Reuters: Regulatory News: UPDATE 1-Medicines Co skin infection antibiotic meets trial goal

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UPDATE 1-Medicines Co skin infection antibiotic meets trial goal Dec 20th 2012, 15:39 Thu Dec 20, 2012 10:39am EST Dec 20 (Reuters) - Medicines Co said a late-stage trial of its experimental drug for bacterial skin infections met the main study goal of stopping the infection from spreading and the absence of fever, sending the company's shares up 9 percent. The drug oritavancin was being tested for the treatment of acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible gram-positive bacteria, including a highly contagious drug-resistant bacteria. The trial, named Solo-1, showed that oritavancin was non-inferior to the standard-of-care antibiotic vancomycin in its efficacy. Solo 1 is the first of two late-stage trials to test oritavancin in ABSSSI. "Results appear clean so far from an efficacy and safety perspective and if replicated in the second ongoing Phase III study, like we expect them to, could lead to U.S. and EU regulatory filings in 2013," RBC Capital Markets analyst Adnan Butt wrote in a note. The trial had enrolled 968 ABSSSI patients worldwide and compared treatment with a single dose of oritavancin with 7 to 10 days of twice-daily doses of vancomycin. "These data show that a single dose of oritavancin given on presentation of a patient with ABSSSI to hospital can cure gram positive infections ... and be as efficacious as multiple days of vancomycin infusions," CEO Clive Meanwell said in a statement. Gram positive bacteria are one of the most common causes of hospital-acquired infections. It includes the highly contagious and difficult to treat bacteria -- methicillin-resistant Staphylococcus aureus (MRSA). MRSA is a staph infection that is resistant to antibiotics that are usually used to treat the infection. It is spread by skin contact but can spread to bones and joints, the blood, or any organ. Antibiotic resistance has become a serious healthcare threat due to growing drug-resistant superbug infections, and is driven by the misuse and overuse of antibiotics in people and livestock. Unless measures are taken, patients could soon face a time when even the most common infections will be untreatable by antibiotics. The company's shares were up 7 percent at $23.94 on Thursday on the Nasdaq. They touched a high of $24.40 earlier in the day. Link this Share this Digg this Email Reprints

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