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Jul 31, 2013

AstraZeneca to Co-Develop FibroGen Anemia Compound in Up to $815M Deal

  • AstraZeneca said today it will work with FibroGen to develop and commercialize its late-stage drug candidate FG-4592, a first-in-class oral compound for anemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), in a deal that could generate as much as $815 million for the privately held biotech.

    The companies said they plan to launch Phase III trials of the drug candidate in China and undertake “an extensive” Phase III development program for FG-4592 in the U.S.; the first late-stage study to support approval there and in Europe was initiated in December. Regulatory filings are anticipated for 2015 in China and two years later in the U.S.

    U.S. commercialization of FG-4592 will be overseen by AstraZeneca, with FibroGen carrying out promotional activity in the ESRD market segment. The companies will co-commercialize FG-4592 in China, where FibroGen will be responsible for clinical trials, regulatory matters, manufacturing, and medical affairs, while AstraZeneca will oversee promotion and commercial distribution.

    “Our collaboration with FibroGen on FG-4592 is an important addition to AstraZeneca’s growing late-stage portfolio in cardiovascular and metabolic disease, one of our core therapy areas,” AstraZeneca CEO Pascal Soriot said in the statement. “Through our collaboration with FibroGen we aim to offer a first-in-class, convenient treatment option for doctors and patients.”

    AstraZeneca will pay FibroGen committed up-front and subsequent noncontingent payments totaling $350 million, as well as up to $465 million in potential future payments tied to development and sales milestones, in addition to tiered royalty payments in the low 20% range on future sales on FG-4592. AstraZeneca will make additional payments for development milestones in any later indications the companies pursue. The strategic collaboration “may be extended to other anemia indications,” the companies added.

    “This agreement secures proper development and commercialization resources for FG-4592, and ensures U.S. clinical trial efforts are fully funded,” FibroGen CEO Thomas B. Neff said in a statement.

    FG-4592 has met its primary Phase II objective of demonstrating anemia improvement in treatment-naïve CKD patients not on dialysis, as well as maintenance of hemoglobin levels and anemia correction in patients on dialysis, all with an acceptable safety profile and without intravenous iron supplementation.

    Iron supplements and injectable erythropoiesis-stimulating agents (ESAs) comprise current treatment options for anemia. FG-4592 is a small molecule inhibitor of hypoxia-inducible factor (HIF) that has shown potential as an oral anemia treatment by inducing erythropoiesis as a response to oxygen changes in the cellular environment, much as high-altitude conditions trigger production of red blood cells.

    Under a licensing agreement with FibroGen, Astellas is developing FG-4592 (which Astellas calls ASP1517) for anemia in CKD and ESRD patients in Europe, the Commonwealth of Independent States, the Middle East, South Africa, and Japan, where the companies have just launched a Phase II study for the experimental drug. That launch resulted in Astellas paying FibroGen a $12.5 million milestone payment, the companies said yesterday.

    FibroGen said Astellas plans to conduct an additional Phase II clinical study in Japan of ASP1517/FG-4592 in nondialysis patients later this year.


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