IMS Health

Court supports data privacy law

Maureen Martino — Thu, 20 Nov 2008 10:42:26 -0500

A federal appeals court in Boston has upheld states' rights to block the sale of doctor-specific prescription drug data. That's the kind of data drug companies use to determine whether a particular doctor would be receptive to what their sales reps have to say.

It's a major blow for data-mining companies like IMS Health and Verispan, which gather and sell the information to pharma companies. The case originally arose in New Hampshire, which implemented a law to block data-mining in order to cut down on health costs. The two companies sued the state in 2006. IMS and Verispan argued that such data is important for supporting public health, and banning it tramples on commercial free speech.

The federal court disagreed, saying that New Hampshire's efforts were reasonable and constitutional. "The record contains substantial evidence that, in several instances, detailers armed with prescribing histories encourage the overzealous prescription of more costly brand-name drugs regardless of both the public health consequences and the probable outcome of a sensible cost/benefit analysis," wrote United States Court of Appeals Judge Bruce Marshall Selya. The court's decision overturns two earlier courts' rulings.

"We are disappointed with the First Circuit Court of Appeals decision. Two federal courts previously have examined the issue and validated the view that the First Amendment protects the dissemination of prescriber-identifiable data, which we believe is vital to efforts to improve the quality, efficiency and safety of our healthcare system. We are currently reviewing the decision and evaluating potential next steps," IMS Health said in a statement.

- here's the New York Times article
- see IMS's response

IMS: Pace of outsourcing accelerating

Tracy Staton — Tue, 27 May 2008 09:39:45 -0400

Drugmakers are pulling out of manufacturing at an unprecedented rate, according to a new report from IMS Health. Four of the top 10 pharma players announced big new outsourcing programs last year. That's evidence that pharma execs are thinking in vastly different ways from their predecessors, who believed R&D and manufacturing had to work hand-in-glove, and that the skills required to make drugs couldn't be found in emerging markets.

This shift toward contract manufacturing has risks, IMS concludes. First, there are safety concerns. Just think of Baxter's heparin supplier Scientific Protein, which made crude heparin in partnership with a Chinese manufacturer whose plant was riddled with problems when the FDA finally inspected it after millions of doses of the blood thinner had to be recalled. Then there's Sanofi-Aventis, whose contract manufacturer went bankrupt, leaving Sanofi to deal with its manufacturing breaches. Secondly, in other industries, contract manufacturers have found ways to enter the market as competitors. Finally, there's economic implications of shipping work to emerging markets. Europe, for instance, counts 640,000 pharma jobs. If they are perceived to be under threat from outsourcing, politicians might intervene.

- read the story at Outsourcing Pharma

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money

Generics makers face Chinese threat

Wed, 14 May 2008 06:59:57 -0400

In an interesting twist on the usual generics news, it's the copycat makers who are predicted to suffer as competitors undercut their products. The source of this competition? None other than China, where generics companies are gearing up to supply finished products--rather than just pharma ingredients--for the first time. IMS Health is predicting that the Chinese manufacturers will "undercut all others on price." The result? Pain for international generics companies and, in trickle-up fashion, brand-name players, too.

Meanwhile, Goldman Sachs has downgraded its outlook for the generics sector as a whole, citing weak-to-mixed first-quarter results and fewer big new copycats on the horizon as some brand-name drugmakers ironed out their differences with generics challengers. The only two companies Goldman still favors are Teva and Mylan.

- see the China news at Pharmalot
- check out the downgrade story at CNN Money
- find the Goldman note at Barron's

Avastin-Lucentis trial may reshape pharma

Wed, 14 May 2008 06:59:56 -0400

We thought the head-to-head trial of Avastin and Lucentis for age-related macular degeneration was a big deal for Genentech, which makes both drugs. Now, IMS Health is saying that the trial could be "a Pandora's box" for the entire pharma industry.

Conducted by the National Eye Institute, part of the National Institutes of Health, the trial is designed to see whether the much cheaper Avastin, often used off-label to treat AMD, measures up to the AMD-specific--and very expensive--Lucentis. If Avastin passes muster, then prescribers may desert Lucentis completely. And if docs don't do so voluntarily, then insurers and other payers may nudge, cajole, incentivize, or downright push them to.

And there's the rub, IMS says. By taking the drugmaker out of the testing, this trial could fundamentally reshape relations between payers and pharma. Payers could sponsor comparative drug studies of their own or lobby the government to do so, IMS theorizes, especially as databases make those comparisons easier. There's plenty of time to worry about it, though: The Avastin-Lucentis trial won't wrap till 2010.

- see the story in the Financial Times

Emerging markets drive global growth

Wed, 16 Apr 2008 06:59:56 -0400

Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. But the rate of growth is slowing--6.4 percent compared with 11.8 percent in 2001. And without the big engines in Asia, that figure would be lower still. China, South Korea, and India grew by 25.7 percent, 10.7 percent, and 13 percent respectively. Russia and Turkey, 20.2 percent and 17.2 percent. The U.S.? Just 3.8 percent.

The IMS report also included the top 10 sellers worldwide (drum roll, please):

Lipitor, $13.5 billion, Pfizer
Plavix, $7.3 billion, Sanofi-Aventis
Nexium, $7.2 billion, AstraZeneca
Seretide/Advair, $7.1 billion, GlaxoSmithKline
Enbrel, $5.3 billion, Amgen and Wyeth
Zyprexa, $5 billion, Eli Lilly
Risperdal, $4.9 billion, Johnson & Johnson (Janssen)
Seroquel, $4.6 billion, AstraZeneca
Singulair, $4.5 billion, Merck
Aranesp, $4.4 billion, Amgen

Note that Aranesp made the top 10 despite a 12.9 percent drop in sales on safety worries. And the biggest gainer of the year was Plavix, the anti-clotting med; it racked up a 20.5 percent increase in sales.

- see the item at Pharmalot

ALSO: In response to the growing overseas market, DIA is opening an office in India. Release

Related Articles:
Pharma growth drops to 1961 levels. Pharma growth report
Biotech, emerging markets are big VC targets. VC report
Big Pharma blunders in emerging world. Pharma report
PwC to pharma: Adapt and invest or die. PwC report

ALSO NOTED: Merck agrees to extended deadline; Millennium disputes IMS data on Velcade;

Wed, 26 Mar 2008 07:59:50 -0400

> Merck agreed to extend the deadline for Vioxx settlement filings to May 1, giving patients who want in on the deal more time to get their paperwork together. Report

> Upset by a report from IMS Health that showed sales of cancer med Velcade dropping, Millennium Pharmaceuticals filed a rejoinder with the Securities and Exchange Commission; at least some analysts were convinced, advising investors to ignore IMS's first-quarter data on the drug. Report

> As expected, California regulators agreed to delay their plans to track all prescription drugs from factory to patient; the deadline for drug makers and pharmacists to comply is now January 2011 instead of January 2009. Report

> Novartis stock gained 3 percent Tuesday on news that Health Canada approved its Diovan drug for congestive heart failure patients who can't take ACE inhibitors. Report

> Big Pharma is spending more on magazine advertising and less on online marketing, according to a report from Neilsen Monitor-Plus. Report

> The German drug maker Ursapharm Arzneimittel announced it would enter the Indian pharma market via a joint venture called Ursapharm India, planning to launch eye drops, ointments, nasal sprays and nasal drops. Report

> Research spending into new drug developments jumped to $58.8 billion last year, according to a new study by PhRMA and Burrill & Co. That represents an increase of $3 billion. Release

> Looks like stressed out doctors might soon have a little less paperwork to worry about. According to the Wall Street Journal, the nonprofit group iHealth Alliance is set to launch an online network "that will email alerts [about warnings and label changes, etc.] to doctors who sign up." Report

> Frustrated by the long years of research needed to prove the effectiveness of a new cancer therapy, British officials have designated a network of 19 hospital units that will be allowed to administer early-stage experimental cancer drugs to terminal patients. Report

> Big Pharma companies are often quick to turn their backs on a drug that doesn't deliver the kind of data needed to win approval as well as big markets. But a series of these failed development programs have been resurrected by scientists who decided to search for the kind of genetic biomarkers that would define a group of patients who would respond positively. Report

> Manipulating insulin levels raises the level of the master gene-regulating protein SKN-1, significantly prolonging the lives of microscopic worms in one study. Report

And Finally... Think your dog has spring fever? It may be Attention Deficit Hyperactivity Doggie Disorder, easily treatable with Fidolin--and you can take it, too! Report

Pharma growth drops to 1961 levels

Wed, 12 Mar 2008 07:59:58 -0400

IMS Health is out with its new annual pharma sales report, and it ain't pretty. Revenue grew by only 3.8 percent to $286.5 billion, the slowest pace of expansion since 1961. By contrast, sales expanded by 6 percent in 2006. Total prescription volume rose only by 2.8 percent, compares with 4.6 percent the previous year.

A few bright spots buried within those overall numbers, though. Cancer meds grew by 14 percent. Biotech product sales expanded by 9 percent, and specialist-driven therapies by 10 percent. The offsetting dark spots? Try a 15.4 percent drop in year-over-year cholesterol-med sales.

IMS cited a few reasons for the slowing growth, including--of course--increasing competition from generics; $17 billion worth of branded drugs lost exclusivity in 2007. Plus, new meds only represented $441 million worth of sales last year because of fewer product launches and slower adoption of the new products. And then there were the safety issues: Black Box warnings, withdrawals, and the like. IMS estimates that safety concerns cut into sales of products that account for 10 percent of the market.

- check out the press release from IMS
- read the CNN Money story
- check out the analysis and charts at Pharmalot

Related Articles:
The specter of generic competition grows. Report
Wanted: Rugged pharmas for tough trip. Report
Say goodbye to Big Pharma's gilded age. Report
PwC to pharma: Adapt and invest or die. Report
New drug approval lags in 2007. Report

Agencies take aim at patent settlements

Wed, 20 Feb 2008 06:59:57 -0500

Are quid pro quo deals between brand-name drug makers and generics firms in real danger? Euro watchdogs are scrutinizing them, the FTC is suing over them, and the U.S. Congress is considering an outright ban on them.

Perhaps that's because Big Pharma has been cutting deals with generics makers right and left. There's the big Cephalon arrangement that's attracted the FTC's ire: That company paid Teva, Barr, Ranbaxy, and Mylan a total of $200 million to say out of the Provigil market until 2012. The FTC counts 100 deals like this since 2004.

The FTC hasn't had much success in the courts so far, but it's hoping for a grand slam in the Cephalon case. The agency would like the issue to go to the Supreme Court so it can be resolved "once and for all." There's no guarantee, though, that the newly conservative court would rule against these deals. The government's best shot may be in Congress. A Senate committee last week approved a bipartisan bill that would prohibit these arrangements; similar legislation is pending in the House.

Meanwhile, the generics market isn't growing at quite the pace it once was. According to preliminary figures from IMS Health, sales increased by 3.8 percent last year--the same rate as the overall drug market. The market research firm was surprised by those results: "I checked this number and checked it twice," an IMS rep told In Vivo. "We have seen generics growing over the last couple of years somewhere between 10 percent and 20 percent. So to come in...at 3.8 percent is quite dramatic."

- read the Fortune article
- check out the market figures at In Vivo

Related Articles:
FTC sues Cephalon for blocking generics. Report
AstraZeneca, Par collaborate on authorized generic. Report
Wyeth makes its own Protonix copy. Report
Analysts get bullish on generics makers. Report

Can specialty drugs turn pharma tide?

Wed, 13 Feb 2008 06:59:57 -0500

Want a preview of some "sobering" and "possibly a little alarming" market data? IMS Health gave preliminary figures on the state of the pharma industry to the Health Industry Group Purchasing Organization. Brace yourself: U.S. market growth for drugs grew by only 3.8 percent in 2007--the worst growth rate since 1961.

Can new products turn the tide? In Vivo notes that new drugs in general aren't delivering the same bang of bucks they used to. But here's a bright spot. Specialty drugs do deliver. According to IMS, the number of primary-care blockbusters dropped to 29 from 33 in 2006, but the number of specialty blockbusters grew to 30 from 25.

IMS has its eye on four 2008 drug launches that have blockbuster potential, and three of them are specialty drugs. So, says an IMS rep, "the blockbuster model isn't dead, but perhaps the primary care-driven market is."

- find out more--including the potential blockbusters--at In Vivo

Related Articles:
Specialty drugs emerge as key price driver. Report
Is pharma addicted to blockbusters? Report
Blockbusters on their way to generic-land. Report
IMS lists best drug launches of all time. Report

VT to revise data-mining law

Wed, 16 Jan 2008 06:59:54 -0500

Vermont is apparently determined to restrict data-mining--so determined that it delayed implementation of a new law curtailing it. Facing a free-speech lawsuit, the state's attorney general decided to hold the law back until at least September so that legislators could tweak the law to thwart its critics.

The data-mining issue is contentious partly because some companies--IMS Health, for instance--make their living by selling info on docs' prescriptions to drug companies. Not to mention the fact that this information is one of the cornerstones of pharma marketing. Sales reps use it to identify physicians whose prescribing habits might be open to profitable changes--such as a switch to their companies' products. State critics say that drives up healthcare costs, because reps steer doctors toward more expensive drugs. But IMS and its brethren say laws against data-mining keep valuable info out of doctors' hands.

- read the article from the Boston Globe

Related Articles:
Companies tackle prescribing data laws. Report
Fight continues over state limits on prescription data mining. Report
States tighten screws on pharma marketers. Report
Physicians protest prescribing-data use. Report

IMS Health catches layoff bug

Mon, 07 Jan 2008 06:59:55 -0500

Call it the ripple effect. Making a living off pharmaceutical companies suddenly isn't so lucrative: IMS Health, the market research company responsible for so much of the hard data on drug sales, is laying off about 10 percent of its work force.

The company sells detailed market data and medical data to drug makers. That info is mostly used by sales departments--which of course have been shrinking like the Arctic ice lately. Guess it goes to show that layoffs can be contagious.

- here's the article from The Wall Street Journal

Wanted: Rugged pharmas for tough trip

Wed, 02 Jan 2008 06:59:58 -0500

Batten down the hatches. The voyage ahead is one of Odyssean proportions, with generic drugs ready to suck away sales like the Charybdis maelstrom and biotech bewitching R&D like the irresistible Circe. By year's end, we're expected to see only 5 to 6 percent growth industry-wide. But like all voyages, this one can be a transition, a route from one place to another. The layoffs and restructuring that will play out this year can lead to better, stronger, faster companies--or not. The new execs still gearing up or taking over this year could lead their crews into new, creative passages--or not. Biotech fever could transform pharma into exciting and profitable innovators--or R&D execs could transform into farm animals.

Okay, that's taking the analogy a bit far. But the point is this: Pharma could consider itself embattled, stymied, doomed. It could look back wistfully at the old ways of doing business, at its portfolios of aging meds. Or it could face forward to steer through the tight straits ahead, toward a new, very different destination.

Our bet? A few companies will reinvent themselves. The rest will tack here and there, looking for ways to recapture the cozy past, and founder.

- read the report about Pharma's upcoming challenges
- see this press release from IMS Health on 2008 sales growth
- read The Motley Fool's Big Pharma forecast

Related Articles:
Say goodbye to Big Pharma's gilded age. Report
PwC to pharma: Adapt and invest or die. Report
New drug approval lags in 2007. Report
Lines blur as Big Pharma crosses borders into biotech. Report

The specter of generic competition grows

Fri, 21 Dec 2007 06:59:58 -0500

We can officially call 2007 the year generic competition became a byword on the markets as well as in Big Pharma hallways. It's always first on the list of ills plaguing the industry (followed by slow-flowing pipelines; we'll get to that later). It's been cited in almost every media report about layoffs and restructuring. And it's safe to say that every one of the top drug makers is bracing for more. Some $23 billion in drugs go off patent in 2008, some of them the biggest names in pharma.

But let's take a look at the generic blows pharma took in 2007. Drugs accounting for $16 billion in annual sales went off patent, according to a report from IMS Health. That's more than 100 branded products. Among them:

Pfizer's antihistamine Zyrtec, $1.2 billion in 2006 sales
Pfizer's blood pressure drug Norvasc, $5 billion in 2006 sales
GlaxoSmithKline's blood pressure remedy Coreg, $1.7 billion in 2006 sales
GlaxoSmithKline's antidepressant Seroxat/Paxil CR, $1.2 billion in 2006 sales
Novartis' blood pressure drug Lotrel, $1.4 billion in 2006 U.S. sales alone
Sanofi-Aventis' clotting drug Lovenox, $2 billion in 2006 U.S. sales

It may be painful for Big Pharma, but not for generics makers. As we reported yesterday, Wall Street analysts are paying more attention to copycat companies like Teva Pharmaceutical Industries, which has won more than one top rating recently. We suppose that bite out of Big Pharma's bottom line has to go somewhere.

- take a look at the off-patent situation
- read how drug makers are trying to protect sales
- see how Indian drug makers cashing in on off-patent drugs

Fewer U.S. patients buy Canadian drugs

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

The northward migration of drug buyers is slackening, according to pharmaceuticals datameister IMS Health. In 2006 U.S. customers only spent $211 on meds from Canadian pharmacies, compared with $420 million in 2005.

Once upon a time, hordes of thrifty customers finagled their way into filling prescriptions in Canada, where drugs can be as much as 40 percent cheaper. But Medicare's prescription drug benefit has cut into the business. Canadian pharmacies also raised their prices. And drug makers Pfizer and GlaxoSmithKline threatened to cut off Canadian pharmacies that catered to U.S. customers. Meanwhile, the U.S. dollar ain't what it used to be. But the saga of drug-buying on foreign markets isn't over yet. Congress is still considering opening up imports.

- read the report from the Philadelphia Inquirer

Related Articles:
Senate approves, cripples drug import bill. Report
Reimportation issue makes a comeback in Senate. Report
Canada moves to block drug exports. Report
Dems tackle Medicare drug costs. Report

Pharma growth sinking to historic low

Thu, 01 Nov 2007 07:59:58 -0400

Here's statistical confirmation of the gloom-and-doom facing Big Pharma. Worldwide sales growth will slow next year to around 5 percent from 6 to 7 percent this year, according to a new report from IMS Health. In the U.S., growth will hit a historic low of 4 to 5 percent as generics march in to battle with brand-name drugs like Johnson & Johnson's Risperdal and Merck's Fosamax. And because of increased FDA scrutiny, new drugs aren't likely to fill the void.

Meanwhile, emerging markets will account for one-quarter of the increase in pharma sales--but they'll be buying generics because they can't afford brand-name meds.

- check out the release from IMS Health
- read the article from the Washington Post

Related Articles:
Moody's downgrades pharma industry. Report
Patent 'cliff' looms for Big Pharma. Report
Generic competition heats up. Report
PwC to pharma: Adapt and invest or die. Report
Is pharma's drug discovery model sustainable? Editorial

Analyst: Generics makers sitting pretty

Fri, 07 Sep 2007 06:59:54 -0400

Speaking of generic drug makers, here's a news flash: Their revenue will continue to soar in coming years, according to a top industry analyst from IMS Health.

Global sales of generics already are growing at 14 percent annually, compared with single-digit increases at brand-name drug makers. Medicines worth $12 billion lose patent protection this year, and $20 billion will go unprotected next year.

But, the analyst said, a dearth of innovation in brand-name drugs won't end by hurting Big Pharma--it will wound generics makers, too, because their growth depends on having new drugs to copy. And the rise of generics makers in India and China will bring price competition to the party. None of this is news to alert observers of the industry, but it was said at a conference podium, so that makes it official.

- check out the AP report for more information

Related Articles:
FDA backlog slows generic drug approval. Report
Patent 'cliff' looms for Big Pharma. Report
Democrats to push for generic biotech drugs. Report
Generic competition heats up. Report

Companies tackle prescribing data laws

Thu, 30 Aug 2007 06:59:58 -0400

In the pharma world, the divide between public and private is often the front line of a fierce market fight. Case in point: A group of companies that buy prescription data and then analyze the haul for information on doctors' prescribing patterns are out to block new state laws that put a freeze on their work. IMS Health, Wolters Kluwer Health and Verispan are going to court in Maine and Vermont, saying their new laws would simply block access to vital data without doing a thing to lower the cost of pharmaceuticals. The new legislation would also crimp their data sales to pharma companies, who use the information to market their drugs.

Some physicians have howled in protest about having their prescribing habits tracked--but recent reports suggest that few have signed up on new registries designed to keep those habits private. The states, meanwhile, say they learned from a recent lawsuit involving New Hampshire and will take up the battle with the data companies.

- see the release on the suit
- here's the report from the Wall Street Journal (sub. req.)

Related Articles:
Pharmas protest NH drug info law. Report
NH ban on prescription data use overturned. Report
States tighten screws on pharma marketers. Report
Physicians protest prescribing-data use. Report