FDA cites Novartis for distributing ‘misleading’ promotional card
WASHINGTON A promotional file card Novartis has put out is “misleading” and misbrands the company’s Alzheimer’s disease drug Exelon, “suggest[ing] that Exelon is safer or more effective than has been demonstrated,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.
According to the Aug. 8 warning letter, posted to the FDA’s website Aug. 14, the file card “makes unsubstantiated superiority claims for Exelon, overstates the efficacy of Exelon, includes misleading risk presentations, and recommends or suggests a combination use of Exelon that has not been approved by FDA.”
Exelon (rivastigmine tartrate) is approved to treat mild-to-moderate Alzheimer’s disease, but is “associated with numerous risks,” such as gastrointestinal adverse reactions including nausea, vomiting and weight loss; anorexia, dyspepsia, asthenia, peptic ulcers and gastrointestinal bleeding; as well as effects on the cardiovascular, pulmonary and neurological systems (i.e., seizures), and risk of urinary obstruction, the warning letter said. The package insert also contains precautions for interactions with other drugs, and warns of potential problems if a patient is given anesthesia.
P&G announces Gorman, 70, to step down from board of directors
CINCINNATI Procter & Gamble has announced that Joseph T. Gorman, in accordance with the company’s customary retirement age for directors, has announced his intention to retire effective October 2007 Gorman, who has been a director since 1993, will turn 70 on Oct. 1.
“Joe Gorman has served P&G’s board with distinction for more than 14 years. Among his many contributions, he has served as chair of the Fnance Committee and a member of the Compensation & Leadership Development Committee,” stated A.G. Lafley, P&G’s chairman and chief executive. “We have benefited greatly from his long experience and seasoned counsel. We will miss him, and wish him continued success.”
Gorman is the retired chairman and chief executive of TRW, an automotive, aerospace and information systems company. He currently serves as chairman and chief executive officer of Moxahela Enterprises LLC, a venture capital firm. He also serves as a director of Alcoa Inc., Imperial Chemical Industries plc, Tonsburg Magnesium Group International AB, and Vector Intersect Security Acquisition Corp.
Eli Lilly looking to new blood-thinner to be best seller
By early November, Eli Lilly hopes to release results of a large patient trial of prasugrel, the most important experimental drug in its pipeline. Prasugrel is a blood-thinning agent designed to prevent recurring heart attacks and strokes in people with cardiovascular disease, The Wall Street Journal reported this week.
Plavix, the current leading blood thinner, generated nearly $6 billion in sales last year for its co-marketers, Sanofi-Aventis and Bristol-Myers Squibb. Lilly and its Japanese development partner, Daiichi Sankyo Co., hope their drug will steal some market share from Plavix—if it receives regulatory approval.
Lilly hopes to submit prasugrel for Food and Drug Administration approval by the end of this year. If the drug gets timely FDA approval, it could hit the market in 2008. Initially, the approved uses for prasugrel would be narrower than those for Plavix, but Lilly and Daiichi might seek additional approvals later.
One reason that Lilly is betting so much on prasugrel is that its current best seller, the antipsychotic Zyprexa, is set to lose U.S. patent protection in 2011. Zyprexa generated more than one-fourth of Lilly’s total revenue last year, or about $4.4 billion. Lilly needs another big seller on the market before much of Zyprexa’s sales are lost to cheaper, generic competition.
Lilly is trying to downplay prasugrel’s importance in their pipeline. “While it’s a very important compound in late-stage development, it’s not the only product in late-stage development,” chief financial officer Derica Rice told the Journal. He said the company is developing an inhaled form of insulin for diabetics, as well as an injectable form of Zyprexa.
In the meantime, Bristol-Myers Squibb is watching as closely as Lilly at the prasugrel study results. Plavix last year accounted for approximately 18 percent of its revenue, according to the Journal.