By SCOTT HENSLEY
Staff Reporter of THE
WALL STREET
JOURNAL
Crestor,
AstraZeneca PLC's much-anticipated cholesterol drug, is sure to have side
effects -- on other drug makers.
Now in late-stage development, Crestor has an excellent shot at becoming an immediate blockbuster when it has its expected U.S. launch next year. Pulses are racing at other drug companies as London-based AstraZeneca considers whether to tap a U.S. partner for the rollout.
![[Go]](../images/Marketplace-is.gif){kind=small} AstraZeneca
Prepares to Battle Pfizer for Cholesterol-Lowering Drug Market (March
19) |
The partner, if AstraZeneca chooses one, will almost instantly become a marquee player in the exploding market for cholesterol-lowering "statin" drugs. At present, 13 million Americans take prescription drugs to lower their cholesterol, but that number could almost triple under new, more aggressive cholesterol guidelines issued last month by a government health panel. Statins, already the largest-selling drug category with U.S. sales of nearly $10 billion last year, are expected to grow by 30% this year alone to about $13 billion.
Crestor is the newest and potentially most powerful member of the statin family. And it represents a serious threat to the pair of gorillas at the head of the statin pack: Pfizer Inc.'s flagship drug, Lipitor, which had U.S. sales of $4.72 billion last year, according to data from NDCHealth, of Atlanta, and Merck & Co.'s Zocor, with U.S. sales of $2.93 billion. Annual sales of Crestor in the U.S. could hit $4.5 billion in 2005, says investment firm Sanford C. Bernstein of New York.
Crestor, Lipitor and other statins lower cholesterol by slowing an enzyme in the liver that produces LDL, the "bad" cholesterol that delivers fat to arteries. Statins also modestly increase production of HDL, the "good" cholesterol that removes fat from arteries. The latest clinical data show Crestor edged out even Lipitor in lowering LDL.
As pharmaceuticals players brace for Crestor's arrival next year, they are preparing to wage the drug-marketing equivalent of trench warfare. Pfizer, Merck and AstraZeneca and its partner are expected to mobilize armies of sales reps and deploy weapons including extensive consumer ads and scientific studies supporting the use of one cholesterol fighter over another. Pfizer says it expects to spend $500 million on new clinical studies just to support the use of Lipitor in various groups of patients.
AstraZeneca, which expects to apply for Food and Drug Administration approval for Crestor this month, confirms it is reviewing proposals for sales partners but declines to comment on candidates or the process. "There's an incredible interest in Crestor," a company spokeswoman says. "We'll probably make some sort of announcement in the third quarter."
Among the drug giants thought to be in the running are Bristol-Myers Squibb Co., whose chances appear strong. Other possible candidates include American Home Products Corp. and Johnson & Johnson.
![[Statin Power]](../images/2f_crest06202001215555.gif)
However, there's the possibility that AstraZeneca won't choose a partner. "My very strong feeling is that they won't," says Richard Evans, a drug analyst with Sanford C. Bernstein. He says the company's sales force is big enough to cover all the important doctors.
More than 230,000 cardiologists, family practitioners and internists may prescribe cholesterol drugs. AstraZeneca could reach 80,000 or so heavy prescribers with its sales force of about 5,000 representatives, the third largest behind Pfizer and GlaxoSmithKline PLC, according to Scott-Levin, a Newtown, Pa., research firm.
AstraZeneca has a lot riding on Crestor. The company needs a new drug to cushion the blows its ulcer drug Prilosec will be getting from generic competitors. Later this year, AstraZeneca is expected to lose patent protection on Prilosec, its best-selling drug with U.S. sales of $4.2 billion last year.
Then why consider a joint venture? For one thing, it doesn't cost anything to entertain suitors, and each one provides some sales ideas and sometimes even detailed market research. Plus, there is a strong precedent for hiring a marketing partner with extra sales muscle for an important product with entrenched competitors.
In 1997, Pfizer, for example, helped Warner-Lambert Co. turn Lipitor, a latecomer to the statin field, into a star by touting its superiority in lowering cholesterol. Pfizer eventually mounted a hostile takeover of Warner-Lambert to keep the valuable Lipitor franchise from falling into another company's hands.
To build demand quickly, AstraZeneca might rely on a partner's sales force to call on certain prescribers or to have a fresh face reinforce the message with key doctors. In its search, AstraZeneca is said to be driving a hard bargain: It is said to be requiring that a partner immediately pony up a large share of the selling and administrative expenses for Crestor and delay taking commissions on sales.
Bristol-Myers Squibb, of New York, tops the short list of potential partners. "The rumor has been that Bristol-Myers Squibb is very interested, and the company has done very little to squelch that rumor," says Michael Krensavage, a drug industry analyst at Raymond James.
Bristol-Myers would be keen to give its sales reps a sexy product like Crestor to use as a calling card with primary-care doctors. The company's pipeline is running dry as a number of its top-selling drugs, including diabetes remedy Glucophage and cancer blockbuster Taxol, face low-price generic competition. The company is still reeling from its decision to temporary withdraw its hypertension drug Vanlev from FDA consideration because of side effects.
In addition, Bristol-Myers has experience selling statins, namely Pravachol, one of the earliest ones. It rang up $1.54 billion in U.S. sales last year, according to NDCHealth, which tracks drug sales, but it has been losing market share and is particularly vulnerable to competition from Crestor -- an incentive for Bristol-Myers to make a deal. A company spokeswoman declined to comment.
American Home Products, of Madison, N.J., would love to land Crestor, some analysts say, because it would make a good companion with an increasingly popular blood-pressure drug, Altace, that American Home sells under a co-marketing agreement with King Pharmaceuticals, of Bristol, Tenn. American Home has bulked up its sales force for cardiovascular drugs and would make "an ideal partner," says Ed Pykon, an analyst with Fred Alger Management, New York. But he worries the company hasn't pursued Crestor vigorously enough to prevail. A company spokesman declined to comment.
Johnson & Johnson, of New Brunswick, N.J., has a large drug sales force that is also hungry for new products, analysts say. Eli Lilly & Co., of Indianapolis, lacks a strong franchise in cardiovascular drugs, but its sales reps will have plenty of time on their hands when Prozac loses patent protection in August. Spokesmen for both companies declined to comment.
Write to Scott Hensley at scott.hensley@wsj.com
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March 19, 2001
By GAUTAM NAIK and RON
WINSLOW
Staff Reporters of THE
WALL STREET
JOURNAL
AstraZeneca PLC is gearing up for war with Pfizer Inc. over one of the pharmaceutical industry's single biggest prizes -- the $13 billion (14.51 billion euros) global market for drugs that can reduce risk of heart attack by lowering cholesterol.
![[Go]](../images/Front-is.gif){kind=small} 1
New AstraZeneca Drug Slashes Cholesterol Levels 65% in Trial (June 29,
2000)
|
The British drug maker is expected to announce data Tuesday from several human trials showing that its experimental drug Crestor is significantly more potent in reducing cholesterol levels than Pfizer's Lipitor. AstraZeneca expects to file for U.S. and European regulatory approvals in about three months, and hopes to have Crestor available for patients in some markets by next year.
"We're confident we have an excellent product," says Hamish Cameron, head of AstraZeneca's cardiovascular therapy group. "Our data will confirm that."
Brewing Showdown
The brewing scientific and marketing showdown will pit Crestor against Lipitor, the world's No. 1 cholesterol drug, which racked up $5.83 billion in sales last year. Along with Merck & Co.'s Zocor and Bristol-Myers Squibb Co.'s Pravachol, two older drugs with a somewhat less potent cholesterol-lowering profile, the medicines belong to a pharmaceutical class known as statins. These drugs are transforming the treatment of heart disease by substantially reducing a patient's risk of heart attack and death from heart disease, the western world's leading cause of death.
![[chart]](../images/crestor03182001205145.gif)
Lipitor, which was developed by Warner-Lambert Co. before that company was acquired last year by Pfizer, was the fifth statin on the market when it was introduced in early 1997. In a co-marketing arrangement between Pfizer and Warner-Lambert, the companies quickly persuaded doctors to prescribe Lipitor by arguing its edge in reducing cholesterol made it more effective in preventing disease. With new data on the potency of Crestor now in hand, AstraZeneca hopes to soon out-Lipitor Lipitor.
Partly to prepare for the battle, AstraZeneca hired 1,300 additional sales representatives in the U.S. in the last year. It also tapped two former Warner-Lambert executives who played significant roles in the development and initial marketing of Lipitor. It also may strike a co-marketing deal with another large drug maker to help it sell the drug in the U.S.
Though the new statin is probably 15 months or more away from the market -- at least in the U.S.
Pfizer has invested more than $500 million in clinical studies of Lipitor involving nearly 80,000 patients. Among other things, Pfizer expects the trials to demonstrate the effectiveness of aggressive cholesterol lowering in preventing heart attacks and strokes. "We've got a freight train of data coming over the next six years," says Rob Scott, vice president in Pfizer's cardiovascular group who oversees the team that markets Lipitor. He argues that it will take years for AstraZeneca to develop such data to support marketing of Crestor.
Both companies will benefit from the fact that millions of patients at risk of a heart attack in the U.S., Europe and elsewhere still aren't taking any statin, an underserved market that will be targeted by all statin makers.
Researchers will present results of large Crestor studies Tuesday at a meeting of the American College of Cardiology in Orlando, Fla., but the college posted summary reports of the findings on its Web site several weeks ago. They show the new rival to be superior to Lipitor in several measures of effectiveness, including reduction of so-called LDL, or bad, cholesterol, an increase in good, HDL cholesterol and more potency at low doses. For instance, Crestor at five-milligram and 10-milligram doses lowered LDL cholesterol by 40% and 43%, respectively, compared with 35% for 10 milligrams of Lipitor. Another finding: For patients with a genetic defect that results in extraordinarily high levels of cholesterol, Crestor led to 24% of patients reaching acceptable levels compared with 3% for Lipitor.
Lipitor demonstrated similar benefits as compared with Zocor when that drug was the market leader. Pfizer's Dr. Scott has seen the results on the Web site, but declined to address the specific findings until the data are presented. He said Pfizer plans to continue delivering the message that lower is better -- a strategy that likely will prime the market for its new rival when it eventually is released.
Write to Gautam Naik at gautam.naik@wsj.com3 and Ron Winslow at ron.winslow@wsj.com4
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By RACHEL ZIMMERMAN
Staff Reporter of THE WALL STREET
JOURNAL
AstraZeneca PLC said its experimental lipid-lowering agent cut cholesterol levels up to 65% in early trials, setting up a potential battle between the British pharmaceutical company and rival Pfizer Inc., New York, which currently dominates the so-called "statin" market with the cholesterol-lowering drug Lipitor.
In second-phase clinical trials over the course of six weeks, AstraZeneca's medication ZD4522 reduced low-density lipoprotein cholesterol levels an average of 65% at an 80 mg dose among 206 patients. It also increased high-density lipoprotein cholesterol levels -- so-called "good" cholesterol -- up to 14%.
Researchers, who announced their findings Wednesday at an International Society of Atherosclerosis meeting in Stockholm, reported that 90% of cholesterol reduction was seen in the first two weeks of treatment and the most commonly reported side effects were gastrointestinal disorders and headaches. Phase III trials already are under way, a company spokesman said, adding that if results are positive, AstraZeneca will apply in the second quarter of 2001 for regulatory approval to market the drug.
When early promising test results were presented late last year, investors speculated that ZD4522 could be a blockbuster for AstraZeneca and compete with Lipitor in the $9 billion statin market.
"We are totally confident, with the profile already given, that this will be more effective at lowering cholesterol than Lipitor," said Tom McKillop, AstraZeneca's chief executive, speaking earlier this week at the opening of the company's new $100 million research facility in suburban Boston. Lipitor's annual sales are about $4 billion world-wide. Other widely used statins include Merck & Co.'s Zocor and Mevacor and Bristol-Myers Squibb Co.'s Pravachol.
Rob Scott, head of the cardiovascular and metabolic medical group for Pfizer says it is too early to assess the new drug's potential. "We've been watching the development of this compound with interest," he said, adding that Phase II trials can be misleading because they are conducted on a small group under tightly controlled conditions. "In third-phase trials, with larger groups of patients, it's more of a real-world situation and the data tends to be less astounding."
High LDL cholesterol is one of the most significant factors contributing to coronary artery disease, in which arteries supplying blood to the heart are blocked by cholesterol-filled plaques.
In 4 p.m. New York Stock Exchange composite trading Wednesday, AstraZeneca rose $1.0625 to $44.8125. Pfizer rose 42.2 cents to $46.58 a share.
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January 24, 2000
By RON WINSLOW
Staff Reporter of THE WALL STREET
JOURNAL
ANN ARBOR, Mich. -- If not for the impassioned pleas of a biologist 11 years ago, the unusual genetic illness of a South African boy and a "left-handed" chemical, the titanic drug-industry tug of war over control of Warner-Lambert Co. probably wouldn't be happening.
All played crucial roles in the discovery and development of a superpotent cholesterol-lowering drug that is central to the Warner-Lambert battle that now pits Pfizer Inc. against American Home Products Corp. and Procter & Gamble Co. The drug, Lipitor, although available only since 1997, is already expected to become the biggest-selling prescription medicine in the world. By itself, Lipitor will generate profits that will assure its eventual owner strong financial growth and the funds to fuel new drug research for the next 10 years.
|
1
P&G's Board May Discuss Buying Warner-Lambert, American Home (Jan. 21)
|
Indeed, Lipitor is already transforming heart care world-wide. Just one of five similar-acting drugs known as statins that reduce dangerous cholesterol levels in the bloodstream, Lipitor can do it more effectively than its rivals, and that will help it post world-wide sales of more than $5 billion this year, outpacing Merck & Co.'s Zocor and Bristol-Myers Squibb Co.'s Pravachol.
This spring, Lipitor is expected to be introduced in Japan's $2 billion statin market. And U.S. heart experts are discussing revisions of national cholesterol guidelines that some think will double the number of Americans regarded as prime candidates for statins to more than 25 million. Although a potent new rival could emerge from AstraZeneca PLC by 2002, many analysts believe that Lipitor is on a trajectory to become the first-ever drug to garner $10 billion annually.
Yet Lipitor very nearly didn't make it out of Warner-Lambert's labs here at the company's Parke-Davis research facility. How it was transformed from an initially unspectacular compound known as CI-981 to the most prized drug-company product ever illustrates the role chance and the dedication of a handful of people can play in a medicine's success.
During more than a decade of development before its launch in February 1997, the drug overcame a series of scientific and strategic challenges within Parke-Davis, almost any one of which could have derailed the compound. Then, in the home stretch toward approval by the Food and Drug Administration, marketing strategies by Warner-Lambert's chief competitors unwittingly laid the groundwork for Lipitor to become a sensation from the day it hit pharmacy shelves.
'Boggles the Mind'
"The number of factors, internal and external, that had to come together for the drug to be a success really boggles the mind," says Bruce D. Roth, a senior director and chemist at Parke-Davis who invented the molecule that became Lipitor.
![[illustration]](../images/mrkt_lipitor101232000202402.gif)
One of the most boggling episodes -- in retrospect, at least -- came near the beginning. In the early 1980s, Dr. Roth and his colleagues were several months into the development of a different compound only to learn that Sandoz AG, the former Swiss drug company that is now part of Novartis, had obtained a patent for it. So they switched to a different molecule. Lipitor was actually Parke-Davis's Plan B.
Once scientists turned to Lipitor, the pivotal moment came in late 1989, when top executives at Parke-Davis met to consider whether to advance CI-981 into human trials. Scientists had by then spent eight years developing the compound, and there was a problem: In animal studies, it proved no better than competitors at reducing cholesterol. With one statin already on the market and three others in late-stage human studies, some officials argued that the potential payoff was too slim to justify further development.
But Roger Newton, a biologist who co-directed development of the drug with Dr. Roth, mounted an impassioned defense. "We'd spent a lot of years and blood, sweat and tears on this compound," he says. "Why would you spend all this money just to get to the edge of where you find out if it's viable?"
Indeed, scuttling CI-981 would have wasted an intense, two-year effort to come up with a process to manufacture the drug in commercial quantities. Dr. Roth's initial Lipitor molecule had what chemists describe as both left-handed and right-handed sides. But only the left-handed portion latched onto targets in the body, blocking enzymes and causing a reduction in cholesterol. The inactive, right-handed side amounted to a glove that wouldn't fit.
Dr. Roth and his colleagues worried that this would leave their synthetic compound less potent than rivals from Merck and Bristol-Myers, which are natural molecules with no inactive components. Moreover, a lot of inactive material could cause unwanted side effects and even jeopardize approval at the FDA. "It forces patients to metabolize 50% of material that is of no value to them," Dr. Roth explains.
'Right Relationship'
In collaboration with other scientists, Dr. Roth fashioned a version of the molecule that was only left-handed, but it proved especially tricky to produce in large batches. "The chemistry needed to get the right relationship of the atoms was just coming available," says Jim Zeller, a chemist in the company's Holland, Mich., facilities, where the scale-up work was done. He and his colleagues spent months experimenting with various processes, but they kept getting side reactions that produced right-handed gloves.
Finally, after a global search for equipment, the scientists hit pay dirt by running their reactions at liquid-nitrogen-cooled temperatures lower than minus 80 degrees Celsius. A manufacturing process that took three weeks from raw materials to end product yielded a compound that was 100% left-handed gloves.
Ultimately, though, the decision to move forward with CI-981 was based on less esoteric factors. Lopid, the company's top-selling drug at $600 million in annual sales, was about to come off patent. The market for statins was expected to be so big that even if this one got just a 10% share, it could become Warner-Lambert's top seller. And, other than a new antibiotic and an experimental treatment for Alzheimer's disease, the pipeline was anemic. Says Donald Black, vice president of clinical research: "We were desperate."
But desperation turned to elation after the first tests of the drug on 24 employee-volunteers. At 10 milligrams, LDL, or bad, cholesterol dropped 38%. That was as good as or better than competing compounds at their recommended maximum doses. At 80 milligrams, LDL dropped 58% -- about 40% more than any other statin at any dose.
"You could tell immediately that this was something really different," says Dr. Black. "This was the real deal."
Based on those results, Dr. Black devised an all-or-nothing strategy for the trials needed to win FDA approval: Parke-Davis would test 10 milligrams as a starting dose and 80 milligrams for patients with especially high cholesterol. "It allowed you to go for a strategy that essentially took the competition out," says Ronald M. Cresswell, who recently retired as head of Parke-Davis. "You were going to beat them at LDL even at your lowest dose."
But there wasn't any assurance at the time that the market would want a supercharged low-dose pill. Indeed, because of studies in the 1980s linking low cholesterol with an increased risk of death from non-heart-related illnesses, many doctors in the early 1990s were wary of aggressive treatment. Dr. Cresswell himself was modestly reducing his own LDL levels by taking a Merck statin then and says his heart doctor told him the market didn't need a more potent pill.
The 80-milligram strategy was risky too. If it turned out to have unacceptable side effects, it could taint the drug even at low doses and leave the company with only a 10-milligram tablet to take to the market.
But results of larger studies vindicated Dr. Black's strategy. In October 1994, he and his colleagues made the first public presentation of human trial data of the compound -- now known as atorvastatin -- at a scientific conference in Montreal. The results were so stunning a senior Merck official stood up to suggest the drug be called "turbostatin."
'You've Got a Winner'
Even Dr. Cresswell's cardiologist would come around. In 1995, Dr. Cresswell enrolled in a special clinical program to get the drug before the FDA had approved it and, at 20 milligrams a day, his LDL fell from 160 to 90 -- below the 100 goal for people with heart ailments. "I faxed my results to him," Dr. Cresswell recalls. "I got faxed back: 'You've got a winner.' "
But other challenges loomed. Scientists wondered how they could persuade the FDA that the compound deserved "fast-track" review, a status reserved for products that fill an unmet medical need and can shorten the time to market by at least six months. The problem: By mid-1994, four other statins were already on the market.
So the company approached two South African doctors who had a group of patients with a rare genetic disorder that impaired their ability to clear cholesterol from their bodies. For children born with two copies of the defective gene -- one from each parent -- the condition is particularly severe: a cholesterol level of 600 or more, compared with about 200 for the average adult. Such children typically suffer heart attacks or have bypass surgery by their teens. "If we can't do anything," says Frederick J. Raal, head of the lipid clinic at Johannesburg General Hospital, "the average age of death is about 14 years."
Previously, the doctors had tried Merck's Zocor -- the most powerful statin then on the market -- on these patients with little effect, but they agreed to try Lipitor.
Among 10 such children in the clinic was a youngster named Andre who had a cholesterol level of 1,100, "the highest I'd ever seen," Dr. Raal says. Like others, he had tell-tale signs of the condition: tiny lumps of cholesterol deposits just under the skin between his fingers and around his knuckles.
Within a month of starting on Lipitor, the children's cholesterol started coming down. Andre's dropped to about 700; that of others, who didn't start so high, fell much lower. "It was the first time we found a medication that was really working in this group of patients," says Dr. Raal. It wasn't always enough. Andre died late last year of a heart attack at age 10, four years after he began taking the drug. "We never got his cholesterol to anywhere near normal," Dr. Raal says. But several other young patients continue to do well.
The South Africa results were enough for the FDA to put Lipitor on priority review. The company enrolled the last patient in its major trial in October 1995 and filed for approval in June 1996. Six month later, Lipitor was cleared to begin sales.
Yet, in the months leading up to approval, top Warner-Lambert officials were still uncertain about what they had. The company had recently emerged from an FDA-ordered halt to the manufacture of several old-line drugs because of quality problems. Cognex, its once-touted Alzheimer's disease drug, had failed to match blockbuster sales expectations.
Meantime, sales of Merck and Bristol-Myers were beginning to soar. Both had recently completed large-scale, long-term studies showing use of their drugs reduced deaths and heart attacks among high-risk patients. Warner-Lambert had no data to support such claims. Selling what was vulnerable to being branded a niche product against two marketing powerhouses seemed daunting.
More Skeptics
Wall Street was skeptical, too. Dr. Cresswell says he and Warner-Lambert's then-chairman Melvin Goodes, who was also on Lipitor after having taken a Merck pill for years, sought to drum up enthusiasm by regaling analysts with their own before-and- after cholesterol numbers. But investors continued to question its prospects.
These were among the factors that led the company, shortly before FDA approval, to seek out a marketing partner for Lipitor. Out of several companies that expressed interest, Pfizer, highly regarded for its marketing, was chosen.
It wasn't until the product-launch meeting staged in a big auditorium atop San Francisco's Nob Hill early in 1997 that Warner-Lambert's mindset about Lipitor seemed to change. Roger Newton, the drug's ardent champion, Dr. Black, its chief strategist, and Dr. Cresswell spoke to an increasingly enthusiastic hall in an atmosphere that resembled a rock concert.
Then the price was announced. Instead of demanding a premium reflecting Lipitor's superior potency, the Warner-Lambert-Pfizer partnership had decided to go for a knockout punch by pricing it lower than Merck's top seller, Zocor. "The roar almost lifted the roof off the place," says Dr. Cresswell.
The market soon became enthusiastic too. Thanks in part to Merck's and Bristol Myers's own big studies, doctors began to embrace the statins. Lipitor, with its low-dose power and competitive price, hit the market just as worries about going too low on cholesterol were giving way to the belief that lower is better.
"Merck and Bristol-Myers spent 10 years educating doctors to get them to use their drugs," says Kevin Graham, a cardiologist at Minneapolis Heart Institute, Minneapolis. "But Lipitor, at lower doses, is a much better deal. It's kind of a marketing coup."
All of this comes with plenty of irony for Warner-Lambert. In the mid-1990s, the company was on every stock analyst's list of likely takeover candidates amid a consolidating pharmaceutical industry. Inside the company, Lipitor came to be viewed as the only hope for Warner-Lambert to remain independent. Now, it's the reason the company is all but certain to be acquired, and it's triggering a reshaping of the entire global pharmaceutical industry.
Why is it so powerful? The scientists who developed it credit the left-handed glove, along with an attribute that wasn't apparent in any of the early studies: It has a much longer half-life than its competitors, meaning it lingers in the body much longer to do its work.
"The beauty of this is it shows that serendipity is still left in science," says Dr. Newton, now chief executive of Esperion Therapeutics Inc. of Ann Arbor. "You have to follow your nose and your instincts. You create your luck."
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Copyright © May 20, 2008 6:25 AM by Karl Loren on behalf of Vibrant Life, ALL RIGHTS RESERVED. Permission is granted for non-commercial downloading, copying, distribution or redistribution on two conditions: One, that some form of copyright notice is included in every copy distributed or copied, showing the copyright belonging to Vibrant Life, Burbank, CA, at www.oralchelation.com . The second condition is that the material is not to be used for any purpose contrary to the purposes and objectives of this site. This permission does not extend to materials on this site which are copyrighted by others.
