STREPTOKINASE MORTALITY LABELING DATA WILL BE KEY to the effort to establish the product's position in the thrombolytic therapy market prior to the introduction of other biotechnology competitors, SmithKline Chairman Henry Wendt told analysts at a Nov. 2 meeting in New York sponsored by Smith Barney. Discussing the future for streptokinase compared to tissue plasminogen activator (TPA), Wendt declared: "There is certainly far less mortality data with TPA than streptokinase and that may something to do with the labeling." Wendt pointed out that "labeling has everything to do with promotional position, product claims, and advertising." Hoechst and SmithKline will have a good forum for introducing the new labeling claims at the American Heart Association meeting in the middle of November. Wendt pointed out, even before the streptokinase mortality data was confirmed by FDA's approved labeling, that it would be an important product differentiation point. "What we know we have with streptokinase," Wendt said, "is a product that is backed by superb data, over 20,000 patients: excellent mortality data. We also know what the record is on the FDA advisory committee's review of both streptokinase and TPA. That's on the record and it's not speculation. It's also in the literature and it will be displayed in spades at the cardiology meeting in Anaheim." At the same Nov. 2 meeting in New York, Abbott President Jack Schuler questioned the ultimate importance of product differentiation in the lytic products market. Noting that the hospital market is very price sensitive, Schuler said that Abbott's experience in the lytic with Abbokinase (urokinase) has been that the specialty groups using the product have set their own use patterns. Schuler noted that Abbokinase is "approved for one small indication. But we find in this market that these physicians typically, when they decide how to use the product, it is more based on their own study, their own experience." Schuler maintained that "actually the vast majority of our sales are in applications which we don't have approval for . . . So I have never felt that the particular approval . . . that that was so important."
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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