AM-Pharma has raised €116 million ($131 million) to run a pivotal clinical trial in sepsis-associated acute kidney injury (SA-AKI). The financing sets AM-Pharma up to advance recAP independently now that Pfizer has turned down its option to acquire the Dutch company.
Pfizer paid AM-Pharma $87.5 million in 2015 for a minority stake and option to acquire the rest of the company for $512.5 million following the publication of phase 2 data. AM-Pharma released the phase 2 data last year, generating evidence of long-term kidney function improvements and reduced mortality to offset the failure to hit the primary endpoint. But Pfizer opted to pass on the buyout.
That decision positioned AM-Pharma to remain in control of the asset, a recombinant human form of alkaline phosphatase, and start preparing for life as an independent, commercial-stage company.
New investors LSP and Andera Partners have moved AM-Pharma a step closer to realizing that vision by co-leading a €116 million investment. Existing investors Forbion, Ysios Capital, Kurma Partners, ID Invest Partners, BB Pureos Bioventures and Gilde Healthcare also returned for the latest round, giving AM-Pharma a syndicate of European investors capable of quickly putting together a sizable financing.
"It went pretty fast, maybe just a bit more than half a year,” AM-Pharma CEO Erik van den Berg said. “It says something about the current climate of financing, especially around larger rounds. Maybe a couple of years ago this would not have been thinkable to do in Europe.”
Back then, a company in AM-Pharma’s position may have needed to enter into a partnership, attract significant investment from U.S. funds or go public. AM-Pharma considered an IPO but concluded a private round was the fastest way to get the money it needed. An IPO is a possibility if AM-Pharma needs to raise money in the future.
With AM-Pharma aiming to commercialize the drug itself, at least in some markets, the phase 3 data will dictate its future financing needs. AM-Pharma plans to start the phase 3 in the first half of next year. The trial will echo the design of the phase 2, which used a set of inclusion/exclusion criteria that van den Berg thinks enabled the enrollment of participants with modifiable disease.
If the 1,400-subject phase 3 is a success, AM-Pharma has a shot at winning approval in Europe and the U.S. on the strength of the single pivotal study, reflecting the high mortality rate associated with SA-AKI and lack of drugs approved in the indication.