Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
Chicago Tribune - September 18, 2003
Bruce Japsen
Kaletra has kept HIV at undetectable levels in nearly two-thirds of patients who have taken it for five years, according to new research unveiled at this week's Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Chicago through Thursday.
The ability of any drug to keep HIV undetectable has long been a challenge for doctors and pharmaceutical researchers. When AIDS drugs first came on the scene in the mid-1990s, some of the drugs were unable to keep the virus undetectable for even a year, including an earlier Abbott drug, Norvir.
"Within the first year of therapy you would recognize patients developing drug resistance," said Dr. Scott Brun, Abbott's global project head of antiviral development. "Most of the antivirals out there you do see development of resistance [to drugs] within two years of therapy."
But Kaletra is part of a class of next-generation protease inhibitors--drugs that bind to and block a key enzyme vital to the virus' growth--keeping the disease undetectable in human blood for longer periods of time.
Kaletra, like other protease inhibitors, is typically taken with two other drugs known as nucleoside reverse transcriptase inhibitors to make the so-called AIDS cocktails that are common in treating the virus.
In the new study of 100 patients who had not taken an AIDS drug before Kaletra, 64 percent of patients had an undetectable amount of the virus. An undetectable level means less than 50 copies of the HIV virus per milliliter of blood.
Since Kaletra was approved by the Food and Drug Administration in 2000, Abbott and researchers have known the drug was potent, but the study of patients' five-year history backs up what the company had hoped for in developing an answer for patients who have failed to be treated effectively with Norvir or other older protease inhibitors.
"Resistance--that's what it's all about," said Dr. Joseph Eron, an infectious-disease specialist and associate professor of medicine at the University of North Carolina who is a paid consultant to Abbott.
The success of Kaletra in patients has been a pleasant surprise for Abbott. When Kaletra was approved by the FDA three years ago, analysts expected Abbott to generate $500 million in annual worldwide sales by now.
But the drug has far surpassed Wall Street's expectations. In the first half of this year alone, Kaletra generated $349 million in sales, putting the drug on pace to generate $700 million in worldwide sales this year, analysts say.
Abbott vet to lead diagnostics: Abbott Laboratories has promoted a 23-year veteran company insider to head the company's worldwide diagnostics division.
Joseph Nemmers Jr., 48, this week was named senior vice president, diagnostic operations. Nemmers reports to Richard Gonzalez, president and chief operating officer of Abbott's medical products group.
Nemmers, who has held various positions at Abbott since 1980, most recently served as vice president, global commercial diagnostic operations. Nemmers replaces Thomas Brown, who retired last year.
Since Brown's departure, the top diagnostics executives have been reporting directly to Gonzalez.
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