Biocon Limited and Optimer Pharmaceuticals Inc have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient fidaxomicin.

The US-based company is focused on the treatment of serious infections like Clostridium difficile infection (CDI), and fidaxomicin is a lead product candidate for the treatment of CDI.

Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile. The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while most broad-spectrum antibiotics, including metronidazole and vancomycin, disrupt these flora.

Fidaxomicin may facilitate the return of the normal physiological conditions in the colon and reduce the probability of CDI recurrence. Optimer has successfully completed two phase-3 trials showing superiority in global cure rates (defined as cure with no recurrence within four weeks of completing therapy) as well as a reduction in recurrences of up to 50% when compared with Vancomycin, the only US FDA approved product for CDI. Optimer expects to submit an NDA in the second half of the year.

"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, 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, he added.

According to Kiran Mazumdar Shaw, CMD Biocon Group, the partnership with Optimer is a recognition of our capabilities as an R&D partner. 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, she said.

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 US 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 US 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 US, Canada, the Netherlands, France, UK, Switzerland, and Japan.