD).
For important information regarding the safety and use of ANTARA and FACTIVE, please see the full prescribing information available at www.antararx.com and www.factive.com.
This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements with regard to (i) the ultimate issuance of the patent and (ii) the consummation of a partnership or other strategic alliance to continue the development of Ramoplanin. 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. These risks include, but are not limited to (a) our ability to successfully commercialize and market ANTARA or FACTIVE 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; delays in the supply of products by the third party manufacturers and suppliers on which we rely; inadequate distribution of the products by wholesalers, pharmacies, hospitals and other customers; and competition from other products; (b) 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; (c) delays by the FDA; and (d) claims against us by third parties, including claims relating to our intellectual property position. 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, 2007 and in other filings that we may make with the Securities and Exchange Commission from time to time.
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