WASHINGTON, Dec. 18 (UPI) -- A Food and Drug Administration advisory committee's recommendation that use of Sanofi-aventis' antibiotic Ketek should be limited due to liver failure concerns may have little financial impact because the company has already absorbed much of that damage.
The results of the meeting of the agency's Drug Safety and Risk Management Advisory Committee and the Anti-infective Drugs Advisory Committee, which discussed the drug Friday, led to several news reports, but this may give a misleading impression about the effect that it will have on Sanofi.
"There's obviously a lot of sentiment surrounding this, but in terms of financial, I don't think it's going to have much of an impact," Ben Yeoh, an analyst with Dresdner Kleinwort, told United Press International.
Ketek itself only makes up a small percentage of Sanofi's total sales and it's not an important growth driver, Yeoh added.
The FDA's advisory committees recommended against two of Ketek's approved uses, acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis, voting 17 to 2 that the risks outweigh the benefits.
However, the committees also voted 16 to 3 that Ketek should continue to be used as a treatment for community-acquired pneumonia.
The negative recommendations may mean Sanofi loses a few Ketek sales, but since it isn't that significant to the company's bottom-line, it won't make much of a difference, Yeoh said.
In addition, much of the impact of the Ketek concern has already occurred. "There was lot of noise of reports of Ketek earlier on in the year, so this is no surprise at all," Yeoh said.
In June, Sanofi adding a bold-type warning to Ketek labeling about the possibility of liver failure after it received several reports of patients developing liver problems, including some that were fatal. In November, a European Medicines Agency panel recommended against Ketek for patients with a history of certain liver conditions, such as hepatitis or jaundice.
The initial approval of Ketek by the FDA also is facing scrutiny. The Senate Finance Committee is investigating allegations that the agency knowingly relied on fraudulent safety data to approve the drug in 2004.
Sanofi said it planned to meet with the FDA about the advisory committees' recommendations.
"Sanofi-aventis respects the Advisory Committee process and the open discussion that was part of the past two days," Doug Greene, Sanofi's chief medical officer, said in a statement.
"Sanofi-aventis will be in further discussion with the FDA regarding today's recommendations," Greene added. "We treat patient safety as a matter of the highest priority, and we are committed to working to ensure that healthcare professionals continue to have the information they need to address the medical needs of their patients."
Company spokeswoman Emmy Tsui told UPI that a date for meeting with the FDA has not yet been established.
Overall, Yeoh thinks Sanofi has a positive future and rates the stock a "buy."
"Their risk/reward profile, the upcoming Acomplia and Plavix decisions and their pipeline are being overlooked by investors because they can only focus on the some of the risks," he said. "There are a lot of opportunities in Sanofi in 2007 and 2008."
However, Sanofi posted weak third quarter earnings in October that left some analysts questioning the future outlook of the company. Several of Sanofi's drugs are facing patent expiration or challenges, including Eloxatin, Lovenox and Plavix and the FDA has delayed the approval of Acomplia until April, for what some analysts suspect may be safety issues.
In addition, Acomplia's launch in Europe is facing reimbursement problems in some countries, including Germany, which recently declined reimbursement status for the drug.
But Acomplia got a boost earlier this month with the release of the SERENADE trial that showed it improved several risk factors in type 2 diabetes patients. Some analysts speculated that this may help Acomplia gain reimbursement status in some countries.
In addition, the drug was awarded a class 2 resubmission status by the FDA, which some analysts viewed as a positive.
"We remain confident of Acomplia approval for weight loss," Alistair Campbell, an analyst with J.P. Morgan, stated in a research report.
The company's Plavix, which is facing a court case over a patent challenge from generic manufacturer Apotex, also received some positive news. An FDA advisory committee discussing concerns that drug-eluting stents may cause fatal blood clots recommended FDA include in the package insert information about professional guidelines, such as those from the American College of Cardiology, that endorse 12-month Plavix use following the stent procedure.
"Reinforcing the ACC guidelines could help extend clinical use of Plavix, which we expect to recover for Sanofi through 2007," Campbell stated.
J.P. Morgan told UPI that Campbell was unavailable for comment.
