Brands

Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management

LIPITOR FAILS TO REDUCE NARROWING OF HEART VALVE, RESEARCHERS REPORT ------------------------------------------------------------------------------- Pfizer Inc.'s cholesterol-reducing drug, Lipitor (atorvastatin calcium), does not prevent obstruction of the heart valve leading to the aorta, according to a study published in the June 9 edition of The New England Journal of Medicine.

The double-blind, placebo-controlled study, which included 155 patients, was designed to determine whether the drug could prevent a condition known as calcified aortic stenosis, which occurs when a key heart valve narrows or becomes blocked and usually requires surgery. Those included in the study had calcific aortic stenosis, an aortic-jet velocity of at least 2.5 m/sec and aortic valve calcification. The patients were randomized to Lipitor 80 mg/day or placebo.

The primary endpoints were the change in aortic-jet velocity and aortic-valve calcium score.

After a median follow-up of 25 months, the results showed similar results for the two treatment arms. The Lipitor group showed an increase in aortic-jet velocity of 0.199 m/sec/year compared with 0.203 m/sec/yr in the placebo group. The absolute change in aortic-valve calcium score was 1564 arbitrary units (AU)/yr for those treated with Lipitor compared with an absolute change in score of 1648 AU/yr for those who received placebo.

The researchers found that Lipitor did not stop the progression of aortic stenosis, "despite intensive reductions in serum cholesterol concentrations." While they did not rule out a possible secondary preventive benefit independent of the valvular disease process, they said they "do not recommend statin therapy for patients with calcific aortic stenosis in the absence of coexisting vascular disease." -=-

MAGNITUDE OF TYSABRI, PML ASSOCIATION UNKNOWN; EARLY PML DIAGNOSIS MAY ALLOW FOR TREATMENT, RECOVERY, CASE STUDY SUGGESTS ------------------------------------------------------------------------------- Although the association between Biogen Idec Inc. and Elan Corp. Plc's multiple sclerosis drug, Tysabri (natalizumab), and progressive multifocal leukoencephalopathy (PML) "seems clear . . . the magnitude of the risk of PML per year of exposure" is unknown, Dr. Jeffrey Drazen, editor-in-chief of The New England Journal of Medicine (NEJM), said in an editorial posted Thursday on the journal's Web site.

The editorial is one of several Tysabri articles posted ahead of print in July's NEJM. According to The Wall Street Journal, the NEJM posted the stories early in response to the possible fourth case of PML reported in a Tysabri-treated patient last week.

The early-release articles range from case studies of each of the three confirmed patients to a statement by Biogen Idec.

"The review of data on these patients, who are described in this issue of [NEJM], is part of a larger analysis under way in consultation with regulatory authorities and the National Institutes of Health to assess the risk of PML in [Tysabri]-treated patients," Biogen Idec said in its statement.

Biogen Idec added that one of the case studies noted that patients may experience a reactivation of the JC virus, a common infection acquired in childhood that remains dormant in bone marrow, kidney epithelia and the spleen, before they develop PML. This possibility may allow for testing to detect the reactivated virus in plasma, which would "permit early diagnosis and discontinuation of [Tysabri] therapy and allow patients to recover."

Another report focused on a Tysabri-treated patient who developed PML, was treated and subsequently recovered. The report's authors suggested that "some degree of recovery from [Tysabri]-associated PML is possible."

This chance for recovery, along with the potential to test for the virus that may precede PML, may offer "a possible company strategy for getting the drug back on the market," The Journal noted.

Biogen Idec and Elan suspended Tysabri in February when a patient taking the drug in combination with Biogen Idec's Avonex (interferon beta-1a) developed, and died from, PML. In early March, the companies confirmed that a second patient, who had also taken the drug along with Avonex, had developed the same disease. Later in March, the companies said they had determined that the December 2003 death of a patient in a Crohn's disease trial was caused by PML.

Last week, a report in The Boston Globe said that Biogen Idec informed the Food and Drug Administration that a fourth patient taking Tysabri might have PML.

Biogen Idec shares closed at $35.13, up $1.78, or 5.3 percent, in heavy trading on the Nasdaq. Elan shares closed at $7.37, up $0.77, or 11.7 percent, in heavy trading on the New York Stock Exchange. -=-

RITUXAN IMPROVES SYMPTOMS IN PATIENTS WITH RHEUMATOID ARTHRITIS, DATA SUGGESTS ------------------------------------------------------------------------------- Genentech Inc., Biogen Idec Inc. and F. Hoffman-La Roche Ltd. said preliminary results from a randomized trial of 465 patients with rheumatoid arthritis showed Rituxan (rituximab) is capable of improving symptoms associated with the disease.

The Phase IIb trial, known as the DANCER study, included patients who had experienced an inadequate response to treatment with methotrexate and had failed previous treatment with other disease-modifying antirheumatic drugs.

The data showed Rituxan, in combination with methotrexate, to be clinically and statistically significantly more effective than placebo at achieving American College of Rheumatology (ACR) response rates of 20, 50 and 70. A patient's ACR response rate indicates the percentage of improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.

Adverse events were primarily mild to moderate in intensity and included headache, nausea and rigors, the companies said. The incidence of serious adverse events was higher among patients who received Rituxan compared with those treated with placebo, but similar to previous studies of the drug in RA.

"The results of the DANCER study, which evaluated the efficacy and safety of Rituxan in a difficult-to-treat patient population, further validate selective B-cell depletion as a potentially new and viable approach to the treatment of RA," said Dr. Roy Fleishmann, of the University of Texas Southwestern Medical Center. "For the first time, these data also showed that the benefits of Rituxan were independent of short-course corticosteroids, which were given in all previous Rituxan RA trials."

The DANCER data were presented at the annual meeting of the European League Against Rheumatism in Vienna, Austria.

Genentech shares closed at $80.93, up $1.83, or 2.3 percent, in moderate trading on the New York Stock Exchange while Biogen Idec shares closed at $35.13, up $1.78, or 5.3 percent, in heavy trading on the Nasdaq. -=-

ALTEON DISCONTINUES ALAGEBRIUM HYPERTENSION TRIAL; ED TRIAL PLACED ON CLINICAL HOLD ------------------------------------------------------------------------------- Alteon Inc. will discontinue a Phase IIb trial for alagebrium after an interim data evaluation indicated that the drug was not efficacious for the treatment of uncontrolled systolic hypertension.

"While the drug has been observed to be safe and well tolerated in clinical trials to date, the independent efficacy review committee conducting the interim analysis of [the trial] found that the data did not indicate a treatment effect of alagebrium against systolic hypertension and that there was a low probability of meeting clinical endpoints by the planned conclusion of the study," the company said.

Alteon also said it was notified by the Center for Drug Evaluation and Research's Division of Reproductive & Urologic Drug Products that further enrollment in a Phase IIa study of alagebrium as a treatment for erectile dysfunction has been placed on clinical hold, which will remain in effect until additional data are submitted.

The company is "actively continuing to develop data to support resumption" of this trial.

Clinical protocols of Alteon's cardiovascular disease trials are still open.

In February, Alteon voluntarily suspended patient enrollment in its alagebrium clinical trials on a temporary basis, pending additional preclinical data and discussions with the Food and Drug Administration.

Alteon shares closed at $0.67, down $0.03, or 4.3 percent, in moderate trading on the American Stock Exchange. -=-

BMS' INVESTIGATIONAL RA DRUG INHIBITS JOINT DAMAGE PROGRESSION, STUDY SHOWS ------------------------------------------------------------------------------- Bristol-Myers Squibb Co.'s abatacept inhibits the progression of joint damage in patients with active rheumatoid arthritis, according to updated results from a Phase III trial presented at the European League Against Rheumatism annual meeting in Vienna, Austria.

The AIM study included 652 patients with active RA who had responded inadequately to methotrexate. In addition to continuing their methotrexate regimen, patients were randomized in a 2:1 ratio to receive a 30-minute infusion of abatacept (approximately 10 mg/kg of body weight; n=433) or placebo (n=219) on days one, 15 and 29, and every 28 days thereafter.

At six months, one additional disease-modifying antirheumatic drug was allowed.

Radiographs of the hands and feet, which were taken at the beginning and end of the one-year study, were collected for 391 patients in the abatacept group and for 195 patients in the placebo group. The radiographs were scored using the Genant-modified Sharp scoring method.

Compared with patients in the placebo cohort, patients in the abatacept group showed inhibition of structural damage progression based on the median change from baseline and measured by the joint erosion score, the joint space narrowing score and the total score. Patients treated with abatacept also had fewer increases in mean joint erosion scores (0.63 vs. 1.14), joint space narrowing scores (0.58 vs. 1.18) and total scores (1.21 vs. 2.32).

Both groups had similar adverse events, according to BMS; the most common were headache (abatacept, 17.6 percent vs. placebo, 11.9 percent), nasopharyngitis (abatacept, 15.2 percent vs. placebo, 11.4 percent) and nausea (abatacept, 12 percent vs. placebo, 11 percent). Serious adverse events occurred in 15 percent of abatacept-treated patients and in 11.9 percent of placebo-treated patients.

Abatacept is one of a new class of drugs called T-cell co-stimulation modulators. Analysts predict that if abatacept is approved, it could generate sales of more than $1 billion, Reuters reported. -=-

UNCOMPENSATED CARE FOR UNINSURED INDIRECTLY LEADS TO INCREASES IN EMPLOYER-SPONSORED INSURANCE PREMIUMS, NEW REPORT INDICATES ------------------------------------------------------------------------------- In 2005, treatment costs for uninsured adults could increase private health insurance premium rates by an average of 8.5 percent for families, individuals and employers, according to new data.

Families USA, a health consumer organization, contracted with Dr. Kenneth Thorpe from Emory University to quantify the impact of uncompensated health care on private, employer-sponsored health insurance premiums. Thorpe's estimates were based on data derived from the U.S. Census Bureau, the Agency for Healthcare Research and Quality, the National Center for Health Statistics and other sources.

More than 35 percent of health care costs incurred by uninsured individuals were paid by the uninsured themselves, the study noted. The remaining costs were covered by federal, state and local government sources (approximately one-third) or were paid through increased premiums by those with private health coverage (two-thirds).

The report estimated that nearly 48 million individuals living in the United States will have no health insurance coverage for the full year of 2005.

The cost for uncompensated health services provided to the uninsured will exceed $43 billion in 2005, the report predicted. As a result, employer-provided health insurance premiums for families will cost an average of $922 extra in 2005; individuals covered by employers will pay, on average, an extra $341. This translates into approximately $1 out of every $12 spent on employer-provided health insurance premiums.

Families USA Executive Director Ron Pollack said the problem of costs related to the lack of insurance for certain individuals is no longer just an issue for those without health coverage.

"The stakes are high both for businesses and for workers who do have health insurance because they bear the brunt of costs for the uninsured," he said.

Health insurance premium rates in 2005 are anticipated to rise at an even greater rate in New Mexico ($1,875), West Virginia ($1,796), Oklahoma ($1,781), Montana ($1,578), Texas ($1,551) and Arkansas ($1,514).

By 2010, the extra costs related to uncompensated care are projected to rise to $1,502 for families and by $532 for individuals nationwide, according to the data. Among 11 states--Alaska, Arizona, Arkansas, Florida, Idaho, New Mexico, Montana, Oklahoma, Texas, Washington and West Virginia--employer-provided health coverage for families will cost more than $2,000 extra to compensate for health services provided to the uninsured.

"This report underscores the importance of strengthening and protecting public programs such as Medicaid that are the health safety net for millions of Americans," Pollack said. "Medicaid cuts would only force more and more families into the ranks of the uninsured, thereby increasing insurance premiums for everyone who has health coverage." -=-

Brands
SCHERING AG ------------------------------------------------------------------------------- Schering AG said it will post a second-quarter gain from the sale of a 25 percent stake in one of its distribution partners, Medac GmbH, according to Dow Jones Newswires. Schering sold its stake to Medac shareholders for "a two-digit million euro figure" as part of the company's intent to concentrate its efforts on cancer products. As part of this new strategy, Schering acquired the remaining 50 percent of shares in a joint venture formed in 2000 between the two companies; the venture, Medac Schering Onkologie GmbH, focuses on the sale of cancer products. -=-

Brands
U.S. HOUSE OF REPRESENTATIVES ------------------------------------------------------------------------------- The U.S. House of Representatives passed a measure that would prohibit scientists who have ties to the industry from serving on advisory committees for the Food and Drug Administration. The House voted 218-210 on Wednesday to pass an amendment to legislation that appropriates funds for the FDA; the amendment would prevent the FDA from spending any money on granting waivers of conflict-of-interest rules for committee members. The Senate must adopt the measure for it to become law. -=-

Brands
ABLE LABORATORIES INC. ------------------------------------------------------------------------------- Able Laboratories Inc., a manufacturer of generic drugs, is making additional staff reductions. This latest step follows last month's termination of 200 employees and suspension of the company's operations as a result of improper laboratory practices. Able said the extra reductions will help the company "conserve assets and assist it in retaining key employees as it continues to address pending regulatory issues." The company gave no indication as to when it will resume manufacturing operations. Able shares closed at $4.01, down $0.32, or 7.4 percent, in moderate trading on the Nasdaq. -=-

Brands
SOMAXON PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Somaxon Pharmaceuticals Inc. initiated its first Phase III trial of Silenor (doxepin hydrochloride) in patients with insomnia. The placebo-controlled trial will evaluate the drug's safety and efficacy in adults with primary chronic insomnia. According to Somaxon's Chief Executive Officer Ken Cohen, "Silenor's active ingredient is not a Schedule IV controlled substance, and its mechanism of action is different from all currently approved" insomnia treatments. -=-