Abbott Expects Prevacid Growth Of 25% Despite Looming PPI Competition

Abbott is expecting 25% U.S. growth for TAP's Prevacid next year, despite potential competition from two new proton pump inhibitors.

"Sales continue to exceed our expectations," Abbott VP-Investor Relations & Public Affairs Catherine Babington said during a July 9 teleconference. Prevacid (lansoprazole), marketed by the Takeda-Abbott joint venture, had U.S. sales of approximately $495 mil. in the second quarter ended June 30, up 37% over the quarter last year.

Prevacid's share of new anti-ulcer prescriptions is "nearly 21%," Babington said, "while share in the total proton pump inhibitor sector is just under 40%."

The proton pump sector is expected to become more crowded shortly. Eisai/Janssen's Aciphex (rabeprazole) was designated "approvable" at FDA Jan. 29, and Wyeth-Ayerst's Protonix (pantoprazole) became "approvable" June 30.

Abbott Senior VP-Finance & Chief Financial Officer Gary Coughlan predicted that the PPIs will target AstraZeneca's Prilosec (omeprazole), the market leader, "which is what they've done internationally."

Promotion for the new proton pump inhibitors "is going to raise awareness of the PPI market in general," Coughlan said. "We think that will help continue the strong growth of PPI." Coughlan asserted that the new PPIs "have no significant clinical advantage over Prevacid in terms of efficacy."

"Prevacid's growth going forward is going to be a function of what the PPI market does," Coughlan said. He acknowledged, however, that "these two new competitors could have some effect."

Coughlan noted that TAP had "another outstanding" quarter with sales of Prevacid and its prostate cancer treatment Lupron. Abbott does not book TAP sales, but records the income on the "other income" line.

Lupron (leuprolide) sales in the U.S. were $200 mil. for the quarter, up roughly 9%. "We continue to see very strong convergence in urology scripts to the four-month Depot formulation which is helping to drive strong unit volume growth during the first half of the year," Babington said. International sales for Lupron, which Abbott books directly, were $435 mil. in the quarter, also up 9% over the quarter a year ago.

The Federal Trade Commission is investigating TAP's marketing practices for Lupron, which allegedly involved urging physicians to bill Medicare for more than they were paying for the drug and for samples.

Abbott looked to TAP as some of its own franchise drugs faltered in the second quarter, most notably Abbokinase, which has been off the market after reovirus was found in three lots of the in-process urokinase product (¹ (Also see "Abbott Abbokinase "Dear Doctor" Letter Draws Warning From FDA" - Pink Sheet, 29 Mar, 1999.)).

The company's overall pharmaceutical performance suffered as a result, with U.S. sales falling 8% to $543 mil. Had Abbokinase been available, sales would have risen approximately 5%, the company estimated.

Abbott and FDA are discussing trial designs for a recombinant prourokinase. "I think everybody's concern - both ours and the agency's - would be to try to accelerate a recombinant version of the drug to address some of the issues," Babington said.

Norvir capsules were unavailable because of manufacturing problems, causing a 45% drop in U.S. sales for the protease inhibitor line to $19 mil. FDA approved a new Norvir soft gel cap June 29, before the user-fee deadline (² (Also see "Abbott Norvir Returns To Market Via Contract Manufacturer" - Pink Sheet, 5 Jul, 1999.)). "We had not originally factored any capsules into our 1999 financial plan, so the Norvir relaunch will provide upside to our forecast," Babington said.

Second quarter Hytrin sales in the U.S. were $153 mil., up 14% over the year-ago quarter. On July 1 the company lost an appeal of a court decision invalidating one of the drug's patents because the Form IV andydrate crystalline version of terazosin was commercially available prior to the patent filing.

"We have additional legal avenues and continue to maintain Hytrin in our financial projections in the third and fourth quarter," Coughlan said. Abbott expects generic competition beginning in February 2000.

Abbott expects to continue to build its urology line with the second quarter announcement of a $7.3 bil. merger with Alza, which markets the urinary incontinence drug Ditropan XL and oncology products (³ (Also see "Alza Brings Ditropan XL To Abbott As Near-Term Project In $7.3 Bil. Merger" - Pink Sheet, 28 Jun, 1999.)).

Sales for Abbott's macrolide antibiotic Biaxin were up slightly in the U.S. to about $88 mil. Abbott recently filed for U.S. approval of once-daily Biaxin XL.