GSK, Tolerx’s late-stage trial for otelixizumab doesn’t meet endpoints
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.
Dendreon’s manufacturing expansion for Provenge OKed
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.
BioScrip reports Q4, full-year sales results
ELMSFORD, N.Y. — Specialty pharmacy provider BioScrip had sales of $450.4 million in fourth quarter 2010 and $1.6 billion for the year as a whole, according to financial results released Friday.
Sales for the quarter were $108.8 million higher than in fourth quarter 2009, while sales for the fiscal year were $300 million higher than in fiscal year 2009. However, the company still had net losses of $67.1 million for the quarter and $69.1 million for the year.
“2010 was a challenging year for BioScrip,” the company’s president and CEO Rick Smith said. “During the year, revenue and margins were impacted by pricing concessions on various specialty drugs, reimbursement pressures, the new industrywide [average wholesale price] standard and the overall impact of the weak economic environment. As a result, we commenced a strategic assessment of our business lines and overhead structure to position BioScrip for the future.”
Highlights for the year included the acquisition of CHS, which Smith said bolstered the company’s position in infusion and home services.
“We believe there are significant opportunities for BioScrip to improve operating performance and cash-flow generation,” Smith said.