Optimer Pharmaceuticals, Inc. a biopharmaceutical company focused on the treatment of serious infections such as Clostridium difficile infection (CDI), and Biocon Limited, one of India’s premier biotechnology companies and a global provider of manufacturing services, announced today that they have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient fidaxomicin, Optimer’s lead product candidate for the treatment of CDI.
“This long-term agreement with a world-class manufacturing expert such as Biocon is an important step in establishing a stable supply of fidaxomicin in the event it is approved,” said Pedro Lichtinger, President and CEO of Optimer. “For the past five years, Biocon has been an important partner in our fidaxomicin development program and we look forward to continuing the relationship.”
Kiran Mazumdar Shaw, CMD Biocon Group, added “Our partnership with Optimer is another wonderful recognition of Biocon’s capabilities as an R&D partner as well as an acknowledgement of our global manufacturing facilities. The close research and development partnership over the last five years has been an enriching learning experience from a world class team for all the Biocon staffers working on this project.”
Biocon’s expertise in fermentation technology and the team’s prior analytical development work with fidaxomicin made Biocon the most suited manufacturer for Optimer’s product requirements.
CDI is caused by Clostridium difficile a spore-forming bacterium that can cause serious infection of the colon in humans by multiplying and producing toxins resulting in inflammation, severe diarrhea and, in serious cases, death. The primary risk factor for the development of CDI is the use of broad-spectrum antibiotics, as they can disrupt normal gastrointestinal flora, promoting C. difficile overgrowth. C. difficile typically affects older or severely ill patients who are hospital inpatients or residents of long-term-care facilities.
The Centers for Disease Control and Prevention (CDC) estimates that CDI affects nearly 500,000 people in the U.S. annually. Currently underreported and under-diagnosed, the CDC recognizes CDI as an unmet medical need and an emerging global public health crisis. In 2005, the U.S. Agency for Healthcare Research and Quality reported 28,600 deaths from CDI. Highly virulent strains of C. difficile bacteria have been identified in virtually every country, including the U.S., Canada, the Netherlands, France, UK, Switzerland, and Japan.