NEW YORK (The Deal) -- Pharmaceuticals heavyweight Pfizer (PFE) has purchased a minority interest in venture capital-backed Dutch biotech AM-Pharma, deploying financial firepower in the global battle to control hospital-acquired kidney disease and reduce the need for dialysis.
Announcing the deal late on Monday, the New York-based company said it had made an up-front payment of $87.5 million and secured an exclusive option to acquire the remaining equity in the company for up to $512.5 million if its work leads to a launch of a new drug. A separate source said the initial investment was enough to buy a 17.5% interest in the company.
Bunnik, Netherlands-based AM-Pharma is focused on the development of recombinant human Alkaline Phosphatase, or recAP, as a treatment for inflammatory diseases. Pfizer's option could be exercised as early as the second half of 2016, following the results of the current Phase II trial of recAP in the treatment of Acute Kidney Injury, or AKI, related to sepsis.
AKI involves inflammatory processes in the kidney which can lead to complete loss of renal function. As there are presently no drugs approved for the condition. The only treatment option is dialysis and supportive care. Yet the incidence of AKI is considerable, according to Pfizer.
In a joint statement with AM-Pharma, Pfizer said hospital-acquired AKI annually affects around 3 million patients in Europe, the U.S. and Japan, and is associated with mortality in roughly 700,000 patients. It occurs in as many as 4% of hospital admissions and 40% of critical-care admissions. Depending on the severity and cause of renal injury, mortality ranges from 10% to as high as 70%.
In the U.S. alone, Pfizer said, hospitals spend around $10 billion each year on managing the problem. The most important causes of AKI are sepsis, cardiovascular surgery, exposure to nephrotoxic drugs and trauma. AKI patients who need dialysis have the worst prognosis.
AM-Pharma therapeutic candidate recAP is a proprietary recombinant human alkaline phosphatase constructed from two naturally occurring human isoforms of the AP enzyme, which is highly stable and active. It is under development for testing the potential treatment of AKI, with the potential to be developed for hypophosphatasia. An oral formulation may be developed for the treatment of ulcerative colitis.
AM-Pharma worked on a human AP formulation following the results of results of Phase II trials with bovine AP in both AKI and ulcerative colitis. The human recAP formulation will be used in future trials and for commercialization, the company said.
Since inception, the company has raised €67 million ($75.3 million) from a syndicate of international investors including Inventages Venture Capital, Forbion Capital Partners, Gilde Healthcare Partners, Ysios Capital Partners, Kurma Life Sciences Partners, IDInvest Partners, BB Biotech Ventures, Abbvie (ABBV) and Shire (SHPG). The most recent financing round in September 2014 was €12.2 million, for the completion of a Phase II study of recAP in AKI patients, as well as continued development of an oral formulation of recAP for ulcerative colitis patients.