Free of Pfizer, AM-Pharma raises €116M for phase 3

AM-Pharma CEO Erik van den Berg (AM-Pharma)

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.

Sponsored by BHE

[Webinar] State of Data Analytics and Machine Learning in the Life Sciences Industry: 2020 Benchmarking Survey

Thursday, June 25, 2020 | 2:00pm ET | 11:00am PT

Join us Thursday, June 25th for a look at the current state of analytics in the life sciences industry. We will present the results from our industry survey with FiercePharma on how 100 of your peers are leveraging data analytics to respond to today’s challenges and generate timely, high value insights.

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. 

Suggested Articles

The minimally invasive device developer Lumendi reported that its system was used to perform its first fully incisionless appendectomy.

Genor Biopharma banked $160 million from the likes of Hillhouse and Temasek Holdings to advance its clinical-stage autoimmune and cancer programs.

Going from being the CSO of Bristol Myers Squibb to running one of the biggest cancer research organizations in the world is a major career shift.