FDA approves Novartis drug for Cushing’s disease
EAST HANOVER, N.J. — The Food and Drug Administration has approved a new drug to treat a rare but serious endocrine disorder.
Swiss drug maker Novartis announced the approval of Signifor (pasireotide), an injectable drug for treating Cushing’s disease in adults for whom pituitary surgery is not an option or has not been curative. Novartis said Signifor was the first drug to be approved in the United States that addresses the disease’s underlying mechanism.
The disease is a debilitating disorder that most commonly affects patients aged 20 to 50 and is caused by a benign pituitary tumor that leads to excessive amounts of the metabolic hormone cortisol, leading to weight gain, obesity, fatigue, weakness, high blood pressure, depression and anxiety.
Takeda to sell URL Pharma to Caraco Pharmaceutical Labs
OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is selling its generics business to India-based Sun Pharmaceutical Industries, Takeda said Monday.
Takeda said it would sell URL Pharma, through U.S. subsidiary Takeda Pharmaceuticals USA, to Sun subsidiary Caraco Pharmaceutical Labs while retaining control of the gout treatment Colcrys (colchicine). Takeda acquired rights to Colcrys when it bought URL Pharma for $800 million in June 2012; financial terms of the current deal with Caraco were not disclosed.
"The addition of Colcrys has allowed Takeda to become a leader in gout, which is part of our strategy to focus on best-in-class, innovative pharmaceuticals," Takeda Pharmaceuticals USA president Douglas Cole. "URL Pharma has many great assets, and Takeda was committed to finding a buyer for the remaining business that would be dedicated to leveraging all that URL Pharma has to offer."
Colcrys had sales of $155 million between June 1 and Sept. 30, 2012, according to Takeda.
Federal court upholds validity of Crestor patent
WILMINGTON, Del. — A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.
AstraZeneca said the Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the District of Delaware ruling that a patent covering the drug Crestor (rosuvastatin calcium) was valid and enforceable. The patent, which expires in 2016, covers the active ingredient of Crestor.
Under the court’s decision, the Food and Drug Administration can’t approve generic versions of the drug made by Apotex, Aurobindo, Cobalt, Mylan, Par, Sandoz, Teva, Sun and Torrent, but those companies may seek review by the Supreme Court.