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Chemistry and Industry - Safety concerns over Crestor

admin — Mon, 12 Jan 2009 10:41:02 +0000

There have been questions over the safety of Crestor, the cholesterol drug on which AstraZeneca has pinned most of its hopes for future growth.
US patient group Public Citizen has asked the US Food and Drug Administration (FDA), to withdraw the drug, following the death of a patient who suffered from a muscle damaging condition called rhabdomyolysis, Baycol, Bayer’s successful cholesterol-fighting drug, was withdrawn from the market in 2001, when it was linked to dozens of rhabdomyolysis-related deaths worldwide.

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A 30-year old woman is reported to have died from kidney failure and rhabdomyolysis. Other patients have experienced similar side-effects. In the wake of the Baycol crisis, Crestor’s entry to market was delayed by almost a year, as the FDA demanded studies showing Crostor to be safer or more effective than existing statins.
However, AstraZeneca stands by its product, stressing that it was the most extensively studied drug in its class, with more than 40 000 patients involved in clinical trials and more than one million patients using the drug.
‘Public Citizen’s comments are nothing new,’ said a spokesperson. ‘AstraZeneca monitors the postmarketing adverse events, reports intensively and dedicates intensive efforts to follow up reports and evaluate individual cases.’
Meanwhile, French healthcare authorities have decided that Crestor should be covered under the country’s health service, but only after treatment with other statins. AstraZeneca points out that the same advice was originally given for Pfizer’s market-leading statin Lipitor.
AstraZeneca’s shares seemed unaffected by the news.
COPYRIGHT 2004 Society of Chemical Industry
COPYRIGHT 2008 Gale, Cengage Learning

Chemistry and Industry - FDA approves Crestor for AZ

admin — Sun, 11 Jan 2009 04:06:03 +0000

AstraZeneca’s second-generation cholesterol drug, Crestor, has finally been approved by the US Food and Drug Administration (FDA).
The drug, which is seen as a key product for the company, has been approved at all doses, and without the kidney testing requirements that many were expecting for higher doses.
The drug has faced delays and safety concerns following the withdrawal of Bayer’s similar drug. Baycol, in 2001. An FDA advisory committee recommended that patients taking the largest dose should have regular kidney check-ups to identify possible side-effects, but this was not a condition of approval.

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Analysts at Credit Suisse First Boston expect the drug to hit peak sales of $3.4bn/year in 2007.
COPYRIGHT 2003 Society of Chemical Industry
COPYRIGHT 2008 Gale, Cengage Learning

Medical Marketing and Media - Crestor market share hit by damning AHA article

admin — Wed, 07 Jan 2009 19:41:05 +0000

ASTRAZENECA’S cholesterol-lowering drug Crestor lost U.S. market share following the recent publication of a negative report in the American Heart Association journal Circulation.
Crestor’s U.S. new prescription market share fell to 6.1 percent from 6.6 percent in the week ending May 27, and to 5.8 percent the following week, London-based Code securities investment banking house analyst Paul Diggle told MMtSiM, citing figures provided by IMS Health.
“If U.S. market share remains below 6 percent, management will face a dilemma deciding whether to continue the very high level of Crestor promotional support or to ease back spending to protect financial performance,” Diggle said in an equity research note where he rated the stock to underperform.

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Circulation published a critical review of Crestor in its May 23 issue, saying that it had twice as many side effects - including deaths - of rival statin drugs.
AstraZeneca said it strongly disagreed with the findings and that it was incorrect to make assumptions about Crestor’s risks based on rates of post-marketing spontaneous adverse event reports.
-Stephen McGuire
Copyright CPS Communications Jul 2005
Provided by ProQuest Information and Learning Company. All rights Reserved

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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