Pfizer voluntarily withdraws Mylotarg
SILVER SPRING, Md. Pfizer has withdrawn one of its cancer drugs from the market at the request of the Food and Drug Administration amid concerns about its safety and efficacy, the FDA said Monday.
The drug maker started the voluntary withdrawal of the drug Mylotarg (gemtuzumab ozogamicin), used to treat acute myeloid leukemia, following the abrupt halting of a post-marketing trial in which patients taking Mylotarg with chemotherapy showed no clinical benefit and also died at a higher rate than those taking chemotherapy alone. Wyeth, now part of Pfizer and the original developer of the drug, started the trial in 2004. The drug was approved under the FDA’s accelerated approval program in 2000 for patients aged 60 and older with AML.
“Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products director Richard Pazdur said in a statement. “However, a confirmatory clinical trial and years of post-marketing experience with the product have not shown evidence of clinical benefit in patients with AML.”
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.