Abbott's revised forecast for the anti-obesity agent Meridia (sibutramine) still assumes a 50% increase in worldwide sales for 2002.

After the withdrawal of sibutramine in Italy and a "slowing" in growth trends in the U.S., Abbott is reducing its expectations for the product significantly - but still expects sales to increase from the 2001 base of $200 mil. to just over $300 mil. this year.

Abbott's original forecast was for sales to double for the year, to just under $400 mil.

The slowdown in the growth rate of Meridia is one factor that led Abbott to announce a downgrade in its earnings forecast for the year. The continuing compliance difficulties in the Abbott Diagnostics Division was the primary reason.

Abbott expects FDA to respond to a citizen's petition seeking the withdrawal of Meridia by the fall. Public Citizen's Health Research Group petitioned FDA to withdraw the obesity agent in March (¹ Also see "Meridia Fatality Rate “Substantially Lower” Than Obese Population – Abbott" - Pink Sheet, 25 March, 2002., p. 21).

"The signals that we are getting are that [FDA] will be prepared to have a response at some point in the fall," Abbott Pharmaceutical Products President Jeffrey Leiden, MD/PhD, told a June 11 conference call.

While petitions theoretically have a 90-day response deadline, Leiden noted that Abbott submitted "extensive" analyses to the agency that will take some time to review (² Also see "Abbott Responds On Meridia: Morbidity Standard Is Unworkable" - Pink Sheet, 6 May, 2002., p. 36).

"We remain highly confident in the safety and efficacy of the drug," Leiden declared, "but we also understand the need for regulatory bodies to complete their due diligence, and the time required to do so."

"The negative publicity that has accompanied this issue in the past few months has contributed to a marked slowing in prescription and sales growth in the U.S.," Leiden said. "We project that this trend will continue until the issue is resolved."

The Public Citizen petition to pull Meridia was submitted after Italian regulatory authorities suspended the approval of the drug based on 50 adverse event reports and two deaths.

Leiden noted that no other countries have followed Italy's lead. The European Committee for Proprietary Medicinal Products met at the end of May to review the marketing status of Meridia, and Abbott expects "that a formal opinion will be issued soon."

According to Public Citizen, there have been 29 deaths reported to FDA associated with sibutramine, including 19 cardiovascular-related fatalities. Meridia labeling includes warnings about increased heart rate and blood pressure associated with the drug.

Abbott maintains that the deaths reported with Meridia are entirely consistent with the underlying obese population, and that, in fact, the number of deaths is 200 times lower than the mortality rate in the general population.

Public Citizen supplemented its petition in May with a call for a criminal investigation of Abbott based on an FDA inspection that resulted in a 483 report. Public Citizen asserts that Abbott did not report all adverse event information related to Meridia properly.

The $100 mil. change in the projected sales for Meridia is primarily due to the slowdown in U.S. growth. Abbott estimates that three-quarters of the impact is from the slowdown in the U.S., with one-quarter from Europe (primarily Italy and Spain, where "there was extensive publicity surrounding the Italian action").

Abbott's expectations for 2003 are that Meridia will continue to grow from the $300 mil. base, but not to the level that the company previously expected.

Despite the setback with Meridia, Abbott's worldwide pharmaceutical business continues to perform well, Leiden said. Even after accounting for the change in outlook for the obesity agent, Abbott expects U.S. pharmaceutical sales to grow in the mid-teens range, with international pharma sales growth in the high-teens (before currency effects).

Leiden stressed that the compliance difficulties affecting the diagnostics business are not affecting the timelines for pharmaceutical launches. "Our pharmaceutical manufacturing plants have received numerous satisfactory inspections," Leiden said. "We continue to maintain a constructive relationship with FDA and we don't anticipate any delays in our approval timelines" (see ³ Also see "Abbott GMP Investments “Pay Off” In Pharma, Despite Diagnostics Setback" - Pink Sheet, 17 June, 2002.).

Meridia Growth Forecast Is 50% In 2002, Despite Italian Withdrawal – Abbott

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