Under the deal, the Bangalore-based biotechnology firm’s manufacturing unit will supply fidaxmicin to support commercial launch of the antibiotic, which is ecpected to filed for US Food and Drug Administration (FDA) approval this year.
Biocon has produced the active pharmaceutical ingredient (API) for Optimer throughout OPT-80’s clinical development, which was a key factor in winning it the long-term contract.
Optimer CEO Pedro Lichtinger said that: “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 that: “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.”
According to India’s Business Standard, Biocon expects the supply agreement to generate revenue of $50m a year in the next five to six years.
However, the deal has the potential to generate even more revenue if the predictions of analysts at Zacks Investment research prove correct.
In an investment note on its website, Zacks predicted that: “[Optimer] is on the lookout for a suitable partnership for the commercialization of fidaxomicin outside North America.
“Optimer also plans to submit a Marketing Authorization Application (MAA) for fidaxomicin with the European Medicines Agency (EMEA),” which given Biocon’s seemingly pivotal role in OPT-80’s development, could result in further supply deals.
CDI potential
Clostridium difficile infection (CDI) can result in serious damage to the colon through the bacteria’s production of toxins that resulting in inflammation, severe diarrheoa and, in serious cases, death.
Such infections, which affect 50,000 people a year according to US Centres for Disease Control and Prevention (CDC), are caused by treatment with broad-spectrum antibiotics that remove “normal” gut flora giving CD the opportunity to infect and multiply.
As a result, CDI is a major problem in hospitals and long-term care facilities where broad-spectrum antibiotics are commonly employed, creating a need for drug candidates that target Clostridium difficile specifically.
OPT-80 is one such candidate. The drug is the first of a new class of antibiotics known as macrocycles, which are designed to inhibit enzymes necessary for C.difficile’s replication without impacting on normal gut flora.
Recently completed Phase III trials indicate the drug is superior to the current standard treatment for CDI, the broad-spectrum antibiotic Vancomycin, both in terms of treatment of acute infection and recurrence prevention.