Lilly, BI gear up to present data from studies of diabetes drugs
RIDGEFIELD, Conn. — Just after the approval of their new treatment for Type 2 diabetes, Eli Lilly and Boehringer Ingelheim plan to present data in more than two dozen presentations at the American Diabetes Association Scientific Sessions starting this week.
Lilly and BI, which recently launched the oral diabetes drug Tradjenta (linagliptin) will present data from studies of the drug, as well as studies on BI-10773, an investigational diabetes drug made by BI.
The Food and Drug Administration approved Tradjenta in May, and the drug became available in pharmacies last week. Soon after the approval, Amylin Pharmaceuticals, which markets the injected Type 2 diabetes drug Byetta (exenatide), filed a lawsuit against Lilly in an attempt to prevent it from using the same sales staff to market both drugs, alleging that it would infringe on their Byetta agreement; however, a federal judge in San Diego threw out Amylin’s claims.
Mylan wins summary judgment pertaining to generic Copaxone
PITTSBURGH — Mylan has scored a victory in its efforts to make a generic version of a Teva drug for multiple sclerosis.
The U.S. District Court for the Southern District of New York denied Teva’s motion for a summary judgment finding no inequitable conduct in relation to Copaxone (glatiramer acetate).
Inequitable conduct is when the maker of a branded drug did not properly complete its application when filing for a patent for the drug. When a generic drug maker wishes to gain early entry for its version of the branded drug, it can file an approval application with the Food and Drug Administration that contains a paragraph IV certification, an assertion that the patent is invalid, enforceable or won’t be infringed, based on a finding of alleged inequitable conduct.
A trial in which Mylan will defend its assertion of inequitable conduct will begin on July 11.
J&J subsidiary recalls one lot of Risperdal, risperidone tablets
TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.
J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.
The recall was started after reports of an “uncharacteristic odor” that is believed to be due to trace amounts of 2,4,6-tribromoanisole, or TBA, a chemical preservative sometimes applied to wood used in the construction of shipping pallets.
The company has recalled several prescription and over-the-counter drug products due to TBA contamination since 2009. Most recently, in May, J&J subsidiary Janssen-Cilag International recalled five lots of the HIV drug Prezista (darunavir) in Canada, the United Kingdom, Ireland, Germany and Austria. In January 2010, J&J instituted actions designed to reduce the potential of TBA contamination, including requiring suppliers to certify that they don’t use pallets made from chemically treated wood.
TBA is not considered toxic, but many people find its odor offensive, and there have been some reports of patients experiencing gastrointestinal problems after taking drugs with the odor.