CSL Behring forms supply agreement with ProFibrix
Australia-based CSL has a considerable presence in the plasma protein therapeutics market and its fibrinogen and thrombin are approved in a number of markets around the world.
ProFibrix will use the fibrinogen and thrombin from CSL as active components in its lead product Fibrocaps. Using products from CSL will offer ProFibrix “a tremendous advantage with regulatory authorities when seeking approval for Fibrocaps”, said Jaap Koopman, CEO of ProFibrix.
CSL Behring also provides clients with toll manufacturing services and supplies the excipient human serum albumin.
The Netherlands-based ProFibrix believes the experience and reputation built up by CSL performing these activities, and manufacturing in-house products, will be beneficial as it seeks regulatory approval.
Fibrocaps development
With the supply deal in place ProFibrix is positioned to continue the development of Fibrocaps. Results from a Phase II study conducted in Europe, which began in June 2009, were released in March and showed the product to be safe and efficacious.
ProFibrix now plans to begin a global Phase II trial. To support development ProFibrix has sought funding over the past 12 months. In January the company received a €5m ($6.2m) loan from SenterNovem, a Dutch government agency, to support clinical development of Fibrocaps.
This was preceded by $11m of series B financing that the company secured in August 2009. New investor Gilde Healthcare Partners led the financing round, joining existing investor Index Ventures.
