Regulatory - Update on Stent Guidelines


in
 Regulatory - Update on Stent Guidelines
by Stephen Cervieri, Managing Director 
 
A little dated, but we are cleaning out the news file.
 
The FDA proposed tougher clinical-trial guidelines last month for drug-coated stents.  This  in response to concerns about blood clotting in the artery-opening devices long after implantation.
 
The move is the first concrete change since an FDA two-day meeting in December 2006.  This in response to whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. Coated stents don't appear to increase deaths or blood clots overall; whether they increase late clots years after implantation is still debated.
 
Instead of assessing patients' progress and health in trials nine months after a stent is implanted, the FDA will now require companies to submit trial data on patients' health one and two years after the procedure, before stents can be approved. The new draft guidelines appear to codify standards that the FDA used to assess trials for new stents from Medtronic and Abbott.
 
About a million people each year in the U.S. undergo procedures to treat heart-artery blockages. Models coated with drugs to reduce reclogging, from BSX to J&J account for most of the U.S. market.
 
The guidelines aren't expected to affect coated stents already on the market, or cause further delays at Boston Scientific, which is still under a new-product probation from the FDA that has held up introduction of its next-generation heart stent in the U.S., said Mr. Nalbone.
 
The guidelines could affect up-and-comers such as medical-device company Xtent, a Menlo Park, Calif., a development-stage firm that is working to commercialize its stent.
 
The FDA said that after a stent is approved, companies should continue monitoring, preferably for five years after implantation, for blood clots, heart attack or other complications. The guidelines are an effort to "minimize risks while preserving for patients the benefits of drug-eluting stents," the agency's device chief, Daniel Schultz, said in a statement. The FDA guidelines aren't legally binding, but most companies follow them to ensure approval of devices.
 
Strategy Shift – Generics as Offense
 
Wyeth decided to beat the copycats to the punch.
 
The drug maker will launch its own generic version of the blockbuster heartburn med Protonix, more than two years ahead of its patent expiration.  You'll recall that Wyeth had been negotiating with generics giant Teva Pharmaceutical, hoping to settle a dispute over Protonix's patent.
 
Late last year, a Canadian judge refused to stop Teva's launch of a copycat drug, even though the two companies' litigation was ongoing. But Teva agreed to a truce; it would stop shipping the generic to sit down with Wyeth for settlement talks.
 
Apparently, the two companies couldn't come to terms, and Wyeth came out swinging. "We believe the Protonix compound patent is strong and we will vigorously pursue out litigation against Teva and other infringing generics," President and CEO Bernard Poussot said in a statement.
 
Teva, on the other hand, says Wyeth nullified the truce by launching its own generic. The company's statement doesn't specify whether it would continue to ship the copycat version. Given the fact that Sun Pharma--which shares 180-day marketing exclusivity for the generic with Teva--is now launching its Pantoprazole product, it's hard to imagine Teva holding back. But, of course, any generics maker that sells a copycat form of the drug risks paying triple damages to Wyeth if its patent is upheld.
 
Wyeth's move is emblematic of the challenges drug makers face as their top-selling products attract generic competition. Copycat drug makers like Teva and Sun are increasingly aggressive in disputing patents; they start early and keep pushing.
 
And Wyeth isn't the only company to launch its own authorized generic to capture at least some of the copycat revenues for itself. Merck announced that it would partner with a generics maker on an authorized version of Fosamax, whose patent expired in February.
 
With billions in revenue at stake--Protonix sold $1.43 billion worth in the first nine months of 2007--who can blame them? But even with an authorized generic going out the door, Wyeth sales will take a big hit. Analysts expect flat revenues for all of 2008, and the company is looking to cut jobs to save some bucks over the next three years.
 
Clinical – Predicting Statin Response
 
Will statins soon be targeted at patients with a specific genetic variation?
 
If some new research bears out, maybe so. Celera Group-Applera Corp., the folks who won the race to map the human genome, say they've identified a genetic variation that not only increases risk of heart attack, but also the chances that statins would prevent it.
 
Dubbed KIF6, the variation is present in nearly 60 percent of the population, and carriers showed a risk of heart attacks, strokes, or death from heart disease as much as 55 percent higher than those who don't have it. Celera plans to roll out a genetic test for the variation.
 
Celera's research has to be verified before statin therapy is linked with it. But in studies the company analyzed, the differences between carriers' response and non-carriers' is clear. Carriers treated with Pravachol had 37 percent fewer heart attacks compared with placebo-takers, for instance; non-carriers had 14 percent fewer attacks than those on placebo did.
 
And - in a finding that could fuel debate over the direct link between lowering LDL and preventing heart attacks - the prevention benefits weren't related to how much a statin lowered cholesterol.