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Continuous ART therapy superior to episodic therapy, halted AIDS trial finds A large-scale AIDS trial was halted by the National Institute of Allergy and Infectious Diseases on the recommendation of the trial's independent Data and Safety Monitoring Board.

The SMART trial, which began in 2002, was testing whether it was more beneficial for patients with AIDS to receive ongoing antiretroviral therapy or episodic ART given only when their CD4+ cells fell below 250 cells/mm3.

The 5,472 trial enrollees (from 33 countries) were taking HIV drugs prescribed by their providers, whether the drugs were approved for this indication or not.

A review by the DSMB, which took place after an average of 15 months of follow-up, found that patients randomized to episodic therapy had more than two times the risk of their disease progressing as compared with patients randomized to continuous therapy. The committee also observed an increase in major complications in patients who received episodic therapy. Since cardiovascular, kidney and liver complications have been associated with ART therapy, researchers had hoped that patients who received less ART therapy would experience fewer complications.

"Although the risk-to-benefit ratio of drug conservation over the longer term remains uncertain, the DSMB recommended that enrollment into the trial be halted in light of the findings to date, and the SMART executive committee and NIAID agreed with the recommendation," the National Institutes of Health said.

While the SMART team considers possible long-term follow-up plans, trial participants will continue to attend follow-up visits, according to the NIH. The agency added that investigators will analyze the available data to determine why the increased risk was observed among the group who received episodic ART.

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FDA approves black box warning for eczema creams The Food and Drug Administration approved a black box warning that will be added to Novartis AG's Elidel (pimecrolimus) and Astellas Pharma Inc.'s Protopic (tacrolimus) atopic dermatitis treatments.

The drugs' labels will now include the warning of a possible cancer risk associated with the drugs and clarify that the drugs should be used as second-line treatments. A Medication Guide will also be distributed to inform patients of the potential risk. The FDA noted that these drugs are not recommended for use in patients aged less than 2 years.

"Although a causal link has not been established, rare reports of cancer (for example, skin and lymphoma) have been reported in patients who had been receiving these products," the agency noted.

In March, the FDA issued a public health advisory to warn of the potential cancer risk and to announce that the drugs would have to carry a black box warning.

Astellas said it has updated the label of Protopic to reflect the warning and is issuing a Medication Guide to patients who are prescribed the drug.

"Protopic is safe and effective when used in a manner consistent with its label," Astellas said.

Although Novartis said it is confident that Elidel is safe, the firm also will comply with the FDA's labeling changes, Reuters reported.

"While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes and will communicate them to physicians and patients so they can continue to use Elidel as labeled to effectively manage eczema," the firm said in a statement obtained by Reuters.

The FDA noted that both companies are conducting studies to assess the risk of cancer and that the updated label says the long-term safety of the drugs has not yet been established.

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Pfizer's Q4, full-year earnings hurt by generic competition Pfizer Inc.'s fourth-quarter and full-year net income fell, but the drug firm's cost-cutting efforts helped it exceed analysts' expectations for the final quarter.

The company earned $2.73 billion, or $0.37 per diluted share, in the most recent quarter compared with $2.83 billion, or $0.38 per diluted share, in the fourth quarter of 2004.

Excluding charges, Pfizer earned $0.51 per share, which beat the $0.42 average estimate from Reuters Estimates analysts.

Revenue for the fourth quarter fell 9 percent, from $14.92 billion in 2004 to $13.59 billion in 2005. Wall Street analysts were expecting the firm to report revenue of $13.27 billion, according to Reuters.

For the full year, Pfizer's earnings were hurt by generic competition and safety issues surrounding its COX-2 inhibitors, Celebrex (celecoxib) and Bextra (valdecoxib).

Full-year net income fell 29 percent, from $11.36 billion in 2004 to $8.09 billion in 2005. Diluted earnings per share decreased from $1.51 in 2004 to $1.10 in 2005.

Full-year revenue decreased 2 percent from 2004, dropping from $52.52 billion to $51.3 billion.

For 2006, Pfizer said "investors should be aware that the factors driving Pfizer's performance may differ materially. . . ." The firm will discuss its financial guidance at an analyst meeting on Feb. 10.

Pfizer shares closed at $24.97, up $0.88, or 3.7 percent, in heavy trading on the New York Stock Exchange.

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Novartis reports steady Q4, full-year results Novartis AG posted flat fourth-quarter and strong full-year earnings as the firm benefited from strong performances by its pharmaceuticals and generics divisions.

The firm earned $1.35 billion, or $0.58 per share, in the fourth quarters of both 2004 and 2005. Analysts had expected Novartis to earn $1.38 billion this past quarter, according to Reuters.

Fourth-quarter net sales, which met analysts' expectations, increased by 14 percent. In the fourth quarter of 2005, the firm recorded $8.66 billion in net sales compared with $7.58 billion recorded in the fourth quarter of 2004.

For the full year, the firm's net income and net sales increased. In 2005, Novartis earned $6.14 billion, or $2.63 per share, compared with $5.6 billion, or $2.37 per share, in 2004.

Full-year sales rose from $28.25 billion in 2004 to $32.21 billion in 2005.

For 2006, Novartis expects net sales growth to be in the high single-digit range.

Daniel Vasella, the firm's chief executive officer, told reporters there is only a small chance that Novartis will be involved in any major acquisitions, according to a Reuters report. The statement may serve to dispel rumors of a potential Novartis bid for Serono AG, the news service noted.

"On Serono, I decline to comment," Vasella said.

Novartis shares closed at $55.23, down $1.02, or 1.8 percent, in heavy trading on the New York Stock Exchange.

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New Medicare drug benefit may lower out-of-pocket costs, but not equally across all senior groups, new research shows Medicare beneficiaries who do not qualify for subsidies may experience modest to moderate declines in out-of-pocket spending thanks to the Medicare Part D drug benefit, but new data indicate the savings may not be equal among all senior groups.

Researchers assessed results from the 1996-2000 Medical Expenditure Panel Survey Household Component and focused on projected 2006 out-of-pocket expenses for 5,996 seniors whose annual incomes were higher than 150 percent of the federal poverty level, meaning they would not be eligible for Medicaid. The sample represented approximately 23 million adults when weighted.

On average, 9.2 percent of seniors will spend more than $5,100 in total drug expenses during 2006. However, the researchers noted that black beneficiaries, those with lower incomes and adults with multiple chronic health conditions appear to be more likely to have increased total spending compared with white and Hispanic beneficiaries, those with higher incomes and those who do not have chronic health problems.

With the Part D benefit, seniors without employer-sponsored drug coverage will experience an average decrease in annual out-of-pocket drug costs of $478, the estimates showed. Seniors with more chronic illnesses will experience greater absolute savings, while black and Hispanic beneficiaries will save less than white beneficiaries will in out-of-pocket drug expenses.

The analysis also predicted that seniors with an annual income of less than $21,450 per year who will not receive subsidies will experience savings similar to seniors in the highest income category, although their absolute out-of-pocket drug costs will still be higher.

"Clinicians, the public and the government need to consider how this new drug benefit will affect vulnerable seniors and whether additional subsidies will be needed to improve their health," the authors concluded.

The research results can be found in the January/February edition of the journal Health Affairs.

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Patient insurance type, demographics affect physician prescription of Remicade versus Enbrel for RA, study finds In a study investigating physician prescribing behavior of Centocor Inc.'s Remicade (infliximab) and Amgen Inc. and Wyeth's Enbrel (etanercept) among patients with rheumatoid arthritis, researchers found that patients' insurance plan type was predictive of which biologic agent would be prescribed.

Despite similar drug efficacy, insurance reimbursement policies may provide incentives for differential prescribing, the authors noted. Prior to the implementation of the Medicare Modernization Act, policy called for reimbursement of physician-administered drugs under Part B, which included infused and intramuscular injectable drugs but not self-injectable (subcutaneous) drugs. Consequently, physicians treating Medicare beneficiaries may have had an incentive to prescribe Remicade, which is infused, rather than Enbrel, which is self-injected.

To further explore this issue, the researchers conducted an observational study of 1,663 patients with RA who had been newly prescribed Remicade or Enbrel.

Univariate analyses of demographic characteristics revealed that 29 percent of patients who received Enbrel had public insurance, whereas 60.3 percent of patients who received Remicade did, a difference that the study authors said was statistically significant. Several other demographic characteristics--including age, marital status, income, education and paid employment--differed significantly between patients in the two drug cohorts.

Moreover, eight of the 10 disease characteristics of patients who received Enbrel differed significantly from those of patients who received Remicade, although stratification by type of insurance reduced many of these differences, including those related to demographics.

Multivariate analyses found that patients with public insurance were 30 percent more likely to receive Remicade than were those with private insurance.

"Differential drug coverage has an impact on patient care and health care costs because it influences physicians' prescribing behavior," the researchers concluded. They noted that it remains to be seen how the MMA will alter the current patterns of prescription.

The findings were published in the Jan. 9 edition of Archives of Internal Medicine.

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Shire Plc Shire Plc settled its pending litigation with Impax Laboratories Inc. concerning Shire's attention-deficit/hyperactivity disorder treatment, Adderall XR (mixed amphetamine salts). By January 2010, Impax will be able to market generic versions of the drug in the United States. In return, Impax will pay sales royalties to Shire. Should another generic version of the drug be launched, Impax may be allowed to serve as Shire's authorized generic. The two firms also entered into a promotion agreement for Shire's Carbatrol (carbamazepine) epilepsy treatment. Under the agreement, Shire will pay Impax to promote the drug to neurologists for three years.

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Mylan Laboratories Inc. Mylan Laboratories Inc.'s generic version of Aciphex (rabeprazole sodium) delayed-release tablets was granted tentative approval by the Food and Drug Administration. According to Mylan, as of June 2005, the brand-name version of the acid reflux disease treatment had yearly U.S. sales of approximately $1.3 billion. Aciphex is co-promoted in the United States by Eisai Inc. and Janssen Pharmaceutica Inc.

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UnitedHealth Group Inc. UnitedHealth Group Inc. posted increased earnings and revenue for the fourth quarter and full year of 2005. Net income for the latest quarter was $870 million, or $0.65 per diluted share, compared with $739 million, or $0.54 per diluted share, in 2004's fourth quarter. Fourth-quarter revenue increased from $10.51 billion in 2004 to $12.05 billion in 2005. For the full year, net income rose from $2.59 billion, or $1.97 per diluted share, in 2004 to $3.3 billion, or $2.48 per diluted share, in 2005. Full-year revenue increased to $45.37 billion in 2005, up from $37.22 billion in 2004. The firm increased its guidance based on these strong results and now expects to earn from $2.85 to $2.90 per share in 2006. The previous per-share forecast was $2.82 to $2.85. UnitedHealth shares closed at $61.47, up $0.25, or 0.4 percent, in heavy trading on the New York Stock Exchange.

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GTx Inc. GTx Inc. is continuing its two Phase III trials of Acapodene (toremifene citrate), as planned, on the recommendation of an independent Drug Safety Monitoring Board. "This welcome news, along with the efficacy demonstrated recently in the interim analysis of bone mineral density in our androgen deprivation therapy trial, reduces the risk in Acapodene's clinical development and improves the prospects that we will be able to submit these product candidates for marketing approval," said Dr. Mitchell Steiner, chief executive officer of GTx. Acapodene is being studied as a treatment for the side effects of androgen deprivation therapy in men with advanced prostate cancer and to prevent prostate cancer in men who are at high risk of developing the disease.