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Optimer Pharmaceuticals, Inc. (OPTR) Message Board

  • mikeadd@bellsouth.net mikeadd Nov 3, 2011 9:18 AM Flag

    Might be old news but

    here it is anyway
    Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the Company filed a new drug submission (NDS) with the Therapeutic Products Directorate of Health Canada (Health Canada) for DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD). Health Canada awarded Optimer priority review of the DIFICID NDS, reducing the time to a potential regulatory approval in Canada. To address the country-specific needs and relationships, Optimer also announced the establishment of Optimer Pharmaceuticals Canada, Inc., a subsidiary from which the Company plans to make DIFICID available in Canada.
    (Logo: http://photos.prnewswire.com/prnh/20090413/LA97352LOGO)
    "C. difficile has been a major problem in Canada as evidenced by recent outbreaks, and we believe there is a significant need there for new CDI treatment options," said Pedro Lichtinger, President and CEO of Optimer Pharmaceuticals. "Canada represents our first direct entry into an international market, supporting wider DIFICID access to patients in need and advancing the treatment of hospital acquired infections."
    "The problems presented by C. difficile infection and the need for new therapies for patients are widely understood in Canada, and there is also significant physician interest in DIFICID based on experience and familiarity gained there during the clinical development program, in which we enrolled over 400 Canadian CDI patients," noted Mr. Mohsen. "With these understandings, we conducted a thorough analysis of the most efficient way to facilitate patient access to DIFICID in the Canadian market and determined that a direct effort leveraging regional experience from our clinical program and manufacturing logistics is the best means to do so."
    The NDS is based on the results of two Phase 3 clinical studies of DIFICID in patients with CDI. The trials were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects. Subjects with confirmed CDI received either DIFICID (200 mg twice daily) or oral vancomycin (125 mg four times daily). The primary objective of both studies was to show that a 10-day course of DIFICID was as effective as oral vancomycin in achieving a clinical response, defined as patients requiring no further CDI therapy two days after completion of study medication, at the end of therapy. An additional efficacy endpoint was sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDI recurrence through 30 days beyond the end of treatment. In both of these studies, DIFICID achieved its primary endpoint of non-inferiority compared to vancomycin. DIFICID was also statistically superior to vancomycin in sustained clinical response and reduced CDI recurrences by 47%. The most common treatment related adverse reactions in these studies were vomiting (1.2%), nausea (2.7%) and constipation (1.2%).
    Optimer's Canadian subsidiary plans to hire approximately 25 employees in general and administrative, commercial, and medical affairs positions.
    About CDAD

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OPTR
12.780.00(0.00%)Oct 23 4:00 PMEDT

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