Lipitor

Study: Data doesn't support women's Lipitor use

Tracy Staton — Fri, 19 Sep 2008 11:34:29 -0400

Should women stop using statins? A new study is taking issue with the efficacy--or lack thereof--of the cholesterol fighters when women are the ones using them. Analyzing a group of studies that looked at Pfizer's Lipitor and other statins, Cornell University researchers found that the drugs didn't prevent heart attacks in women with cardiovascular risks in any statistically significant way, although they did in men.

Lipitor's label already points out a dearth of efficacy data in women, the researchers said. But Lipitor advertising typically doesn't. "Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks, but that scientific evidence supporting their hope does not exist,” the authors concluded.

The study wasn't published in a medical journal, but a law journal: the Journal of Empirical Legal Studies. In fact, Pfizer was sued back in 2006 by a class of women and seniors over the lack of outcomes data supporting their use of the drug. At press time we couldn't find out whether the suit has been resolved, but we'll update when we do.

- read the Science Daily article

Pfizer's 2007 Lipitor Ad

Calisha Myers — Wed, 03 Sep 2008 10:15:58 -0400

Pfizer's Lipitor commercial, which featured Dr. Robert Jarvik. Both Pfizer and Jarvik drew fire from critics who questioned Dr. Jarvik's endorsement of a medication they argued he is neither licensed to prescribe or qualified to evaluate.

Pfizer's 2008 Lipitor Ad

Calisha Myers — Wed, 03 Sep 2008 10:10:32 -0400

The latest Lipitor ad, which features John Erlendson, a 58-year-old California talent agent rather than Dr. Robert Jarvik. Video courtesy of www.marketwatch.com.

Abbott, AZ team up on Crestor

Tracy Staton — Thu, 14 Aug 2008 11:16:30 -0400

The battle of the cholesterol meds could heat up even further now that two Big Pharma companies have forged an alliance. AstraZeneca and Abbott Laboratories are joining forces to market Crestor, AstraZeneca's statin med. With Lipitor scheduled to go generic in a couple of years--and Pfizer pulling out all the stops to capture as much of that brand-name revenue it can in the meantime--competitors are having to fight for their own share of the market.

And with the continued weakness in sales of Vytorin, the Zocor-and-Zetia combo that's seen so much negative publicity this year, now is prime time for another drug to come to the fore. In fact, when the American College of Cardiology advised that docs use other cholesterol meds before resorting to Vytorin, analysts pegged Crestor as one drug that could benefit from the change.

This isn't the first time Abbott and AZ have worked together on a cholesterol drug, or even on Crestor. The two companies have been working on a product that would combine Abbott's TriLipix with Crestor into one combo pill, aiming to file for FDA approval in 2009.

- read the companies' news release

Ireland probes Lipitor patient's death

Tracy Staton — Fri, 08 Aug 2008 10:55:38 -0400

An Irish man's death has prompted calls for doctors to suspend Lipitor use when treating patients with certain antibiotics. A 58-year-old man died from a rare muscle-deterioration malady that officials say was likely caused by the interaction of Pfizer's cholesterol med and the antibiotic fucidic acid. According to the Independent, medical journals have reported three other deaths from a bad interaction between Lipitor and antibiotics.

The Cork County Cororner, who presided over an inquest into the man's death, advised physicians to consider taking patients off Lipitor when they're being treated for an acute illness--and the jury recommended changing the drug's label to highlight the interaction risk with fucidic acid.

Of course, a county coroner and jury has no jurisdiction to change a drug's label or issue prescribing advice. But the case is all over the Irish papers today--and the publicity may prompt the proper officials to get involved. Indeed, the Irish Medicines Board is said to be looking into the man's death now. Pfizer, however, says that the drug's label already cautions doctors about the potential for the muscle problem, known as rhabdomyalisis. The risk of developing it is about 1 in 10,000 for Lipitor patients, the company said.

- read the story in the Irish Times
- check out the Independent's coverage

Pfizer: New users likely to stick to Lipitor

Christe Bruderlin-Nelson — Wed, 09 Jul 2008 11:01:09 -0400

If you want to have your cake and take a pill to stave off the ill effects on cholesterol, Pfizer's Lipitor might be on your plate. It's the best-selling drug in the world for a reason, and a new study by the company itself says you're more likely to stick to your drug regimen if you take Lipitor rather than simvastatin.

Pfizer looked at over 186,000 patients from one of the largest U.S. managed care claims databases and published its findings in this month's issue of Current Medical Research and Opinion.

A recent study showed that placebo was just as effective as Lipitor when it came to artery thickening--in fact, thickness was worse for those on Lipitor than for those on placebo. Another study showed that the drug did nothing to reduce mental or physical worsening of symptoms in Alzheimer patients. Pfizer, of course, is poking any holes it can in the negative findings about its billion dollar baby. Lipitor brought in $12.7 billion for the drug maker in 2007 alone.

- read the story at CNN Money
- find out more from Forbes
- see the study abstract

Pfizer, Ranbaxy settle Lipitor patent dispute

Maureen Martino — Wed, 18 Jun 2008 10:08:52 -0400

Pfizer and Ranbaxy have come to an agreement that will end most of their five-year battle over the generic production of Lipitor, the world's best-selling drug. Ranbaxy will have a license to sell generic versions of Lipitor and Caduet in the U.S. effective November 30, 2011, and on varying dates in seven additional countries. Lipitor's patent expires in 2010, but two patents covering the production of the drug don't run out until 2016. Pfizer had argued in the past that Ranbaxy's plans to produce a generic version of the $10 billion-a-year drug violated those two patents. Under the agreement, Ranbaxy gets access to all the patents it need to product generic Lipitor. Ranbaxy will have exclusive rights to the generic drug for the first six months of its production.

"This agreement is a win-win-win because it is pro-patient, pro-competition and pro-intellectual property," said Ian Read, president of Worldwide Pharmaceutical Operations for Pfizer. "The agreement provides patients with access to a generic product much earlier than if Ranbaxy were unsuccessful in obtaining approval for its product and overcoming the relevant patents."

Daiichi Sankyo, of course, just made a $4.6 billion bid for Ranbaxy. Just one day after that deal was announced, reports circulated that Pfizer would consider a counter-offer, based partially on the fact that Ranbaxy was planning to launch a generic version on Lipitor.

- see this release for more
- here's the Wall Street Journal article

Will DTC hearing lead to new regulation?

Thu, 08 May 2008 06:59:56 -0400

Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article
- find the video link at the committee website

New Canadian rules to delay big generics

Tue, 06 May 2008 06:59:56 -0400

Generics makers are up in arms over proposed patent rules in Canada. The drug copycats say the rules will delay generic Lipitor and several other blockbusters by as much as two years. (Can you hear Pfizer cheering that idea?) And they say the new rules are nothing but a sop to brand-name drugmakers.

The government says it's simply trying to put the worms back into the can after two court rulings unexpectedly curbed the practice of "evergreening," otherwise known as "filing new patents on a drug to keep generics away." Canada's Industry Minister's office says that the new regulations would uphold government policy as it was before the court rulings. "We need predictable and stable intellectual property laws" to remain attractive to international investment, a spokeswoman said.

- read the story in the National Post

Make generic-switching bonuses illegal?

Mon, 05 May 2008 06:59:55 -0400

Should insurers be allowed to reward docs who switch patients to generics? That debate is going public in Colorado, where legislators have proposed a bill that would prohibit the practice. On the "pro" side: Sen. Paula Sandoval, who sponsored the bill; she says docs should be thinking about patients, not money. Also on the pro side: Pfizer.

The AARP, Kaiser Permanente, and the Colorado Association of Health Plans are on the "con" side in this debate. Interestingly, Kaiser's opposition doesn't stem from support of the payments. The insurer is decrying a lack of reciprocal bans on Pfizer and other drugmakers, which leaves pharma free to incentivize docs--with gifts, lunches, and so on--to buy more expensive meds.

You'll recall that last year, a Blue Cross HMO offered to pay $100 each time a doctor switched a patient off an expensive brand-name cholesterol med--such as Pfizer's Lipitor--to a cheaper generic. The 90-day program saved Blue Care Network $5 million, a company spokeswoman said. But the plan drew sharp criticism; some charged it put money before patients' interests.

- read the Associated Press story
- check out the Denver Post article

Office upholds Pfizer's Lipitor patent

Thu, 01 May 2008 06:59:54 -0400

Pfizer is breathing a big sigh of relief. The U.S. Patent & Trademark Office has said it will confirm the drugmaker's basic patent on the blockbuster Lipitor drug. The office had been re-examining the patent in response to a request by Indian generics maker Ranbaxy Laboratories.

It's been a long road for Pfizer, fighting Ranbaxy's patent challenges on Lipitor. The company has grappled with the generics maker in multiple U.S. court cases over Lipitor--and won. This patent confirmation finally appears to shut the book on Ranbaxy's challenges, in the U.S. at least. Until March 2010, when that patent actually will expire.

Ranbaxy has been more successful with its Lipitor challenges in other countries. It prevailed in Norway, and in Canada it and other generics makers defeated Pfizer at the lower court level (Pfizer appealed). But Pfizer's biggest Lipitor challenge actually isn't in any court--it's Zocor, the now-generic statin. Generic-switching has been eating into Lipitor's sales; they dropped by 13.6 percent year-over-year through April 18.

- see the brief in BusinessWeek
- check out Motley Fool's take
- read CNN Money's assessment of Lipitor sales

Crestor aces huge study, says AZ

Mon, 31 Mar 2008 07:59:57 -0400

Some cholesterol med-makers do have reason to rejoice today. AstraZeneca stopped a study of its blockbuster Crestor, saying the pill had already demonstrated clear benefits over placebo. The 15,000-strong study aimed to determine whether Crestor cut the risk of major cardiovascular events in patients without symptoms and with low cholesterol, but with high levels of C-reactive protein, which has been linked to cardiovascular disease.

Analysts said the trial news would give Crestor an edge over its rival--yes, you guessed it--Vytorin. Launched in the U.S. in 2003, Crestor initially lagged, but a 2006 study showing it could hold back the progression of atherosclerosis, and even help shrink arterial plaque, helped it gain market share.

- see AstraZeneca's press release
- read the story in the Wall Street Journal

Related Articles:
It's Crestor vs. Lipitor in AZ trial. Report
AZ hits back at Crestor imitators. Report
FDA hands Crestor a fighting chance. Report
AZ's Crestor flubs key heart failure trial. Report
AZ hit with Crestor patent challenge. Report
Crestor less safe than competing statins. Report

Pfizer sues for Lipitor protection till 2016

Wed, 26 Mar 2008 07:59:54 -0400

Pfizer is hitting back at would-be Lipitor copycat Ranbaxy. The drugs giant sued the generics maker for patent infringement over the blockbuster cholesterol med Lipitor and Caduet, a combo of Lipitor and blood-pressure med Norvasc. Already blocked from selling copycat versions of the drugs till 2010, Ranbaxy would be stymied till 2016 if Pfizer's legal maneuvering succeeds.

Lipitor, of course, is Pfizer's cash cow, with $12.7 billion in 2007 sales, more than a quarter of the company's revenues; Caduet brought in $568 million. The suits allege that generic Lipitor and Caduet would trample on two Lipitor process patents, which don't expire until 2016. Pfizer asked the court to ban Ranbaxy from making, selling, or importing generic Lipitor till then. A Canadian court recently ruled in Pfizer's favor, protecting Lipitor from Ranbaxy until 2010.

- read the article at MarketWatch
- see the story at India Infoline
- check out Pfizer's release on the Canadian ruling

ALSO: EMTs to Lipitor's rescue? A union representing emergency medical techs and paramedics recently mailed a letter to its doctors' network endorsing the cholesterol med. "When appropriate, we ask that you please consider an agent like Lipitor for our members with high cholesterol," an official of the International Association of EMTs and Paramedics wrote. "IAEP leadership stands behind Lipitor as the lipid-lowering agent of choice." Report

Related Articles:
Lipitor patent gets U.S. thumbs-down. Report
Lipitor is No. 1, but faces generic threat. Report
Generic battle looms for Lipitor. Report
Pfizer, Ranbaxy get mixed ruling in Lipitor patent fight. Report

Shire stock jumps on Pfizer rumors

Fri, 14 Mar 2008 07:59:57 -0400

Less than 10 days after CEO Jeffrey Kindler pooh-poohed big acquisitions, U.K. markets are aswirl with rumors that Pfizer is on the hunt for British pharma group Shire. The company's shares leapt this morning on huge trading volume. Never mind the fact that analysts don't think Shire would be a good fit for Pfizer; deal talk has its own psychology. Alan Greenspan might call it irrational exuberance.

Of course, it's not the first time a Pfizer buyout rumor moved markets. Last fall when Biogen Idec went on the block, Pfizer was a rumored suitor; the chattering classes quickly mused that the drugs giant might prefer Genzyme. Frenzied deal talk around the same time linked Pfizer with Sanofi-Aventis and with Wyeth. Why so much speculation? Everyone knows Pfizer has to do something to replace the sales it'll lose when Lipitor goes generic in a few years.

- read the blog item in The Guardian
- see the Citywire article

Related Articles:
Analysts not impressed with Pfizer. Report
Sanofi stock up on Pfizer buyout talk. Report
Lipitor is No. 1, but faces generic threat. Report

Pfizer's Kindler can't quash mega-deal talk

Mon, 10 Mar 2008 07:59:57 -0400

Kids who want ice cream won't take no for answer. Neither, apparently, will some Pfizer investors, who are clamoring again for a big acquisition just days after CEO Jeff Kindler said he wouldn't play Let's Make a Deal. Mega-M&A is just too disruptive, Kindler said at last Wednesday's analyst confab. And he should know: He's leading a company that's still absorbing Warner-Lambert and Pharmacia.

Nonetheless. A CreditSuisse analyst maintains that "a large scale deal may be the best option" for shoring up the company as it nears the loss of its biggest money-maker, Lipitor, to generic competition. And the analyst has a couple of ideas about which companies to pursue, namely Wyeth and Amgen.

So, the Wall Street Journal's Health Blog has posted a basketball tournament-style bracket of pharma deals, pairing Pfizer with Amgen and Merck with Schering-Plough, plus a few other big names we'll leave it to you to find out. We won't be placing any bets on these deals, but who knows. Considering the state of the market these days, anything might happen.

- see the item at the WSJ Health Blog

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Pfizer plots big outsourcing push. Report
Analysts not impressed with Pfizer. Report
Pfizer seeks salvation in late-stage biotherapeutics. Report
Is Pfizer's CEO as bold as promised? Report

Analysts not impressed with Pfizer

Thu, 06 Mar 2008 06:59:56 -0500

Investors and analysts are none too impressed with Pfizer's new strategies as outlined by CEO Jeffrey Kindler and other execs during an annual Wall Street update yesterday. The stock fell to within 50 cents of its 52-week low, and analysts expressed disappointment, boredom, and frustration. Here's a sampling:

"The message I hear is, 'Don't expect anything radical,' but the challenges require radical change," Morgan Stanley's Jami Rubin told the Wall Street Journal.
"In my own judgment, I don't think they're going to be able to replace Lipitor in 2011," les Funtleyder at Miller Tabak told CNN Money. "There's nothing I've seen today [at the analyst meeting] that would change that."

It was a tough audience. Analysts have been hoping--expecting--big changes from Kindler, and not unfairly, because he promised them. The moves he outlined yesterday do include some sweeping alterations to the way Pfizer manages its business; for instance, Kindler says he's giving company units more autonomy so they can move more quickly. But cultural change takes time to bear fruit, especially at a behemoth like Pfizer, and it's not the kind of big-deal dramatic move that energizes investors. Promising to vault a bunch of drug candidates into Phase III this year is another long-term, slow-to-pay-off strategy. The one thing that might have set observers abuzz--a big acquisition--Kindler ruled out completely.

Now, Kindler may be laughing all the way to the bank in 2010 when his patient strategies start to pay off. He might be able to thumb his nose at all the investors and analysts who yawned at the meeting yesterday. But Wall Street is all about psyche. The audience went in wanting, if not expecting, revelation. Instead they got step-by-step-by-painful-step improvement plans. Which may end up being the best thing for Pfizer. But they won't do a thing for investors' returns next quarter.

- read the story at CNN Money
- check out the WSJ's article
- find this comprehensive summary at The Day
- read Kindler's word on acquisitions
- see Forbes' focus on Kindler's plans
- view Kindler's interview with CNBC's Maria Bartiromo

ALSO: Pfizer has staked out plans to make 15 to 20 regulatory filings for new drug approvals and expanded use of existing drugs between 2010 and 2012, insisting that the pharma giant can gin new revenue to replace the $12 billion a year it will see evaporate when Lipitor loses its patent protection. Report

Related Articles:
Pfizer seeks salvation in late-stage biotherapeutics. Report
Pfizer got tax break but didn't deliver jobs. Report
Is Pfizer's CEO as bold as promised? Report

Is Pfizer's CEO as bold as promised?

Tue, 04 Mar 2008 06:59:58 -0500

Like natives encountering a strange explorer in an old B movie, investors hailed Jeffrey Kindler (photo) when he was picked to succeed Pfizer CEO Hank McKinnell. Now, 19 months into his tenure, the natives are getting restless. Kindler hasn't delivered the kind of sweeping change he promised. The company is no closer to replacing the fast-running revenue engine that is Lipitor, which could face generic competition in 2010. And shares have fallen 15 percent. "We're getting close to the end of the period where one can say it's too early to see change," one portfolio manager told The Wall Street Journal. Another said, "I've been a buyer for two years and I don't have a lot to show for it."

Observers had high hopes for Kindler in part because of his heritage as an ex-McDonald's exec; he was seen as an outsider who could see pharma's challenges more objectively and meet them in a nontraditional way. But last year's strategy update for analysts disappointed some in the audience, the WSJ said, because far from featuring radical solutions to Pfizer's problems, it revolved around old-hat tactics like layoffs and plant closures. This year's strategy, scheduled to be announced tomorrow, may prove little better, a source told the newspaper. "The Street may be disappointed with what he says Wednesday because he may not be as bold" as investors want.

Granted, Kindler inherited a tough situation. Pfizer stock dropped by half while his predecessor held the reins, and the company is still digesting two big acquisitions. Kindler may have good reason to be cautious, not least of which is a fear of over-promising and under-delivering. Some say he'll soft-pedal his initiatives tomorrow but his actions in the coming months will show just how aggressive he can be. One hint might lie in his hiring a Pfizer outsider but industry insider--venture capitalist and ex-Eli Lilly exec William Ringo--to head up strategy and business development. But for more specifics we'll just have to watch and wait.

- read Pfizer's release about Ringo
- see the report from The Wall Street Journal
- check out the Pharmalot item on Ringo

ALSO: Pfizer has beefed up its prospects in the cancer arena with the buyout of Durham, NC-based Serenex. The biotech has been developing drugs for tumors and cancers of the blood and bone marrow. But Pfizer also acquires--for an undisclosed sum of money--the company's drug discovery technology. Report

Related Articles:
Pfizer's Kindler leaves analysts feeling flat. Report
Management shakeup at Pfizer. Report
CEO McKinnell gets the boot as Pfizer struggles. Report
What's next for Pfizer? Report
Pfizer hires new R&D chief, launches biotech center. Report

Celebs lose cachet as drug marketers

Mon, 03 Mar 2008 06:59:54 -0500

Celebs may help sell magazines but do they really help market drugs? In the wake of Robert Jarvik's public downfall from Pfizer's pitchman-pedestal, advertising experts are wondering. Famous folk do generate interest, but maybe meds shouldn't be sold using the same techniques used to hawk detergent.

Consider the fact that the Jarvik controversy revolved around his qualifications to recommend Lipitor, a cholesterol med. Inventor of the artificial heart, Jarvik had never practiced medicine. Critics say that more effective pitches come from famous people who are actual patients, such as Sally Field--who was diagnosed with osteoporosis in 2005--promoting Roche and GlaxoSmithKline's Boniva.

Either way, though, celebrities tend to distract from the ad message--and in drug ads, the rapidly spoken voice-over of side effects is, for safety's sake, an important set of info that needs to be conveyed. That's one reason why Big Pharma has backed off from celebrities and turned to animated bees and Abraham Lincoln instead. Expect more backing off, experts said. "I think the latest round of concern is going to cause a lot of agencies to think twice," one ad exec predicted.

- check out the article in the Boston Globe

Related Articles:
Pfizer yanks Lipitor ads starring Jarvik. Report
Drug ads challenge reputation of inventor. Report
Lunesta moth tops memorable drug ads. Report

SPOTLIGHT: Jarvik defends his heart-doc credentials

Wed, 27 Feb 2008 06:59:52 -0500

The star of Pfizer's canceled Lipitor campaign speaks out: "My credibility as a heart expert is fully justified and is fairly represented" in the ads, Dr. Robert Jarvik said in a statement. Plus, he could have rowed in that commercial, but the insurance carrier for the shoot wouldn't allow it. Report

Pfizer yanks Lipitor ads starring Jarvik

Tue, 26 Feb 2008 06:59:57 -0500

All right, already, Pfizer says. The drugmaker is pulling its Lipitor ads that feature artificial heart inventor Robert Jarvik. That's after a flurry of media coverage--in which Jarvik was shown to lack a license to practice medicine and, horror of horrors, to lack rowing ability. The latter deficiency was relevant, of course, because one ad showed Jarvik sculling across a lake, only it wasn't the doctor but a body double.

"The way in which we presented Dr. Jarvik in these ads has, unfortunately, led to mis-impressions and distractions from our primary goal," a Pfizer statement said. "Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople."

Pulling the ads probably has a bit to do with a Congressional investigation as well. You'll recall that the House Committee on Energy and Commerce had been looking into the ads, questioning whether Jarvik was qualified to recommend the cholesterol med. Now, the committee's lead investigators are chuffed. "I commend Pfizer for doing the right thing and pulling the Lipitor ads featuring Jarvik," said Rep. Bart Stupak, who chairs the subcommittee on oversight.

However, the committee doesn't appear to be satisfied. Stupak told the New York Times that the group intends to continue investigating. Including taking a meeting with Jarvik himself.

- read Pfizer's release
- see the article from the New York Times
- check out the item and one ad video at Pharmalot
- see the commentary at DrugWonks
- read the item at the Wall Street Journal Health Blog

Related Articles:
Congress wants more on Jarvik. Report
Lipitor doc doesn't practice rowing, either. Report
House objects to Pfizer's Lipitor pitchman. Report
Drug ads challenge reputation of inventor. Report