The randomized, multicenter trial for Lorediplon will take place at 12 centers in three countries with about 130 patients in Europe. Ergomed will assume a proportion of the clinical and regulatory costs of the Phase IIa trial in return for a share of future revenues received by Ferrer for Lorediplon in this indication.
Ergomed CFO Neil Clark told us, “We’ve been talking with them for over a year now and the co-development terms, study design and our team working with their team will deliver what will be a successful study.”
Spain-based Ferrer also announced it is collaborating with Ildong Pharmaceuticals Co Ltd, Korea on the development of the drug.
With our investments on recruiting patients, and a fixed budget, “we need to deliver on this,” he added.
Ferrer will be eligible to receive payments from the agreement covering countries within East Asia, including South Korea, China and Japan. Ildong will be responsible for the costs and activities related to development and regulatory approvals in their territory.
As far as recent trends in consolidation and a revival in early phase investments, Clark noted that Ergomed has seen US CROs buying more into Europe, especially as smaller EDC (electronic data capture) companies extend beyond their niche.
“Co-development partnerships are our key – we want to operate internationally and as a full-service CRO,” he added.
In April, Ergomed won a Phase III contract that included a profit-sharing deal with Aeterna Zentaris.
“I think in terms of Phase II and proof of concept studies, smaller companies are looking to produce data sets that are workable…Ferrer might be able to market this drug themselves…[but it’s] fair to say we’re seeing an increase in Phase IIa and IIb trials,” Clark said. “It’s definitely one of the more buoyant markets I’ve seen but it’s still really competitive and difficult to deliver with patients and budget.”
“Our target market is mid- and small-size CROs, but underneath that there’s a whole world of development,” Clark added, noting the company’s specialty is close relationships with small biotech and pharmaceuticals. “We don’t work for other CROs…and it’s been a tough few years, but we’re seeing action pick up again and hopefully companies will spend money on sensible drug development.”