Ergomed (LON:ERGO) has struck a deal to buy Haemostatix and its pipeline of treatments for surgical bleeding. The agreement will give Ergomed its first wholly owned assets, including a Phase IIb-ready bleeding product it is aiming to hustle through to the conclusion of a pivotal trial by 2019.
Guildford, U.K.-based Ergomed is best known as a clinical trial service provider that, in some situations, is willing to lower its fees in return for a cut of future profits. When Ergomed first began talking to Haemostatix, a Nottingham, U.K.-based bleeding specialist backed by Albion Ventures, it was with a view to entering into such a co-development agreement. But as Ergomed started digging into the company and its molecules, it gained the confidence to go a step further than in the past.
“We saw that this opportunity had some pretty unique features,” Ergomed Chief Business Officer Andrew Mackie told FierceBiotech. “The preclinical and clinical evidence was very, very aligned and pretty comprehensive. We saw this as a much lower risk opportunity.”
Ergomed reached this view on the strength of data from a 20-person Phase I trial of Haemostatix’s lead candidate PeproStat in liver surgery patients. On average, PeproStat took 1.4 minutes to stop a bleed, a figure that Ergomed sees as comparing favorably to thrombins that are currently used in this situation. PeproStat stopped 95% of bleeds within three minutes. In a larger, Phase III trial in patients undergoing a range of surgeries, Baxter’s ($BAX) Floseal stopped 96% of bleeds within 10 minutes.
The challenge for Ergomed is to translate the early-phase promise of PeproStat into larger studies. By drug development standards, this should be a relatively quick and affordable process, a factor that added to Ergomed’s willingness to take full ownership of the program. Haemostatix has already met with regulators on both sides of the Atlantic to discuss the size and design of the clinical trials. And, because bleeding cessation is an immediate endpoint, Ergomed expects to gather data quickly.
A 120-person Phase IIb proof-of-concept trial is due to start next year, cost £5 million ($7 million) and be finished within 12 months. Once it has the proof-of-concept data, Ergomed plans to seek out a marketing partner, but Mackie is open to going into Phase III solo if the right deal fails to materialize. Either way, the expectation is that PeproStat will come through a Phase III study in 2019, setting it up to reach the market the following year.
With Ergomed putting the combined estimated market for PeproStat and Haemostatix’s earlier-stage product at around £200 million or more, the deal to take control of the assets is relatively small. Ergomed is set to hand over £8 million upfront, with a further £20 million to follow if the programs hit certain milestones. To finance the deal. Ergomed has turned to its investors for a placement of shares that will raise £9 million.
- read the statement