LYCOS RETRIEVER 
Infections: Skin Structure Infections
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This press release contains "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, related to the market for AVELOX and the market for drugs to treat complicated skin and skin structure infections. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of AVELOX, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from Schering-Plough's forward-looking statements due to many factors and uncertainties, which include the market acceptance of AVELOX, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of AVELOX and other items. For further details about these factors and other risks and uncertainties that may impact Schering-Plough's forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's first quarter 2005 10-Q.
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Arpida's leading product candidate is intravenous iclaprim, a potent late-stage antibiotic that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The US Food and Drug Administration has granted fast track status to intravenous iclaprim. In March 2007, Arpida completed patient enrolment in the second pivotal Phase III trial in complicated skin and skin structure infections. The top-line data of the second trial were reported in July 2007. The NDA-filing process is ongoing and expected to be completed by the end of February 2008.
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Recognising the increasing need for new products to fight the growing epidemic caused by healthcare associated infections, Astellas is committed to building a strong anti-infectives franchise. This is reflected by its extensive clinical trial programme which has been very positively received by key opinion leaders in the area. Telavancin, another Astellas product currently under review in the EU regulatory process, is a novel, bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The product review for telavancin continues under the EMEA's Centralised Procedure following its initial submission in April 2007.
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The uSSSI study is a Phase 2, multicenter, randomized, open-label, comparative study to evaluate the safety and efficacy of RX-1741 versus linezolid in the outpatient treatment of adult patients with Uncomplicated Skin and Skin Structure Infections (uSSSI). The study will assess the efficacy of a single dose of RX-1741 given either once daily or twice daily compared to linezolid given twice daily for five to ten days in the treatment of ambulatory patients with uSSSI. It will ... evaluate the safety and tolerability profile of these two doses compared to linezolid.
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Broad categories of skin and skin structure infections (e.g., superficial skin infections, cellulitis and simple abscesses) tend to share common bacterial causes. Skin and skin structure infections that are diagnosed as complicated involve deeper soft tissue (e.g., muscle, fat), may require significant surgical intervention to resolve (e.g., infected ulcers, burns, major abscesses) or are associated with an underlying disease state that complicates response to treatment. The possible bacterial causes of cSSSI are numerous and depend on the clinical situation, the location of the lesion or infection, and past medical history of the individual patient.(2)
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Oritavancin would be indicated for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta believes oritavancin's properties may offer distinct advantages in treating patients who have these serious infections.
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Skin Structure Infections