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BUNNIK, The Netherlands—New York City-based global pharmaceutical company Pfizer Inc. has acquired an $87.5-million minority interest and an exclusive option to acquire the remaining equity in AM-Pharma B.V., a privately held Dutch biopharmaceutical company focused on the development of recombinant human alkaline phosphatase (recAP ) for inflammatory diseases. The company reported favorable Phase 1 data in March 2014 for the drug candidate.
The option, which could total $600 million, could become effective after the completion of a Phase 2 trial of recAP in the treatment of acute kidney injury (AKI) related to sepsis. Results from the Phase 2 trial are expected in the second half of 2016.
AKI affects about 3 million people each year in Europe, the United States and Japan and accounts for the death of approximately 700,000 patients. AKI reportedly occurs in as much as 4 percent of hospital admissions and 40 percent of critical care admissions.
Mortality can be from 10 percent to 70 percent. Hospitals in the United States spend about $10 billion each year on managing this medical problem. According to AM-Pharma, the most important causes of AKI are sepsis, cardiovascular surgery, exposure to nephrotoxic drugs and trauma. AKI patients who require dialysis have the worst prognosis.
Currently, the only treatment option is dialysis and supportive care. No drugs are approved to treat AKI. Typically these patients are treated with dialysis in intensive care units, often with the support of nephrologists.
Dr. Mikael Dolsten, president of worldwide research and development at Pfizer, explained, “Clinical data for recAP show the potential to uniquely address acute kidney injury in the setting of sepsis, and we look forward to working with our partners at AM-Pharma as we aim to accelerate the development of recAP into a potential first-in- class treatment for patients.”
According to Erik van den Berg, CEO of AM-Pharma, “This agreement provides the next step in the development of recAP as a potential treatment for patients with acute kidney injury and other inflammatory diseases.”
The trial, which has two stages, is designed to determine the most effective dose of recAP, establish proof of concept in treating AKI through measuring kidney function and re-establish safety data from previous trials. In the first stage, patients will be evaluated to identify and select the most effective dose. In the second stage, patients will get the best dose or placebo. The effect on kidney function will be measured by creatinine clearance rate, and the trial will also record the incidence and duration of dialysis over 28 days, the prevention of chronic kidney disease and non-kidney related clinical factors. In addition to AKI, AM-Pharma is developing recAP as a potential treatment for ulcerative colitis and hypophosphatasia (HPP). The company has developed and tested a bovine form of alkaline phosphatase in three Phase 2 trials in patients with ulcerative colitis, as well as AKI and sepsis.
AM-Pharma’s therapeutic candidate, recAP, is a proprietary recombinant human AP constructed from two naturally occurring human isoforms of the AP enzyme. It is highly stable and active. The drug candidate is under development for testing the potential treatment of AKI, with the potential to be developed for hypophosphatasia. An oral formulation could be developed for the treatment of ulcerative colitis. The enzyme is produced by cGMP manufacture for preclinical and clinical trial supply and commercialization, according to the company.
Founded in 2001, AM-Pharma is a private company that is backed by a strong syndicate of international investors, both venture capital funds and corporate venture funds. Pfizer, a 150-year-old company, has a global portfolio that includes medicines and vaccines as well as consumer healthcare products.