Takeda, Zinfandel form partnership
OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.
Under the agreement, Zinfandel will receive $9 million upfront plus up to $78 million in milestone payments, plus royalties, for licensing rights to the TOMM40 assay. Zinfandel CEO Allen Roses and researchers at the company recently discovered the TOMM40 biomarker, and the company is developing it to identify people at high risk for developing Alzheimer’s within five years.
The deal includes potential use of the Takeda drug pioglitazone in combination with the assay. Studies have shown the pioglitazone, the active ingredient in the diabetes drug Actos, may slow progression of Alzheimer’s.
FDA extends review time of AstraZeneca’s vandetanib
LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca’s vandetanib has been extended.
The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.
AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.
GSK to pay legal charge relating to Avandia
LONDON — Drug maker GlaxoSmithKline will take a legal charge of $3.4 billion related to its promotion of a controversial diabetes drug.
The British company said the charge related to an investigation by the U.S. Attorney’s Office for the District of Colorado regarding sales and promotion of the drug Avandia (rosiglitazone) in spite of reports of the risk of heart attacks in patients taking it.
“We recognize that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” GSK SVP global litigation P.D. Villarreal said. “We have closed out a number of major cases over the last year, and we remain determined to do all we can to reduce our litigation risk.”