Summary
CSL Behring's human fibrinogen concentrate RiaSTAP, sold for years in Europe as Haemocomplettan P, will be welcomed for management of bleeding problems in U.S. patients with a rare genetic absence or deficiency of this critical clotting protein. RiaSTAP will eliminate the need for infusions of large amounts of "cryoprecipitate" that can cause dangerous clots or potentially transmit blood-borne infections. Most incremental RiaSTAP revenues will go directly to CSL's bottom line, as fibrinogen is already present in same donor plasma from which CSL currently extracts immune globulins, albumin, factor VIII and other therapeutic proteins. RiaSTAP addresses a small market, but each new niche product like this (and there will be others) is like found money: the cost of purifying it is generally modest in relation to the value and pricing it can command.
Analysis
For the 1-2 persons per million in the U.S. who cannot
produce fibrinogen -- a critical protein that is critical for the
clotting process -- CSL Behring's human plasma-based RiaSTAP fibrinogen concentrate will be a welcome new treatment option to manage their acute and sometimes life-threatening bleeding episodes.
CSL is actively investigating the clinical benefits of RiaSTAP in patients with certain "acquired" fibrinogen deficiencies that can occur with extensive blood loss. In Europe, it's estimated that more than 75% of sales are off-label. The bar for success in the U.S. will be fairly high, but the rewards can be higher.
