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MILES KOGENATE SHIPMENTS MAY BEGIN AS EARLY AS WEEK OF MARCH 1,

Executive Summary

MILES KOGENATE SHIPMENTS MAY BEGIN AS EARLY AS WEEK OF MARCH 1, the company said following FDA approval of the recombinant Factor VIII product on Feb. 25. KoGENate will become the second recombinant Factor VIII product in the antihemophilic market. Baxter/Genetics Institute's Recombinate rFactor VIII was approved late last year ("The Pink Sheet" Dec. 14, 1992, p. 13). Miles said it had not finalized KoGENate pricing as of Feb. 26. Recombinate's average wholesale price per unit is $1.18, which translates into annual treatment costs for an adult hemophiliac of up to $70,000. That price far exceeds the cost of using plasma-based Factor VIII and has been considered a limiting factor on the market size of rFactor VIIIs. FDA approval comes more than three years after the September 1989 PLA filing for KoGENate by Genentech licensee Miles. Both KoGENate and Recombinate were recommended for approval by FDA's Blood Products Advisory Committee in December 1991. KoGENate is indicated "for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII," approved labeling states. The product may be used to treat hemophilia A in patients with Factor VIII inhibitor titers of less than 10 B.U./ml, labeling notes. Like Recombinate, KoGENate is not indicated for the treatment of von Willebrand's disease. The two recombinant products are approved for identical indications and labeling carries the same precautions for both. Adverse reactions reported in clinical studies with KoGENate were slightly higher. Clinical studies conducted in previously treated patients found that 47 out of 12,932 KoGENate infusions (.36%) were associated with 58 minor adverse reactions, labeling reports. In a study of previously untreated patients, 3,254 KoGENate infusions were associated with 22 minor adverse reactions (.34%). Reactions included dizziness, nausea, chest discomfort and cold feet, as well as burning, pruritis and erythema at the injection site. No serious reactions were reported. Recombinate labeling reports 13 infusion-related minor adverse reactions out of 13,394 infusions (.097%) in clinical studies conducted in previously treated patients. Adverse reactions are not reported for previously untreated patients. The advisory committee that reviewed the two recombinant Factor VIII products expressed some concern over the lack of safety data for use of Recombinate in previously untreated patients, while KoGENate did receive a recommendation for use in that patient group ("The Pink Sheet" Dec. 16, 1991, p. 13). However, when Recombinate was approved Dec. 10, 1992, labeling did not include such a qualification. The gene used to make KoGENate was originally cloned by Genentech, and licensed by Miles in 1984. Under a separate cross- licensing agreement, Miles and Genentech avoid potential patent disputes with Baxter and Genetics Institute over recombinant antihemophilic factor technology ("The Pink Sheet" March 27, 1989, p. 5). Baxter and Genetics Institute collaborate on the manufacture of Recombinate, with the latter supplying the bulk product and the former the final dosage form and marketing power. In conjunction with the introduction of KoGENate, Miles announced that it is forming a program to provide support to hemophilia patients, their families and physicians. The program will include indigent patient assistance and a study group of KoGENate patients and hematologists "who will design and perform clinical studies to advance the understanding of hemophilia treatment," the company said.
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