PDL Pharma in talks with FDA on heart drug

By Julie Steenhuysen

LOS ANGELES (Reuters) - PDL BioPharma Inc. (PDLI.O: Quote, Profile, Research, Stock Buzz), formerly named Protein Design Labs, said it is in discussions with U.S. regulators about an experimental heart treatment that was shown to relieve symptoms and reduce death in patients with advanced heart failure, Steven Benner, PDL's chief medical officer, said on Thursday.

The drug, ularitide, is a key to the company's new focus on product development as PDL moves from being a developer of antibodies used by other companies to being a drug maker in its own right.

Benner, speaking at the Reuters Biotechnology Summit in Los Angeles, said the company has filed for permission to start human trials in the United States on ularitide, which has shown in a mid-stage European trial to have fewer harmful effects on the kidney than current treatments.

Benner said all prior development work on the drug has been in Europe. For the U.S. trial, the company would likely start with a mid-stage trial, which is typically done to establish safety and dosing.

At the same time, PDL has continued to work with European regulatory authorities.

"We hope to be in pivotal trials this year," Benner said, adding that if the European trial is successful, the company could file for regulatory approval in 2009 with a European launch in 2010.

As for the United States, he said, "We have to have further discussions with the (U.S. Food and Drug Administration) with regards to the next steps," adding, "We believe this is a significant opportunity for us."

The Fremont, California-based company in January announced it was changing its name to reflect its new focus on drug development following the company's acquisition last year of ESP Pharma, a hospital-focused drug maker, for about $475 million.  Continued...