Boston Scientific

Stent, drug makers team up on clot study

Tracy Staton — Thu, 16 Oct 2008 11:06:27 -0400

Stent makers and the drugmakers who treat their patients want to settle the clotting question once and for all. So device and pharma companies are joining forces on a major trial to test blood-thinner use in stent patients. And when we say major, we mean major: four years; 20,000 patients; $100 million.

The trial will test whether stent patients should take clot-busters for one year after the device is placed, or for at least two and one-half years afterward. Abbott Laboratories, Medtronic, Boston Scientific and Johnson & Johnson are holding up the stent side of the equation. Sanofi-Aventis and Bristol-Myers Squibb, which co-market Plavix, will participate on the drug side, along with Eli Lilly and Daiichi Sankyo, whose potential Plavix competitor prasugrel is waiting in the FDA approval queue.

The aim is to develop a stent-and-drug protocol that might quell worries about blood clots. You'll recall the brouhaha over the safety of drug-eluting stents versus bare stents, and over stents versus drug treatment. Well, FDA asked stent and drug makers to determine the best clot-prevention approach. As Bram Zuckerman, an FDA official who helped lay the groundwork for the study, told the Wall Street Journal, "The results will lead to greater clarity of an extremely important problem."

- see the story at the WSJ Health Blog
- check out the WSJ article

For Abbott, Boston stents, it's a draw

Tracy Staton — Mon, 13 Oct 2008 10:11:30 -0400

When doctors and researchers meet, headlines ensue--and this weekend's annual meeting of the Cardiovascular Research Foundation was no exception. A salvo of stent-related news came out of that symposium. Here's a sampling:

A study found that Abbott Laboratories' Xience stent and Boston Scientific's Taxus Liberte product--the newest entrants to the U.S. stent market--worked equally well in heart attack victims. That's good news for Abbott, which has seen Xience gain ground on competitors since it was approved in July. But Boston Sci's new stent didn't get the FDA nod till last week, so it's at a come-from-behind disadvantage, analysts said.
A three-drug cocktail works best at warding off clots in patients with drug-coated stents in their coronary arteries, researchers found. Five studies showed better results when the generic cilostazol--a.k.a. Pletal, from Otsuka Pharmaceuticals--was added to standard therapy with aspirin and the Bristol-Myers Squibb/Sanofi-Aventis med Plavix.
Abbott announced two-year data from 30 patients in an early clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similarly to unstented arteries.

- read the Abbott release
- see the Boston Globe story
- check out Boston Sci's Taxus Liberte approval in the WSJ
- get the three-drug news, also in the Globe

Johnson & Johnson wins reinstatement

Christe Bruderlin-Nelson — Wed, 17 Sep 2008 05:38:20 -0400

In a patent infringement lawsuit over a decade old that has involved multiple trials, Johnson & Johnson's Cordis unit won reinstatement of more than $595 million in damages. The United States District Court in Delaware handed down the decision.

The company went up against Medtronic and Boston Scientific over coronary artery stents. In 2000, the courts told Medtronic to pay $271 million and Boston Scientific to pay $324 million plus interest at the prime rate based on damages after taxes.

Boston Scientific had motioned for a new trial, but the courts denied it and instead ruled favorably on J&J's motion to move toward final judgment, which it will enter on September 30, 2008.

That's not likely to be the end of the story, however, as Boston Scientific says it will appeal the decision.

- view the Boston Scientific release
- check out the Johnson & Johnson release
- read the WSJ Market Watch article

Boston Sci recalls 2,200 stents

Tracy Staton — Fri, 15 Aug 2008 08:43:09 -0400

Boston Scientific has recalled more than 2,200 stents because the tip of the device used to implant them can break off during surgery, causing stroke or internal injury. The artery-opening devices--dubbed NexStent--were distributed worldwide between June 2007 and May 2008. "All U.S. hospitals have responded to Boston Scientific, and a significant number of the distributed devices have been returned," the company said. Because the problem with NexStent happens during surgery, the company said that patients who already have the stent implanted aren't at risk.

It's the second bit of bad news for Boston Sci this week; yesterday, the Wall Street Journal questioned the data on the company's next-generation Taxus stent. The newspaper said the mathematical method the company used to weigh those numbers gave undue advantage to the new stent, and that other statistical methods led to less favorable conclusions. The company's shares fell 2.1 percent yesterday to close at $13.10.

- read the story in Forbes

Boston Scientific's stent data flawed

Tracy Staton — Thu, 14 Aug 2008 10:54:19 -0400

Boston Scientific's new heart stent, awaiting approval for U.S. sales, is backed by flawed research despite the company's claims of success in a clinical trial, according to a Wall Street Journal review of the data. Report

Cleveland Clinic shuns Boston Scientific stents

Tracy Staton — Mon, 11 Aug 2008 10:52:07 -0400

Back in 2006, Cleveland Clinic anointed Boston Scientific as its preferred supplier of drug-coated stents. At the time, though, Johnson & Johnson had the only other coated stent on the U.S. market.

Times have changed--and so has the Cleveland Clinic. Doctors there will be trying out "most of the products" in the drug-coated stent market over the next year. Then, the clinic will whittle the choices down to one or two again.

The thing is, "most" apparently doesn't include Boston Scientific. Medtronic, Abbott Laboratories, and Johnson & Johnson all confirm that their products made the cut. Boston Scientific won't comment. Medtronic and Abbott, as you know, each have new coated stents approved this year; Boston Scientific has a new version of its Taxus product in the regulatory pipeline.

- read the story at CNN Money
- see the Wall Street Journal article

Justice probes biliary stent marketing

Tracy Staton — Tue, 05 Aug 2008 10:39:02 -0400

The U.S. Department of Justice has launched a probe of the bile-duct stent market, trying to determine whether companies such as Abbott Laboratories, Boston Scientific and Johnson & Johnson improperly promoted the devices. The U.S. Attorney's Office in Massachusetts has been subpoenaing stentmakers about their marketing practices, according to SEC filings. The companies have reported that Justice wants to know whether they've promoted the biliary stents for other uses, such as propping open leg arteries.

The U.S. Attorney's office wouldn't comment on the investigation, and the companies themselves wouldn't either, beyond saying that they're cooperating.

- read the Dow Jones story at CNN Money

Earnings up, earnings down for drugmakers

Tracy Staton — Tue, 22 Jul 2008 10:30:14 -0400

A plethora of drug-and-device results today, from falling profits at Boston Scientific and Schering-Plough to higher earnings and flat sales at Merck. Here's the roundup:

Merck posted net income of $1.77 billion, up from $1.68 billion year-over-year; per-share results were 82 cents compared with 77 cents a year ago. Discounting foreign-currency gains, sales were relatively flat, slipping by just 1 percent to 6.05 billion. The company suffered a 48 percent drop in Fosamax revenues because of generic competition, while Vytorin and Zetia sales fell 9 percent. Singulair revenues--expected to rise--stayed flat. But blood-pressure meds Hyzaar and Cozaar saw sales grow by 11 percent to $941 million.
Schering-Plough's earnings suffered on Organon acquisition costs, ending up at $398 million, or 24 cents a share, compared with $517 million, or 34 cents, last year. Excluding those items, EPS would have come to 45 cents, the company says. Sales jumped by 55 percent to $4.92 billion--with $1.4 billion of that increase coming from Organon, which it bought last November. A standout drug was Remicade, which saw sales leap by 41 percent to $557 million.
Boston Scientific's earnings fell 15 percent to $98 million on restructuring charges and declining stent sales. Drug-coated stent revenues plummeted by 30 percent in the U.S. as Medtronic launched its new drug-coated product; worldwide, they fell 13 percent to $382 milion. Total sales came to $2.02 billion.
Biogen Idec boosted its earnings to 70 cents per share for the quarter, compared with 54 cents a year ago, on revenues of $993 million. That's a 28 percent increase over last year's second-quarter sales. On an adjusted basis, EPS came to 91 cents, beating analysts' estimates of 84 cents.
Forest Laboratories posted EPS of 79 cents per share, down from 83 cents a year ago; the numbers suffered from a charge related to Forest's parting ways with Daiichi Sankyo on Azor marketing. Revenues grew by 4.2 percent to $967 million. Sales of its antidepressant, Lexapro, grew by 6.1 percent to $894 million, while Alzheimer's drug Namenda pulled in $219 million, up 14 percent.

- see Merck's earnings at MarketWatch
- get Boston Scientific's news from the Wall Street Journal
- check out Biogen's numbers at MarketWatch
- read Schering's results, also at MarketWatch
- find Forest's earnings release

Boston Sci CEO plans to stick around

Tracy Staton — Tue, 03 Jun 2008 11:00:56 -0400

Tobin, Tobin, he's our man. Or so says Boston Scientific. The device maker says chief executive Jim Tobin will be "extending his tenure," planning to stay with the company "for the foreseeable future." The only difference is that now, Tobin will be more focused on day-to-day operations; since the acquisition of Guidant in 2006, Tobin has been working to integrate the two companies. He'll have to be more operations-focused, we suppose; COO Paul LaViolette is retiring, and he won't be replaced.

The CEO announcement comes just days after a federal jury in Texas ruled that Boston Scientific infringed on three Medtronic patents covering stent technology. The company plans to argue its side of the case--using some defenses that weren't presented to the jury, for some reason--before a judge on July 31.

- see the article in the Boston Globe
- read the CNN Money piece
- check out the Boston Herald story on Medtronic's patent

ALSO NOTED: Abbott's Xience shows well against Boston Sci stent;AstraZeneca nabs new indication for Seroquel

Wed, 14 May 2008 06:59:50 -0400

> Abbott Laboratories' waiting-in-the-U.S.-wings stent, Xience, is as safe as and perhaps more effective than the current market leader made by Boston Scientific, according to new data presented at a European conference. Though not yet approved in the U.S., Xience is on the market in Europe. Report | Report

> AstraZeneca got the FDA's blessing to market its antipsychotic Seroquel as an add-on maintenance med for bipolar disorder. Release

> The FDA has eased restrictions on two drugs used to clarify ultrasound images, lifting a ban on administering them to acutely ill patients; Definity and Optison will still carry black-box warnings, however. Report

> Ex-Pfizer CEO Hank McKinnell joined the board of directors at specialty drug- and device-maker Angiotech Pharmaceuticals. Release

> Novo Nordisk got the FDA nod for its new hemophilia treatment NovoSeven RT. Report

> Lundbeck launched its Circadin insomnia drug in Germany. Report

> FDA warned Novartis for omitting the risks of Trileptal, an epilepsy treatment, from a promotional magnet. Report

> GlaxoSmithKline's Indian subsidiary inked a deal to co-promote Daiichi Sankyo's blood pressure remedy Olmesartan and its combo products. Report

> HollisterStier wrapped up two big construction projects that will expand its ability for analytical testing and contract manufacturing. Report

Biotech News

> One of the great pioneers of the British biotech industry, Sir Chris Evans, is fretting that turmoil in the public markets will have a particularly harsh affect on drug discovery work in Europe. Report

> A month after Schering-Plough pulled the plug on its collaboration with Novacea for a new prostate cancer therapy--Asentar--the little biotech company announced that it will cut its work force by more than half. Report

> The little Maryland-based vaccine developer Iomai is being bought out by Intercell for about $189 million. Buyout report

> Vaptans are a new class of drug that target a wide variety of conditions by inhibiting vasopressin, which regulates the circulatory system. Report

> Stem cell researchers at Cornell have genetically engineered a human embryo, a pioneering development that was immediately condemned as a big step toward designing babies. Report

And Finally… Imagine employing a legion of gaming fanatics to channel their obsession into finding solutions to some of the thorniest problems in protein chemistry. That's what biochemist David Baker and a small group of colleagues did in creating Foldit, which challenges gamers to see if they can improve the 3-D structures of proteins. Report

ALSO NOTED: Pfizer demands peer reviews from NEJM; Novartis gets EU nod for diabetes combo;

Mon, 25 Feb 2008 06:59:50 -0500

> Pfizer wants the New England Journal of Medicine to turn over confidential peer reviews of studies involving the painkillers Celebrex and Bextra; those articles have been cited in plaintiffs' lawsuits over the drugs. Report

> Novartis won the nod from European regulators for its diabetes combo treatment Eucreas, which comprises the company's new Galvus treatment and old standby metformin. Report

> President Bush's new FDA budget includes a boost in funding for examination of DTC ads; the catch is that the funding comes from user fees, a method Congress rejected last year. Report

> FTC Commissioner Jon Leibowitz explained his agency's opposition to pay-to-delay deals between brand-name drug makers and generics firms in a Washington Post op-ed piece. Report

> Boston Scientific got the FDA nod for three heart-related products: Confient and Livian, two defibrillators; and Latitude, a computer system that helps doctors monitor patients' hearts between visits. Report

> The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. Report

> Novartis has established the Novartis Vaccines Institute for Global Health, a nonprofit venture that will take aim at diseases in the developing world. Report

And Finally... The shooting spree at Northern Illinois University has revived a debate over antidepressants and whether they might be linked to violent behavior. Report

SPOTLIGHT: Inventor wins $431M from Boston Sci

Wed, 13 Feb 2008 06:59:52 -0500

A Texas jury ruled that Boston Scientific's drug-coated stents violate a 1997 patent and awarded $431 million to patent holder Dr. Bruce N. Saffran. Confident it can win on appeal, the company won't set aside money to pay the damages. Report

ALSO NOTED: Boston Sci reports $495 million loss; FDA on the fence about Requip XL;

Wed, 06 Feb 2008 06:59:50 -0500

> Boston Scientific reported a $495 million loss for 2007, on a 6.9 percent increase in revenues to $8.357 billion; drug-coated stent sales worldwide dropped to $1.788 billion from $2.358 billion, a 24 percent decrease. Release

> The FDA delayed its approval decision on Requip XL, a reformulation of GlaxoSmithKline's Parkinson's drug, dealing a blow not only to GSK but to its partner SkyePharma. Report

> Alpharma says it's selling its Active Pharmaceutical Ingredients business to a private equity firm for $365 million. Release

> Altus Pharmaceuticals saw its shares rise on news that its president and chief executive, Sheldon Berkle, had resigned. Report

> Shares of UK biotech CeNeS Pharmaceuticals rocketed up almost 70 percent after the developer confirmed that it's engaged in talks with a mystery suitor. Report

> The UK's Wellcome Trust says it will pump up its research spending by 60 percent over the next five years as it ambitiously seeks a better understanding of diseases at a genetic level. Report

> Buried in the modest 5.7 percent budget hike for the FDA is a provision that the government will seek authority to begin approving generic versions of biologics. Report

> PDL BioPharma has auctioned off two marketed drugs and two experimental therapies as it restructures in the face of some severe criticism over how it's been managed. Report

And Finally... Need a handy-dandy breakdown of presidential candidates' positions on Pharma-related issues? Here you go. Report

Stent sales stabilize as rival enters

Mon, 04 Feb 2008 06:59:57 -0500

In the stent world today, it's good news, good news, and bad news. First, the bad news: Last year's fourth quarter was the worst in several years for drug-coated stents. In December, only 62 percent of stent procedures used a coated device; that's compared with 80 percent as recently as mid-2006. You'll recall that sales of these stents dropped precipitously after some studies showed they might increase the risk of blood clotting; since then, additional studies have shown that the drug-eluting stents are actually safer for some patients, though they're not recommended for others.

Next, some good news: It looks as if the market has bottomed out, so there's nowhere to go but up for coated stents. At least that's the Wall Street Journal's estimation of the figures; as a percentage of stent procedures, the coated versions accounted for 68 percent in July, 66 percent in August, and 62 percent for each month until year's end.

Meanwhile, Medtronic got some good news from the FDA. The device maker got the nod to sell its new Endeavor drug-coated stent; in this case, the tiny mesh tube is coated in zotarolimus, a clog-prevention drug developed specifically for use on a stent. That may not be such great news for stent-makers Boston Scientific and Johnson & Johnson, which have suffered as sales declined. But perhaps they'll be comforted by the fact that Medtronic will soon have to join them in competing with a new rival; FDA is expected to give the go-ahead to another coated stent, the Xience V, sold jointly by Abbott Laboratories and Boston Scientific.

- see the FDA's release about the stent approval
- here's the release from Medtronic
- check out the article from the Wall Street Journal
- read the report on Endeavor's approval

Related Articles:
Study: Bypass better than stents. Report
Docs reconsider drug-coated stents. Report
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report

SEC scolds BMS, Baxter on exec pay

Wed, 30 Jan 2008 06:59:57 -0500

On a mission for more info on how companies set top execs' pay, the SEC has been pushing for details--and now it's knocking on doors at Bristol-Myers Squibb, Boston Scientific, and Baxter. Here's the skinny:

Why is compensation for BMS' executive vice presidents set to increase by 50 percent, and other officials are getting 25 percent bigger deals? The company says it needed to bring pay in line with salaries at peer firms.
Boston Scientific needs to analyze how executive compensation was determined, exactly, the SEC says. How tough has it been for execs to meet their performance targets? Plus, just what is this "executive allowance?" The company says the allowance is exactly what it sounds like: A lump sum cash payment. It's made, the company says, in lieu of perks that execs get at other companies. Must be nice.
Baxter also needs to be more forthcoming about every element of executive compensation, the SEC says, asking for details on metrics, incentives, and the rationale behind various dollar amounts. That's lots of info. Baxter wasn't very cooperative; it said it would include more details in its future SEC filings.

- check out the item in the Wall Street Journal Health Blog
- read the WSJ's comprehensive coverage of the SEC's quest

Related Articles:
Cornelius get big payday for BMS temp job. Report
Wyeth discloses new CEO's salary. Report
Despite company losses, Maryland CEOs enjoy a payday. Report
Novartis CEO's pay drops with profits. Report

J&J CEO talks tech

Mon, 14 Jan 2008 06:59:57 -0500

What do you obsess about when you're CEO of Johnson & Johnson? Well, it's not Band-Aids. In an interview with the Financial Times, Bill Weldon (photo) admits to a fascination with technology. Perhaps that's one reason he's so determined to get new ideas from his so-called "Office of Strategy and Growth" set up in November. Could J&J soon partner up with the likes of, say, Google? "Who knows who it's going to be?" Weldon says.

The interview glances off controversy--Weldon briefly defends his decision to let Boston Scientific outbid J&J for device-maker Guidant, and all he says about suing the American Red Cross for trademark violation is that it was "the last thing we wanted to" do. It only mentions J&J's restructuring --and 4,000 layoffs-- in passing. But it gives Weldon plenty of space to talk over J&J's virtues, as he sees them, such as its approach to innovation and its decentralized management structure. Though the latter, he says, causes at least some people to wonder just how he spends his time in exchange for that his most recent annual paycheck of $28 million. "My son says I just sit around and drink coffee and go to meetings," he says.

- read the rest of the interview in the Financial Times

Related Article:
J&J weathers fallout from Red Cross suit. Report

Pharma layoffs set new record

Fri, 21 Dec 2007 06:59:56 -0500

You can't talk 2007 in the drug industry without mentioning the L word: layoffs. Everyone who's anyone in pharma these days is doing it. Why? Generic competition and the pipeline troubles, for starters. Pfizer is slashing its payroll by 10,00 jobs due to a one-two blow on Lipitor; already due to go off patent in 2010, the drug already has attracted generic challengers, and Pfizer's hoped-for replacement, trocetrapib, failed a late-stage trial. AstraZeneca announced a total of 7,600 job cuts, about 11 percent of its workforce, blaming the layoffs on upcoming generic competition and falling sales.

Safety issues came into play, too; without the brouhaha over stent safety, for instance, Boston Scientific may not have had to cut 2,300 jobs as announced in XX. Or take Amgen and Johnson & Johnson; sales of their blockbuster anemia drugs have been, well, a bit anemic since questions first arose about their propensity for serious side effects at high doses. This year, they announced cutbacks of 2,600 (Amgen) and 5,000 jobs (J&J). And then there's GlaxoSmithKline and its Avandia problem. Before studies showed the diabetes drug could cause heart failure, heart attack, and stroke in some patients, Avandia was one of the company's top sellers. GSK said in October that it would carve 5,000 jobs off its payroll.

The job cuts, of course, are all part of restructuring plans designed not only to cut costs, but to streamline operations and, in some cases, prune low-performing plants or off-the-subject operations. Novartis' recently announced job cuts--3,750 of them--are part of a company-wide flattening of the org chart, designed to speed up decision-making. Will a more nimble, innovative Big Pharma result? That's a wait-and-see kind of question.

- see our special report on the biggest layoffs of 2007
- read Fortune's take on the record-setting layoffs in Big Pharma

Boston Sci settles more Guidant cases

Tue, 20 Nov 2007 06:59:54 -0500

How's about $45 million more? Boston Scientific says it's bolstering its fund for Guidant defibrillator patients to $240 million from the $195 million it agreed to pay in July. The new total covers more patients, too. It will settle 8,500 claims stemming from Guidant defibrillators that were recalled or subject to safety warnings before Boston Scientific bought the company in April 2006. The previous deal had involved some 4,000 claims.

The company believes this will lay to rest "substantially all" of the U.S. cases. And given that it had set aside some $732 million to cover expenses, it may have money to spare. But it has to pay its attorneys first.

- check out the release from Boston Scientific
- read the BusinessWeek report

Related Articles:
Boston Scientific hands out pink slips. Report
Boston Scientific preps for big layoffs. Report
Boston Scientific deals with debt. Report
Tough times for stent market. Report

Boston Scientific hands out pink slips

Thu, 08 Nov 2007 06:59:56 -0500

Look for Boston Scientific workers at the nearest job fair. The device maker's previously announced job cuts--some 2,300, according to company forecasts--have begun. The Massachusetts-based company started letting staff go in Minnesota on Tuesday, with terminated workers getting 60 days' notice, plus severance and outplacement services. An estimated 500 to 600 will be laid off in Arden Hills, Minnesota; the company has another big operation in Maple Grove.

- read the Bizjournal report
- get more details from TwinCities.com

Related Articles:
Boston Scientific preps for big layoffs. Report
Boston Scientific deals with debt. Report
Tough times for stent market. Report
Boston Scientific implant gets EU nod. Report
Top five layoffs of 2007. Report

FDA panel to review Abbot's coated stent

Wed, 07 Nov 2007 06:59:55 -0500

Will Johnson & Johnson and Boston Scientific soon have even more competition in the drug-coated stent market? The FDA has called an advisory committee meeting to review data on Abbott Laboratories' Xience stent late this month. You'll recall that Abbott released data last month that showed its stent in a favorable light compared with Boston Scientific's--more than 40 percent better, in fact. According to the study, patients with the Xience stent developed 43 percent fewer complications than those with Boston's Taxus stent.

Drug-eluting stents have spawned a whirlwind of warring studies ever since researchers concluded last year that the tiny devices might cause deadly blood clots. The bottom fell out of the market after those risks were reported, but some recent studies have shown that the drug-coated stents are actually more effective and less risky in some patients than bare ones are.

Speaking of data, some industry analysts are skeptical that Abbott will have enough to persuade the FDA committee that Xience is ready for prime time. When Medtronic got the panel's thumbs up last month for its drug-coated Endeavor stent, it had longer-term figures than Abbott does, they say.

Abbott's hoping to get the device to market by the first half of 2008, hard on the heels of Medtronic's Endeavor which is expected to hit by year's end. Whether Abbott will meet its goal depends, of course, on what happens at the Nov. 29 meeting.

- see the release from Abbott
- check out the CNN Money report
- read an analysis of Abbott's fortunes and Xience's potential effect

Related Articles:
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report
Tough times for stent market. Report
Congress spotlights J&J stent ops. Report
Medical device makers to fund stent safety study. Report
Decline in drug-coated stent use at cardiac centers. Report