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ERBAMONT EPIRUBICIN NDA TO BE RESUBMITTED IN EARLY 1988

Executive Summary

ERBAMONT EPIRUBICIN NDA TO BE RESUBMITTED IN EARLY 1988, the Italian firm's Chief Financial Officer Richard Williams announced May 7 at Goldman Sachs' annual health care seminar in New York. Currently marketed in 40 countries including the U.K. and Canada, the second generation anthracycline Pharmarubicin (epirubicin) accounted for 9%, or about $55 mil. of Erbamont's total $616 mil. human pharmaceutical volume in 1986. The company withdrew its NDA for use in breast cancer following an unfavorable review by FDA's Oncological Drugs Advisory Committee in 1985. "Pharmarubicin . . . exhibits lower acute and chronic toxicity than Adriamycin (doxorubicin) while maintaining a high degree of efficacy," Williams maintained. "As such it extends the benefits of anthracycline therapy to the elderly and other high risk patients." Adriamycin, however, remains Erbamont's flagship product. The company reported that doxorubicin sales accounted for one third, or just over $200 mil. of total pharmaceutical volume. Introduced in the mid-1970s, Adriamycin "is often included in multidrug regimens and has become the mainstay of chemotherapy," Williams pointed out. "New proprietary formulations and delivery systems for Adriamycin will be introduced over the next few years to further protect our market position after patents expire," he said. One of the company's more promising anticancer products under development for the U.S. market, according to Williams, is idarubicin, "a parenterally and orally active agent effective in treating hematological cancer and solid tumors." He siad clinical trials are currently underway in both the U.S. and Europe, and that the company hopes to have sufficient data to file for initial registration "in several European countries" by the end of this year. Meanwhile, Erbamont has taken steps to ensure its position as a leading full line anticancer agent supplier by broadening its line of branded generic products. Williams noted that during 1986 the company introduced a vincristine product, called Vincasar, in the U.S. and finalized an inlicensing agreement to acquire eight additional branded generic antineoplastics. The first launch is scheduled for this year. In addition, Williams pointed out that extensions of the Folex (methotrexate) line were made in 1986. Erbamont's current R&D pipleline includes "23 drug entities," including 20 discovered by Erbamont and three licensed agents. Williams predicted that the products would begin to reach the market in 1989 or 1990. The firm's development work in the infectious disease area is focused on two classes of antibiotics, penems and ansamycins. While Erbamont's first penem product is just reaching the clinic, the ansamycin product rifabutin is currently in Phase III. Rifabutin is the subject of a Centers for Disease Control study to examine its effects on atypical mycobacteria in patients with AIDS and in rifampin-resistant tuberculosis. In the cardiovascular area, Erbamont said it expects to begin U.S. clinical trials late in 1987 for its lipid lowering agent Olbetam (acitimox). In addition, studies are continuing for the development of a sustained release formulation. The company reported that about 16% of its 1986 pharmaceutical sales were in the cardiovascular area, dominated by Sermion (nicergoline), which accounted for 8% of total drug sales. Asked about Erbamont's interest in a possible U.S. acquisition, Williams responded: "Our intention has been, ever since Erbamont was spun off and started, that a major acquisition would be part of our growth strategy. We are not in a position where we believe that we are willing to pay the premiums that have been in the market place with American Critical Care, etc."
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