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Taxus stent favored over Cypher stent in study of patients with diabetes; difference not significant

Boston Scientific Corp.'s paclitaxel-eluting stent, Taxus, is associated with a non-significantly lower incidence of major adverse cardiac events compared with Johnson & Johnson's sirolimus-eluting stent, Cypher, among patients with diabetes mellitus (DM) and de novo coronary artery disease at one year, according to study results published in the Aug. 1 issue of The American Journal of Cardiology.

Between April 2002 and December 2003, 293 unselected consecutive patients with DM and de novo coronary artery disease were treated with drug-eluting stents. Until February 2003, Cypher was exclusively used; subsequently, Taxus became the default stent, the study investigators noted.

The primary outcome was the occurrence of major adverse cardiac events, which researchers defined as a composite of all-cause death, nonfatal myocardial infarction or target vessel revascularization.

During the first month following stent implantation, a major adverse cardiac event occurred in 9.7 percent of patients in the Cypher group and in 6.1 percent of the Taxus group. There were five deaths in each group, with three clinically suspected to be due to stent thrombosis. In addition, there were five nonfatal MIs and five target vessel revascularizations in the Cypher group and three each, respectively, in the Taxus group.

At one year, investigators said the composite endpoint of death, MI or target vessel revascularization was non-significantly different, though a trend favored Taxus (Taxus, 15.6 percent vs. Cypher, 20.4 percent). Also, there were no significant differences in the incidence of death between groups (Taxus ,7.2 percent vs. Cypher, 7.7 percent) and no significant differences in the incidence of death or myocardial infarction (Taxus, 10 percent vs. Cypher, 14.1 percent).

"The major finding of this study is that the unrestricted use of [Taxus stents] in a universal drug-eluting stent environment is associated with a non-significantly lower incidence of major cardiac events at one year compared with [Cypher stents]," the study authors concluded.

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Connetics Desilux for atopic dermatitis meets endpoint in Phase III trial; NDA submission expected by year-end

Connetics Corp.'s Desilux (desonide) VersaFoam-EF, 0.05% showed a "highly statistically significant treatment effect for Desilux compared to placebo foam" as a treatment for atopic dermatitis, according to results of a new trial.

In the Phase III trial, 581 patients aged 3 months to 17 years were randomized to Desilux or placebo foam twice a day for four weeks. Patients were then followed for three weeks. The primary endpoint was improvements in the Investigator's Static Global Assessment (ISGA), erythema and induration/papulation.

Treatment success was defined as being clear or almost clear, using ISGA criteria, with at least a two-point improvement in ISGA score from baseline, and erythema and induration/papulation were absent or minimal. While only 9 percent of the placebo group achieved treatment success on the primary endpoint, 39 percent of those treated with Desilux did. In addition, Desilux was found to be safe and well tolerated among study patients.

Desonide is the topical steroid most often prescribed by U.S. dermatologists, Connetics said. Connetics developed Desilux, a low-potency formulation of desonide, using a patented, proprietary emollient foam delivery vehicle that contains no alcohol. The company expects Desilux to be its first product with a pediatric indication.

Connetics plans to submit a New Drug Application for Desilux by the end of the year and hopes the drug will enable the company to expand its product line "into the three segments of the $1.1 billion topical steroid market."

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Acetaminophen, NSAIDs increase risk of hypertension in women, study suggests

Higher doses of the widely used pain medications acetaminophen and nonsteroidal anti-inflammatory drugs independently increase the risk of hypertension in women, according to new data.

The study, which included patients from two prospective cohort studies comprised of a total of 5,123 women aged 34 to 77 years, was designed to assess incident hypertension according to categories of average daily dose of acetaminophen, NSAIDs and aspirin.

Multivariable analysis showed that older women (aged 51 to 77 years) and younger women (aged 34 to 53 years) who took more than 500 mg/day of acetaminophen had a 93 percent and a 99 percent increased risk of developing hypertension, respectively, compared with women who did not use acetaminophen.

Older and younger women who took more than 400 mg/d of NSAIDs were found to have a 78 percent and a 60 percent increased risk of developing hypertension, respectively, compared with women who did not take NSAIDs. "These associations remained significant among women who did not report headache," the authors noted.

Aspirin dose, however, was not significantly associated with hypertension.

"Given their common consumption and the high prevalence of hypertension, our results have substantial public health implications, and suggest that these agents be used with greater caution," the authors concluded.

The study was published online ahead of print in the September issue of the journal Hypertension.

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Remicade, Enbrel reduce frequency of anterior uveitis flares in ankylosing spondylitis, study shows

Pooled data show that Centocor Inc.'s Remicade (infliximab) and Amgen Inc. and Wyeth's Enbrel (etanercept) significantly reduce the number of anterior uveitis flares in patients with ankylosing spondylitis.

Anterior uveitis, or inflammation of the eye's vascular middle layer, is a common symptom of ankylosing spondylitis, or spinal arthritis.

Investigators studied four placebo-controlled trials (two with Enbrel and two with Remicade) and three open-label studies that contained a total of 717 patients who received therapy for anterior uveitis. Four of the trials contained anterior uveitis follow-up information (n=397 patients). Of these patients, 297 received Enbrel, 90 were exposed to Remicade and 190 received placebo. This corresponded to a total of 430 years, 146.4 years and 70.5 years of exposure, respectively.

During placebo treatment, anterior uveitis flares occurred at a rate of 15.6 per 100 patient-years. In contrast, patients who received the biologic therapies experienced only 6.8 flares per 100 patient-years.

Actually, flares occurred less often with Remicade than with Enbrel (3.4 per 100 patient-years vs. 7.9 per 100 patient-years), but not significantly so.

These results appear in the August issue of the journal Arthritis & Rheumatism.

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P&G's Actonel increases bone mineral density in poststroke elderly men, study shows

New research indicates that treatment with Procter & Gamble's Actonel (risendronate sodium) increases bone mineral density and reduces hip fractures in elderly men who are poststroke.

In an 18-month double-blind trial, 280 men aged 65 years or older who were poststroke were randomized to receive 2.5 mg of Actonel or placebo daily.

Hip fractures were sustained by 10 patients in the placebo group and by two Actonel-treated patients. Bone mineral density increased by 2.5 percent and decreased by 3.5 percent in the Actonel and placebo groups, respectively.

In addition, urinary deoxypyridinoline, a marker of bone resorption, declined by 58.7 percent in the Actonel group and by 37.2 percent in the placebo group.

Two Actonel-treated patients had esophagitis and one had abdominal pain; these adverse events were resolved with appropriate therapy, and the patients did not discontinue treatment, the study authors noted.

This study was published in the Aug. 8/22 issue of the Archives of Internal Medicine.

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Increases in drug prices slowing but still far outpacing inflation, according to AARP

Wholesale prices for widely used, brand-name drugs increased at more than double the rate of inflation from April 2004 through March 2005, according to AARP's Rx Watchdog Report, though the rate increase was slowed relative to both 2003 and 2004 rate increases.

Manufacturer prices for the 195 brand-name drugs most widely used by Americans aged 50 and older rose 6.6 percent in the last year. This was more than double the 3 percent rate of general inflation, the report found. This rate of increase is down from both the 7.1 percent increase in 2004 and the 7 percent increase in 2003.

If a typical older American (who takes three prescription drugs per day) were to purchase only brand-name products and the full price increases were passed along to the consumer, he or she is likely to have experienced an increase of $144.15 in the cost of drugs during the 12-month period ended March 2005, according to AARP.

The largest single increase (9.5 percent) in the three-month period ended March 2005 was for Boehringer Ingelheim GmbH's aerosol asthma drug Combivent (ipratropium bromide/albuterol sulfate).

"We are very disappointed that brand-name manufacturers have failed to keep their price increases in line with inflation and we will continue to educate our members and the public about how best to find the most affordable prescription drugs to suit their needs," William Novelli, chief executive officer of AARP, told The Wall Street Journal.

The Pharmaceutical Research and Manufacturers of America, however, accused AARP of using "fuzzy math," the Journal reported.

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Schering-Plough Corp.

Schering-Plough Corp. will collaborate with Centocor Inc. to develop and commercialize CNTO 148, a human monoclonal antibody intended to treat rheumatoid arthritis and "other immune-mediated inflammatory diseases." The collaboration stems from a 1998 agreement between the two companies. Under the agreement, Schering-Plough has rights to market CNTO 148 in countries other than the United States, Japan, China, Taiwan and Indonesia. Schering-Plough anticipates recording approximately $125 million in research and development charges previously incurred by Centocor. The companies will share future expenses associated with the drug's development and commercialization.

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ImClone Systems Inc.

ImClone Systems Inc. and UCB Group entered into a worldwide strategic partnership to develop and commercialize UCB's novel, investigational antibody CDP-791, which targets the vascular endothelial growth factor receptor-2 (VEGFR-2). VEGFR-2 is known to regulate the formation of blood vessels in tumors and the compound has been shown to interfere with the development of tumor vasculature by targeting and blocking the effect of VEGFR-2 on blood vessel cells with a pegylated diFab antibody. The compound completed Phase I testing in patients with refractory solid tumors with encouraging safety data, and a randomized Phase II study in non-small cell lung cancer is scheduled to start in the coming weeks.

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Able Laboratories Inc.

Able Laboratories Inc. said it will sell its business and assets. In May, Able suspended shipments of its products until it could be assured that each product had been properly manufactured and tested; later that month, the firm recalled all of its products and withdrew seven approved Abbreviated New Drug Applications. In July, Able filed a petition to claim Chapter 11 bankruptcy. The Food and Drug Administration rejected a proposed plan to revalidate the product development data included in Able's previously approved ANDAs, indicating that product relaunches would require withdrawal, submission of new data and agency review, Able said.

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Boston Life Sciences Inc.

Boston Life Sciences Inc. (BLSI) said that, at the company's request, the Food and Drug Administration granted a new special protocol assessment (SPA) for Altropane, a molecular imaging agent that is being developed to help differentiate Parkinsonian Syndrome tremor from non-Parkinsonian tremor. Under the agreement, BLSI may conduct two smaller Phase III trials instead of one large Phase III trial without giving up its SPA status; subjects currently enrolled in the existing Phase III trial can be included, the firm added. "[W]e may be in a position to advance partnering opportunities earlier than expected, " said Dr. Mark Pykett, BLSI's president.

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