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Jury finds Merck liable in Vioxx trial Merck & Co. Inc. shares fell 3.2 percent after a New Jersey jury decided that the company concealed the dangers of Vioxx (rofecoxib), a prescription drug previously used to treat pain.

The jury found that Merck committed consumer fraud by misrepresenting information to doctors regarding the cardiovascular risks of the drug, according to an article in The Wall Street Journal. The jury also decided that Merck intentionally concealed or omitted material information when marketing Vioxx, the article noted.

After nearly two days of deliberation, the jury returned a split verdict, concluding that Vioxx caused a myocardial infarction in plaintiff John McDarby, but not in plaintiff Thomas Cona. As a result, Cona was granted only out-of-pocket costs for his Vioxx prescriptions and attorney fees.

"This case was about the McDarbys and the Conas, but it was about more than that," said Robert Gordon, one of McDarby's attorneys, in an Associated Press article. "It was about the 100,000 people in this nation who had heart attacks. It's about the tens of thousands doctors who were lied to by Merck about the dangers of Vioxx."

The Journal article added that the same jury will decide whether Merck should pay punitive damages in addition to the $3 million the jury granted McDarby for pain and suffering and the $1.5 million it awarded McDarby's wife for loss of his "society and services."

Merck has acknowledged that use of Vioxx for more than 18 months increases the risk for myocardial infarction and strokes.

The trial was the first to address long-term use of the drug, and, according to the AP, some analysts believe the jury's decision may encourage Merck to consider changing its policy of defending each lawsuit individually.

Shares of Merck closed at $34.84, down $1.15, in heavy trading on the New York Stock Exchange.

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NDA for Lo Seasonale extended-cycle oral contraceptive withdrawn Duramed Pharmaceuticals Inc. withdrew its New Drug Application for Lo Seasonale (levonorgestrel 0.1 mg/ethinyl estradiol 0.02 mg) extended-cycle oral contraceptive for the prevention of pregnancy.

The decision to withdraw the NDA for the lower dosage formulation of Seasonal was made after discussions with the Food and Drug Administration suggested that an additional, larger clinical trial might be necessary to support continued consideration of the application, the company said. Lo Seasonale uses 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol compared with the respective 0.15 mg and 0.03 mg doses in Seasonale, which received FDA approval in 2003.

Duramed's parent company, Barr Pharmaceuticals Inc., intends to focus now on developing the extended-cycle contraceptive Seasonique (levonorgestrel 0.15 mg/ethinyl estradiol 0.03 mg and ethinyl estradiol 0.01 mg), which the FDA has said would not require additional studies.

"Rather than continue to devote additional resources to the Lo Seasonale NDA, we have made the strategic decision to withdraw the application and concentrate on the approval of Seasonique and the expansion of the Seasonique product franchise with the Lo Seasonique product that is currently in Phase III clinical trials," said Barr's chief executive officer, Bruce Downey.

Brand Consulting Coalition of advertising, public relations associations petitions FDA to revise DTC drug advertising rules The Coalition for Healthcare Communication submitted a petition to the Food and Drug Administration asking the agency to establish direct-to-consumer advertising policies that will make DTC messages simpler and more understandable to consumers and encourage more informed patient-physician dialogue.

According to the coalition, which represents trade associations specializing in medical communications, marketing, advertising and publishing, current regulations governing DTC drug advertising require the inclusion of complicated information that is likely to confuse, rather than inform, consumers.

"Communication is effective only if conducted at the level recipients can use," the petition stated. "For this reason, the coalition believes that regulation of DTC should stress the use of clear, understandable and retainable messages about benefits and safe use of prescription drugs, with an emphasis on the information that a patient needs to discuss medication options with a physician."

Moreover, the group said, attempts to "fully warn patients of all possible risks and side effects" may mislead consumers to believe that they can make drug treatment decisions without professional guidance.

"Instead, DTC advertising policy must support the role of the learned intermediary in educating consumers on the specific side effect risks of advertised drugs and the likelihood of any particular risk affecting an individual patient," the petition recommended.

In a press statement, the coalition noted that current DTC advertising policies have remained largely unchanged since they were first adopted in the 1960s, when the FDA was granted the authority to regulate prescription drug advertising.

"The coalition recommends that the FDA recognize that 1960s rules applied to print advertising in medical journals may not be applicable [today] ... and urges that the new rules be based on a scientific understanding of consumer behavior and a full understanding of both the potential and the limits of consumer advertising," the news release stated.

The petition advised including three core messages--relating to drug risks, the need for a professional consultation and prescription, and the patient's role in such consultations--in all DTC advertisements and called for the creation of a standing advisory committee of academic and professional experts in consumer behavior.

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GSK's Arixtra, Sanofi-Aventis' Lovenox compared in study of patients with acute coronary syndromes A clinical study of GlaxoSmithKline Plc's Arixtra (fondaparinux sodium) revealed that the drug had comparable efficacy to that of Sanofi-Aventis Group's Lovenox (enoxaparin sodium) in reducing the risk of ischemic events in patients with acute coronary syndromes (ACS) at nine days following the start of treatment; moreover, the rate of major bleeding in the Arixtra group was nearly half the rate observed in the Lovenox group.

Arixtra is an antithrombotic agent that selectively inhibits faxtor Xa, a central protein in the coagulation process. It is not yet approved for use in patients with ACS.

In a double-blind trial known as OASIS 5, more than 20,000 patients were randomized to receive Arixtra 2.5 mg once daily for up to eight days or Lovenox 1 mg/kg of body weight twice daily for two to eight days. The study drugs were administered in addition to standard medical care (e.g., aspirin, clopidogrel bisulfate, glycoprotein IIb/IIIa inhibitors and revascularization procedures).

The trial's primary efficacy objective was to determine whether Arixtra was as effective as Lovenox in preventing death, myocardial infarction or refractory ischemia in the acute treatment of patients with ACS and unstable angina or non-ST-segment elevation MI.

Results of the study showed that Arixtra was as effective as Lovenox in preventing death, MI and refractory ischemia; the incidence of the primary composite endpoint at day nine was 5.8 percent in the Arixtra-treated group and 5.7 percent in the Lovenox-treated group.

However, patients treated with Arixtra experienced a 48 percent reduction in major bleeding events: Arixtra-treated patients experienced a 2.2 percent incidence rate compared with a 4.1 percent incidence rate among the Lovenox-treated patients.

In addition to the rates of the primary composite outcome and major bleeding at nine days, the number of deaths at 30 days and 180 days was significantly lower in the group treated with Arixtra.

These data were published in the April 6 issue of The New England Journal of Medicine.

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Roche s oral chemotherapy Xeloda as effective as standard IV chemotherapy regimen for treating stomach cancer, study suggests Roche's chemotherapy drug Xeloda (capecitabine) appears to be as effective as standard drug regimens in patients with advanced or metastatic gastric cancer, according to data from a Phase III trial that showed Xeloda met the study's primary efficacy endpoint of time to disease progression.

The findings, which Roche expects to present at the June meeting of the American Society of Clinical Oncology, suggest that health care providers may choose a regimen of cisplatin plus Xeloda, which is administered orally, instead of cisplatin plus the less-expensive 5-fluorouracil, which is administered intravenously, since Xeloda would significantly reduce the amount of treatment time for patients.

"Compared to the current standard, where patients spend five days every three weeks in [the] hospital receiving treatment, Xeloda has the additional benefit of reducing that amount of time to only one day, which helps patients to live as normal life as possible," said Roche's head of global development, Ed Holdener.

The data support analysts' views of higher sales potential for Xeloda, Reuters reported.

Xeloda is currently indicated for the treatment of certain patients with colorectal or breast cancer. Based on the Phase III results, Roche said it plans to file for Xeloda regulatory approval in treating advanced gastric cancer worldwide; the drug is already licensed in South Korea as a first-line therapy for metastatic gastric cancer.

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90-day follow-up results show Medicure's MC-1 maintains benefits observed in patients 30 days post CABG Medicure Inc.'s cardioprotective product, MC-1, yielded positive Phase II study results in patients 90 days after they underwent coronary artery bypass graft (CABG) surgery.

MC-1 is a naturally occurring small molecule designed to reduce the amount of damage to the heart following ischemia or ischemic reperfusion injury by protecting cardiomyocytes, which are cells from the heart's muscle tissue.

In the double-blind, Phase II study known as MEND-CABG, 902 patients who underwent CABG were randomized to receive 250 mg/day or 750 mg/d of MC-1 or placebo on the day of surgery and for a 30-day period after the procedure.

The primary endpoint of the trial was the reduction in the composite of cardiovascular death, nonfatal myocardial infarction (peak CK-MB 50 ng/mL or more) and nonfatal stroke up to post-operative day 30. The study protocol also included follow-up for 90 days post operation to further evaluate the drug's safety and efficacy.

The patients treated with a 250 mg/d dose of MC-1 experienced a 14 percent reduction in the primary endpoint composite compared with the placebo group, according to Medicure.

Further, the company said an analysis that used a less-conservative definition of MI as peak CK-MB 100 ng/mL or more showed that patients in the 250 mg/d treatment group experienced a 37.2 percent reduction in the composite endpoint compared with the placebo group.

According to Medicure, the lower dose of MC-1 demonstrated greater efficacy than did the higher dose. Clinical results were maintained throughout the 90-day follow-up period.

"The maintenance of the clinical reductions at post-operative day 90 further supports MC-1's ability to significantly reduce heart attacks in this high-risk patient population and clearly warrant[s] advancing MC-1 into pivotal Phase III development," said Albert Friesen, chief executive officer at Medicure. "We will meet with the Food and Drug Administration to discuss these results and develop the Phase III program, which we anticipate commencing in the second half of 2006."

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The Food and Drug Administration The Food and Drug Administration's acting commissioner, Dr. Andrew von Eschenbach, resigned from his position as director of the National Cancer Institute, Reuters reported. Von Eschenbach began his post at the NCI in 2002, but when he was appointed acting FDA chief last September following the sudden resignation of Commissioner Lester Crawford, von Eschenbach said he turned over his day-to-day NCI responsibilities to a deputy. The dual roles had generated criticism among lawmakers and consumer groups.

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Iomai Corp. Iomai Corp.'s dry vaccine patch led to a high immune response among study subjects, protecting against travelers' diarrhea in a manner that outperformed the company's liquid-based patch. A Phase I/II trial included 160 subjects who received the dry patch (n=100) or the wet formulation (n=60). Subjects were tested on a weekly basis for immune responses to enterotoxigenic Escherichia coli (ETEC), which is the major cause of travelers' diarrhea. By week two, the fold rise in ETEC antibodies in the dry patch group was significantly greater at all time points than that of the wet patch group, according to Iomai. These data were presented at a meeting of the Society for General Microbiology in the United Kingdom.

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St. Jude Medical Inc. St. Jude Medical Inc. reduced its quarterly profit and revenue projections, citing lower-than-expected sales of an implantable defibrillator. The company expects to report earnings of $0.35 to $0.36 per share on sales of approximately $784 million for the first quarter. St. Jude's previous estimate had net sales projected between $799 million and $839 million. Analysts anticipated earnings of $0.39 per share on sales of $827.5 million, according to a poll by Thomson Financial, The Associated Press reported.

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Rite Aid Corp. Rite Aid Corp. reported net income of $1.83 per diluted share in its 14-week fourth quarter ended March 4. This figure includes an income tax benefit and is substantially higher than the $0.35 per share the company reported in its 13-week fourth quarter the year before. Rite Aid's net income during the 53-week fiscal 2006 period, which also includes the tax benefit, was $1.89 per share; this compares with $0.47 per diluted share reported for the 52-week fiscal 2005 period. The 2006 tax benefit, which the company said resulted from a reduction of a valuation allowance against deferred tax assets, was $1.23 billion. Rite Aid had a similar tax benefit in fiscal year 2005, in the amount of $179.5 million.

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OrthoLogic Corp. OrthoLogic Corp. said Dr. James Pusey resigned as the company's president and chief executive officer to pursue other opportunities. John Holliman, who is a director and chairman of the board, assumed the title of executive chairman and will head OrthoLogic's business and corporate strategic activities. Dr. Randolph Steer, who has provided consulting services to the company since 2002, was named president.