Friday, July 27, 2007
Article in the Wall Street Journal -- FDA to Seek Guidance Over Avandia, by Jennifer Corbett Dooren and Anna Wilde Mathews. Here's an excerpt:
The Food and Drug Administration is concerned about the potential heart-attack risk tied to the widely used GlaxoSmithKline PLC diabetes drug Avandia, and the agency will ask an advisory panel whether the medication should remain on the U.S. market.
In documents made public yesterday in advance of a public meeting set for Monday, FDA officials wrote that they view Avandia's potential heart-attack risk with "considerable concern," despite "somewhat inconsistent findings that complicate the interpretation of the available data." They wrote that "it is also important to place any risk into context of what is known about the risks of other available therapies" -- notably Japan's Takeda Pharmaceutical Co.'s Actos, the only marketed diabetes drug that works the same way as Avandia.
Monday's meeting could be as significant for the Takeda medication as it is for Avandia. In January, Avandia had 51% while Actos had 49% of the U.S. market for their class of drugs, according to a Morgan Stanley research report that cites data from IMS Health. In May, the New England Journal of Medicine published an analysis by Cleveland Clinic cardiologist Steven Nissen linking Avandia to a potential risk of heart attacks. By July 13, Avandia's market share had dropped to 33% and Actos had soared to 67%. Last year, Avandia was Glaxo's second biggest-selling drug with global sales of $3.38 billion, making up 7% of the Brentford, England, company's total sales of $47.63 billion.
Post on the Wall Street Journal Health Blog -- Merck’s Vioxx Warrior Gets Promoted, by Jacob Goldstein. Here's an excerpt:
Frazier, 52, has won points among Merck defenders for his tell-it-to-the-judge style. He hasn’t settled any of the roughly 27,000 Vioxx lawsuits filed against the company following the withdrawal of the pain medicine. So far, the company has won 10 cases and lost five.
Frazier’s replacement as general counsel is Bruce Kuhlik, who joined the company in 2005 to help deal with the Vioxx litigation. He previously worked for PhRMA, the drug industry trade group.
Article in the Wall Street Journal -- Drug Makers Tighten Their Belts Again: AstraZeneca Expands Job-Reduction Plan Bristol-Myers Sets Cuts, by Peter Loftus and Elena Berton. Here's an excerpt with regard to Amgen and its drug Aranesp:
Amgen, Thousand Oaks, Calif., said profit soared from year-earlier results that were weighed down by a hefty acquisition charge, but the biotechnology company's revenue growth slowed considerably because of safety concerns surrounding antianemia drug Aranesp.
Amgen posted net of $1.02 billion, or 90 cents a share, up from $14 million, or a penny a share, a year earlier. Revenue rose 3% to $3.73 billion. The company posted revenue growth of 15% for both the first quarter and all of last year.
Thursday, July 26, 2007
Article in the Wall Street Journal -- Glaxo, Set Back By Diabetes Drug, Sticks to Forecast, by Elena Berton. Here's an excerpt:
Sales for the Avandia family of drugs, which also include combination products Avandamet and Avandaryl, fell 22% to £349 million. Avandia has been hit by concerns about possible cardiovascular side effects linked to the drug. The company has mounted a robust defense of its second best-selling product, releasing data from studies that appear to back Avandia's safety.
A Food and Drug Administration panel of experts is scheduled to meet next week to decide whether Avandia should remain on the market and, if so, whether its use should be further restricted. Chief Executive Jean-Pierre Garnier said Glaxo has submitted to the U.S. regulator new data from an epidemiology study on 400,000 diabetes patients, which supports the safety of the drug.
Monday, July 23, 2007
Article on cnn.com -- Merck soars on high profits, outlook: Profits grew 12 percent, helped by higher sales of new vaccines, medicines, by Reuters. Here's an excerpt:
Merck & Co. said Monday that quarterly earnings rose 12 percent on strong demand for its newer vaccines and medicines, and raised its 2007 profit forecast, sending its shares up nearly 8 percent.
Merck (up $3.97 to $52.99, Charts, Fortune 500) shares jumped 7.8 percent in heavy midday trading on the New York Stock Exchange after it revealed second-quarter net income rose to $1.68 billion, or 77 cents per share, from $1.5 billion, or 69 cents per share, a year earlier.
The latest results include the impact of setting aside another $210 million for legal fees associated with litigation involving the company's Vioxx arthritis drug. Merck is facing about 27,000 lawsuits filed by people who claim to have been harmed by the widely used pill, which was withdrawn in 2004 after being linked to heart attacks.
Article on cnn.com -- Nigeria to refile suit against U.S. drug giant Pfizer, by the Associated Press. Here's an excerpt:
Nigerian government lawyers withdrew a $7 billion civil lawsuit against Pfizer Inc. on Friday, saying they have discovered new material and plan to file what they called an even stronger case against the U.S. drug maker.
The government has accused Pfizer of taking advantage of a 1996 meningitis epidemic to test an experimental drug without authorization or full understanding of the families involved -- allegedly contributing to the deaths of some of the children and sickening others. Pfizer denies wrongdoing.
"We are here this morning to move an application for notice of discontinuance of this case. ... We have planned to refile a new suit," government lawyer Babatunde Irukera said.
Irukera said lawyers recently discovered material that suggested Pfizer committed fraud in the administration of the drug. The new suit will include these materials, along with clarifying some of the government's original arguments.
Sunday, July 22, 2007
Earlier this month, the Second Circuit Court of Appeals heard oral argument in the Schwab case. Here's an excerpt from an article on Bloomberg.com describing the oral argument -- Cigarette Makers Ask Court to Block $200 Billion Suit, by Bob Van Voris:
Altria Group Inc.'s Philip Morris USA and other cigarette makers asked a federal appeals court to dissolve a $200 billion racketeering class-action lawsuit filed on behalf of smokers of ``light'' cigarettes in the U.S.
The companies argue that legal and factual differences between individual smokers make a trial of all the claims in a class-action, or group, lawsuit impossible. Lawyers for smokers said a class action is the only practical way for their clients to recover damages for an alleged decades-long fraud.
Smokers of ``65 brands with hundreds of advertising campaigns over 35 years'' couldn't have chosen to smoke light cigarettes for a single reason, Theodore Grossman, a lawyer for the companies, told a three-judge appeals panel today.
Class status gives plaintiffs more leverage, increasing potential damages at trial and enabling them to possibly force a better settlement. Filed in 2004 under the Racketeer Influenced and Corrupt Organizations Act, or RICO, the suit claims cigarette makers defrauded smokers of ``light'' and ``low-tar'' cigarettes by marketing them as safer than other brands.
If the appeals court permits the case to go forward, it would represent the biggest potential legal liability for the tobacco industry.