Abbott is projecting strong growth for Synthroid in 2002 despite the phase-down of distribution required during FDA review of the NDA for the levothyroxine product.

Market share should grow by the high single digits from the current 58%, a mark the product has held since before the phase-down began in August, Abbott VP-Investor Relations & Public Affairs Cathy Babbington told analysts during the company's earnings call Jan. 16.

Synthroid sales for 2001 were $455 mil. "For 2002 we are adding additional sales force behind Synthroid and expect sales to increase by double digits," Babbington said.

Fourth quarter sales of $65 mil. "were lower as a result of the significant inventory destocking following the unusually high sales in the third quarter," Babbington said. Third quarter sales were $210 mil. Abbott had developed a large sales base going into the phase-down.

Synthroid's growth will presumably come in the second half of the year following approval of the NDA and lifting of the phase-down. Abbott is projecting sales of $100 mil. in the first quarter of 2002.

Under the phase-down worked out with FDA, Abbott agreed to cut Synthroid product distribution during the NDA review to 60% of pre-Aug. 14 levels by August 2002. Abbott submitted the NDA Aug. 1 (¹ Also see "FDA Seeks To Cut Abbott Synthroid Distribution To 60% By August 2002" - Pink Sheet, 16 July, 2001., p. 16).

In its hospital products division, Abbott expects Abbokinase sales of at least $50 mil. following the mid-2002 re-launch of the thrombolytic agent.

"I can tell you that we expect to do over $50 mil. in sales this year based on that mid-year launch of Abbokinase," Abbott Division VP-Investor Relations John Thomas said. Shipments of Abbokinase (urokinase) were halted in 1999 after FDA identified GMP violations and risks of transmitting infectious agents (² Also see "Abbott Abbokinase" - Pink Sheet, 26 July, 1999., p. 33).

Abbott submitted a sBLA for Abbokinase Dec. 31, which includes a chemistry, manufacturing and controls supplement and also changes the source material for Abbokinase to U.S.-based tissue.

Sales of Abbokinase reached $275 mil. in 1998 before the product was removed from the market, Thomas said.

While the projected 2002 sales rate for Abbokinase is significantly lower than the 1998 figure, the company maintains there is still a medical need for Abbokinase.

"Our market research and our feedback from physicians suggest that there is a need for the product and it will be used," Thomas said. "In the medical literature it is still considered the standard of care."

A version of Genentech's Activase (alteplase) was approved for catheter clearance in September under the name Cathflo Activase . Alternative off-label therapies used in place of Abbokinase for the indication include Centocor's Retavase (reteplase) and AstraZeneca's Streptase (streptokinase).

Abbott is evaluating whether to move forward in the U.S. with the TNF inhibitor Segard for treatment of sepsis, acquired through the purchase of Knoll.

Division VP-Global Pharmaceutical Development Charles Fisher, MD, joined Abbott Jan. 7 from Lilly where he headed the Xigris development program.

The hiring of Fisher, "who has been running a key competitive program...leads us to be more optimistic about the potential for Segard than we have been in the past," Chief Financial Officer Thomas Freyman said. "We look forward to making that decision by the end of the first quarter."

Segard (afelimomab) failed to show unequivocal efficacy for sepsis in two pivotal trials (³ Also see "Knoll Considering Segard Plans; Sepsis Study Shows Small Mortality Benefit" - Pink Sheet, 10 July, 2000., 2000, p. 17). An application was filed in Europe in mid-2001.

Abbott is raising its peak sales projections for the anti-TNF monoclonal antibody D2E7 (adalimumab) to $1 bil. from $800 mil. due to long-term efficacy and safety data and expected growth in the rheumatoid arthritis market.

Amgen estimates that the TNF inhibitor Enbrel (etanercept), which it will obtain through its acquisition of Immunex, will reach sales of $2.4 bil. in 2004.

Abbott Projects Synthroid Double-Digit Growth Despite Early-2002 Phase-Down

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