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ORTHO’s FLOXIN MAY BE NEARING FDA APPROVAL

Executive Summary

ORTHO's FLOXIN MAY BE NEARING FDA APPROVAL based on a prediction by M.D. Anderson Cancer Center Director of Pharmacy-Patient Care Services Stephen Huber, who is working on a quinolone database for Ortho. "Ofloxacin [Ortho's Floxin] will challenge the ciprofloxacin [Miles' Cipro] market," Huber told pharmacists at the American Society of Hospital Pharmacists (ASHP) Midyear Clinical Meeting on Dec. 3. "There are 12 products in that category in the R&D pipeline," and "one more product will probably be out there within the next six months...and that is ofloxacin," Huber said. An NDA for Floxin, licensed by Ortho from Daiichi Seiyaku under a co-marketing agreement, has been pending at FDA since December 1987. In April, Daiichi President and CEO Tadashi Suzuki predicted approval of the product by the end of 1990 ("The Pink Sheet" April 23, T&G-7). Ofloxacin might have "a slight advantage" over Cipro, according to Huber, because of its longer half-life (five to eight hours, v. four hours for Cipro) and because its oral bioavailability is "a little better." The bioavailability data for ofloxacin "is actually so good at this point in time that they're considering at FDA approving the I.V. based on the oral data," Huber claimed. Once an I.V. quinolone formulation "becomes available I see a tremendous increase in use" in hospitals, "whichever product gets that [approval] first," he added. Huber made his remarks in a presentation sponsored by Ortho entitled "New Tools for the Formulary Decision" in which he described the quinolone database that is being underwritten by Ortho. The company says it will distribute the database free of charge to hospitals. "We hope to have this product [the database] available at the same time the drug becomes available," Huber said. Data for the program "comes from much of the data that was submitted in terms of the NDA to FDA for review, as well as other articles and information that has been published," he added. Huber explained that the database has been designed to aid pharmacists in evaluating the clinical and fiscal appropriateness of using quinolone antibiotics in general and to help evaluate the therapeutic advantages of different quinolones. "When the new [quinolone] products come out, we'll give them a trial...to try to determine therapeutic equivalence," Huber predicted, "and then we'll choose one quinolone." The database will be used primarily in drug information centers, Huber said: "I certainly will put it in place in ours." It will also be made available to pharmacists and physicians. He added that "perhaps the pharmaceutical-medical liaison people, as they call them at Ortho, who are highly trained individuals, will have the database available on laptop computers" in order to answer questions from physicians and pharmacists in the field. A second component of the database, Huber said, will be a "formulary disk" that will help "perform a formulary review for ofloxacin -- not like the Madison Avenue approach," but with "accurate information" reviewed by "respected authorities," and compiled through a "trusted process." Huber joked about formulary disks provided by drug companies in the past: "It was amazing to me that whatever company's disk you put in, their product came out the cheapest." The ofloxacin disk, Huber said, "is intended to be modified [and] will allow you to prepare a formulary review in a way much faster than we have in the past." The genesis of the project, Huber said, was his belief that pharmaceutical company drug information was not respected as an authority by physicians and other health-care managers. "It's not that the pharmaceutical industry isn't respected," Huber said, "but when it comes looking like a Madison Avenue package, the source of the information begins to be questioned...that's what stimulated me to go to Ortho and say, 'Would you take some of those funds and work with pharmacy to provide a database?'"

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