C.R. Bard (NYSE:BCR) said it expects to file the final module in its pre-market approval application with the FDA for the Lutonix drug-eluting balloon after a clinical trial met its primary endpoints for efficacy and safety.
The trial of the Lutonix device, designed to treat peripheral artery disease by delivering the drug paclitaxel to the arterial wall, met its 12-month endpoints, Bard’s senior vice president of science technology & clinical affairs John DeFord told analysts yesterday during a conference call.
"[W]e completed the 1-year follow-up of the Levant 2 study for the treatment of [superficial femoral artery disease] and popliteal disease in Q3. Though we continue to work through this data to finalize our analysis and the clinical study report, we are very pleased to say that at this point, the results indicate that we met both our primary safety and efficacy endpoints. We’re certainly not taking FDA approval for granted though. Our team has a lot of work to do and is focused on completing the final module of the PMA for submission this quarter," he said during the call.
Data from the 6-month phase of the trial is slated to be presented next week at the Transcatheter Cardiovascular Therapeutics conference in San Francisco, DeFord said. Bard bought Lutonix for $325 million in late 2011.
"We know everyone’s anxious to know more about our results. However, we’re sticking with the plan we articulated several months ago to preserve the 12-month randomized data for a first look by the FDA. We’ll also preserve the ability of our investigators to seek publication in the best and most appropriate journal possible. Next week at TCT, 1 of our primary investigators will present 6-month data from our randomized cohort. This protects our publication strategy, while beginning to help the scientific community better understand the study," he said.
Leerink Swann analyst Richard Newitter said today that news of the positive 12-month trial results came ahead of schedule, but the results aren’t likely to be revealed until next year.
"Even though we now know the full 12-month data hit its endpoints, we still won’t get full top-line trial results until the FDA review is complete and it has been published in a peer-reviewed journal (both could be early- to mid-2014 events)," Newitter wrote in a note to investors this morning.
Bard beat Wall Street’s expectations for its 3rd-quarter earnings by 1 thin dime and raised its outlook for the rest of the year, sending share prices up today.
Murray Hill, N.J.-based Bard posted profits of $93.2 million, or $1.15 per share, on sales of $758.0 million for the 3 months ended Sept. 30. Although that’s a profit slide of 27.9% on sales growth of 4.9% compared with Q3 2012, adjusted earnings per share reached $1.50 – handily beating The Street’s $1.40 forecast.
The news pushed BCR shares to a $129.60 open today, up 2.1% over yesterday’s close. Shares were trading at $131.58 apiece as of about 9:35 a.m., up 3.6%.