Brand Analysis

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Jury finds Merck liable in Vioxx trial

A jury found Merck & Co. Inc. liable for the 2001 death of a Texas man who once took Vioxx (rofecoxib), awarding his widow a total of $253.4 million, The Associated Press reported. Merck plans to appeal the verdict.

The jury dismissed Merck's argument that the man died of clogged arteries rather than a Vioxx-induced myocardial infarction that led to his fatal cardiac arrhythmia, the AP said.

"We believe that the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst's death. There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmias, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis," said Jonathan Skidmore, a member of Merck's defense team, in a press release.

Merck is examining various bases for appeal, including the following: allowing opinion testimony to be given to the jury by unqualified experts, allowing opinion testimony that was not based on a reliable scientific basis required by Texas law, allowing evidence with no relevance to the issue of the case and allowing undisclosed surprise witness and expert testimony contrary to Texas law.

Currently, there are more than 4,200 state and federal Vioxx related-lawsuits pending across the country, according to the AP. Merck plans to "vigorously defend them one by one over the coming years."

Merck's shares closed at $28.06, down $2.35, or 7.7 percent, in heavy trading on the New York Stock Exchange. Brand Analysis

FDA approves new formulation of Allergan's Alphagan

Allergan Inc. received approval from the Food and Drug Administration to market a new formulation of Alphagan P (brimonidine tartrate) 0.2% ophthalmic solution.

The new product, Alphagan P (brimonidine tartrate) 0.1% ophthalmic solution, is an optimized formulation of Alphagan P 0.2%, which is indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The product was developed to minimize drug exposure while maintaining the drug's efficacy profile.

In a clinical study, Alphagan P 0.1% was shown to have the IOP-lowering efficacy that was equivalent to that of Alphagan 0.2%. Specifically, the new formulation effectively lowered IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2 mmHg to 6 mmHg.

"By improving bioavailability compared to the original Alphagan 0.2%, we have managed to decrease drug concentration by half without sacrificing efficacy," said Dr. Scott Whitcup, Allergan's executive vice president of research and development.

Brand Analysis

Vicuron files NDA for potential invasive candidiasis/candidemia treatment, anidulafungin

Vicuron Pharmaceuticals Inc. filed a New Drug Application for anidulafungin to treat invasive candidiasis/candidemia.

The NDA included data from a Phase III study that demonstrated the drug's superiority over Pfizer Inc.'s Diflucan (fluconazole) in invasive candidiasis/candidemia, which is the most common hospital-acquired fungal infection.

Results of the previously reported trial showed that 75.6 percent of anidulafungin-treated patients reached the primary endpoint of global response at the end of intravenous therapy in the microbiological intent-to-treat population compared with 60.2 percent of Diflucan-treated patients.

In June, Pfizer, which recently lost patent protection for Diflucan, agreed to acquire Vicuron for approximately $1.9 billion in cash, with the goal of expanding its anti-infectives lineup.

"We are pleased to have filed this NDA in the third quarter as planned," said George Horner, III, chief executive officer of Vicuron.

Brand Analysis

Taxotere improves overall survival compared with paclitaxel among women with advanced breast cancer, study suggests

Sanofi-aventis Group's Taxotere (docetaxel) was shown to significantly improve overall survival and median time to disease progression compared with paclitaxel in women with advanced breast cancer whose cancer had progressed after previous treatment with an anthracycline-based therapy, according to new results.

In the controlled, open-label, Phase III study, 449 patients with locally advanced or metastatic breast cancer were randomized to either Taxotere (100 mg/m2 one-hour intravenous infusion every 21 days) or paclitaxel (175 mg/m2 three-hour intravenous infusion every 21 days).

Treatment continued until tumor progression, unacceptable toxicity or withdrawal of consent.

Results showed that the median overall survival for Taxotere was significantly longer than survival with paclitaxel (15.4 months vs. 12.7 months, respectively). The median time to disease progression was also significantly longer for Taxotere than for paclitaxel (5.7 months vs. 3.6 months, respectively), and the overall response rate was higher for Taxotere (32 percent vs. 25 percent, respectively), but not significantly so.

"The results from this head-to-head study provide oncologists with the clinical evidence of these differences. Rarely have we seen trials for the treatment of women with advanced breast cancer that demonstrate significant differences in survival," Dr. Stephen Jones, director of breast cancer research at the Baylor-Sammons Cancer Center in Dallas, said in a press release.

The study was published in the Aug. 20 issue of the Journal of Clinical Oncology.

Brand Analysis

Humira plus methotrexate effectively treats rheumatoid arthritis, slows radiologic progression, review shows

A Cochrane database review indicates that Abbott's Humira (adalimumab) plus methotrexate is efficacious in treating rheumatoid arthritis and may even slow radiographic progression at 52 weeks.

Two reviewers evaluated six controlled trials that included 2,381 patients. In the studies, Humira plus methotrexate (or other disease-modifying antirheumatic drugs) were compared with placebo plus methotrexate (or DMARDs) or Humira monotherapy was compared with placebo.

After 24 weeks, 43 percent of patients who received Humira plus methotrexate showed a 50 percent improvement in symptoms compared with 9 percent of placebo-treated patients, the investigators found.

After 52 weeks, patients who received 20 mg/week of Humira or 40 mg every other week of Humira demonstrated slowed joint damage compared with those who received placebo.

"More people had improved symptoms with [Humira] alone than with fake injections, but the improvement was not as much as when [Humira] was taken in combination with methotrexate," the authors said.

The investigators concluded that Humira in combination with DMARDs other than methotrexate was efficacious, but data were only available from one small study. As a monotherapy, the drug was also efficacious, but the effect size was lower than that of combined treatment.

These data appeared in the latest issue of The Cochrane Library.

Brand Analysis

Combination of acetaminophen, aspirin, caffeine more effective than Imitrex in early treatment of migraine, study suggests

The over-the-counter combination of aspirin, acetaminophen and caffeine appears to be more effective than GlaxoSmithKline Plc's Imitrex (sumatriptan succinate) in the early treatment of migraines, a new study suggests.

During the trial, 188 patients were randomized to treat a single migraine attack with acetaminophen 500 mg, aspirin 500 mg and caffeine 130 mg; oral Imitrex 50 mg; or placebo. Participants were instructed to take the study drug at the first sign of migraine. The primary efficacy variable was the sum of pain intensity differences from baseline to four hours postdose; pain intensity was measured with a four-point scale (none, mild, moderate, severe).

Of the 188 patients randomized to treatment, 170 were included in the efficacy analysis (OTC group, n=68; Imitrex group, n=67; placebo, n=35).

Compared with patients randomized to Imitrex, those randomized to the OTC combination achieved a significantly greater reduction in the sum of pain intensity differences at four hours. OTC-treated patients also reported significantly better assessments of pain relief, measured using a five-point scale ranging from 0 (no relief) to 4 (complete relief).

At 30 minutes postdose, the proportion of responders (i.e., patients whose migraine pain decreased from moderate or severe to mild or none) was significantly higher among Imitrex-treated patients versus patients randomized to OTC treatment. However, by two hours postdose, the proportion of responders was significantly greater among OTC-treated patients; this difference remained significant at four hours.

Both the OTC combination and Imitrex performed better than placebo on all of these measures, but most differences between Imitrex and placebo were not significant. The authors acknowledged, however, that the lack of significance was likely due to the small sample size of the placebo arm, especially in light of recent research supporting Imitrex's efficacy in acute migraine treatment.

"The results of this study suggest that migraine sufferers can use [the combination of aspirin, acetaminophen and caffeine] to treat their migraine episodes at the first sign of an attack. Prescription medications can be reserved for headaches that are refractory to OTC therapy, since most patients have tried an OTC before seeing their physician," the authors concluded. "The assumption that prescription remedies are, by definition, superior to OTC medications could be challenged--and a shift in the standard of care for migraine could occur--if these preliminary results are corroborated by additional research."

The study was published in the September issue of the journal Headache.

Brand Analysis

Brand Analysis
F. Hoffmann-La Roche Ltd.

F. Hoffmann-La Roche Ltd. and Memory Pharmaceuticals Corp. amended their PDE4 collaboration whereby Memory will reacquire the right to develop and commercialize the PDE4 inhibitors MEM 1414 and MEM 1917, which Roche had been developing to treat Alzheimer's disease. Under the amended collaboration, Roche will retain exclusive license to the other PDE4 inhibitors. It will also have the option to continue the development and commercialization of the drug candidates after Phase II trials are completed. If Roche exercises this option, Memory will receive payments and a U.S. co-promotion option.

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Brand Analysis
Merck KGaA

Merck KGaA was granted a non-exclusive license to Dyax Corp.'s proprietary phage display libraries for the discovery and development of therapeutic antibodies and peptides. Under the agreement, Merck will pay Dyax an up-front technology license fee; Dyax will also receive annual maintenance fees, clinical milestone payments and royalties on net sales of any products developed through Merck's use of the libraries. In addition, Merck holds an option for Dyax to conduct funded research on its behalf, Dyax said.

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Brand Analysis
Discovery Laboratories Inc.

Discovery Laboratories Inc. received a formal request from the Food and Drug Administration asking for further information on its drug Surfaxin (lucinactant), a potential respiratory distress syndrome preventive for premature infants. The FDA's request included 12 items that centered on chemistry and manufacturing, both of which need further clarification or additional information in order to deem the response complete. The firm anticipates submitting a new response in October and expects the drug to be approved in April 2006.

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Brand Analysis
Seattle Genetics Inc.

Seattle Genetics Inc. selected the first target to advance from Celera Genomics Group as part of an antibody-based cancer therapy collaboration formed between the firms last year. Products developed under the agreement can be either monoclonal antibodies or antibodies linked to cell-killing payloads that use Seattle Genetics' antibody-drug-conjugate (ADC) technology. Under the terms of the agreement, the companies will jointly fund preclinical and clinical development and jointly receive any resulting profits. Either firm can choose not to co-develop a certain product and still receive royalties on net sales. Celera, an Applera Corp. business, will make milestone payments for any ADCs that are co-developed. Additional terms were not disclosed.

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