PHARMACY

GSK develops community pharmacy team

BY Allison Cerra

RESEARCH TRIANGLE PARK, N.C. — GlaxoSmithKline said it is establishing a dedicated team to support community pharmacists and other healthcare professionals.

Effective March 28, GSK said its community pharmacy liaisons will provide information and tools to help community pharmacists communicate with their patients about chronic diseases and the appropriate use of medicines and vaccines.

In developing the new team, the drug maker said it consulted with community pharmacists to better understand their needs and to ensure that the new team will provide a helpful service.

“Our research shows that community pharmacists want to spend more time engaging with their patients, and many patients would welcome more counseling about their medication,” said David Moules, GSK VP channel development and sales. “The GSK community pharmacy team will provide community pharmacists with education and tools to support those important patient conversations.”

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GSK, Tolerx’s late-stage trial for otelixizumab doesn’t meet endpoints

BY Alaric DeArment

CAMBRIDGE, Mass. — A late-stage trial of a biologic treatment for Type 1 diabetes appears to have failed, according to results announced Friday.

GlaxoSmithKline and Tolerx said results of the 272-patient, phase-3 “DEFEND-1” study of otelixizumab indicated it did not preserve the function of insulin-producing cells in the pancreas, as measured by levels of the protein C-peptide, which is used to measure the amount of insulin the body is producing. Patients received a single, eight-day intravenous course of the drug no more than 90 days after diagnosis. Pending review of the results of DEFEND-1, patient recruitment for a second study, “DEFEND-2,” has been suspended, the companies said.

“While we are disappointed in the DEFEND-1 results of otelixizumab, we remain committed to the development and commercialization of the candidates in our pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses,” Tolerx president and CEO Douglas Ringler said.

Type 1 diabetes, formerly called juvenile-onset diabetes, is an autoimmune disorder in which the immune system destroys the pancreatic cells that produce insulin.

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Dendreon’s manufacturing expansion for Provenge OKed

BY Alaric DeArment

SEATTLE — The Food and Drug Administration has approved biotech company Dendreon’s expansion of manufacturing capacity for an immunotherapy treatment for prostate cancer, Dendreon said Thursday.

The company said it would be able to increase the ability of Provenge (sipuleucel-T) manufactured at its plant in New Jersey by increasing the number of workstations to produce it from 12 to 48.

The treatment is designed to induce an immune response against prostatic acid phosphatase, an antigen present in most prostate cancers.

The company said it expects to have around 225 infusion centers prepared to treat their first patient by the end of the second quarter, and 500 by the end of the year.

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