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Biotech Brand
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Takeda's investigational sepsis treatment granted fast track status
Takeda Global Research & Development Center Inc.'s investigational severe sepsis treatment, TAK-242, recently received fast track status from the Food and Drug Administration.
Phase I studies of the compound have been conducted in the United States, Japan and Europe. Based on discussions with the FDA and Japan's Pharmaceuticals and Medical Devices Agency, Takeda intends to begin a global Phase III trial this August.
TAK-242 works by inhibiting the signal transduction through toll-like receptor 4, thereby by suppressing the production of inflammatory mediators such as cytokine.
"Severe sepsis is a really life-threatening disease and is one of the main causes of death in the intensive care unit, and there is no drug widely indicated for the severe sepsis patients," said Yasuchika Hasegawa, president of Takeda. "Through clinical studies, which will start soon, we expect to confirm the efficacy of this compound as early as possible to provide a life-saving treatment option for this disease, which I believe will lead to realization of our management mission to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products."
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Genzyme submits BLA for Pompe disease treatment, Myozyme
Genzyme Corp. submitted a Biologics License Application to the Food and Drug Administration for Myozyme (alglucosidase alfa) as a long-term enzyme replacement therapy for all patients with a confirmed diagnosis of Pompe disease.
If approved, Myozyme would be the first treatment indicated for patients with Pompe disease, a debilitating and often fatal muscle disorder caused by an inherited enzyme deficiency, which affects fewer than 10,000 people worldwide, Genzyme said.
The BLA includes positive data from the drug's pivotal study, which demonstrated that 15 of 18 patients (83 percent) with infantile-onset Pompe disease who began receiving Myozyme by 6 months of age were alive and free of invasive ventilator support at 18 months of age.
Researchers compared the outcomes for these patients to a historical cohort, rather than a placebo cohort, due to the disease's rapid progression and typically fatal nature. In the historical cohort, 2 percent of patients were alive at 18 months of age.
"This is a very exciting and hopeful moment for Pompe patients and their families," said Henri Termeer, Genzyme's chief executive officer. "Myozyme could be available in the United States and Europe by the early part of next year ... ."
Genzyme said the BLA is expected to receive priority review by the FDA; Myozyme was previously granted an orphan drug designation by the agency.
In addition, the firm expects to initiate a clinical trial "shortly" of Myozyme in patients with late-onset Pompe disease.
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Phase III trial of Novartis, Idenix's chronic hepatitis B treatment reaches primary endpoint
Novartis AG and Idenix Pharmaceuticals Inc. said that the Phase III Globe registration trial for telbivudine successfully reached its primary composite endpoint of therapeutic response at one year in patients with chronic hepatitis B.
Involving more than 1,350 patients in more than 130 centers worldwide, the ongoing GLOBE trial is designed to compare the safety and efficacy of 600 mg of telbivudine to that of 100 mg of GlaxoSmithKline Plc's Epivir (lamivudine) for two years of treatment in patients with compensated chronic hepatitis B that is positive or negative for hepatitis B e-antigen (HBeAg).
The endpoint evaluated the combination of viral suppression along with either improved liver function or loss of detectable HBeAg. So far, results show the drug has a favorable safety profile, the companies added.
The trial's one-year analysis will be the main data included in marketing registration applications; Novartis and Idenix expect to file a New Drug Application with the Food and Drug Administration by the end of 2005.
"We believe that telbivudine is emerging as an important, potent new treatment option for hepatitis B, providing rapid and profound viral suppression," said Joerg Reinhardt, global head of development for Novartis Pharma AG.
The companies plan to submit complete data from the GLOBE study for presentation at the American Association for the Study of Liver Disease meeting in San Francisco this November.
In addition, another Phase III trial is evaluating the safety and efficacy of telbivudine compared with Epivir in HBeAg-positive and HBeAg-negative patients with decompensated chronic hepatitis B.
According to the World Health Organization, approximately 350 million people, or 5 percent of the world's population, are chronically infected with the hepatitis B virus.
GSK manufactures Epivir under an agreement with Shire Pharmaceuticals Group Plc.
If approved, telbivudine will be co-promoted in the United States, France, Germany, Italy, Spain and the United Kingdom by both Novartis and Idenix; Novartis holds exclusive license to the drug in the rest of the world.
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Neoadjuvant Arimidex as effective as tamoxifen in postmenopausal women with operable, ER-positive, nonmetastatic breast cancer, researchers report
Neoadjuvant treatment with AstraZeneca Plc's Arimidex (anastrozole) is as effective and well tolerated as tamoxifen in estrogen receptor (ER)-positive operable breast cancer in postmenopausal women, according to data from a recent study.
The Phase III double-blind, randomized study, which enrolled a total of 330 patients, was designed to compare neoadjuvant tamoxifen (n=108), Arimidex (n=113) or a combination of the two (n=109) before surgery in postmenopausal women with ER-positive, invasive, nonmetastatic breast cancer.
Tumor objective responses, measured by caliper, were 37 percent, 36 percent and 39 percent for Arimidex, tamoxifen and the combination, respectively, with no significant differences reported between the treatment groups. Ultrasound response rates were also not significantly different.
However, significantly more patients treated with Arimidex rather than tamoxifen were deemed eligible for breast-conserving surgery (BCS) because they had achieved sufficient tumor regression. Indeed, 46 percent, 22 percent and 26 percent of patients who received Arimidex, tamoxifen and the combination, respectively, were deemed eligible for the surgery. Of the 124 patients who were considered at baseline to require mastectomy, 44 percent of those who received Arimidex versus 31 percent of those who received tamoxifen underwent BCS.
Patients with higher levels of ER expression were also found to be statistically significantly more likely to respond to therapy.
There was no significant difference in tolerability among the treatment groups, except in vaginal discharge, which was reported in 0 percent, 6 percent and 8 percent of patients taking Arimidex, tamoxifen and the combination, respectively.
The authors concluded by noting that the trial provides further supportive evidence that third-generation aromatase inhibitors, such as Arimidex, "are significantly more effective than tamoxifen in downstaging large breast cancers and reducing the need for mastectomy in postmenopausal women."
This study appeared in the Aug. 1 issue of the Journal of Clinical Oncology.
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Geodon capsules efficacious in improving symptoms in patients with acute bipolar mania, findings suggest
Pfizer Inc.'s Geodon (ziprasidone hydrochloride) was shown to be rapidly efficacious and superior to placebo in improving symptoms and global illness severity in patients with acute bipolar mania, according to results of a new study.
In the double-blind replication trial, inpatients with bipolar I disorder, manic or mixed, were randomized to receive 40 mg to 80 mg of Geodon or placebo twice daily. For evaluating efficacy, 137 Geodon-treated patients and 65 placebo-treated patients were included in the analysis.
The Mania Rating Scale (MRS) total score derived from the Schedule for Affective Disorders and Schizophrenia-Change Bipolar Scale was the primary efficacy parameter.
The baseline mean MRS scores were 26.2 in the Geodon group and 26.4 in the placebo group, reflecting a moderately severe degree of symptoms. MRS scores from baseline to endpoint in both groups improved, with the Geodon group demonstrating a significantly greater improvement, with a MRS score change of -11.1 compared with a change of -5.6 in the placebo group.
There was a significant difference noted between Geodon and placebo at the first postbaseline assessment on day two; this difference continued from day seven to the end of the study. The responder rate at the end of the study was significantly higher in the Geodon group (46 percent) than in the placebo group (29 percent).
Geodon also produced significantly greater improvements in the Manic Syndrome and Behavior and Ideation Subscales, Clinical Global Impression-Severity score, Positive and Negative Syndrome Scale total and positive subscale scores and Global Assessment of Functioning measurements.
The study appeared in the August issue of the Journal of Clinical Psychopharmacology.
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Perioperative beta-blocker treatment lowers risk of in-hospital mortality among high-risk patients, study finds
Perioperative treatment with beta-blockers appears to be associated with a reduced risk of in-hospital death among patients with a Revised Cardiac Risk Index (RCRI) score of 2 or higher who are undergoing major noncardiac surgery, according to a study in the July 28 issue of The New England Journal of Medicine.
Patients with an RCRI score of 0 or 1, however, saw no benefit from perioperative treatment with beta-blockers, and may possibly be harmed by it, the authors found.
To establish a patient's RCRI score, researchers assigned one point for each of the following risk factors: ischemic heart disease, high-risk surgery, cerebrovascular disease, diabetes mellitus and renal insufficiency.
Researchers conducted a retrospective study of patients aged 18 years or older who had major noncardiac surgery between Jan. 1, 2000, and Dec. 31, 2001, at 329 U.S. hospitals that participate in the Premier's Perspective database. Patients who had obstetrical procedures were excluded from the analysis, leaving a total of 782,969 patients, 663,635 of whom had no known contraindications to beta- blockers.
Of the patients eligible for perioperative treatment with beta-blockers, 122,338 (18 percent) received such treatment during their first two days in the hospital. Those who received it after the second day were grouped with those who did not receive such treatment, since it may have been prescribed for complications and not for prevention.
Patients who received perioperative beta-blocker treatment and had an RCRI score of 2, 3, 4 and up were found to be 88 percent, 71 percent and 58 percent as likely to die in the hospital as compared with those who did not receive perioperative beta-blockers.
Therefore, researchers concluded that perioperative beta-blocker treatment should be used in high-risk patients, adding that "the lack of benefit of this approach in moderate-risk patients and the potential harm of this approach in the lowest-risk groups suggest that careful patient selection remains necessary."
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The Food and Drug Administration
The Food and Drug Administration named Dr. Steven Galson as director of the agency's Center for Drug Evaluation and Research, which is in charge of approving and regulating prescription and over-the-counter drugs. Galson joined the FDA in April 2001 as deputy director of the center and most recently served as the acting center director. "Dr. Galson's scientific and management experience will benefit all Americans as the FDA continues to advance and protect public health," said FDA Commissioner Lester Crawford.
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Schering AG
Schering AG licensed exclusive U.S. rights to Indevus Pharmaceuticals Inc. to market Nebido (testosterone depot), the first injectable product for treating male hypogonadism with dosing only once every three months. Under the agreement, Indevus will develop and commercialize Nebido in the United States, and Schering will manufacture and supply commercial products to Indevus. Indevus will receive $30 million in up-front and milestone payments. Following product approval, Indevus will pay Schering a percentage of the net sales to cover the supply of finished product and royalties. Indevus expects to file a New Drug Application with the Food and Drug Administration in the second half of 2006.
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Advancis Pharmaceutical Corp.
Advancis Pharmaceutical Corp. said it will reduce its workforce by more than one-third and eliminate all nonessential temporary personnel, leaving the firm with 54 employees. Advancis expects this move to reduce its net annual spending by approximately $4.1 million and plans to take approximately $3.3 million in restructuring charges during the third quarter of 2005. Included in the workforce reductions are six corporate officers such as the firm's chief scientific officer and senior vice president of pharmaceutical research and development. Last month, the company announced its investigational pediatric strep throat treatment, Amoxicillin Pulsys, failed to meet the endpoints of a Phase III trial.
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President Bush
President Bush signed the Patient Safety and Quality Improvement Act of 2005 Friday, citing the need to "reduce medical errors that injure and cause the deaths of thousands of Americans each year." The law will allow health care providers to exchange information on medical errors without the fear of sparking new lawsuits. According to Reuters, the legislation has been in the works since 1999, when the Institute of Medicine released a study that found up to 98,000 Americans die annually from hospital medical errors.
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