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Jan 28, 2014

AstraZeneca, FOB Synthesis in Antibiotic Development Deal

  • AstraZeneca (AZ) and FOB Synthesis will join to develop a new antibiotic to treat drug-resistant bacterial infections, by potentially combining AZ’s preclinical beta lactamase inhibitor (BLI) with the custom synthesis company’s preclinical carbapenem antibiotic, designed to help break down bacteria’s resistance to carbapenems.

    The companies did not disclose the value of their research and development option and license agreement “at this time.”

    Two investigational carbapenem antibiotics developed by FOB Synthesis, FSI-1671 and FSI-1686, will be examined for their treatment of MDR gram-negative bacterial infection. The companies reason that combining a carbapenem with a BLI may allow a new treatment of the multi-drug resistant bacteria.

    “We are confident with AstraZeneca’s expertise in the anti-infective field for the successful development of this combination therapy,” Woo-Baeg Choi, Ph.D., CEO of FOB Synthesis, said in a statement.

    The deal comes at a time of renewed interest by biopharma giants in antibiotic development, spurred by incentives included in the FDA Safety and Innovation Act (FDASIA) law, which includes the Generating Antibiotic Incentives Now (GAIN) Act. Most notably, the law created the “qualified infectious disease product” (QIDP) designation for antibiotic drug candidates, which entitles their developers to faster FDA reviews and five additional years of market exclusivity.

    Since last year, Genentech began an antibacterial partnership with RQx Pharmaceuticals, while in November, Genentech’s parent Roche joined with Polyphor to develop and commercialize its Phase II-initiated investigational macrocycle antibiotic, in a deal that could net Polyphor up to CHF 500 million  ($556.3 million).

    In the latest deal, AZ will develop investigational combinations of compounds through Phase I during the deal’s option phase. AZ will be solely responsible for development and commercialization of the candidate combination compound through the option phase—and thereafter, should the company exercise its option to develop a compound.

    While carbapenem antibiotics have been developed and used widely for bacterial infections, the value of antibacterial chemotherapy has been reduced in recent years by the surge in drug-resistant bacteria. Accordingly, carbapenem-resistant (CR) forms of gram-negative bacteria such as Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, and Pseudomonas aeruginosa have increased worldwide.

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