Bristol-Myers Squibb, AstraZeneca: Dapagliflozin meets trial endpoints
PRINCETON, N.J. An investigational drug used by Type 2 diabetes treatment-naive adult patients showed statistically significant reductions in glycosylated hemoglobin levels, according to a study published in Diabetes Care.
Dapagliflozin was administered as a monotherapy for 24 weeks in a phase 3 trial, under joint development by Bristol-Myers Squibb and AstraZeneca. The compound is an investigational, potential first-in-class sodium-glucose cotransporter-2 inhibitor. SGLT2 inhibitors facilitate the elimination of glucose by the kidney, which should result in lowering serum glucose levels, the drug makers said.
The study of 485 individuals (ages 18 to 77 years) was designed to assess the efficacy and safety of dapagliflozin in treatment-naive patients with newly diagnosed Type 2 diabetes and inadequate glycemic control with diet and exercise alone. The data represented findings from a 24-week, parallel-group, double-blind, placebo-controlled phase 3 study, with a two week diet/exercise placebo lead-in. Throughout the study, all patients received diet and exercise counseling per American Diabetes Association recommendations. By week 24, the HbA1c levels of the study subjects decreased, thus meeting the study’s endpoints.
“These findings of dapagliflozin as a monotherapy, together with an additional phase 3 study of dapagliflozin in combination with metformin, which was presented at the 2009 European Association for the Study of Diabetes annual meeting, show the potential of this agent to help patients with Type 2 diabetes,” said Ele Ferrannini, professor of internal medicine at the University of Pisa School of Medicine in Italy.
A1c readings may not be accurate for some ethnic groups, study finds
NEW YORK The hemoglobin A1c test may not provide accurate results for elderly Asians, according to published reports about a new study.
The American Diabetes Association said the test works when doctors use an A1c reading of 6.5% to indicate diabetes, but the study, conducted in Singapore, found that the cutoff often misses the disease in older Asians. The study was conducted on participants between the ages of 20 and 93 years.
The study’s findings were scheduled to be presented Sunday at the Endocrine Society’s annual meeting in San Diego, according to the reports.
Valeant, Biovail to merge
TORONTO U.S. drug maker Valeant and Canadian drug maker Biovail will merge, the two companies said Monday.
The combined company will carry the name Valeant Pharmaceuticals International but will have its headquarters in Mississauga, Ontario. Valeant is currently based in Aliso Viejo, Calif.
Under the agreement, Valeant stockholders will receive $16.77 per share immediately before the merger’s closing and, after its closing, 1.78 shares of Biovail stock for every share of Valeant stock they own. After the merger closes, Biovail shareholders will own around 50.5% and Valeant shareholders will own 49.5% of the combined company.
Biovail is known mostly for such specialty drugs as the antidepressant Wellbutrin XL (bupropion), while Valeant’s range of branded and branded generic drugs include the acne treatment Acanya Gel (clindamycin phosphate and benzoyl peroxide).
Valeant CEO J. Michael Pearson will reside in Barbados as the new CEO, while Biovail CEO Bill Wells will be nonexecutive chairman. The company’s 11-member board of directors will include five representatives from Biovail, five from Valeant and one independent Canadian resident director.
“This compelling combination will create tremendous value for stockholders of both companies as our business benefits from cost savings, greater scale, efficiencies from extending Biovail’s corporate structure and enhanced financial strength and flexibility,” Pearson said.