Abbott, Neurocrine Biosciences to commercialize elagolix
ABBOTT PARK, Ill. Two drug makers will work together to develop a drug for the treatment of endometriosis, a condition estimated to affect 100 million women around the world.
Abbott and Neurocrine Biosciences said they would develop and commercialize the drug elagolix, which recently finished a mid-stage study as a treatment for endometriosis and also is under development as a treatment for uterine fibroids. Endometriosis causes chronic pelvic pain throughout the menstrual cycle and dysmenorrhea, pain associated with mestruation. Uterine fibroids are benign tumors that form on the wall of the uterus.
“Extensive preclinical and clinical experience with elagolix suggests this drug could be an important advance for women with endometriosis and uterine fibroids, highly prevalent conditions where there is a need for new treatments,” Abbott SVP pharmaceutical research and development John Leonard stated. “This agreement enhances Abbott’s late-stage pipeline, with the potential for additional compounds in earlier-stage development.”
Abbott will pay $75 million upfront to Neurocrine while funding ongoing development activities. Neurocrine also will be eligible to receive milestone payments of around $500 million and potential royalties.
Intellipharmaceutics files new drug application for generic Protonix
TORONTO Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat gastrointestinal issues, the drug maker said.
Intellipharmaceutics said its pantoprazole sodium delayed-release tablets — a generic version of Protonix — inhibits gastric acid secretion and is prescribed for the short-term treatment of such conditions as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
Sales of pantoprazole sodium delayed-release tablets in the United States were approximately $1.8 billion in 2009.
“I am extremely pleased with the progress we continue to make with the advancement of our product pipeline,” said Isa Odidi, Intellipharmaceutics CEO. “Protonix is the second ANDA we have filed with the FDA this year and, together with Focalin XR and Effexor XR, it represents another potential source of future revenue from our company’s ANDA pipeline.”
Injunction blocks Dr. Reddy’s generic Allegra D24
NEW YORK A U.S. District Court has granted French drug maker Sanofi-Aventis and Albany Molecular Research an injunction halting the launch of a generic version of one of its drugs made by Dr. Reddy’s Labs, Dr. Reddy’s said.
The U.S. District Court for the District of New Jersey blocked the release of Dr. Reddy’s fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets in the 180 mg and 240-mg strength, a generic version of Allegra D24, marketed by Sanofi-Aventis and discovered by Albany Molecular Research.
Dr. Reddy’s said it strongly disagreed with the lawsuit and intended to appeal. According to published reports, the Food and Drug Administration had approved Dr. Reddy’s version of the drug following a 30-month stay of approval resulting from a patent infringement lawsuit filed against the company when it tried to seek approval for the generic. The last patents covering Allegra D24 expire in December 2020.