ARMOUR’s MONONINE MONOCLONAL FACTOR IX APPROVED BY FDA

Executive Summary

ARMOUR's MONONINE MONOCLONAL FACTOR IX APPROVED BY FDA on Aug. 20 for the "prevention and control of bleeding in Factor IX deficiency" in patients with Hemophilia B. Monoclonally-purified Mononine Coagulation Factor IX carries an average wholesale price of $1.04 per unit. The clotting factor is the "world's first monoclonal antibody (MAb) purified Hemophilia B therapy," the Rhone-Poulenc Rorer subsidiary states. Mononine is supplied in single dose vials of 250, 500 and 1000 IUs. "When reconstituted as directed to approximately 100 units/ml, Mononine should be administered at a rate of approximately 2.0 ml per minute," approved labeling notes. Each ml of the reconstituted concentrate contains approximately 100 IU of Factor IX and non-detectable levels of Factor II, VII and X. Mononine is contraindicated in patients hypersensitive "to mouse protein." Two other Factor IX biologics also were recently approved by FDA: Alpha Therapeutics' AlphaNine SD (Coagulation Factor IX) on Aug. 26 and Oestereichisches' Bebulin VH Immuno (Factor IX Complex) on Aug. 19. AlphaNine SD is an improved version of Alpha Therapeutics' AlphaNine, which was approved on Dec. 31, 1990 ("The Pink Sheet" Jan. 7, 1991, p. 7). The firm filed a PLA amendment in June 1991 to include the use of solvent/detergent as a viral inactivation process in its Factor IX product. The product's launch date is planned for Oct. 1. A third generation product evolved from Alpha's first generation Profilnine, AlphaNine SD has an improved viral inactivation step utilizing the solvent/detergent, tri-n-butyl phosphate (TNBP) and Polysorbate 80. The purification process also reduces the non-Factor IX proteins to "very low levels," augmenting the safety and purity of the product, the company said. Vienna, Austria-based Oesterreichisches Institut's Factor IX Complex, vapor heated biologic, Bebulin VH Immuno, is a purified, sterile, stable, freeze-dried concentrate of the coagulation Factor IX, Factor II (Prothrombin) and Factor X (Stuart Prower) as well as low amounts of Factor VII. The product also contains small amounts of heparin. "No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency," approved labeling notes.