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Chemistry and Industry - Crestor takes heart

admin — Sun, 04 Jan 2009 17:21:02 +0000

The METEOR trial examined AstraZeneca’s Crestor (rosuvastatin) in patients with early signs of atherosclerosis. C&I notes that because the METEOR study did not show regression of atherosclerosis, it ‘dashes hopes for an expanded label’ (C&I 2007, 7, 7). While METEOR did not show regression, this was not its primary endpoint. METEOR was designed to see if Crestor could halt the progression of atherosclerosis in patients at low-risk for coronary heart disease with early signs of atherosclerosis as determined by an increased carotid intima-media thickness. The study met its primary endpoint and demonstrated a slowing of progression of atherosclerosis in these patients.

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Leading cardiologists, financial analysts and news outlets recognised that METEOR slowed the progression of atherosclerosis. Below please find examples of what these industry leaders have said about METEOR.
‘It met its pre-specified end point and there are not a lot of trials here at this whole meeting that met their end point.’–Steven Nissen, Reuters, 25 March, 2007
‘The core clinical message is that aggressive statin therapy seems to slow progression of atherosclerosis even in people where the LDLs are low.’–Paul Ridker, TheHeart.org, 25 March, 2007
‘The difference in growth between the Crestor and placebo groups was enough to demonstrate that Crestor significantly slowed progression.’–The Associated Press, 25 March, 2007
‘These data alongside ASTEROID demonstrate that Crestor can provide a significant disease modifying effect across the risk-spectrum of atherosclerosis.’–Deutsche Bank
‘We believe Crestor is the best statin available.’
–JP Morgan
Adam Silverstein
Edelman
COPYRIGHT 2007 Society of Chemical Industry
COPYRIGHT 2008 Gale, Cengage Learning

AFP - Anti-cholesterol drug Crestor reverses plaque buildup: study

admin — Thu, 01 Jan 2009 00:26:03 +0000

ATLANTA, United States (AFP) — The anti-cholesterol drug Crestor has been found to reverse plaque buildup in the arteries of the heart, according to a study released.
Unlike other anti-cholesterol medications, which have been found merely to slow the buildup of plaque responsible for arteriosclerosis, Crestor, manufactured by the British drug company AstraZeneca, was actually found to help break up accumlations of plaque in the arteries.
“It’s good news for patients,” Steven Nissen, a doctor with the Cleveland Clinic and lead author of the study.
“Previous similar studies … have shown slowing of coronary disease, but not regression,” he said at a press conference here on the margins of the 55th annual meeting of the American College of Cardiology.

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The upbeat news about Crestor’s plaque-reducing properties is counterbalanced however, against earlier reports of …

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Medical Marketing and Media - Disciplined mix for next Crestor effort

admin — Sat, 27 Dec 2008 11:41:03 +0000

IN THE WAKE OF new safety issues, AstraZeneca has disclosed plans for a upcoming DTC initiative for Crestor. Noting rapid growth in the U.S. statins market, chief financial officer John Symond told analysts there will be a “disciplined” approach to a marketing mix that carries significant investment in the new Crestor campaign.
Symond attributed the growth to promotion efforts for this drug class and lower LDL levels recommended for patients.
Meanwhile, Public Citizen Health Research Group director Sidney Wolfe said in a letter to the FDA that Crestor “is uniquely toxic without offering any unique benefit.”

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-James G. Dickinson
Copyright CPS Communications Jan 2005
Provided by ProQuest Information and Learning Company. All rights Reserved

Chain Drug Review - Withdrawal of Crestor urged

admin — Thu, 25 Dec 2008 04:41:03 +0000

The Health Research Group charges that Crestor, a recently approved cholesterol-lowering drug, holds more potential harmful side effects than similar medications. But the FDA and manufacturer AstraZeneca PLC assert that the risk-to-benefit equation in Crestor is similar to that of the other drugs.

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HealthDay - Crestor for High Cholesterol

admin — Tue, 23 Dec 2008 12:26:03 +0000

Only a month after getting a government advisory committee’s go-ahead, Crestor (rosuvastatin) has received approval from the Food and Drug Administration (FDA) to be used to fight high cholesterol.
Crestor, a prescription medication, is in a class of drugs known asHMG-CoA reductase inhibitors (statins).
The FDA, in granting its approval, said:

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“Rosuvastatin was approved based on multiple trials of at least 6 weeks duration in which Rosuvastatin treatment was compared to placebo and other marketed statins. In these trials, rosuvastatin reduced total-C, LDL-C, and TG and increased HDL-C with therapeutic response occurring within one week and maximum response seen at four weeks. Approximately 12,000 patients …

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AstraZeneca PLC:Third Quarter and Nine Months Results 2008

admin — Thu, 18 Dec 2008 04:51:02 +0000

Robust third quarter performance.
Third quarter sales increased by 3 percent at constant exchange rates (CER). Core EPS increased by 20 percent at CER to $1.32.
Third quarter sales in Emerging Markets increased by 18 percent at CER to $1.1 billion. Sales in China increased by 35 percent.
Crestor sales up 28 percent (CER) in the third quarter. US sales increased by 23 percent fuelled by atherosclerosis indication. Crestor is the only branded statin to gain market share in the US this year.
Nine months sales increased by 3 percent and Core EPS by 8 percent at CER.
Core EPS target for the year increased to reflect stronger operational and financial performance as well as additional currency benefit.

Revised target range for Core EPS is $4.90 to $5.05.*

No further share repurchases will take place in 2008 in order to maintain the flexibility to invest in the business.

LONDON, Oct. 30, 2008-David Brennan, Chief Executive Officer, said: “AstraZeneca has delivered a robust set of results that deliver on our performance commitments despite an increasingly challenging environment for the pharmaceutical sector and business in general. We continue to make good progress on reshaping our cost base, including advancing innovation in our research and development activities with greater productivity and efficiency. I am pleased to be able to raise our financial guidance for the full year on the back of these results.”
For full report, see attachment

Internal Medicine News - Simvastatin trial points to benefits in PCOS.(Women’s Health)(polycystic ovarian syndrome)

admin — Tue, 16 Dec 2008 14:01:02 +0000

LOS ANGELES — Simvastatin lowered testosterone levels by 41%, normalized gonadotropin levels, and reduced cardiovascular risk factors in a small, randomized, controlled trial, suggesting that statins may be a potential treatment for polycystic ovarian syndrome.
The findings suggest that “statins would improve the metabolic profile in those patients in terms of lipid levels as well as improve the hormonal problems,” study investigator Antoni J. Duleba, M.D., said at the annual meeting of the Society for Gynecologic Investigation.

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Elan: Elan Signs License Agreement with Abbott for Elan’s Proprietary NanoCrystal(R) Technology; To Develop a Single Fixed-Dose Combination of TriCor(R) and Crestor(R) for High Cholesterol Patients

admin — Sun, 14 Dec 2008 16:01:02 +0000

DUBLIN, Ireland–(BUSINESS WIRE)–July 6, 2006–Elan Corporation, plc (NYSE:ELN) today announced that it has entered into a License Agreement with Abbott Pharmaceutical PR Ltd (NYSE:ABT) in which Abbott has been granted US rights, in a partnership with AstraZeneca Pharmaceuticals, LP, to utilize Elan’s proprietary NanoCrystal Technology to develop and commercialize a single fixed-dose combination product containing the active pharmaceutical ingredients in Abbott’s TriCor(R) 145 (fenofibrate) and AstraZeneca’s Crestor(R) (rosuvastatin calcium) products. Under the terms of the License Agreement, Elan will receive payments upon the achievement of development, clinical, and regulatory milestones for such new combination product. Additionally, Elan will receive royalty payments based on US sales of the combination product, if successfully developed and commercialized.Under the License Agreement, Elan’s NanoCrystal Technology may be utilized in the combination product in order to optimize bioavailability and absorption in patients. TriCor(R) 145 and Crestor(R) are both currently marketed and used to treat adults with high cholesterol. TriCor, part of a class of medications called fibrates, has been shown to predominately reduce triglycerides, a form of fat or lipid obtained through food sources, raise HDL cholesterol and lower LDL cholesterol. Crestor is part of a class of medications called statins, which have been shown to reduce LDL cholesterol. The successful combination of the two products into one oral dosage form, could provide patients with a single treatment.Presently, health care professionals are advised to consider carefully the benefits of the combined use of fibrate and statin drugs, in light of concerns regarding potentially serious side effects that could lead to acute renal failure. Rigorous clinical study of these agents in combination to evaluate their safety and efficacy is important for patients and warranted, and could produce an important new comprehensive cholesterol treatment tool for physicians.”We are very pleased to execute this agreement, which follows on from the successful application of our NanoCrystal Technology in the current TriCor 145 product. We hope applying this technology will result in the successful development and launch of a combination product that will benefit patients”, commented Paul V. Breen, Executive Vice President and Head, Elan Drug Technologies.About NanoCrystal(R) Technology and Elan Drug TechnologiesElan’s NanoCrystal technology is a proven, robust, drug optimization technology enabling solubility easily and effectively for many poorly water-soluble compounds. The technology which can offer enhanced commercialization opportunities is covered by 1,077 U.S. and foreign patents and patent applications and is part of a suite of technologies which Elan’s Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.Currently four products marketed in the United States utilize Elan’s NanoCrystal Technology, including TriCor(R) (marketed by Abbott), Megace(R) ES (marketed by Par Pharmaceuticals) and Rapamune(R) (marketed by Wyeth).The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visitwww.elan.com/EDT.About ElanElan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visithttp://www.elan.com.About Crestor(R)Crestor (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. Crestor has not been determined to prevent heart disease, heart attacks or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of Crestor is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C greater than 190 mg/dL) and aggressive lipid targets, a 20mg starting dose may be considered. AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co., Ltd.Crestor (rosuvastatin calcium) Important Safety InformationCrestor is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Crestor and with other drugs in this class. The 40mg dose of Crestor is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of Crestor once daily. When initiating statin therapy or switching from another statin therapy, the appropriate Crestor starting dose should first be utilized, and only then titrated according to the patient’s individualized goal of therapy. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided.Crestor should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Crestor is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to Crestor were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).About TriCorTriCor (fenofibrate tablets) is a member of the fibrate class of medications, used to treat abnormal lipid levels in the bloodstream, including cholesterol and triglycerides. TriCor is a once-daily treatment available in 145 mg and 48 mg tablets that can be taken with or without food.TriCor, in addition to appropriate diet, is used to treat adults with high cholesterol, with or without elevated triglycerides (Fredrickson types IIa, IIb). TriCor reduces elevated LDL-C (”bad” cholesterol), total cholesterol, triglycerides and apolipoprotein B, and increases HDL-C (”good” cholesterol). The independent effect of raising HDL cholesterol or lowering triglycerides on the risk of cardiovascular morbidity and mortality has not been established with TriCor. Abbott markets TriCor in the U.S. through an agreement with Solvay Pharmaceuticals, Inc.TriCor, in addition to appropriate diet, is also used to treat adults with high triglycerides (Fredrickson types IV and V). Excessive body weight, drinking alcohol, diseases such as diabetes and hypothyroidism, and various drugs can contribute to high triglyceride levels and these should be assessed before a patient is prescribed TriCor tablets. TriCor should only be prescribed after reasonable attempts to modify lipid profile with diet modification, exercise and decreased alcohol consumption have failed. It is important for patients to stay on a diet restricted in saturated fat and cholesterol while taking TriCor.TriCor Important Safety InformationTriCor tablets are not for everyone. TriCor should not be taken by people with serious liver, kidney or gallbladder disease, or by those who may be allergic or sensitive to the drug.The combined use of TriCor and HMG-CoA reductase inhibitors (statins) has not been advised because of a potential for serious side effects that could lead to acute renal failure. The benefit of further alterations in lipid levels needs to be weighed against the increased risks of this drug combination.TriCor tablets may cause changes in laboratory reports, especially in liver chemistry results. Regular periodic liver tests should be performed while patients are taking TriCor. Patients should

Research proves that drug reverses heart disease

admin — Tue, 09 Dec 2008 00:36:03 +0000

People involved in the study got their “bad cholesterol” to the lowest levels ever and, as a result, they noticed that blockages in their blood vessels declined. It’s too early to state whether the shrinkage of deposits in arteries will result in fewer heart attacks, but doctors were enthusiastic about the possibility.

“The holy grail has always been to try to reverse the disease,” and this shows how to do it, stated Dr. Steven Nissen, the cardiologist at Cleveland Clinic and the head of this nationwide experiment. He reported its results during a meeting of heart doctors.

“This is a paper to take seriously. It’s another chapter in the story, a proof of principle,” emphasized Dr. Elizabeth Nabel, head of the National Heart, Lung and Blood Institute.

The study examined 349 participants. Two-thirds of them experienced regression of heart artery buildups when they received the maximum dosage of Crestor. It is the most powerful of the cholesterol-lowering statin drugs and one criticized by the consumer group Public Citizen, which claims that Crestor causes more side effects than other drugs of this type.

The group declared on Monday that the study “does not alter our assessment that Crestor has unique risks without evidence of unique benefits” and it should not be prescribed, particularly at the dosage used in this study unless lower dosage and other medicine didn’t help.

The study was sponsored by AstraZeneca PLC, the manufacturer of Crestor. Some reports have connected it with higher rates of severe muscle problems as well as kidney damage, particularly among Asians. Last year, Food and Drug Administration demanded an adequate warning on Crestor’s label.

No important safety issues were detected in the new study, but doctors said it was too minor to reveal rare side effects and was not conducted for that purpose.

The purpose was to check whether patients who already suffered from heart disease, not only increased cholesterol, could turn back time.

Clots in arteries are the major reason of heart attacks. Big clotes are treated either with angioplasty to flatten them or by surgery to bypass them, but doctors have long looked for a less radical solution that also treats minor buildups that can gradually worsen until squash vessels shut.

Statins such as Pravachol, Zocor and Lipitor have become top-selling drugs worldwide by gravely lowering bad cholesterol (LDL) responsible for clot formation.

In the research, Crestor not only decreased average LDL levels from 130 milligrams per deciliter of blood to around 60, but also increased “good cholesterol” (HDL) level from 43 to 49.

Doctors claim that this dual effect could cause blockages to shrink, as confirmed by ultrasound measurements before treatment and two years after.

The amount of each patient’s major blockage decreased 1 percent. The volume of buildup in the most clogged artery declined 9 percent, and in the total length of the vessel, 7 percent, on average.

“The results are very, very exciting and break new ground,” noted Dr. David Williams of Rhode Island Cardiology Center, who was not involved in the research.

According to Dr. Roger Blumenthal of Johns Hopkins University, it would have been better if the study had tested AstraZeneca’s drug against a lower dosage of another statin drug. Blumenthal’s opinion will appear in an editorial in the Journal of the American Medical Association. The study will be published in the journal in April.

The maximum dosage for Crestor is 40 milligrams per day. It means 80 milligrams for the weaker statins. Insurers have already restricted use of particular brands, something likely to increase in the next months as Zocor and Pravachol lose patent protection and cheaper generic drugs become available.

The research also gets back to debate about the desirable level of LDL. According to federal guidelines it is 70 in people who are at high risk of heart disease, but Nissen stated that the benefits noticed when it drops to 60 suggest that “as low as we can go might make more sense.”

“The body needs about 40 LDL, so we’re getting pretty close to what the body needs for general repair,” noted Dr. Christopher O’Connor, a cardiologist at Duke University who was not involved in the study.

Further details from the conference:

A cure for migraine headaches - patching a hole in the heart like in case of Ariel Sharon, the Israeli Prime Minister - failed to succeed in its first major test. Only three patients of the group of 74 whose holes were plugged did not suffer from more migraines six months later, the same cure factor as the 71 patients who received a sham procedure to make them think their hearts were being cured, said the leader of the study, Dr. Peter Wilmshurst of Royal Shrewsbury Hospital in England.

However, more patients with patched hearts had a considerable reduction in number of their headaches - a result that brings hope to the NMT Medical Inc. from Boston, the device’s maker. The company has commissioned a larger study of it in the USA.

Doctors reported promising results with the first completely absorbable stent, a small mesh scaffold used to prop open arteries. No blood clots, heart attacks or deaths were reported in the first 63 patients who got the experimental device made by Biotronik, a Berlin-based company, noted Dr. Raimund Erbel of University Clinic in Essen, Germany.

If further research prove that device is successful and safe, it could become the first one device of this type usable in children, who can’t use present metal as well as plastic stents coated with drugs because these devices are not able to grow as the children do.

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M2 Presswire - Investor Alert for Kosan Biosciences Inc.

admin — Sun, 07 Dec 2008 02:36:05 +0000

Par Pharmaceutical Companies, Inc. has announced that it’s partner, Genpharm Inc. of Toronto, Canada, has received final approval from the FDA for its Abbreviated New Drug Application for pravastatin 10 …

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