ABBOTT TO FILE PREVACID (LANSOPRAZOLE) NDA "LATER THIS YEAR"

ABBOTT TO FILE PREVACID (LANSOPRAZOLE) NDA "LATER THIS YEAR," VP-Investor Relations & Public Affairs Ellen Walvoord reported at the Bear Stearns Health Care Conference in New York City Sept. 20. The proton pump inhibitor product is being developed by the Takeda Abbott Pharmaceuticals (TAP) joint venture. If approved, the drug would compete in the anti-ulcer market against Merck's proton pump inhibitor Prilosec (omeprazole). TAP's first product, Lupron (luprolide), "continues to grow very impressively" and will end the year with sales of "well over $400 mil.," Walvoord said. Lupron sales are split approximately evenly between Abbott and Takeda. A new indication for Abbott's alpha blocker Hytrin (terazosin) for treatment of benign prostatic hyperplasia is very near approval, Walvoord said. "We understand it is on the last desk in the last row at FDA. We're expecting approval before the end of the year at the most conservative, and we'd like to be able to see it sooner." The supplemental NDA was designated "approvable" by FDA on Aug. 12 ("The Pink Sheet" Aug. 23, In Brief). Also nearing approval, Walvoord said, is Anesta's Oralet, a transmucosal fentanyl product that Abbott will market. Oralet was recommended for approval as a premedication for anesthesia in a monitored setting by an FDA advisory committee in August ("The Pink Sheet" Aug. 30. p. 12). Oralet "will not be a large product in and of itself," Walvoord said, placing its market potential at "several million dollars." However, she indicated, Abbott sees potentially broader applications of the transmucosal delivery system. The advantage of the lozenge dosage form, Walvoord said, is that "you automatically titrate it....When you feel the effects of it, you stop sucking on it." Oralet is also significant to Abbott as part of its anesthesia and pain management franchise, Walvoord said. Abbott in turn uses this business to attract larger hospital supply contracts. Abbott is "probably the worldwide leader in [the anesthesia and pain management] arena," Walvoord said. She cited the company's launch of the first generic version of the inhaled anesthetic isoflurane as an example of the tie-in with hospital contracts. "By including isoflurane in existing hospital contracts, we quickly captured a significant portion of the roughly $150 mil. inhalation anesthesia market," Walvoord said. "All we had to do was take the product and insert it into those existing contracts and off we went." Abbott has a new inhaled anesthetic under development. Sevoflurane, licensed from Maruishi, Japan, "offers important advantages over the existing anesthetics, including rapid smooth induction, recovery and a better side-effect profile," Walvoord maintained. It "may be ideally suited for outpatient surgery... as well as for pediatric use." An NDA may be filed by early 1995, Walvoord indicated. In competing for managed care contracts, Walvoord suggested that Abbott has an edge over other pharmaceutical companies because it can bundle drugs with its device and nutritional product lines. Abbott's hospital contracts "now typically involve generic injectable pharmaceuticals...drug delivery systems, medical and infant nutritionals, critical care and anesthesia products," Walvoord said. "Oral pharmaceuticals...and diagnostics are starting to be part of that product mix as well." In 1993, Biaxin (clarithromycin) will surpass erythromycin as Abbott's number one pharmaceutical product, with sales of "over $400 mil.," Walvoord said. Erythromycin has remained a $300 mil. to $400 mil. product for Abbott, indicating that Biaxin has not cannibalized sales to the extent Abbott expected, Walvoord said. Biaxin sales should receive a boost from approval of pending supplements for a pediatric suspension and a Mycobacterium avium complex indication, she added. Biaxin continues to outperform Pfizer's Zithromax (azithromycin), which was approved by FDA at the same time as Biaxin. Pfizer Chief Financial Officer Henry McKinnell told the Bear Stearns meeting that Zithromax volume is "holding at 1%" of new prescriptions, which he called "disappointing." Pfizer continues to expect increased detailing strength and a new unit- of-use "Z-pak" to improve sales, McKinnell said. One possible advantage over Biaxin, he claimed, is that Zithromax has been shown not to interact with Marion Merrell Dow's nonsedating antihistamine Seldane.