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TAP LUPRON U.S. SALES EXPECTED TO DOUBLE IN 1988; GYNECOLOGICAL INDICATIONS PLANNED FOR FUTURE EXPAND LHRH ANALOG's MARKET POTENTIAL TO $100 MIL. LEVEL

Executive Summary

Lupron (luprolide) sales will double in 1988 compared to 1987, Abbott told financial analysts at a Nov. 28 presentation in New York City. Describing Lupron's current market performance as "very very good," the company estimated that sales could reach $100 mil. "in time." A product of TAP Pharmaceuticals, Abbott's joint venture with the Japanese firm Takeda, Lupron is marketed in the U.S. by Abbott for management of advanced prostatic cancer. The product is an LHRH analog. As TAP currently awaits FDA approval of a once-monthly dosage form of Lupron, the company is also planning supplemental NDA filings for Lupron "in the next few years" that will expand the product beyond the relatively narrow anticancer indication for which it was originally approved in 1985. For the once-monthly indication, Lupron is in a race with an ICI product, Zoladex (goserelin). "We now believe that the full potential for Lupron will be considerably greater than originally expected based on ongoing research that indicates that Lupron may also be useful in treating several widespread gynecological disorders," Abbott Chairman Robert Schoellhorn remarked. "In addition, researchers are studying Lupron in connection with in vitro fertilization." In the added indications, Lupron also faces competition. Syntex, for example, recently filed an NDA for its LHRH analog product, nafarelin, for use in treating endometriosis. The Abbott exec projected a 1990 launch date for another TAP compound, estazolam, a sedative/hypnotic under development as a treatment for sleep disorder. "Estazolam has a fast onset of action and a favorable side effect profile," he noted. "It will be positioned for elderly patients and persons with chronic sleep disorders." Schoellhorn also reported strong acceptance of Depakote (divalproex), the anti-epileptic agent marketed by Abbott in the U.S., Canada and Latin America. He attributed the product's rapid growth to an increasing trend toward monotherapy in the treatment of epilepsy. "There is also increasing evidence that it may be useful for other indications such as manic depressive illness and complex partial seizures," Schoellhorn commented. Schoellhorn said the company's clot dissolving agent Abbokinase (urokinase) is "just beginning to scratch the surface of its potential." The thrombolytic is currently approved to treat blood clots in the lung via I.V. administration and by direct infusion in the coronary artery following a heart attack. "We are also pursuing a claim to give the drug I.V. by way of a peripheral vein to heart attack victims, which will put Abbokinase in direct competition with TPA," the exec added. "Just last April we announced a major clinical study that looks at the effectiveness and cost of Abbokinase alone, TPA alone and combination therapy involving Abbokinase and TPA." During Q&A, the company was asked to comment on the status of its "Corporate Alliance," a hospital electronic order entry program begun in the fall of 1987 in conjunction with 3M. IBM and other companies have since joined. Abbott Vice Chairman and Chief Financial Officer Duane Burnham described the program as one that expands the product line and delivery services by companies in non-competing businesses that market to hospitals. "We think it is going to be very important in the hospital segment of the market to have these types of alliances that enable hospitals to take less frequent deliveries and yet still reduce their inventories," Burnham said.
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