Biotech Values

[DewDiligence]

FDA Advisory Panel Supports TriCor/TriLipix Use With Statins

[The panel voted 9-4 that TriCor/TriLipix use with a statin *remain* an approved indication, and it voted 13-0 that ABT conduct a new “outcomes” study to support such use. See #msg-62207709 for background info. ABT’s own PR is in http://finance.yahoo.com/news/Abbott-Statement-on-the-FDA-prnews-1763558306.html?x=0&.v=1 .]

http://www.bloomberg.com/news/2011-05-19/abbott-wins-u-s-panel-s-backing-with-further-use-of-trilipix.html

›By Catherine Larkin - May 19, 2011 4:30 PM ET

Abbott Laboratories (ABT) should continue marketing the cholesterol pill Trilipix with standard statin therapy while conducting a new study to examine what effect the combination has on heart risks, a U.S. panel said.

Outside advisers to the Food and Drug Administration voted 9-4 against a proposal to withdraw Trilipix’s approval for use with drugs such as Merck & Co.’s Zocor after a study suggested the combination didn’t reduce heart attacks and strokes. The panel, meeting today in Silver Spring, Maryland, voted 13-0 in favor of requiring Abbott to conduct a new long-term trial.

The review follows a government study released in March 2010 involving Abbott’s Tricor, an older version of Trilipix that may face generic competition next year. The panel agreed with Abbott that the data weren’t definitive because two-thirds of the study participants didn’t meet the criteria for high cholesterol in the Trilipix prescribing information. [This has been ABT’s contention all along—see #msg-47808752.]

“In my view, we have no data to change anything and we clearly need a study to answer the question,” said panel member Lamont Weide, the chief of endocrinology at the University of Missouri School of Medicine in Kansas City.

Abbott, based in Abbott Park, Illinois, fell 40 cents to $53.42 at 4:02 p.m. in New York Stock Exchange composite trading. Amarin Corp., a Dublin-based biotechnology company developing a competing medicine, rose the most in a month on the Nasdaq Stock Market. The company’s American depositary receipts, each representing one ordinary share, gained $1.30, or 7.9 percent, to $17.87, the biggest percentage gain since April 18.

Drug Revenue

Trilipix and Tricor generated $1.58 billion last year, or 4.5 percent of Abbott’s revenue. About half of the 940,000 patients on Trilipix in 2010 were also receiving a statin, considered to be the appropriate initial therapy for high cholesterol, according to an FDA analysis of prescription data. The figures exclude mail-order pharmacies.

The National Institutes of Health trial, dubbed Accord, followed about 5,500 patients with Type 2 diabetes who were at high risk of developing heart disease [#msg-47808450]. Patients taking Tricor and statin therapy didn’t have significantly fewer heart attacks, strokes or cardiac deaths compared with those on the statin alone. In women, more heart risks were seen in those whose regimen included Tricor. The patients were studied for an average of almost five years.

Six of 13 panel members recommended the Accord study data be added to the drug’s prescribing information.

The financial risk to Abbott is minimized because analysts expect cheaper copies of Tricor to enter the market beginning in mid-2012. Larry Biegelsen, an analyst at Wells Fargo in New York, estimates that sales will fall to $990 million next year and decline further in later years.

Abbott said in October that about 30 percent of patients had switched from Tricor to Trilipix, a delayed-release version that was approved in 2008. Last year, the company abandoned efforts to win approval for Certriad, an experimental heart pill that combined Trilipix with Crestor, from London-based AstraZeneca Plc. (AZN) [#msg-58066714]‹