natrecor

ALSO NOTED: AstraZeneca completes cancer study enrollment; Smallpox vaccine success triggers milestone; and much more...

Fri, 30 Nov 2007 06:59:50 -0500

> Here's a good estimate of how much it costs when a drug goes into free-fall: $440 million. That's how much Johnson & Johnson is writing off on Natrecor, a heart failure treatment that went into a downward spiral when medical researchers suggested that it might boost the risk of kidney problems and death. Report

> AstraZeneca says that it has completed patient enrollment in a study of Zactima (vandetanib), an oral anti-cancer drug. It's the first of four planned studies of the drug, and data from the trial is expected in 2008. Release

> Bavarian Nordic has successfully completed a Phase II trial of its next-generation smallpox vaccine candidate Imvamune. The trial completion has triggered a $25 million milestone payment from the Department of Health and Human Services. Release

> Cell Therapeutics has entered into agreements to sell approximately $6.5 million of its 7 percent convertible preferred stock and warrants in a registered offering to several institutional investors. Release

> According to TheScientist.com, a former University of Washington researcher who was discovered to have faked data in a number of instances, is now working at Schering Plough. Post

> An FDA advisory panel gave its backing to Abbott's new Xience stent, albeit an endorsement tinged with caution. The committee said Xience should be cleared for sale on one condition--that Abbott conduct post-marketing research on the product. Report

> Herceptin has become a lightning rod for debate over cancer treatment in England. Radiotherapists--including the specialty's chief at the National Health Service--are saying that cancer treatment is weighted too heavily toward expensive drugs and not enough toward more cost-effective radiation treatments. Report

And Finally... Wondering what Jean-Pierre Garnier will do with his free time when he steps down as GSK's head honcho in May? Wonder no more. Report

J&J makes big cuts at Alza and Scios

Wed, 01 Aug 2007 06:59:58 -0400

Two Bay area biotechs, Alza and Scios, are in line for some big layoffs as Johnson & Johnson slims down its pharma operations. Acquired for $12 billion six years ago, J&J says that it is shutting down Alza's Mountain View facility and laying off 600 workers. J&J is largely ending the R&D efforts at Alza, which had been structured to tweak the pharma giant's therapies. The San Jose Mercury News also reported that Scios--which markets Natrecor--has already seen the pink slips fly and more cuts are expected. Two other J&J companies working in medical devices are also expected to undergo significant restructuring.

- read the report from the Wall Street Journal (sub. req.)

Related Articles:
J&J restructures pharma unit, laying off workers. Report
Big Pharma brings home the cash, slices payroll. Report
J&J: Natrecor study failed to reveal two deaths. Report
Feds seek drug data from Scios. Report

ALSO NOTED: Barr raises bid on Pliva; Synta touts new data; regulators question Factive rashes;and much more...

Sun, 10 Sep 2006 20:01:30 -0400

> Barr Pharmaceuticals has raised its bid for Pliva to $2.5 billion. Report

> Synta Pharmaceuticals has released positive Phase IIB data for STA-4783, a heat shock protein 70 inducer that activates natural killer cell-mediated tumor killing in metastatic melanoma. Median progression free survival for patients receiving STA-4783 plus paclitaxel was 112 days versus 56 days for those receiving paclitaxel alone, a statistically significant difference that met the primary endpoint. STA-4783 was well-tolerated in the study, with adverse events typical of those expected for paclitaxel alone. Release

> The FDA's regulatory staff has raised questions about the risk of skin rashes from Oscient's Factive antibiotic. Report

> Light Sciences Oncology has detailed plans to raise $96.6 million from the sale of 6 million shares. Report

> J&J is touting new, mid-stage data on Natrecor. Report

> GlaxoSmithKline will settled a U.S. tax dispute for a reported $3.1 billion. Report

> Venture capitalists and other investors have shown some real passion for India's pharma sector, but biotechnology is still largely being overlooked. Report

> Acuity Pharmaceuticals is touting positive results from its Phase II trial for bevasiranib sodium (formerly Cand5), its lead compound for the treatment of wet age-related macular degeneration. Release

> Amphora Discovery has created two stand-alone business units. The Amphora Pharmaceuticals Business Unit, based in Los Altos, CA, will focus on leveraging the company's high-value drug candidates and creating partnerships with pharmaceutical and biotech companies. The Amphora Discovery Business Unit, based in Durham NC, will offer a contract research offering. Release

> Codexis announced it hit a milestone in its research pact with Schering-Plough. Release

And Finally… A new and frighteningly lethal strain of TB is spreading in South Africa. Report

DCRI tapped for major new Natrecor study

Thu, 07 Sep 2006 20:01:38 -0400

The Duke Clinical Research Institute has been enlisted to launch a major new study of Johnson & Johnson's Natrecor to test its safety and efficacy. Natrecor is a therapy designed to treat patients whose hearts stop beating properly, leaving them gasping for breath. J&J bought Scios three years ago for $2.4 billion primarily to gain control of Natrecor. Some 7,000 volunteers will be enlisted in the trial, which is being initiated after a string of reports raised questions about possible links to kidney failure and death. Enrollment in the study will begin in early 2007. Duke will collaborate with the Cleveland Clinic Cardiovascular Coordinating Center.

"The ASCEND-HF trial will add to the growing body of evidence and will provide important clinical data about the impact of Natrecor on outcomes that matter: most importantly, symptom relief, readmission to the hospital for heart failure and death," said Dr. Robert Califf, the director of DCRI and vice chancellor for clinical research and professor of medicine in the Division of Cardiology at Duke University Medical Center.

- read the AP report on the study

J&J prepares $100M Natrecor study

Thu, 01 Jun 2006 20:01:37 -0400

Plagued by reports of dangerous side effects, Johnson & Johnson says it will spend $100 million to retest its heart failure drug Natrecor. Its subsidiary, Scios, says it will test 7,000 patients in the U.S., Canada and Europe. No lead researcher has been selected for the study. Specialists have voiced their concern that the drug has been used in an outpatient setting instead of being restricted to the hospital.

- read this New York Times report

Slumping Natrecor sales spur layoffs at Scios

Thu, 23 Feb 2006 19:01:38 -0500

With sales of its heart drug Natrecor hampered by reports of safety concerns, Johnson & Johnson announced that about 150 of Scios' 900 employees will receive pink slips. Sales and marketing workers will be among the most heavily hit, along with employees in the unit's Fremont, CA headquarters. Sales peaked in 2004 at $400 million but began to slide as medical experts raised possible links to kidney problems and death. The Justice Department is also looking at whether Scios improperly marketed the drug for an unapproved use. The company has denied any illegal off-label promotions. Johnson & Johnson paid $2.4 billion for the drug about three years ago.

- here's the report from The New York Times for more

J&J: Natrecor study failed to reveal two deaths

Tue, 03 Jan 2006 19:01:37 -0500

Johnson & Johnson's Scios unit has reported that drug investigators failed to report the deaths of two patients taking the controversial heart failure medication Natrecor during a study of the drug. The trial investigators had reported five deaths of patients taking Natrecor within a thirty-day trial period in 2001 and early 2002. The company did not say how the deaths were omitted but said that including the additional deaths would not have changed the safety profile of the drug. The disclosure comes as Merck has been forced to explain why negative safety data for Vioxx had been withheld from published study results.

- read this report from The New York Times for more

ALSO NOTED: Generics cheaper in US; J&J panel surprisingly independent; and much more...

Mon, 08 Aug 2005 20:00:50 -0400

> Lured by Canada's reputation for cheaper medicines, many Americans have been paying a premium for generic drugs that can actually be cheaper in the US. Story

> The New York Times examines the fiercely independent work of a panel of experts Johnson & Johnson assembled to look into safety concerns involving Natrecor. Article

> Chutes & Ladders: Dr. Rahul Singhvi has been named president and CEO of Novavax. Release

> Executives at Altea Therapeutics in Atlanta are finding it hard to locate the kind of facilities needed by a growing biotech company. Story

> DOV Pharmaceutical of Hackensack, New Jersey, has amended its deal with Merck regarding novel antidepressants. Release

> Germany's Cenix BioSciences says it has delivered a collection of potential new drug targets to Bayer HealthCare. Release

> New River Pharmaceutical of Radford, Virginia, says it has reprioritized its preclinical drug candidates in a pipeline review. Release

> Alexion Pharmaceuticals and Procter & Gamble Pharmaceuticals have completed enrollment of a Phase III trial of a PRIMO-CABG2 efficacy trial of pexelizumab. Release

And Finally… Is the rising rate of melanoma the result of an epidemic, or is the rapid spread of screening really behind the scary surge? Article

FEATURE: New generation of biomarkers may reduce health risks

Thu, 21 Jul 2005 20:01:32 -0400

Dr. Mario Ehlers discusses how new biomarkers can reduce the risks from pharmaceutical drugs.

The problem of serious physical risks associated with pharmaceutical drugs is not going away. While the arthritis drug Vioxx, pulled from the market by its manufacturer last year after it was shown to double the risk of heart attack and stroke, remains the most high-profile example, a significant number of pharmaceutical medications have been linked with health risks in recent years.

Rezulin, for type 2 diabetes, was taken off the market in 2000 because of its association with severe liver toxicity. This past year, Celebrex and Bextra, in the same class as Vioxx, made headlines for their adverse effects; and in February, sales of the multiple sclerosis drug Tysabri were suspended after it was suspected of triggering a rare brain disease in three patients, two of whom died from the disease. Most recently, safety concerns have emerged about the heart failure drug Natrecor, and doctors at the Cleveland Clinic are considering curtailing its use, after two medical journal studies reported that it increased kidney problems and death rates among patients.

Some people fault the FDA, claiming that the agency does not sufficiently monitor pharmaceutical drugs for safety during clinical trials. Based on my own years of experience in the biopharmaceutical industry, I consider the FDA to be extremely rigorous in their standards for drug safety during the approval process. But no matter how carefully the FDA and drug companies monitor for safety, the potential for a low incidence of serious side effects will always exist: There is simply no way to guarantee that pharmaceutical drugs will ever be entirely risk-free.

That said, there are actions that legislators and drug-development scientists can take to minimize serious health risks associated with pharmaceutical agents. (On the science front, progress is already underway.) What's more, this can be accomplished without unduly delaying the development of new medical treatments. These measures fall into two categories:

Greater FDA Control Following Drug Approval
Although a pharmaceutical drug cannot be marketed without FDA approval, the agency has insufficient control over what happens to a drug after it reaches the market. Federal laws governing drug safety withdrawals are limited and therefore in the event of reported health risks the FDA generally asks manufacturers to withdraw the drug voluntarily. While drug makers almost always comply, there is a question about the completeness and promptness of product withdrawals.

A recent example: In April, the FDA requested that Pfizer, the maker of Bextra, withdraw the drug after reports of some users experiencing serious skin reactions, as well as concerns about cardiovascular risks. On its website, the FDA posted, "Pfizer has agreed to suspend sales and marketing of Bextra in the US, pending further discussions with the agency." Despite widespread reports in the media that the drug was withdrawn, sales of Bextra have been suspended but the drug has not been formally removed.

To prevent the availability of potentially unsafe medications, legislation is needed that will give the FDA greater resources for post-marketing surveillance and unilateral power to withdraw drugs that the agency regards as posing insufficient benefit or serious risk.

Identifying At-Risk Consumers
As the Genome project and other scientific advances have brought about a greater understanding of human genetics and biology, one extremely promising result has been the increased use of biomarkers in drug discovery and development. A biological indicator that can be used to measure the progress of disease or the effects of treatment (the biomarker hemoglobin A1C, for instance, shows how well a diabetes drug is controlling blood glucose), biomarkers are used today during drug discovery in every therapeutic area.

The newest generation of biomarkers, still in its incubation phase, will enable a new treatment paradigm known as theranostics (for "therapeutic" and "diagnostic"). Theranostics involves a tight coupling between diagnostics and therapies, such that a biological indicator determines in advance which patients will respond to a particular treatment. By targeting these patients, the biomarkers favorably alter the risk-benefit profile of pharmaceutical drugs, allowing non-responders to avoid potential side effects unbalanced by therapeutic gain. These biomarkers promise to eliminate much of the uncertainty involved in prescribing medications -- and result in significant healthcare savings.

The best-known theranostic currently on the market is the biomarker for Herceptin, a drug for suppressing tumor growth in patients with metastatic breast cancer, which is used to test biopsy samples of tumors: A sample that tests positive indicates that the patient can be helped by the drug. Given that Herceptin is effective in only about a quarter of patients, the biomarker for this drug is particularly useful.

The next phase of biomarker research, already underway, is to develop biological indicators identifying patients likely to experience adverse effects from a pharmaceutical drug. Not only will such biomarkers reduce the incidence of side effects from medications -- they will also be a means to help keep widely effective, potentially lifesaving drugs available to the public.

Consider the case of Tysabri, the multiple sclerosis drug removed from the market after three users developed brain disease. As a result of the withdrawal, thousands of MS patients who were not adversely affected by the drug nonetheless lost access to it. Once there is a way to target the tiny minority of individuals who cannot safely take a particular drug, the medication can then remain available to the overwhelming majority of patients able to use it without adverse effect. (Biogen Idec, the maker of Tysabri, announced in April that it is conducting a safety review of the drug to determine whether it can be prescribed to certain patients if they are closely monitored.)

It will be years before these biomarkers become available, but there is already much to be excited about. Virtually every major drug and biomedical companies is now engaged in biomarker research. The companies collect genetic information from patients (via blood samples) at clinical trials, and the FDA, which recently issued guidelines on performing these procedures, is encouraging such collection of genetic material toward further research on the new science of "pharmacogenomics," the link between specific genetic profiles and the effects of drugs. Theranostics is taking us closer to what, arguably, is our ultimate goal: true personalized medicine.

Pharmaceutical drugs will never be 100 percent free of risk. But with greater FDA control of drugs already on the market -- and continued advances in biomarker research -- we can greatly reduce the risk of serious side effects for the millions of people who take these medications.

Mario R. Ehlers, MD, PhD, is chief medical officer of Seattle-based Pacific Biometrics, a central laboratory supporting drug and diagnostics development.

Feds seek drug data from Scios

Wed, 20 Jul 2005 20:01:37 -0400

Federal prosecutors in Massachusetts have subpoenaed Johnson & Johnson subsidiary Scios for documents related to the sale of Natrecor, its drug for congestive heart failure. Some critics contend that Natrecor increases the risk of kidney problems and even death in some patients. Researchers reported in a small study April 20 that they found evidence that patients given Natrecor appeared much more likely to die in the first month after treatment than those given traditional medication, such as nitroglycerin. Scios is performing additional tests on the drug and plans to notify doctors not to use Natrecor off-label.

- read this report from the San Jose Mercury News for more