Ablynx (EBR:ABLX) has decided to retain full ownership in the U.S. and Europe of its Phase III-ready drug for the orphan blood disease acquired thrombotic thrombocytopenic purpura (TTP). A Phase III trial of caplacizumab is due to start soon, setting Ablynx on a path it expects to lead to a filing for conditional approval in Europe early in 2017.
Ghent, Belgium-based Ablynx had been considering cashing in on the asset now but has decided to keep hold of the rights in its main markets. If the Phase III trial goes to plan and caplacizumab is shown to help people with acquired TTP--who currently lack treatments other than daily plasma exchanges--Ablynx will use it as the spearhead in its campaign to develop into a commercial-stage biopharma business.
"We have concluded that this product represents a strategic opportunity in our evolution into a commercial stage company and the value is best maximised by Ablynx retaining 100% ownership of the product," Ablynx CEO Edwin Moses said in a statement. Having issued a €100 million ($112 million) convertible bond earlier this year, Ablynx has a bank balance of €268 million to finance its plans.
Commercializing caplacizumab should be comparatively cheap given the small pool of hematologists who deal with cases of TTP. These characteristics led Jefferies analyst Peter Welford to describe the drug as "an ideal asset to make the transition to a fully integrated biopharma." Investors reacted favorably to the news, too, sending shares in Ablynx up by around 5%. Attention now turns to the Phase III trial, the first sites in which are due to come online soon.
The decision to take caplacizumab to market solo is contributing to a period of change at Ablynx, which expects to grow its headcount by 10% this year as it takes on staff to handle its expanded R&D alliance with Merck ($MRK).
- read the release (PDF)