ChronicleMIDWEEK
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BAYER DROPS TRASYLOL FOLLOWING RELEASE OF TRIAL DATA
BAYER Monday (11/05) canned worldwide sales of hemostatic aprotinin (Trasylol), following release of results from the BART trial, led by Ottawa Health Research Institute researchers. Regulators cited increased fatalities among trial participants. Ottawa cardiologist Dr. Fraser Rubens describes the findings to Canadian Press: “It’s a double-edged sword. This drug stops bleeding but then it causes clotting.” More info =>
TROUBLE CREEPS UP ON CRESTOR: NO BENEFIT FOR HEART-FAILURE PATIENTS, PLUS A PATENT CHALLENGE
ASTRAZENECA this week faced a pair of disappointing developments concerning its CV blockbuster rosuvastatin (Crestor.) Trial results released Monday (11/05) demonstrate the Rx shows no additional benefit in preventing fatal MI or stroke among elderly heart-failure patients. AZ hoped an added indication would increase Crestor sales by another billion annually. Earlier, AZ announced little-known Cobalt Pharmaceuticals, a Canadian clonemesiter, is seeking to invalidate Crestor patents, which will not begin to expire until 2016. Cobalt, of Mississauga, Ont., is owned by Arrow Group, which also controls branded drugmaker Oryx Pharmaceuticals. AZ said it will fight the challenge, adding: “AstraZeneca has full confidence in its intellectual property portfolio protecting Crestor.” More info =>
CROSS-BORDER RX RETAILING IS OLD NEWS FOR EVERYONE, EXCEPT, IT SEEMS, THE FDA
THE RISING CANADIAN DOLLAR — which will buy you US$1.10 as of this morning — is achieving what Big Pharma couldn’t manage, namely, the extinction of the cross-border Rx retailing phenomenon. IMS Health says retail exports from here to the US fell by half between 2005 and 2006, to $211 million. Add to that the newly expanded Medicare Rx benefits in the US, and developments such as Wal-Mart’s new $4-a-month generics promotion, and the appeal of Canadian-sourced drugs to Americans will be drastically curtailed in 2007. Now tell that to the FDA, which during the last several months has begun stopping shipments to individual patients from Canadian Internet drugstores. According to the Philadelphia Inquirer, the G-men have adopted the practice of seizing prescription products at their point of entry, and corresponding with patients, inviting them to travel to border crossings to personally account for their purchases. Heavy-handed? Sure. Potentially injurious to needy seniors? Yup, but as the FDA’s form-letter says to disappointed patients waiting for their medicine, “These laws are designed to protect you.” More info=>
JOHNSON & JOHNSON GET A SETBACK IN THEIR ODDBALL LAWSUIT AGAINST THE US RED CROSS
THE ONLY THING WORSE for a company’s public image than suing the American Red Cross for trademark infringement would be suing them and then having a judge throw out big portions of your litigation. That’s what happened to Johnson & Johnson this week, as the New York jurist overseeing J&J’s action against the Red Cross rejected a large portion of the company’s claims. Said American Red Cross boss Mark Everson: appreciate the court’s decision and hope that Johnson & Johnson will reassess their actions and drop the case altogether.” Or else switch the suit to someone less lovable than the Red Cross: perhaps Bambi. More info =>
CHIPMAKER’S GRIPE WITH PHARMA R&D: WHY TOSS BABY OUT WITH BATHWATER?
LATEST TO DRAW UNFLATTERING COMPARISONS between the thriving IT industry and the lagging pharma sector is Andrew S. Grove, who co-founded Intel, the computer chipmaker. Addressing a group of neuroscientists Grove raised questions about his industry’s practices, and those of the drugbiz. His main point: when IT researchers don’t get the lab result they hoped to achieve, they turn their attention toward investigating the cause of the failure. Grove notes pharma R&D usually abandons a compound, and moves on to the next one. That’s nuts, he says, observing that determining the precise cause of a failure can often lead to serendipitous discoveries. More info =>
PFIZER RESPONDS TO LIPITOR SALES DECLINE WITH EXPANDED US MARKETING EFFORT
PFIZER’S atorvastatin (Lipitor) is being nibbled to death stateside by newly available generic versions of simvastatin, with Lipitor’s market share of anti-lipemics having swooned to 30 per cent, from 40 per cent in the a year and a half since simvastatin (Zocor, Merck) went off-patent. Now Pfizer is fighting back against the generics, increasing the product’s US ad budget by 50 per cent this year, over 2006, in a bid to maintain revenues. The New York Times reports Pfizer’s medical team is raising questions about the potential health consequences of switching a patient from Lipitor to a generic. More info =>
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