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BRISTOL-MYERS SQUIBB’s PROHANCE NON-IONIC MRI CONTRAST AGENT APPROVED FOR CNS DISORDERS; SHIPPING BEGINS "IMMEDIATELY," UNIQUE DOSING OPTIONS STRESSED BY BMS

Executive Summary

Bristol-Myers Squibb began shipping ProHance (gadoteridol injection) "immediately" following Nov. 16 approval by FDA, the company said. ProHance will be marketed by Squibb Diagnostics and should be available before the close of November. The non-ionic magnetic resonance imaging contrast agent is intended for use in diagnosing central nervous system disorders. The approval comes two years after BMS submitted the NDA (20-131) and one year after FDA's Medical Imaging Drugs Advisory Committee gave ProHance a favorable review ("The Pink Sheet" Nov. 11, 1991, p. 9). ProHance is indicated for providing "contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization (compared with unenhanced MRI) of lesions with abnormal vascularity or those thought to cause a disruption of the normal blood-brain barrier," approved labeling states. The most common adverse reactions are mild-to-moderate nausea and taste perversion, with an incidence of 1.4%. A Phase III study comparing unenhanced scans with enhanced scans in 411 patients found that ProHance provided more diagnostic information in 70% of brain studies and 59% of spinal studies. In cases where initial diagnostic information was obtained following use of ProHance, "the data included improved visualization of the lesion, increased definition of lesion quarters, improved ability to detect lesions as well as to classify disease," the company told the advisory committee last year. ProHance will be priced on par with Berlex' Magnevist (gadopentetate), the only other available gadolinium contrast agent, BMS said. A five-vial package will have a "list price" of $151.25 for 5 ml vials; packages of 10, 15 and 20 ml vials will be priced at $296.75, $434.25 and $536.25, respectively. A 20 ml vial of Magnevist is listed at $107.25 in the 1992 Red Book, which mirrors the 20 ml vial price for ProHance. Bristol-Myers Squibb is highlighting ProHance's flexible dosing schedule. ProHance will offer physicians "the widest range of dosing options available for an MRI contrast agent," the company maintained. The recommended dose for ProHance is 0.1 mmol/kg administered as a rapid intravenous infusion or bolus, but the labeling also provides for a second dose of 0.2 mmol/kg within 30 minutes of the first dose when the initial scan is negative or equivocal in patients "suspected of having cerebral metastases or other poorly enhancing lesions." A BMS study comparing a 0.1 mmol/kg dose of ProHance with 0.3 mmol/kg dose presented at the November 1991 advisory committee meeting demonstrated that the lower dose generated initial diagnostic information in 55% of patients compared to 65% with the higher dose. In addition to Magnevist, ProHance may face competition from Sterling Winthrop's Omniscan (gadodiamide), which also received a favorable advisory committee review in November 1991. Sterling Winthrop said in September that it expected to introduce Omniscan "later this year." Bristol estimates the MRI market in the U.S. is currently $160 mil. and will grow to $200 mil. in 1993. Both ProHance and Omniscan are non-ionic agents, while Magnevist is an ionic agent. In its presentation to the advisory committee last year, FDA said that "the efficacy of these three drugs is exactly the same." One committee member suggested that FDA should look at the benefits of non-ionic agents compared to ionic agents. No direct comparative studies have been done, BMS said. Bristol-Myers Squibb preempted a possible patent dispute over ProHance with Schering AG last November when it signed a licensing agreement for worldwide rights to Schering's patents relating to gadolinium-based imaging agents; in return, the German firm obtained U.S. marketing rights to BMS' beta-blocker Betapace (sotalol). Betapace was approved Oct. 30 and is set for a January launch. Schering AG struck a similar deal in August when it granted a clear license to market Omniscan to Sterling Winthrop in exchange for cash and options to comarket certain MRI contrast agents in earlier stages of development.
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