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Optimer Pharma in deal with Astellas on antibiotic
Feb 08, 11 Drug NewsOptimer Pharmaceuticals Inc said it signed a licensing deal for its experimental antibiotic, fidaxomicin, with Japanese drugmaker Astellas Pharma Inc’s European unit and will receive an upfront payment of $68 million.
Fidaxomicin is being developed as a treatment for C. difficile infection (CDI), a serious illness caused by infection of the lining of the colon.
Under the terms of the deal, Astellas gains the rights to develop and sell the drug in Europe and parts of the Middle East and Africa.
Optimer is also eligible to receive additional cash payments of up to $156 million upon the achievement of regulatory and commercial milestones.
Should the drug be approved, San Diego-based Optimer would receive tiered double-digit royalty payments on net sales of fidaxomicin in the Astellas territories.
Astellas will assume all future costs associated with the development, manufacturing and commercialization of fidaxomicin in its territory, as well as the costs of filing for European approval of the antibiotic.
“We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin and will help position this medication in these countries as the first line of treatment, both for treating CDI and reducing recurrences,” Optimer Chief Executive Pedro Lichtinger said in a statement.
Fidaxomicin is an oral macrocyclic antibiotic with a new mechanism and narrow spectrum of action, the company said.
In late stage clinical trials, fidaxomicin proved an equally effective cure compared with vancomycin, the only FDA approved product for CDI, and demonstrated superiority in reducing recurrences of the infection.
Patients considered at high risk of recurrence include the elderly, those taking concomitant antibiotics, immune system compromised patients or those with kidney impairment.
C. difficile is a significant problem in hospitals and long-term care facilities and can result from the use of broad-spectrum antibiotics.
(Reporting by Bill Berkrot; editing by Andre Grenon and Gerald E. McCormick)
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