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As GSK’s Avandia sales slide, competitors work to fill gap
Triangle Business Journal - b
RESEARCH TRIANGLE PARK – Even if thecides to kee embattled diabetes drug Avandia on the market, scrutiny of the drug has opened the door to alternatives. Offerings fro and Sanofi Aventis stand ready to pick up Avandia’s slumping sales, with the companies touting that their products do not pose the same health risks. Meanwhile, some industry observers think concerns about Avandia may be too much for GSK to overcome. “I don’t think that patients would like to continue using Avandia if there are alternatives with better safety profiles,” says Marcel Wijma, president of research fiin New York. “If I were a diabetes patient, I definitely would think twice.” After advisory committee voted to recommend keeping Avandia on the market, GSK reiterated its position that clinical trials conducted since a 2007 FDA warning about cardiovascular risks show Avandia does not increase the overall risk of heart attack, stroke or death. Still, the publicity has hurt Avandia’s sales, and Takeda is among the companies seizing the opportunity to launch a marketing blitz promoting its drug Actos as an Avandia alternative. Actos, which generated $3.4 billion in global sales in 2009, is in the same drug class as Avandia – and it does have some cardiac risks. Dr. John Buse, professor of medicine at the UNC School of Medicine and former president of th says studies have shown that Actos can increase fluid retention, contributing to heart failure. But he says Actos has not been tied with fatal heart failure as has Avandia. And he says studies show Actos actually could have heart benefit, such as lowering cholesterol and triglycerides. Ernest Gates, president of Massachusetts consulting fir is not ready to close the book on Avandia. He says Avandia has been proven to be one of the most beneficial drugs to control blood glucose. Patients already taking Avandia would have to be transitioned to another treatment, and there’s no guarantee another treatment would be as effective. Given the millions who have benefited from Avandia versus the adverse incidents tied to the drug, Gates questions whether there is enough reason to withdraw the drug. The market already is making that decision. Avandia sales, which topped $3 billion in 2006, were $1.2 billion in 2009. Buse says Avandia use aas fallen to virtually zero, a gradual shift that occurred over the last three years following the FDA’s 2007 warning about the drug. Buse says he doesn’t know if doctors are choosing Actos. Doctors wrote 2.6 million Avandia prescriptions in the United States in 2009, down by 27 percent from 2008, accordin a health care information and consulting company. By comparison, doctors wrote 13.5 million U.S. Actos prescriptions in 2009. Avandia’s U.S. prescriptions peaked in 2006 when 13.3 prescriptions for the drug were written. There are 25 million Americans with diabetes, and there are 13 classes of drugs to treat them. Doctors are accustomed to switching therapies. Wijma says GSK may decide to withdraw Avandia even if the FDA decides to keep it on the market with a stricter warning. As an example, he points to Merck’s painkiller Vioxx, which the drug maker voluntarily withdrew in 2004 after studies showed greater heart attack and stroke risks. Concern about Vioxx has since widened to include other painkillers in the same class, including Celebrex and Bextra. In coming years, Raleigh company Dara BioSciences could enter the market for type II diabetes treatments. The company has a compound in phase I studies that CEO Richard Franco says should not pose the same heart risks as the class of drugs that includes Avandia and Actos. For the short-term, if Avandia’s cardiovascular concerns taint Actos by association, Merckuld benefit. Sanofi-Aventis’ Lantus totalled $4.1 billion in 2009 sales. Merck’s Januvia generated $1.9 billion in global sales. Neither drug poses the same kind of cardiac risks as Avandia or Actos, Wijma says. Januvia is a tablet while Lantus is an injectable. Januvia has become a popular choice among primary care doctors. “It’s not as powerful as Avandia, but it’s in the ballpark,” Buse says. Triangle Business Journal Raleigh/Durham, North Carolina

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