Barr Withdraws ANDA; Court Rules Against Natural Biologics

Barr has elected to withdraw its pending abbreviated new drug application (ANDA) from the FDA for a generic version of Wyeth's Premarin, after a federal appeals court ruled that Barr's development partner misappropriated information from Wyeth.

The U.S. Court of Appeals for the Eighth Circuit decided to uphold an earlier district court ruling that ordered Natural Biologics to stop making or selling conjugated estrogens derived from urine, a process that the judge said was misappropriated from Wyeth. The September 2003 decision by the U.S. District Court for the District of Minnesota prohibited Natural Biologics from using or disclosing any information it obtained related to Wyeth's process.

Barr signed agreements with Natural Biologics in March 2002 to allow Natural Biologics to supply the raw materials to Barr to develop a generic version of Premarin (conjugated estrogens tablets).

The drug is derived from the urine of pregnant horses and is used to treat symptoms of menopause and to reduce the effects of hysterectomy, osteoporosis, and risk of heart attack in women over 50.

Barr said it will continue to review all options regarding its efforts to bring a generic version of Premarin to market. As a result of the appeals court's decision, Barr said it has recorded an expense of $15.7 million from a reserve established for the Natural Biologics case.