Court upholds Lilly’s patent for Cymbalta
INDIANAPOLIS — Drug maker Eli Lilly will get at least two more years of patent exclusivity on a drug used to treat depression, anxiety and pain resulting from diabetic neuropathy and fibromyalgia, thanks to a court order issued Wednesday.
The U.S. District Court for the Southern District of Indiana ruled to forbid Wockhardt and other generic drug companies from selling generic versions of Cymbalta (duloxetine hydrochloride) until patent protection expires, which is expected to occur in June 2013.
Cymbalta has annual sales of about $3 billion, according to Sun Pharmaceutical Industries, which won tentative approval for a generic version of the drug from the Food and Drug Administration in November 2010.
Investigational drug, in combo with chemo, shown to help colorectal cancer patients survive longer
PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.
The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.
“We are pleased with the results of the Zaltrap phase-3 study in this group of patients,” stated Debasish Roychowdhury, SVP and head of Sanofi-Aventis’ global oncology division. “We are committed to bringing Zaltrap to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine.”
FDA looks to simplify drug info packets
NEW YORK — The Food and Drug Administration is working on creating new and simplified drug information sheets for consumers to replace the multipage and sometimes labyrinthine packets supplied with drugs at retail pharmacies, according to published reports.
The Wall Street Journal reported that the agency was testing the information sheets while the U.S. Pharmacopeia Convention was developing a new standard for drug labels.
The large inserts — called consumer medication information, or CMI — that accompany drugs have long been cited as a problem for consumers because of their tiny print and the confusing way they present drug indications, guidelines and warnings.
In 2008, the FDA conducted a study that found that while 94% of shoppers received CMI with their prescriptions, about 75% of CMI met the “minimum criteria for usefulness,” a number that the agency said fell short of its goal of having 95% of prescriptions accompanied by useful CMI by 2006.