Company Names

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

Eleven deaths reported in trial of Eisai's Aricept in vascular dementia Eleven patients taking Eisai Co. Ltd.'s Aricept (donepezil hydrochloride) died in a Phase III study testing the drug in vascular dementia.

Patients in nine countries participated in the trial and were randomized to receive 5 mg of Aricept (n=648) or placebo (n=326) once a day for 24 weeks. No deaths occurred in the placebo group.

Eisai explained that the 1.7 percent mortality rate observed in this trial is consistent with the mortality rate from a combined analysis of two previous trials of Aricept in vascular dementia. However, the analysis of the earlier trials showed a 2 percent mortality rate among patients who received placebo in those trials.

"An analysis of all three vascular dementia trials shows no statistically significant difference in observed mortality rates between the [Aricept] and placebo groups (1.7 percent vs. 1.1 percent)," the firm said, noting that patients with vascular dementia commonly take drugs for other conditions, particularly cardiovascular therapies.

Eisai has informed regulatory authorities of the deaths in this trial and said it will continue discussing the vascular dementia program with regulators.

A company spokeswoman told Reuters that an application for Aricept's use in vascular dementia is pending in the United States.

Eisai noted that, compared with those who received placebo, patients who received Aricept in this trial experienced statistically significant improvement in cognitive function, one of the study's primary measures.

Aricept, which is co-promoted in the United States by Eisai Inc. and Pfizer Inc., is approved to treat mild to moderate Alzheimer's disease.

Company Names

Wyeth discontinues Phase III trial of investigational breast cancer treatment Wyeth Pharmaceuticals discontinued the Phase III HORIZON trial on the recommendation of an independent Data Monitoring Committee.

The trial was testing Wyeth's investigational temsirolimus tablets in combination with Novartis AG's breast cancer drug Femara (letrozole) in postmenopausal women with hormone receptor-positive metastatic breast cancer. The trial compared the combined treatment regimen with Femara alone.

Based on an interim analysis, the DMC said the trial was not likely to achieve the targeted efficacy level for the temsirolimus/Femara combination compared with Femara alone. Further, the committee concluded that the risk-benefit ratio did not support continuation of the trial.

"While not the anticipated outcome, it is unfortunately not unusual for cancer drugs to work in some tumor types and not others, or even work in only some specific subpopulations of cancer patients," said Dr. Gary Stiles, chief medical officer of Wyeth Pharmaceuticals. "We remain committed to studying temsirolimus in other cancer indications."

The firm noted that two other Phase III trials of the drug will continue. These trials, in renal cell carcinoma and mantle cell lymphoma, are testing an intravenous formulation of the drug.

Company Names

Medtronic updates product label for CRT biventricular pacing systems Medtronic Inc. received approval from the Food and Drug Administration to expand the labeling for its cardiac resynchronization therapy (CRT) biventricular pacing systems to incorporate data from a recent trial demonstrating additional benefits the implantable devices may provide to patients with heart failure.

According to Medtronic, new key clinical benefits of the CRT systems include reduced risk of all-cause mortality and unplanned HF or cardiovascular hospitalization. Improved quality of life, improved exercise capacity and reductions in New York Heart Association classification are among the previously established outcomes in the devices' original labeling.

Approval to expand the label was based on the results of the CARE-HF (Cardiac Resynchronization in Heart Failure) trial, which demonstrated that Medtronic's CRT systems reduced hospitalizations and saved lives in patients with moderate or severe HF and poor heart pumping function. Specifically, they reduced all-cause mortality by 36 percent and unplanned hospitalizations for worsening HF by 52 percent.

"The revised labeling ... provides further validation that CRT and CRT defibrillator systems should be routinely used in patients with moderate to severe HF," said Dr. William Abraham, director of Ohio State University Medical Center's division of cardiovascular medicine.

Company Names

Ligand updates Ontak's label to warn patients of reported adverse events Ligand Pharmaceuticals Inc. sent a letter to health care professionals regarding changes made to the product labeling for Ontak (denileukin diftitox), a drug indicated to treat patients with persistent or recurrent cutaneous T-cell lymphoma.

Patients have reported loss of visual acuity after taking the drug, usually accompanied by loss of color vision with or without retinal pigment mottling. Recovery has been reported in some cases, but most patients reported persistent visual impairment.

The firm noted that since the reactions were reported voluntarily from a population of unknown size, it was not able to establish a causal relationship to drug exposure or to estimate the frequency of the events.

The Warnings and Adverse Reactions sections of the label were updated to include information regarding these adverse events.

Company Names

BioMarin, Serono's potential PKU treatment meets endpoints in Phase III trial BioMarin Pharmaceutical Inc. and Serono SA's Phenoptin (sapropterin dihydrochloride), an oral small molecule intended to treat phenylketonuria (PKU), was shown to statistically significantly reduce blood phenylalanine (Phe) levels as compared with placebo in a recent Phase III trial.

The double-blind study involved 89 patients (aged 8 years or older) with elevated blood Phe levels who had shown a reduction in blood Phe levels after being treated with Phenoptin in a Phase II screening study.

The patients were randomized to receive Phenoptin 10 mg/kg of body weight or placebo each day for six weeks; 87 patients completed all six weeks of treatment. Every two weeks, the patients were evaluated for adverse events and changes in blood Phe levels.

The trial's primary endpoint was the difference in mean blood Phe levels between the placebo-treated patients and the Phenoptin-treated patients at week six.

Results showed that Phenoptin-treated patients had a mean decrease in blood Phe level of 29 percent compared with the placebo-treated patients' mean increase of 3 percent at week six, BioMarin said. Furthermore, among patients who were treated with Phenoptin, the mean blood Phe level showed a consistent reduction at each visit compared with that of placebo-treated patients.

After completing the six-week trial, patients could choose to participate in an ongoing 22-week, open-label, Phase III extension study that is intended to further assess the drug's long-term safety and efficacy, in addition to dose titration.

BioMarin and Serono plan to file applications for Phenoptin in the treatment of PKU in the United States and the European Union in 2007. BioMarin licensed exclusive rights to the drug, excluding the United States and Japan, to Serono.

BioMarin shares closed at $13.92, up $1.47, or 11.8 percent, in heavy trading on the Nasdaq, while Serono shares closed at $18.28, up $0.21, or 1.2 percent, in moderate trading on the New York Stock Exchange.

Company Names

Chiron recalls, withdraws Morupar MMR vaccine; adjusts 2005 results Chiron Corp. recalled and withdrew its measles, mumps and rubella (MMR) vaccine, Morupar, from Italy and developing world markets because of potential adverse events following immunization.

The recall and withdrawal were based on the results of routine pharmacovigilance surveillance in Italy. Data indicate that patients immunized with Morupar may report a higher rate of adverse events, such as fever, allergic reactions and swelling of the glands, after immunization as compared with patients who receive other MMR vaccines. Chiron said the adverse events do not appear to present any long-term risk for patients who have previously received the vaccine.

The company is working with the World Health Organization to determine whether it is appropriate to continue selling a limited quantity of the existing inventory to public health programs such as the United Nations Children's Fund and the Pan American Health Organization.

Morupar sales totaled approximately $10 million in 2005. As a result of the recall and withdrawal, Chiron revised its 2005 fourth-quarter and full-year results.

For the fourth quarter, net income was revised to $138.1 million, or $0.68 per share, from the previously reported $144.2 million, or $0.71 per share. Total revenue for the quarter was revised to $614 million from $615.6 million.

For the full year, net income was revised to $180.5 million, or $0.94 per share, from $186.6 million, or $0.97 per share. Revenue was revised downward by $10 million to $1.92 billion.

Chiron shares closed at $45.51, down $0.19, or 0.4 percent, in moderate trading on the Nasdaq.

Company Names

Company Names
President Bush President Bush nominated Dr. Andrew von Eschenbach to serve as commissioner of the Food and Drug Administration. Eschenbach now serves as acting commissioner of the FDA and as director of the National Cancer Institute at the National Institutes of Health. Some Democratic senators said they will put a hold on the nomination until the FDA makes a decision regarding whether the Plan B emergency contraceptive will be made available without a prescription.

Company Names

Company Names
Roche Roche selected additional production partners for its influenza drug, Tamiflu (oseltamivir), to increase global production of the drug, which has shown promise as a treatment for pandemic flu. Roche now plans to produce 400 million doses of the drug per year, representing an annual increase of 100 million doses. Sanofi-Aventis Group, Martek Biosciences Corp., Albemarle Corp. and Ampac Fine Chemicals LLC are among the companies that will supply materials needed to manufacture Tamiflu.

Company Names

Company Names
Novartis Pharma AG Novartis Pharma AG licensed pimecrolimus to Conor Medsystems Inc. for use in Conor's next-generation, reservoir-based, drug-eluting stents. The nonexclusive license allows Conor to begin a trial to evaluate stents that use pimecrolimus, alone or in combination with paclitaxel, in treating coronary artery disease. Under the agreement, Conor will pay licensing fees, milestones payments and royalties to Novartis, which will supply the pimecrolimus to Conor and will collaborate on technical and regulatory issues. Novartis markets pimecrolimus, a cell-selective inhibitor of cytokines, as Elidel, a cream used in treating atopic dermatitis.

Company Names

Company Names
Novo Nordisk A/S Novo Nordisk A/S expanded its four-year supply agreement with Serologicals Corp.'s subsidiary, Celliance Corp. The expanded agreement gives Celliance worldwide rights to distribute Novo Nordisk's Incelligent, a recombinant human insulin, in the cell culture market. Additional details of the agreement were not disclosed.